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Mar.17.2021

Influenza Virus Vaccine

Indications/Dosage

Labeled

  • seasonal influenza prophylaxis

Off-Label

    † Off-label indication

    For annual seasonal influenza prophylaxis

    Intramuscular dosage (Fluzone High-Dose)

    Geriatric 65 years and older

    0.5 mL IM as a single dose.[51849]

    Intramuscular dosage (Fluzone Quadrivalent High-Dose)

    Geriatric 65 years and older

    0.7 mL IM as a single dose.[64726]

    Intramuscular dosage (Fluzone Quadrivalent)

    Adults

    0.5 mL IM as a single dose.[54943]

    Children and Adolescents 9 years and older

    0.5 mL IM as a single dose.[54943]

    Children 3 to 8 years

    0.5 mL IM. For children who have not received at least 2 doses of trivalent or quadrivalent influenza vaccine before the beginning of the influenza season, administer a second dose of 0.5 mL IM at least 4 weeks after the initial dose.[54943] The Advisory Committee on Immunization Practices (ACIP) recommends that infants and children aged 6 months through 8 years who have previously received at least 2 doses of trivalent or quadrivalent influenza vaccine before the beginning of the influenza season, receive only 1 dose for the current influenza season. The 2 previous doses need not have been given during the same season or consecutive seasons.[63436]

    Infants and Children 6 to 35 months

    0.25 mL or 0.5 mL IM. For infants and children who have not received at least 2 doses of trivalent or quadrivalent influenza vaccine before the beginning of the influenza season, administer a second dose of 0.25 mL or 0.5 mL IM at least 4 weeks after the initial dose.[54943] The Advisory Committee on Immunization Practices (ACIP) recommends that infants and children aged 6 months through 8 years who have previously received at least 2 doses of trivalent or quadrivalent influenza vaccine before the beginning of the influenza season, receive only 1 dose for the current influenza season. The 2 previous doses need not have been given during the same season or consecutive seasons.[63436]

    Intramuscular dosage (Fluad, Fluad Quadrivalent)

    Geriatric 65 years and older

    0.5 mL IM as a single dose.[60361] [65035]

    Intramuscular dosage (Fluarix Quadrivalent)

    Adults

    0.5 mL IM as a single dose.[52652]

    Children and Adolescents 9 years and older

    0.5 mL IM as a single dose.[52652] 

    Infants and Children 6 months to 8 years

    0.5 mL IM. For infants and children who have not received at least 2 doses of trivalent or quadrivalent influenza vaccine before the beginning of the influenza season, administer a second dose of 0.5 mL IM at least 4 weeks after the initial dose.[52652] The Advisory Committee on Immunization Practices (ACIP) recommends that infants and children aged 6 months through 8 years who have previously received at least 2 doses of trivalent or quadrivalent influenza vaccine before the beginning of the influenza season, receive only 1 dose for the current influenza season. The 2 previous doses need not have been given during the same season or consecutive seasons.[63436]

    Intramuscular dosage (Flulaval Quadrivalent)

    Adults

    0.5 mL IM as a single dose.[55717]

    Children and Adolescents 9 years and older

    0.5 mL IM as a single dose.[55717]

    Infants and Children 6 months to 8 years

    0.5 mL IM. For infants and children who have not received at least 2 doses of trivalent or quadrivalent influenza vaccine before the beginning of the influenza season, administer a second dose of 0.5 mL IM at least 4 weeks after the initial dose.[55717] The Advisory Committee on Immunization Practices (ACIP) recommends that infants and children aged 6 months through 8 years who have previously received at least 2 doses of trivalent or quadrivalent influenza vaccine before the beginning of the influenza season, receive only 1 dose for the current influenza season. The 2 previous doses need not have been given during the same season or consecutive seasons.[63436]

    Intramuscular dosage (Afluria, Afluria Quadrivalent)

    Adults

    0.5 mL IM as a single dose.[41448] [61129]

    Children and Adolescents 9 years and older

    0.5 mL IM as a single dose.[41448] [61129]

    Children 3 to 8 years

    0.5 mL IM. For children who have not received at least 2 doses of trivalent or quadrivalent influenza vaccine before the beginning of the influenza season, administer a second dose of 0.5 mL IM at least 4 weeks after the initial dose.[41448] [61129] The Advisory Committee on Immunization Practices (ACIP) recommends that infants and children aged 6 months through 8 years who have previously received at least 2 doses of trivalent or quadrivalent influenza vaccine before the beginning of the influenza season, receive only 1 dose for the current influenza season. The 2 previous doses need not have been given during the same season or consecutive seasons.[63436]

    Infants and Children 6 to 35 months

    0.25 mL IM. For infants and children who have not received at least 2 doses of trivalent or quadrivalent influenza vaccine before the beginning of the influenza season, administer a second dose of 0.25 mL IM at least 4 weeks after the initial dose.[41448] [61129] The Advisory Committee on Immunization Practices (ACIP) recommends that infants and children aged 6 months through 8 years who have previously received at least 2 doses of trivalent or quadrivalent influenza vaccine before the beginning of the influenza season, receive only 1 dose for the current influenza season. The 2 previous doses need not have been given during the same season or consecutive seasons.[63436]

    Intramuscular dosage (Flucelvax Quadrivalent)

    Adults

    0.5 mL IM as a single dose.[60831]

    Children and Adolescents 9 years and older

    0.5 mL IM as a single dose.[60831]

    Children 2 to 8 years

    0.5 mL IM. For children who have not received at least 2 doses of trivalent or quadrivalent influenza vaccine before the beginning of the influenza season, administer a second dose of 0.5 mL IM at least 4 weeks after the initial dose.[60831] The Advisory Committee on Immunization Practices (ACIP) recommends that infants and children aged 6 months through 8 years who have previously received at least 2 doses of trivalent or quadrivalent influenza vaccine before the beginning of the influenza season, receive only 1 dose for the current influenza season. The 2 previous doses need not have been given during the same season or consecutive seasons.[63436]

    Intramuscular dosage (Flublok Quadrivalent)

    Adults

    0.5 mL IM as a single dose.[52915] [61294]

    Intradermal dosage (Fluzone Intradermal)

    Adults 18 to 64 years

    0.1 mL intradermally as a single dose.[58656]

    Therapeutic Drug Monitoring

    Maximum Dosage Limits

    • Adults

      0.5 mL/dose IM; 0.1 mL/dose intradermal (Fluzone Intradermal only). Safety and efficacy of Fluad and Fluzone High-Dose have not been established.

    • Geriatric

      0.5 mL/dose IM; 0.7 mL/dose IM (Fluzone Quadrivalent High-Dose only). Safety and efficacy of intradermal administration have not been established.

    • Adolescents

      0.5 mL/dose IM for Fluzone, Fluarix, FluLaval, Afluria (excluding the needle-free injection system), and Flucelvax Quadrivalent. Safety and efficacy of Fluzone High-Dose, Agriflu, Flublok, Fluad, and intradermal administration have not been established.

    • Children

      4 to 12 years: 0.5 mL/dose IM for Fluzone, Fluarix, FluLaval, Afluria (excluding the needle-free injection system), and Flucelvax Quadrivalent. Safety and efficacy of Fluzone High-Dose, Agriflu, Flublok, Fluad, and intradermal administration have not been established.

      3 years: 0.5 mL/dose IM for Fluzone, Fluarix, FluLaval, Afluria (excluding the needle-free injection system), and Flucelvax Quadrivalent. Safety and efficacy of Fluzone High-Dose, Agriflu, Flublok, Fluad, and intradermal administration have not been established.

      2 years: 0.25 mL/dose IM for Afluria (excluding the needle-free injection system); 0.5 mL/dose IM for FluLaval, Fluarix, Fluzone, and Flucelvax Quadrivalent. Safety and efficacy of Fluzone High-Dose, Agriflu, Flublok, Fluad, and intradermal administration have not been established.

      1 year: 0.25 mL/dose IM for Afluria (excluding the needle-free injection system); 0.5 mL/dose IM for FluLaval, Fluarix, and Fluzone. Safety and efficacy of Fluzone High-Dose, Agriflu, Flublok, Flucelvax Quadrivalent, Fluad, and intradermal administration have not been established.

    • Infants

      6 to 11 months: 0.25 mL/dose IM for Afluria (excluding the needle-free injection system); 0.5 mL/dose IM for Flulaval, Fluarix, and Fluzone. Safety and efficacy of Fluzone High-Dose, Agriflu, Flublok, Flucelvax Quadrivalent, and intradermal administration have not been established.

      1 to 5 months: Safety and efficacy have not been established.

    • Neonates

      Safety and efficacy have not been established.

    Patients with Hepatic Impairment Dosing

    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Patients with Renal Impairment Dosing

    Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

    † Off-label indication
    Revision Date: 03/17/2021, 03:46:30 PM

    References

    41448 - Afluria (influenza virus vaccine) package insert. Parkville, Victoria, Australia: CSL Limited; 2021 Jan.51849 - Fluzone High-Dose (influenza virus vaccine) package insert. Swiftwater, PA: Sanofi Pasteur Inc.; 2019 Nov.52652 - Fluarix quadrivalent (influenza virus vaccine) package insert. Research Triangle Park, NC: GlaxoSmithKline; 2020 March.52915 - Flublok (influenza virus vaccine) package insert. Meriden, CT: Protein Sciences Corp.; 2018 March53026 - Centers for Disease Control and Prevention. Advisory Committee on Immunization Practices (ACIP) recommended immunization schedules for persons aged 0 through 18 years and adults aged 19 years and older-United States, 2020. MMWR 2020;69(5):130-135.54943 - Fluzone Quadrivalent (influenza virus vaccine) package insert. Swiftwater, PA: Sanofi Pasteur Inc.; 2020 Oct.55717 - Flulaval Quadrivalent (influenza virus vaccine) package insert. Research Triangle Park, NC: GlaxoSmithKline; 2020 April.58656 - Fluzone Intradermal Quadrivalent (influenza virus quadrivalent vaccine) package insert. Swiftwater, PA: Sanofi Pasteur Inc.; 2014 Dec.60361 - Fluad (influenza virus, adjuvanted) package insert. Holly Springs, NC: Seqirus Inc.; 2020 Oct.60831 - Flucelvax Quadrivalent (influenza virus vaccine) package insert. Holly Springs, NC: Seqirus, Inc.; 2021 March.61129 - Afluria Quadrivalent (influenza virus vaccine) package insert. King of Prussia, PA: Seqirus, Inc.; 2020 July.61294 - Flublok Quadrivalent (influenza virus vaccine) package insert. Meriden, CT: Protein Sciences Corporation; 2020 June.63436 - Grohskopf LA, Alyanak E, Broder KR, et al. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices - United States, 2020-2021 Influenza Season. MMWR 2020;69(No. RR-8):1-24.63520 - American Academy of Pediatrics Committee on Infectious Diseases. Recommendations for Prevention and Control of Influenza in Children, 2020-2021. Pediatrics. 2020;146(4):e202002458864726 - Fluzone Quadrivalent High-Dose (influenza virus vaccine) package insert. Swiftwater, PA: Sanofi Pasteur Inc.; 2020 July.65035 - Fluad Quadrivalent (influenza virus, adjuvanted) package insert. Holly Springs, NC: Seqirus Inc.; 2020 Nov.65686 - U.S. Food & Drug Administration. Influenza vaccine for the 2020-2021 season. https://www.fda.gov/vaccines-blood-biologics/lot-release/influenza-vaccine-2020-2021-season?utm_campaign=What%27sNew2020-07-02&utm_medium=email&utm_source=Eloqua

    How Supplied

    Influenza A Virus A/Guangdong-Maonan/SWL1536/2019 CNIC-1909 (H1N1) Antigen (Formaldehyde Inactivated), Influenza A Virus A/Hong Kong/2671/2019 IVR-208 (H3N2) Antigen (Formaldehyde Inactivated), Influenza B Virus B/Washington/02/2019 antigen (Formaldehyde Inactivated) Suspension for injection

    FLUAD 2020-2021 Preservative-Free Formula Suspension for Injection (70461-0020) (Seqirus, Inc. a CSL Company) null

    Influenza A Virus A/Guangdong-Maonan/SWL1536/2019 CNIC-1909 (H1N1) Antigen (Formaldehyde Inactivated), Influenza A Virus A/Hong Kong/2671/2019 IVR-208 (H3N2) Antigen (Formaldehyde Inactivated), Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus B/Washington/02/2019 antigen (Formaldehyde Inactivated) Suspension for injection

    Afluria Quadrivalent 2020-2021 Preservative-Free Pediatric Formula Suspension for Injection (33332-0220) (Seqirus a CSL Company) null

    Influenza A Virus A/Guangdong-Maonan/SWL1536/2019 CNIC-1909 (H1N1) Antigen (Formaldehyde Inactivated), Influenza A Virus A/Hong Kong/2671/2019 IVR-208 (H3N2) Antigen (Formaldehyde Inactivated), Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus B/Washington/02/2019 antigen (Formaldehyde Inactivated) Suspension for injection

    Afluria Quadrivalent 2020-2021 Formula Suspension for Injection (33332-0420) (Seqirus a CSL Company) null

    Influenza A Virus A/Guangdong-Maonan/SWL1536/2019 CNIC-1909 (H1N1) Antigen (Formaldehyde Inactivated), Influenza A Virus A/Hong Kong/2671/2019 IVR-208 (H3N2) Antigen (Formaldehyde Inactivated), Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus B/Washington/02/2019 antigen (Formaldehyde Inactivated) Suspension for injection

    Afluria Quadrivalent 2020-2021 Preservative-Free Formula Suspension for Injection (33332-0320) (Seqirus a CSL Company) null

    Influenza A Virus A/Guangdong-Maonan/SWL1536/2019 CNIC-1909 (H1N1) Antigen (Formaldehyde Inactivated), Influenza A Virus A/Hong Kong/2671/2019 IVR-208 (H3N2) Antigen (Formaldehyde Inactivated), Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus B/Washington/02/2019 antigen (Formaldehyde Inactivated) Suspension for injection

    Fluzone Quadrivalent 2020-2021 Formula Suspension for Injection (49281-0633) (Sanofi Pasteur Inc) null

    Influenza A Virus A/Guangdong-Maonan/SWL1536/2019 CNIC-1909 (H1N1) Antigen (Formaldehyde Inactivated), Influenza A Virus A/Hong Kong/2671/2019 IVR-208 (H3N2) Antigen (Formaldehyde Inactivated), Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus B/Washington/02/2019 antigen (Formaldehyde Inactivated) Suspension for injection

    Fluzone Quadrivalent 2020-2021 Preservative-Free Formula Suspension for Injection (49281-0420) (Sanofi Pasteur Inc) null

    Influenza A Virus A/Guangdong-Maonan/SWL1536/2019 CNIC-1909 (H1N1) Antigen (Formaldehyde Inactivated), Influenza A Virus A/Hong Kong/2671/2019 IVR-208 (H3N2) Antigen (Formaldehyde Inactivated), Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus B/Washington/02/2019 antigen (Formaldehyde Inactivated) Suspension for injection

    Fluzone Quadrivalent 2020-2021 Preservative-Free Formula Suspension for Injection (49281-0420) (Sanofi Pasteur Inc) null

    Influenza A Virus A/Guangdong-Maonan/SWL1536/2019 CNIC-1909 (H1N1) Antigen (Formaldehyde Inactivated), Influenza A Virus A/Hong Kong/2671/2019 IVR-208 (H3N2) Antigen (Formaldehyde Inactivated), Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus B/Washington/02/2019 antigen (Formaldehyde Inactivated) Suspension for injection

    Fluzone Quadrivalent 2020-2021 Preservative-Free Formula High Dose Suspension for Injection (49281-0120) (Sanofi Pasteur Inc) null

    Influenza A Virus A/Guangdong-Maonan/SWL1536/2019 CNIC-1909 (H1N1) Antigen (Formaldehyde Inactivated), Influenza A Virus A/Hong Kong/2671/2019 NIB-121 (H3N2) Antigen (Formaldehyde Inactivated), Influenza B Virus B/Washington/02/2019 antigen (Formaldehyde Inactivated), Influenza B Virus Phuket 3073/2013 antigen Suspension for injection

    Fluarix Quadrivalent 2020-2021 Suspension for Injection (58160-0885) (GlaxoSmithKline Group of Companies) null

    Influenza A Virus A/Guangdong-Maonan/SWL1536/2019 CNIC-1909 (H1N1) Antigen (Formaldehyde Inactivated), Influenza A Virus A/Hong Kong/2671/2019 NIB-121 (H3N2) Antigen (Formaldehyde Inactivated), Influenza B Virus B/Washington/02/2019 antigen (Formaldehyde Inactivated), Influenza B Virus Phuket 3073/2013 antigen Suspension for injection

    Flulaval Quadrivalent 2020-2021 Suspension for Injection (19515-0816) (GlaxoSmithKline Group of Companies) null

    Influenza A Virus A/Michigan/45/2015 (H1N1) Recombinant Hemagglutinin antigen, Influenza A Virus A/Singapore/INFIMH-16-0019/2016 (H3N2) Recombinant Hemagglutinin antigen, Influenza B Virus B/Maryland/15/2016 Recombinant Hemagglutinin antigen, Influenza B Virus B/Phuket/3073/2013 Recombinant Hemagglutinin antigen Suspension for injection

    Flublok Quadrivalent 2018-2019 Suspension for Injection (49281-0718) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus A/Nebraska/14/2019 (H1N1) Antigen (MDCK Cell Derived, Propiolactone inactivated), Influenza A Virus A/Delaware/39/2019 (H3N2) Antigen (MDCK Cell Derived, Propiolactone inactivated), Influenza B Virus B/Darwin/7/2019 antigen (MDCK Cell Derived, Propiolactone inactivated), Influenza B Virus B/Singapore/INFTT-16-0610/2016 antigen (MDCK Cell Derived, Propiolactone inactivated) Suspension for injection

    FLUCELVAX Quadrivalent 2020-2021 Preservative-Free Suspension for Injection (70461-0320) (Seqirus, Inc. a CSL Company) null

    Influenza A Virus A/Nebraska/14/2019 (H1N1) Antigen (MDCK Cell Derived, Propiolactone inactivated), Influenza A Virus A/Delaware/39/2019 (H3N2) Antigen (MDCK Cell Derived, Propiolactone inactivated), Influenza B Virus B/Darwin/7/2019 antigen (MDCK Cell Derived, Propiolactone inactivated), Influenza B Virus B/Singapore/INFTT-16-0610/2016 antigen (MDCK Cell Derived, Propiolactone inactivated) Suspension for injection

    FLUCELVAX Quadrivalent 2020-2021 Suspension for Injection (70461-0420) (Seqirus, Inc. a CSL Company) null

    Influenza A Virus A/Victoria/2454/2019 IVR-207 (H1N1) antigen (Formaldehyde Inactivated), Influenza A Virus A/Hong Kong/2671/2019 IVR-208 (H3N2) Antigen (Formaldehyde Inactivated), Influenza B Virus B/Victoria/705/2018 BVR-11 antigen (Formaldehyde Inactivated), Influenza B Virus B/Phuket/3073/2013 BVR-1B antigen (Formaldehyde Inactivated) Suspension for injection

    FLUAD Quadrivalent 2020-2021 Preservative-Free Formula 65 and Older Suspension for Injection (70461-0120) (Seqirus, Inc. a CSL Company) null

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus B/Iowa/06/2017 Antigen (MDCK Cell Derived, Propiolactone Inactivated), Influenza B Virus Phuket 3073/2013 antigen Suspension for injection

    FLUCELVAX Quadrivalent 2018-2019 Preservative-Free Suspension for Injection (70461-0318) (Seqirus, Inc. a CSL Company) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus B/Iowa/06/2017 Antigen (MDCK Cell Derived, Propiolactone Inactivated), Influenza B Virus Phuket 3073/2013 antigen Suspension for injection

    FLUCELVAX Quadrivalent 2018-2019 Suspension for Injection (70461-0418) (Seqirus, Inc. a CSL Company) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus B/Iowa/06/2017 Antigen (MDCK Cell Derived, Propiolactone Inactivated), Influenza B Virus Phuket 3073/2013 antigen Suspension for injection

    FLUCELVAX Quadrivalent 2019-2020 Preservative-Free Suspension for Injection (70461-0319) (Seqirus, Inc. a CSL Company) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus B/Iowa/06/2017 Antigen (MDCK Cell Derived, Propiolactone Inactivated), Influenza B Virus Phuket 3073/2013 antigen Suspension for injection

    FLUCELVAX Quadrivalent 2019-2020 Suspension for Injection (70461-0419) (Seqirus, Inc. a CSL Company) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus B/Maryland/15/2016 antigen (Formaldehyde Inactivated) Suspension for injection

    Afluria 2018-2019 Formula Suspension for Injection (33332-0118) (Seqirus a CSL Company) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus B/Maryland/15/2016 antigen (Formaldehyde Inactivated) Suspension for injection

    Afluria 2018-2019 Preservative-Free Formula Suspension for Injection (33332-0018) (Seqirus a CSL Company) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus B/Maryland/15/2016 antigen (Formaldehyde Inactivated) Suspension for injection

    FLUAD 2018-2019 Preservative-Free Formula Suspension for Injection (70461-0018) (Seqirus, Inc. a CSL Company) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus B/Maryland/15/2016 antigen (Formaldehyde Inactivated) Suspension for injection

    FLUAD 2019-2020 Preservative-Free Formula Suspension for Injection (70461-0019) (Seqirus, Inc. a CSL Company) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus B/Maryland/15/2016 antigen (Formaldehyde Inactivated) Suspension for injection

    Fluzone 2018-2019 Preservative-Free Formula High-Dose Suspension for Injection (49281-0403) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus B/Maryland/15/2016 antigen (Formaldehyde Inactivated) Suspension for injection

    Fluzone 2019-2020 Preservative-Free Formula High-Dose Suspension for Injection (49281-0405) (Sanofi Pasteur Inc) null

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Brisbane 46/2015 antigen Suspension for injection

    Afluria 2017-2018 Formula Suspension for Injection (33332-0117) (Seqirus a CSL Company) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Brisbane 46/2015 antigen Suspension for injection

    Afluria 2017-2018 Preservative-Free Formula Suspension for Injection (33332-0017) (Seqirus a CSL Company) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Brisbane 60/2008 antigen Solution for injection

    Flublok 2016-2017 Solution for Injection (42874-0016) (Protein Sciences Corporation.) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Brisbane 60/2008 antigen Solution for injection

    Flublok 2017-2018 Solution for Injection (42874-0017) (Protein Sciences Corporation.) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Afluria 2016-2017 Formula Suspension for Injection (33332-0116) (Seqirus a CSL Company) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Afluria 2016-2017 Preservative-Free Formula Suspension for Injection (33332-0016) (Seqirus a CSL Company) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    FLUAD 2016-2017 Preservative-Free Formula Suspension for Injection (70461-0001) (Seqirus, Inc. a CSL Company) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    FLUAD 2017-2018 Preservative-Free Formula Suspension for Injection (70461-0002) (Seqirus, Inc. a CSL Company) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Fluvirin 2016-2017 Formula Suspension for Injection (70461-0119) (Seqirus, Inc. a CSL Company) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Fluvirin 2016-2017 Preservative-Free Formula Suspension for Injection (70461-0119) (Seqirus, Inc. a CSL Company) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Fluvirin 2017-2018 Formula Suspension for Injection (70461-0120) (Seqirus, Inc. a CSL Company) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Fluvirin 2017-2018 Preservative-Free Formula Suspension for Injection (70461-0120) (Seqirus, Inc. a CSL Company) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Fluzone 2016-2017 Preservative-Free Formula High-Dose Suspension for Injection (49281-0399) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Fluzone 2017-2018 Preservative-Free Formula High-Dose Suspension for Injection (49281-0401) (Sanofi Pasteur Inc) (off market)Fluzone 2017-2018 Preservative-Free Formula High-Dose Suspension for Injection package photo

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen Solution for injection

    Flublok 2013-2014 Solution for Injection (42874-0013) (Protein Sciences Corporation.) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen Solution for injection

    Flublok 2014-2015 Solution for Injection (42874-0014) (Protein Sciences Corporation.) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen Suspension for injection

    Fluzone 2013-2014 Preservative-Free Formula Pediatric Suspension for Injection (49281-0113) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen Suspension for injection

    Fluzone 2013-2014 Preservative-Free Formula Intradermal Suspension for Injection (49281-0707) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen Suspension for injection

    Fluzone 2014-2015 Preservative-Free Formula Intradermal Suspension for Injection (49281-0709) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen Suspension for injection

    Afluria 2013-2014 Formula Suspension for Injection (33332-0113) (Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co., Inc.) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen Suspension for injection

    Afluria 2013-2014 Preservative-Free Formula Suspension for Injection (33332-0013) (Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co., Inc.) (off market)Afluria 2013-2014 Preservative-Free Formula Suspension for Injection package photo

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen Suspension for injection

    Afluria 2014-2015 Formula Suspension for Injection (33332-0114) (Seqirus a CSL Company) (off market)Afluria 2014-2015 Formula Suspension for Injection package photo

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen Suspension for injection

    Afluria 2014-2015 Preservative-Free Formula Suspension for Injection (33332-0014) (Seqirus a CSL Company) (off market)Afluria 2014-2015 Preservative-Free Formula Suspension for Injection package photo

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen Suspension for injection

    Fluarix 2013-2014 Suspension for Injection (58160-0880) (GlaxoSmithKline Group of Companies) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen Suspension for injection

    Fluarix 2014-2015 Suspension for Injection (58160-0881) (GlaxoSmithKline Group of Companies) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen Suspension for injection

    FLUCELVAX 2013-2014 Suspension for Injection (63851-0612) (Seqirus, a CSL Company formerly Novartis Vaccinces and Diagnositcs, Inc.) (off market)FLUCELVAX 2013-2014 Suspension for Injection package photo

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen Suspension for injection

    FLUCELVAX 2014-2015 Suspension for Injection (62577-0613) (Seqirus a CSL Company formerly Novartis Vaccines and Diagnostics, Inc.) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen Suspension for injection

    Flulaval 2013-2014 Suspension for Injection (19515-0890) (GlaxoSmithKline Group of Companies) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen Suspension for injection

    Flulaval 2014-2015 Suspension for Injection (19515-0893) (GlaxoSmithKline Group of Companies) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen Suspension for injection

    Fluvirin 2013-2014 Formula Suspension for Injection (66521-0116) (Seqirus, a CSL Company formerly Novartis Vaccinces and Diagnositcs, Inc.) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen Suspension for injection

    Fluvirin 2013-2014 Preservative-Free Formula Suspension for Injection (66521-0116) (Seqirus, a CSL Company formerly Novartis Vaccinces and Diagnositcs, Inc.) (off market)Fluvirin 2013-2014 Preservative-Free Formula Suspension for Injection package photo

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen Suspension for injection

    Fluvirin 2014-2015 Formula Suspension for Injection (66521-0117) (Seqirus, a CSL Company formerly Novartis Vaccinces and Diagnositcs, Inc.) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen Suspension for injection

    Fluvirin 2014-2015 Preservative-Free Formula Suspension for Injection (66521-0117) (Seqirus, a CSL Company formerly Novartis Vaccinces and Diagnositcs, Inc.) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen Suspension for injection

    Fluzone 2013-2014 Formula Suspension for Injection (49281-0392) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen Suspension for injection

    Fluzone 2013-2014 Preservative-Free Formula Suspension for Injection (49281-0013) (Sanofi Pasteur Inc) (off market)Fluzone 2013-2014 Preservative-Free Formula Suspension for Injection package photo

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen Suspension for injection

    Fluzone 2013-2014 Preservative-Free Formula Suspension for Injection (49281-0013) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen Suspension for injection

    Fluzone 2014-2015 Formula Suspension for Injection (49281-0394) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen Suspension for injection

    Fluzone 2014-2015 Preservative-Free Formula Suspension for Injection (49281-0014) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen Suspension for injection

    Fluzone 2013-2014 Preservative-Free Formula High-Dose Suspension for Injection (49281-0393) (Sanofi Pasteur Inc) (off market)Fluzone 2013-2014 Preservative-Free Formula High-Dose Suspension for Injection package photo

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen Suspension for injection

    Fluzone 2014-2015 Preservative-Free Formula High-Dose Suspension for Injection (49281-0395) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Fluzone Quadrivalent 2013-2014 Preservative-Free Formula Pediatric Suspension for Injection (49281-0513) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Fluzone Quadrivalent 2014-2015 Preservative-Free Formula Pediatric Suspension for Injection (49281-0514) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Fluzone Quadrivalent Intradermal 2014-2015 Formula Suspension for Injection (49281-0708) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Fluarix Quadrivalent 2013-2014 Suspension for Injection (58160-0900) (GlaxoSmithKline Group of Companies) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Fluarix Quadrivalent 2014-2015 Suspension for Injection (58160-0901) (GlaxoSmithKline Group of Companies) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Flulaval Quadrivalent 2013-2014 Suspension for Injection (19515-0895) (GlaxoSmithKline Group of Companies) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Flulaval Quadrivalent 2014-2015 Suspension for Injection (19515-0894) (GlaxoSmithKline Group of Companies) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Flulaval Quadrivalent 2014-2015 Suspension for Injection (19515-0891) (GlaxoSmithKline Group of Companies) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Fluzone Quadrivalent 2013-2014 Preservative-Free Formula Suspension for Injection (49281-0413) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Fluzone Quadrivalent 2013-2014 Preservative-Free Formula Suspension for Injection (49281-0413) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Fluzone Quadrivalent 2014-2015 Formula Suspension for Injection (49281-0621) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Fluzone Quadrivalent 2014-2015 Preservative-Free Formula Suspension for Injection (49281-0414) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Massachusetts 02/2012 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Fluzone Quadrivalent 2014-2015 Preservative-Free Formula Suspension for Injection (49281-0414) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen Solution for injection

    Flublok 2015-2016 Solution for Injection (42874-0015) (Protein Sciences Corporation.) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen Suspension for injection

    Afluria 2015-2016 Formula Suspension for Injection (33332-0115) (Seqirus a CSL Company) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen Suspension for injection

    Afluria 2015-2016 Preservative-Free Formula Suspension for Injection (33332-0015) (Seqirus a CSL Company) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen Suspension for injection

    FLUAD 2015-2016 Preservative-Free Formula Suspension for Injection (66521-0000) (Seqirus, a CSL Company formerly Novartis Vaccinces and Diagnositcs, Inc.) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen Suspension for injection

    FLUCELVAX 2015-2016 Suspension for Injection (62577-0614) (Seqirus a CSL Company formerly Novartis Vaccines and Diagnostics, Inc.) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen Suspension for injection

    Fluvirin 2015-2016 Formula Suspension for Injection (66521-0118) (Seqirus, a CSL Company formerly Novartis Vaccinces and Diagnositcs, Inc.) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen Suspension for injection

    Fluvirin 2015-2016 Preservative-Free Formula Suspension for Injection (66521-0118) (Seqirus, a CSL Company formerly Novartis Vaccinces and Diagnositcs, Inc.) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen Suspension for injection

    Fluzone 2015-2016 Formula Suspension for Injection (49281-0396) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen Suspension for injection

    Fluzone 2015-2016 Preservative-Free Formula High-Dose Suspension for Injection (49281-0397) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus B/Maryland/15/2016 antigen (Formaldehyde Inactivated) Suspension for injection

    Fluzone Quadrivalent 2018-2019 Preservative-Free Formula Pediatric Suspension for Injection (49281-0518) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus B/Maryland/15/2016 antigen (Formaldehyde Inactivated) Suspension for injection

    Fluzone Quadrivalent 2019-2020 Preservative-Free Formula Pediatric Suspension for Injection (49281-0519) (Sanofi Pasteur Inc) null

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus B/Maryland/15/2016 antigen (Formaldehyde Inactivated) Suspension for injection

    Afluria Quadrivalent 2018-2019 Formula Suspension for Injection (33332-0418) (Seqirus a CSL Company) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus B/Maryland/15/2016 antigen (Formaldehyde Inactivated) Suspension for injection

    Afluria Quadrivalent 2018-2019 Preservative-Free Formula Suspension for Injection (33332-0318) (Seqirus a CSL Company) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus B/Maryland/15/2016 antigen (Formaldehyde Inactivated) Suspension for injection

    Fluarix Quadrivalent 2018-2019 Suspension for Injection (58160-0898) (GlaxoSmithKline Group of Companies) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus B/Maryland/15/2016 antigen (Formaldehyde Inactivated) Suspension for injection

    Fluarix Quadrivalent 2019-2020 Suspension for Injection (58160-0896) (GlaxoSmithKline Group of Companies) (off market)Fluarix Quadrivalent 2019-2020 Suspension for Injection package photo

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus B/Maryland/15/2016 antigen (Formaldehyde Inactivated) Suspension for injection

    Flulaval Quadrivalent 2018-2019 Suspension for Injection (19515-0909) (GlaxoSmithKline Group of Companies) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus B/Maryland/15/2016 antigen (Formaldehyde Inactivated) Suspension for injection

    Flulaval Quadrivalent 2018-2019 Suspension for Injection (19515-0900) (GlaxoSmithKline Group of Companies) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus B/Maryland/15/2016 antigen (Formaldehyde Inactivated) Suspension for injection

    Flulaval Quadrivalent 2019-2020 Suspension for Injection (19515-0906) (GlaxoSmithKline Group of Companies) (off market)Flulaval Quadrivalent 2019-2020 Suspension for Injection package photo

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus B/Maryland/15/2016 antigen (Formaldehyde Inactivated) Suspension for injection

    Flulaval Quadrivalent 2019-2020 Suspension for Injection (19515-0897) (GlaxoSmithKline Group of Companies) (off market)Flulaval Quadrivalent 2019-2020 Suspension for Injection package photo

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus B/Maryland/15/2016 antigen (Formaldehyde Inactivated) Suspension for injection

    Fluzone Quadrivalent 2018-2019 Formula Suspension for Injection (49281-0629) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus B/Maryland/15/2016 antigen (Formaldehyde Inactivated) Suspension for injection

    Fluzone Quadrivalent 2018-2019 Preservative-Free Formula Suspension for Injection (49281-0418) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus B/Maryland/15/2016 antigen (Formaldehyde Inactivated) Suspension for injection

    Fluzone Quadrivalent 2018-2019 Preservative-Free Formula Suspension for Injection (49281-0418) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus B/Maryland/15/2016 antigen (Formaldehyde Inactivated) Suspension for injection

    Fluzone Quadrivalent 2019-2020 Formula Suspension for Injection (49281-0631) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus B/Maryland/15/2016 antigen (Formaldehyde Inactivated) Suspension for injection

    Fluzone Quadrivalent 2019-2020 Preservative-Free Formula Suspension for Injection (49281-0419) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus B/Maryland/15/2016 antigen (Formaldehyde Inactivated) Suspension for injection

    Fluzone Quadrivalent 2019-2020 Preservative-Free Formula Suspension for Injection (49281-0419) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus B/Maryland/15/2016 Antigen (Propiolactone Inactivated) Suspension for injection

    Afluria Quadrivalent 2019-2020 Preservative-Free Pediatric Formula Suspension for Injection (33332-0219) (Seqirus a CSL Company) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus B/Maryland/15/2016 Antigen (Propiolactone Inactivated) Suspension for injection

    Afluria Quadrivalent 2019-2020 Formula Suspension for Injection (33332-0419) (Seqirus a CSL Company) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus B/Maryland/15/2016 Antigen (Propiolactone Inactivated) Suspension for injection

    Afluria Quadrivalent 2019-2020 Preservative-Free Formula Suspension for Injection (33332-0319) (Seqirus a CSL Company) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus Brisbane 46/2015 antigen Suspension for injection

    Afluria Quadrivalent 2017-2018 Formula Suspension for Injection (33332-0417) (Seqirus a CSL Company) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus Brisbane 46/2015 antigen Suspension for injection

    Afluria Quadrivalent 2017-2018 Preservative-Free Formula Suspension for Injection (33332-0317) (Seqirus a CSL Company) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Fluzone Quadrivalent 2015-2016 Preservative-Free Formula Pediatric Suspension for Injection (49281-0515) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Fluzone Quadrivalent 2016-2017 Preservative-Free Formula Pediatric Suspension for Injection (49281-0516) (Sanofi Pasteur Inc) (off market)Fluzone Quadrivalent 2016-2017 Preservative-Free Formula Pediatric Suspension for Injection package photo

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Fluzone Quadrivalent 2017-2018 Preservative-Free Formula Pediatric Suspension for Injection (49281-0517) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Fluzone 2015-2016 Preservative-Free Formula Intradermal Quadrivalent Suspension for Injection (49281-0708) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Fluzone 2016-2017 Preservative-Free Formula Intradermal Quadrivalent Suspension for Injection (49281-0710) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Fluzone 2017-2018 Preservative-Free Formula Intradermal Quadrivalent Suspension for Injection (49281-0712) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Afluria Quadrivalent 2016-2017 Preservative-Free Formula Suspension for Injection (33332-0316) (Seqirus a CSL Company) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Fluarix Quadrivalent 2015-2016 Suspension for Injection (58160-0903) (GlaxoSmithKline Group of Companies) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Fluarix Quadrivalent 2016-2017 Suspension for Injection (58160-0905) (GlaxoSmithKline Group of Companies) (off market)Fluarix Quadrivalent 2016-2017 Suspension for Injection package photo

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Fluarix Quadrivalent 2017-2018 Suspension for Injection (58160-0907) (GlaxoSmithKline Group of Companies) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    FLUCELVAX Quadrivalent 2016-2017 Suspension for Injection (70461-0200) (Seqirus, Inc. a CSL Company) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    FLUCELVAX Quadrivalent 2017-2018 Preservative-Free Suspension for Injection (70461-0201) (Seqirus, Inc. a CSL Company) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    FLUCELVAX Quadrivalent 2017-2018 Suspension for Injection (70461-0301) (Seqirus, Inc. a CSL Company) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Flulaval Quadrivalent 2015-2016 Suspension for Injection (19515-0898) (GlaxoSmithKline Group of Companies) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Flulaval Quadrivalent 2016-2017 Suspension for Injection (19515-0903) (GlaxoSmithKline Group of Companies) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Flulaval Quadrivalent 2016-2017 Suspension for Injection (19515-0908) (GlaxoSmithKline Group of Companies) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Flulaval Quadrivalent 2017-2018 Suspension for Injection (19515-0896) (GlaxoSmithKline Group of Companies) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Flulaval Quadrivalent 2017-2018 Suspension for Injection (19515-0912) (GlaxoSmithKline Group of Companies) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Fluzone Quadrivalent 2015-2016 Formula Suspension for Injection (49281-0623) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Fluzone Quadrivalent 2015-2016 Preservative-Free Formula Suspension for Injection (49281-0415) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Fluzone Quadrivalent 2015-2016 Preservative-Free Formula Suspension for Injection (49281-0415) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Fluzone Quadrivalent 2016-2017 Formula Suspension for Injection (49281-0625) (Sanofi Pasteur Inc) (off market)Fluzone Quadrivalent 2016-2017 Formula Suspension for Injection package photo

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Fluzone Quadrivalent 2016-2017 Preservative-Free Formula Suspension for Injection (49281-0416) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Fluzone Quadrivalent 2016-2017 Preservative-Free Formula Suspension for Injection (49281-0416) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Fluzone Quadrivalent 2017-2018 Formula Suspension for Injection (49281-0627) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Fluzone Quadrivalent 2017-2018 Preservative-Free Formula Suspension for Injection (49281-0417) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Fluzone Quadrivalent 2017-2018 Preservative-Free Formula Suspension for Injection (49281-0417) (Sanofi Pasteur Inc) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus Brisbane 60/2008 antigen Suspension for injection

    Flublok Quadrivalent 2017-2018 Suspension for Injection (42874-0117) (Protein Sciences Corporation.) (off market)Flublok Quadrivalent 2017-2018 Suspension for Injection package photo

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Victoria 2/87 antigen lineages, Influenza B Virus Yamagata 16/88 antigen Suspension for injection

    Fluzone Quadrivalent 2018-2019 Preservative-Free Formula High Dose Suspension for Injection (49281-0120) (Sanofi Pasteur Inc) (off market)

    Influenza B Virus B/Maryland/15/2016 Recombinant Hemagglutinin antigen, Influenza B Virus B/Phuket/3073/2013 Recombinant Hemagglutinin antigen, Influenza A Virus H3N2 antigen, Influenza A Virus H1N1 antigen Suspension for injection

    Flublok Quadrivalent 2019-2020 Suspension for Injection (49281-0719) (Sanofi Pasteur Inc) (off market)

    Influenza B Virus B/Phuket/3073/2013 Recombinant Hemagglutinin antigen, Influenza A Virus H3N2 antigen, Influenza A Virus H1N1 antigen, Influenza B Virus B/Washington/02/2019 antigen (Formaldehyde Inactivated) Suspension for injection

    Flublok Quadrivalent 2020-2021 Suspension for Injection (49281-0720) (Sanofi Pasteur Inc) null

    Influenza Inactivated Trivalent Virus Vaccine Solution for injection

    Fluogen 45mcg/0.5ml Solution for Injection (64029-4099) (Monarch Pharmaceuticals Inc a Pfizer Company) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Solution for injection

    Fluvirin 2005-2006 Formula Solution for Injection (66521-0108) (Chiron Corp a Division of Novartis ) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Solution for injection

    Fluvirin 2007-2008 Formula Solution for Injection (66521-0110) (Seqirus, a CSL Company formerly Novartis Vaccinces and Diagnositcs, Inc.) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Solution for injection

    Fluvirin 2007-2008 Preservative-Free Formula Solution for Injection (66521-0110) (Seqirus, a CSL Company formerly Novartis Vaccinces and Diagnositcs, Inc.) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Solution for injection

    Fluvirin 2008-2009 Formula Solution for Injection (66521-0111) (Seqirus, a CSL Company formerly Novartis Vaccinces and Diagnositcs, Inc.) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Solution for injection

    Fluvirin 2008-2009 Preservative-Free Formula Solution for Injection (66521-0111) (Seqirus, a CSL Company formerly Novartis Vaccinces and Diagnositcs, Inc.) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluzone 2011-2012 Preservative-Free Formula Intradermal Suspension for Injection (49281-0703) (Sanofi Pasteur Inc) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluzone 2012-2013 Preservative-Free Formula Intradermal Suspension for Injection (49281-0705) (Sanofi Pasteur Inc) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Afluria 2010-2011 Preservative-Free Formula Suspension for Injection (33332-0010) (Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co., Inc.) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Afluria 2011-2012 Formula Suspension for Injection (33332-0111) (Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co., Inc.) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Afluria 2011-2012 Preservative-Free Formula Suspension for Injection (33332-0011) (Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co., Inc.) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Afluria 2012-2013 Formula Suspension for Injection (33332-0112) (Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co., Inc.) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Afluria 2012-2013 Preservative-Free Formula Suspension for Injection (33332-0012) (Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co., Inc.) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Agriflu 2009-2010 Suspension for Injection (46028-0108) (Seqirus, a CSL Company formerly Novartis Vaccinces and Diagnositcs, Inc.) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Agriflu 2010-2011 Suspension for Injection (46028-0110) (Seqirus, a CSL Company formerly Novartis Vaccinces and Diagnositcs, Inc.) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluarix 2009-2010 Suspension for Injection (58160-0876) (GlaxoSmithKline Group of Companies) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluarix 2010-2011 Suspension for Injection (58160-0877) (GlaxoSmithKline Group of Companies) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluarix 2011-2012 Suspension for Injection (58160-0878) (GlaxoSmithKline Group of Companies) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluarix 2012-2013 Suspension for Injection (58160-0879) (GlaxoSmithKline Group of Companies) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Flulaval 2006-2007 Suspension for Injection (19515-0883) (GlaxoSmithKline Group of Companies) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Flulaval 2007-2008 Suspension for Injection (19515-0884) (GlaxoSmithKline Group of Companies) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Flulaval 2008-2009 Suspension for Injection (19515-0885) (GlaxoSmithKline Group of Companies) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Flulaval 2009-2010 Suspension for Injection (19515-0886) (GlaxoSmithKline Group of Companies) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Flulaval 2010-2011 Suspension for Injection (19515-0887) (GlaxoSmithKline Group of Companies) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Flulaval 2011-2012 Suspension for Injection (19515-0888) (GlaxoSmithKline Group of Companies) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Flulaval 2012-2013 Suspension for Injection (19515-0889) (GlaxoSmithKline Group of Companies) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluvirin 2009-2010 Formula Suspension for Injection (66521-0112) (Seqirus, a CSL Company formerly Novartis Vaccinces and Diagnositcs, Inc.) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluvirin 2009-2010 Preservative-Free Formula Suspension for Injection (66521-0112) (Seqirus, a CSL Company formerly Novartis Vaccinces and Diagnositcs, Inc.) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluvirin 2010-2011 Formula Suspension for Injection (66521-0113) (Seqirus, a CSL Company formerly Novartis Vaccinces and Diagnositcs, Inc.) (off market)Fluvirin 2010-2011 Formula Suspension for Injection package photo

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluvirin 2010-2011 Preservative-Free Formula Suspension for Injection (66521-0113) (Seqirus, a CSL Company formerly Novartis Vaccinces and Diagnositcs, Inc.) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluvirin 2011-2012 Formula Suspension for Injection (66521-0114) (Seqirus, a CSL Company formerly Novartis Vaccinces and Diagnositcs, Inc.) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluvirin 2011-2012 Preservative-Free Formula Suspension for Injection (66521-0114) (Seqirus, a CSL Company formerly Novartis Vaccinces and Diagnositcs, Inc.) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluvirin 2012-2013 Formula Suspension for Injection (66521-0115) (Seqirus, a CSL Company formerly Novartis Vaccinces and Diagnositcs, Inc.) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluvirin 2012-2013 Preservative-Free Formula Suspension for Injection (66521-0115) (Seqirus, a CSL Company formerly Novartis Vaccinces and Diagnositcs, Inc.) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluzone 2005-2006 Formula Pediatric Suspension for Injection (49281-0376) (Sanofi Pasteur Inc) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluzone 2005-2006 Formula Preservative-Free Pediatric Suspension for Injection (49281-0005) (Sanofi Pasteur Inc) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluzone 2006-2007 Formula Pediatric Suspension for Injection (49281-0006) (Sanofi Pasteur Inc) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluzone 2006-2007 Formula Suspension for Injection (49281-0378) (Sanofi Pasteur Inc) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluzone 2006-2007 Formula Suspension for Injection (49281-0006) (Sanofi Pasteur Inc) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluzone 2007-2008 Formula Suspension for Injection (49281-0380) (Sanofi Pasteur Inc) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluzone 2007-2008 Preservative-Free Formula Pediatric Suspension for Injection (49281-0007) (Sanofi Pasteur Inc) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluzone 2007-2008 Preservative-Free Formula Suspension for Injection (49281-0007) (Sanofi Pasteur Inc) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluzone 2008-2009 Formula Suspension for Injection (49281-0382) (Sanofi Pasteur Inc) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluzone 2008-2009 Preservative-Free Formula Pediatric Suspension for Injection (49281-0008) (Sanofi Pasteur Inc) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluzone 2008-2009 Preservative-Free Formula Suspension for Injection (49281-0008) (Sanofi Pasteur Inc) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluzone 2009-2010 Formula Suspension for Injection (49281-0384) (Sanofi Pasteur Inc) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluzone 2009-2010 Preservative-Free Formula Pediatric Suspension for Injection (49281-0009) (Sanofi Pasteur Inc) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluzone 2009-2010 Preservative-Free Formula Suspension for Injection (49281-0009) (Sanofi Pasteur Inc) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluzone 2010-2011 Formula Suspension for Injection (49281-0386) (Sanofi Pasteur Inc) (off market)Fluzone 2010-2011 Formula Suspension for Injection package photo

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluzone 2010-2011 Preservative-Free Formula Pediatric Suspension for Injection (49281-0010) (Sanofi Pasteur Inc) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluzone 2010-2011 Preservative-Free Formula Suspension for Injection (49281-0010) (Sanofi Pasteur Inc) (off market)Fluzone 2010-2011 Preservative-Free Formula Suspension for Injection package photo

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluzone 2010-2011 Preservative-Free Formula Suspension for Injection (49281-0010) (Sanofi Pasteur Inc) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluzone 2011-2012 Formula Suspension for Injection (49281-0388) (Sanofi Pasteur Inc) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluzone 2011-2012 Preservative-Free Formula Pediatric Suspension for Injection (49281-0111) (Sanofi Pasteur Inc) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluzone 2011-2012 Preservative-Free Formula Suspension for Injection (49281-0011) (Sanofi Pasteur Inc) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluzone 2011-2012 Preservative-Free Formula Suspension for Injection (49281-0011) (Sanofi Pasteur Inc) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluzone 2012-2013 Formula Suspension for Injection (49281-0390) (Sanofi Pasteur Inc) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluzone 2012-2013 Preservative-Free Formula Pediatric Suspension for Injection (49281-0112) (Sanofi Pasteur Inc) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluzone 2012-2013 Preservative-Free Formula Suspension for Injection (49281-0012) (Sanofi Pasteur Inc) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluzone 2012-2013 Preservative-Free Formula Suspension for Injection (49281-0012) (Sanofi Pasteur Inc) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluzone 2009-2010 Preservative-Free Formula High-Dose Suspension for Injection (49281-0385) (Sanofi Pasteur Inc) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluzone 2010-2011 Preservative-Free Formula High-Dose Suspension for Injection (49281-0387) (Sanofi Pasteur Inc) (off market)Fluzone 2010-2011 Preservative-Free Formula High-Dose Suspension for Injection package photo

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluzone 2011-2012 Preservative-Free Formula High-Dose Suspension for Injection (49281-0389) (Sanofi Pasteur Inc) (off market)

    Influenza Inactivated Trivalent Virus Vaccine Suspension for injection

    Fluzone 2012-2013 Preservative-Free Formula High-Dose Suspension for Injection (49281-0391) (Sanofi Pasteur Inc) (off market)

    Influenza Inactivated Trivalent Virus Vaccine (Mammalian) Suspension for injection

    FLUCELVAX 2012-2013 Suspension for Injection (63851-0611) (Seqirus, a CSL Company formerly Novartis Vaccinces and Diagnositcs, Inc.) (off market)

    Influenza Virus Vaccine Solution for injection

    Flu Shield 45mcg/0.5ml Solution for Injection (00008-0985) (Wyeth Pharmaceuticals Inc, a subsidiary of Pfizer Inc) (off market)

    Influenza Virus Vaccine Solution for injection

    Fluvirin 45mcg/0.5ml Solution for Injection (66521-0107) (Evans Vaccines Ltd, an affiliate of Novartis Vaccines and Diagnostics LTD) (off market)

    Influenza Virus Vaccine Solution for injection

    Fluvirin 45mcg/0.5ml Solution for Injection (66521-0104) (Evans Vaccines Ltd, an affiliate of Novartis Vaccines and Diagnostics LTD) (off market)

    Influenza Virus Vaccine Solution for injection

    Fluvirin 45mcg/0.5ml Solution for Injection (66521-0105) (Evans Vaccines Ltd, an affiliate of Novartis Vaccines and Diagnostics LTD) (off market)

    Influenza Virus Vaccine Solution for injection

    Fluvirin 45mcg/0.5ml Solution for Injection (19650-0100) (Medeva Pharma Ltd) (off market)

    Influenza Virus Vaccine Solution for injection

    Fluvirin 45mcg/0.5ml Solution for Injection (19650-0102) (Medeva Pharma Ltd) (off market)

    Influenza Virus Vaccine Solution for injection

    Fluzone 2002-2003 Formula Solution for Injection (49281-0369) (Sanofi Pasteur Inc) (off market)

    Influenza Virus Vaccine Solution for injection

    Fluzone 2003-2004 Solution for Injection (49281-0370) (Sanofi Pasteur Inc) (off market)

    Influenza Virus Vaccine Solution for injection

    Fluzone Subvirion Solution for Injection (49281-0366) (Sanofi Pasteur Inc) (off market)

    Influenza Virus Vaccine Suspension for injection

    Fluarix 2005-2006 Suspension for Injection (58160-0872) (GlaxoSmithKline Group of Companies) (off market)

    Influenza Virus Vaccine Suspension for injection

    Fluarix 2006-2007 Suspension for Injection (58160-0873) (GlaxoSmithKline Group of Companies) (off market)

    Influenza Virus Vaccine Suspension for injection

    Fluarix 2007-2008 Suspension for Injection (58160-0874) (GlaxoSmithKline Group of Companies) (off market)

    Influenza Virus Vaccine Suspension for injection

    Fluarix 2008-2009 Suspension for Injection (58160-0875) (GlaxoSmithKline Group of Companies) (off market)

    Influenza Virus Vaccine Suspension for injection

    Fluzone 2003-2004 Formula Preservative-Free Pediatric Suspension for Injection (49281-0372) (Sanofi Pasteur Inc) (off market)

    Influenza Virus Vaccine Suspension for injection

    Fluzone 2003-2004 Formula Preservative-Free Pediatric Suspension for Injection (49281-0371) (Sanofi Pasteur Inc) (off market)

    Influenza Virus Vaccine Suspension for injection

    Fluzone 2004-2005 Formula Preservative-Free Pediatric Suspension for Injection (49281-0373) (Sanofi Pasteur Inc) (off market)

    Influenza Virus Vaccine Suspension for injection

    Fluzone 2004-2005 Formula Suspension for Injection (49281-0374) (Sanofi Pasteur Inc) (off market)

    Description/Classification

    Description

    NOTE: The 2020/2021 trivalent inactivated vaccine virus strains for egg-based vaccines are an A/Guangdong-Maonan/SWL1536/2019 (H1N1) pdm09-like virus, an A/HongKong/2671/2019 (H3N2)-like virus, and a B/Washington/02/2019-like virus (B/Victoria lineage). In addition to these virus strains, the 2020/2021 quadrivalent inactivated virus vaccine contains a B/Phuket/3073/2013-like virus (B/Yamagata lineage). The 2020/2021 trivalent inactivated vaccine virus strains for cell- or recombinant-based vaccines are an A/Hawaii/70/2019 (H1N1) pdm09-like virus, an A/HongKong/45/2019 (H3N2)-like virus, and a B/Washington/02/2019-like virus (B/Victoria lineage). In addition to these virus strains, the 2020/2021 quadrivalent inactivated virus vaccine contains a B/Phuket/3073/2013-like virus (B/Yamagata lineage).[65686]

     

    Inactivated influenza virus vaccine (IIV) is used to confer immunity against specific strains of influenza virus. Most IIV products consist of inactivated virus particles prepared from the allantoic fluid of chick embryos inoculated with the influenza virus; however, some egg-free products are now available. Flucelvax employs mammalian cells (Madin-Darby canine kidney epithelial cells) rather than chicken embryos to prepare the inactivated virus particles.[52415] Flublok uses baculovirus (Autographa californica nuclear polyhedrosis virus) infected insect cells (fall armyworm) to produce recombinant influenza virus hemagglutinin (HA) proteins.[52915] Because influenza viruses are continually changing and antibodies produced by the host in response to the vaccine diminish over time, annual immunization is required. The parenteral influenza vaccines contain either 3 (2 type A and 1 type B) or 4 (2 type A and 2 type B) strains that represent the influenza viruses likely to circulate during the annual flu season. The US and Canadian governments (individually) determine annually which strains to include in the vaccine based on epidemiological studies and consultation with several groups, including the World Health Organization.[63436] The Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP) recommend annual flu vaccination with an age-appropriate influenza vaccine (i.e., IIV, quadrivalent recombinant influenza vaccine (RIV4), or quadrivalent live attenuated influenza vaccine (LAIV4)), without preference of 1 product or formulation over another, for everyone 6 months and older.[63436] [63520]

     

    Updates for coronavirus disease 2019 (COVID-19):

    The 2020-21 influenza season will coincide with the continued or recurrent circulation of SARS-CoV-2. Influenza vaccination of patients 6 months and older may reduce symptoms that might be confused with those of COVID-19. Additionally, prevention and reduction of influenza severity could decrease hospitalizations and intensive care unit admissions and alleviate stress on the health care system.[63436]

    Classifications

    • General Anti-infectives Systemic
      • Vaccines
        • Pure Vaccines
          • Influenza Vaccines
    Revision Date: 03/17/2021, 03:57:04 PM

    References

    52415 - Flucelvax (influenza virus vaccine) package insert. Cambridge, MA: Novartis Vaccines and Diagnostics, Inc.; 2015 Apr.52915 - Flublok (influenza virus vaccine) package insert. Meriden, CT: Protein Sciences Corp.; 2018 March63436 - Grohskopf LA, Alyanak E, Broder KR, et al. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices - United States, 2020-2021 Influenza Season. MMWR 2020;69(No. RR-8):1-24.63520 - American Academy of Pediatrics Committee on Infectious Diseases. Recommendations for Prevention and Control of Influenza in Children, 2020-2021. Pediatrics. 2020;146(4):e202002458865686 - U.S. Food & Drug Administration. Influenza vaccine for the 2020-2021 season. https://www.fda.gov/vaccines-blood-biologics/lot-release/influenza-vaccine-2020-2021-season?utm_campaign=What%27sNew2020-07-02&utm_medium=email&utm_source=Eloqua

    Administration Information

    General Administration Information

    For storage information, see the specific product information within the How supplied section.

     

    NOTE: According to U.S. federal laws, the healthcare provider must record in the patient's permanent record: the manufacturer, lot number, date of administration, and the name and address of the person administering the vaccine.

    • Obtain a patient's current health status and immunization history to determine vaccine adverse reactions. Complete a Vaccine Adverse Event Reporting System (VAERS) report form if adverse events have been identified. The reporting of events is required by the National Childhood Vaccine Injury Act of 1986. The toll-free number for VAERS is 1-800-822-7967. Depending on the adverse reaction, subsequent vaccination, if needed, may be contraindicated.
    • The health care professional should have immediate availability of epinephrine injection and other agents used in the treatment of anaphylaxis in the event of a serious allergic reaction.
    • Inform the patient, parent, guardian, or responsible adult of the benefits and risks of the vaccine. The vaccine cannot cause influenza.
    • Provide the Vaccine Information Statements from the manufacturer to the recipient or guardian before each immunization; materials are free of charge from the Centers for Disease Control. Provision of the Vaccine Information Statements is required by the National Childhood Vaccine Injury Act of 1986.

    Route-Specific Administration

    Injectable Administration

    • Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
    • Do not mix with any other vaccine.
    • When concomitant administration of other vaccines is required, they should be given with different syringes and at different injection sites.[43236]

    Intramuscular Administration

    • Before administration, clean skin over the injection site with a suitable cleansing agent.
    • For products supplied as a suspension, shake well immediately before use.
    • For vials, use a sterile syringe and needle to withdraw vaccine from vial. It is recommended that small syringes (0.5 mL) be used to minimize product loss. For prefilled syringes, attach a sterile needle.[41686]
      • For adults and older children, a needle length of at least 1 inch can be considered; needles less than 1 inch might be of insufficient length to penetrate muscle tissue in certain adults and children.[28647]
      • For children 3 years and older, the needle size required for deltoid injection ranges from 5/8- to 1-inch.
      • For children 1 to 2 years, a needle at least 1 inch long is preferred for administration into the thigh; a 5/8 inch needle is sufficient for administration into the deltoid if the skin is stretched flat and the needle is inserted at a 90 degree angle.
      • For the majority of infants younger than 1 year, a 1-inch, 22- to 25-gauge needle is sufficient to penetrate thigh muscle.[43236]
    • Inject into the anterolateral aspect of the mid-thigh (for infants younger than 1 year of age) or the deltoid muscle of the upper arm (for children and adults). Do NOT administer in the gluteal muscle.[41686] [43236]
    • Doses from Afluria vials may be administered to adults (18 to 64 years) using the PharmaJet Stratis needle-free injection system. This spring-loaded device delivers a single IM dose by creating a narrow fluid stream that rapidly penetrates the skin. Safety and efficacy of needless injectors have not been established in geriatric (older than 64 years) nor pediatric (less than 18 years) patients.[41448]
    • Storage of opened vials: Acceptable storage varies depending on vaccine formulation and brand. See How Supplied section or directly contact the manufacturer for specific vaccine being used.

    Other Injectable Administration

    Intradermal administration (Fluzone Intradermal only):

    • Gently shake the device and remove the needle cap.
    • Insert the needle perpendicular to the skin in the region of the deltoid. Maintain light pressure on the surface of the skin and push the plunger to inject the dose. Do not aspirate.
    • After needle removal from the skin, firmly push the plunger to activate the needle shield.[51850][58656]

    Clinical Pharmaceutics Information

    From Trissel's 2‚Ñ¢ Clinical Pharmaceutics Database
      Revision Date: 09/14/2018, 03:07:37 PM

      References

      28647 - Centers for Disease Control and Prevention (CDC). Antiviral Agents for the Treatment and Chemoprophylaxis of Influenza: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2011;60:1-26.41448 - Afluria (influenza virus vaccine) package insert. Parkville, Victoria, Australia: CSL Limited; 2021 Jan.41686 - Fluvirin (influenza virus vaccine) package insert. Cambridge, MA: Novartis Vaccines and Diagnostics, Inc.; 2014 Nov.43236 - National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC). General recommendations on immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2011;60(2):1-64.51850 - Fluzone Intradermal (influenza virus vaccine) package insert. Swiftwater, PA: Sanofi Pasteur Inc.; 2014 Feb.58656 - Fluzone Intradermal Quadrivalent (influenza virus quadrivalent vaccine) package insert. Swiftwater, PA: Sanofi Pasteur Inc.; 2014 Dec.

      Adverse Reactions

      Mild

      • abdominal pain
      • anorexia
      • arthralgia
      • back pain
      • chest pain (unspecified)
      • chills
      • cough
      • diaphoresis
      • diarrhea
      • dizziness
      • drowsiness
      • dysmenorrhea
      • ecchymosis
      • fatigue
      • fever
      • flushing
      • headache
      • hypoesthesia
      • infection
      • injection site reaction
      • insomnia
      • irritability
      • laryngitis
      • malaise
      • myalgia
      • nasal congestion
      • nausea
      • pallor
      • paresthesias
      • pharyngitis
      • pruritus
      • rash
      • rhinitis
      • rhinorrhea
      • shivering
      • syncope
      • throat irritation
      • tremor
      • urticaria
      • vertigo
      • vomiting

      Moderate

      • confusion
      • conjunctivitis
      • dysphagia
      • dysphonia
      • dyspnea
      • encephalopathy
      • erythema
      • lymphadenopathy
      • migraine
      • neuropathic pain
      • photophobia
      • sinus tachycardia
      • thrombocytopenia
      • wheezing

      Severe

      • anaphylactic shock
      • angioedema
      • bronchospasm
      • erythema multiforme
      • Guillain-Barre syndrome
      • muscle paralysis
      • myelitis
      • optic neuritis
      • seizures
      • Stevens-Johnson syndrome
      • vasculitis

      Adverse reactions associated with administration of the influenza virus vaccine are usually mild and are more likely to occur in children than in adults. The most common adverse reaction occurring after influenza virus vaccine is an injection site reaction that can manifest as pain (more than 1%), erythema (more than 1%), tenderness (21% to 77.9%), induration (1% to 58.4%), swelling (0.5% to 56.8%), pruritus (0.2% to 46.9%), or ecchymosis (0.5% to 15.2%).[30823] [41448] [41685] [41686] [47301] [52652] [54943] [55717] [61129] Extensive swelling of the injected limb has been reported with postmarketing use of Flucelvax.[52415] Of 1,806 elderly patients, 23% reported some type of injection site reaction as compared with 14% of those given placebo. This study also revealed that reactions were more frequent in women than men, although the reason for this was unclear.[23572] Among 11,940 adults (18 years and older) who received Afluria from either a single-dose, preservative-free prefilled syringe or a multi-dose, thimerosal-containing vial, 36% to 78% had local tenderness, 15% to 49% had pain, 3% to 19% had erythema (redness), 4% to 20% had swelling, 10% had pruritus, and at least 5% had bruising at the injection site. Of the 616 adults (18 to 64 years) administered Afluria via the PharmaJet Stratis needle-free injection system, 89% had local tenderness, 65% had swelling, 64% had pain, 60% had erythema (redness), 28% had pruritus, and 18% had bruising.[41448] [61129] In studies including 1,528 pediatric patients (5 to 17 years of age) receiving Alfuria, 36% to 68% had pain, 10% to 24% had erythema (redness), 8% to 17% had induration, and 13% to 17% had swelling.[41448] In children 6 to 59 months of age, pain (20.8% to 35.5%), redness (20.8% to 22.4%), and swelling/lump (6.1% to 10.1%) were the most frequently reported injection site reactions. During clinical trials, an 8 year old who received Afluria Quadrivalent experienced a cellulitis-like reaction at the injection site after vaccination.[61129] Local injection site reactions occurred in more patients at least 65 years of age after Fluzone High-Dose and in more patients 18 to 64 years of age after Fluzone Intradermal than after Fluzone. For example, pain was reported in 35.6% to 41.3% of the Fluzone High-Dose and Fluzone Quadrivalent High-Dose recipients, 53.3% of the Fluzone Intradermal Quadrivalent recipients, and 51% of the Fluzone Intradermal Trivalent recipients, whereas 24.3% of Fluzone recipients experienced pain. Further, erythema and swelling were experienced more frequently in the Fluzone High-Dose and Fluzone Quadrivalent High-Dose (6.2% to 14.9% and 4.9% to 8.9%), Intradermal Trivalent (76.4% and 56.8%), and Intradermal Quadrivalent recipients (36.7% and 19.5%) compared to Fluzone recipients (10.8% to 13.2% and 5.8% to 8.4%).[30823] [51849] [51850] [58656] [64726] In a study of 7,082 geriatric patients (at least 65 years of age) randomized to vaccination with Fluad or Agriflu, more patients receiving Fluad had local adverse reactions. Patients receiving Fluad experienced injection site pain (25% vs. 12.2% Agriflu), tenderness (21.1% vs. 11.2% Agriflu), erythema (1.2% vs. 0.5% Agriflu), induration (1.3% vs. 0.5% Agriflu), and swelling (1.2% vs. 0.4% Agriflu).[60361] In pediatric patients 6 months to 8 years receiving Fluzone, 59.3% to 62.1% had pain, 47.3% to 56.3% had tenderness, 27.6% to 32.2% had erythema, 14.5% to 19.9% had swelling, 11.7% to 16.6% had induration, and 12.6% to 15.2% had ecchymosis.[30823] Adverse local reactions typically persist for up to 2 days.

      Systemic adverse reactions such as malaise (1% to 38.1%), drowsiness (13% to 37.7%), fever (0% to 16%), diaphoresis (1% to 10%), arthralgia (0.3% to 15%), chills (2% to 7.3%), shivering (2.6% to 12.1%), fatigue (1% to 20%), headache (1% to 22%), and/or myalgia (1% to 35.5%) can occur after administration of the influenza virus vaccine.[30823] [41448] [41685] [41686] [47301] [52652] [54943] [55717] [58656] [60831] [61129] Of the 616 adults (18 to 64 years) administered Afluria via the PharmaJet Stratis needle-free injection system, 36% had myalgia, 31% had malaise, 25% had headache, 7% had chills, and 0.3% had fever.[61129] These reactions generally begin 6 to 12 hours after administration of the vaccine and persist for 1 to 2 days. Children who have not been previously exposed to influenza virus are more likely to experience these reactions, especially if administered the whole-virus vaccine. It is recommended that children receive the split-virus (subvirion) vaccines instead of whole-virus immunizations. In fact, placebo-controlled trials suggest that among elderly persons and healthy young adults, split-virus influenza vaccine is not associated with higher rates of systemic symptoms than placebo injections. More patients at least 65 years of age who received Fluzone High-Dose as compared with Fluzone had systemic adverse reactions. For example, among Fluzone High-Dose and Fluzone Quadrivalent High-Dose recipients, 18.9% to 22.7% had myalgia, 13.2% to 18% had malaise, 14.4% to 16.8% had headache, 4.7% to 5.4% had shivering, and 0.4% to 3.6% had fever whereas among 1,260 Fluzone recipients, 18.3% had myalgia, 14% had malaise, 14.4% had headache, and 2.3% had fever.[30823] [64726] Similarly, more patients at least 65 years of age who received Fluad as compared with Agriflu had systemic adverse reactions. Geriatric patients receiving Fluad experienced myalgia (14.7% vs. 9.7% Agriflu), fatigue (13.3% vs. 10.4% Agriflu), headache (13.2% vs. 11.2% Agriflu), arthralgia (8.5% vs. 7.8% Agriflu), and chills (6.7% vs. 4.7% Agriflu).[60361] Irritability (1.7% to 32.9%), malaise and fatigue (1% to 14.3%), myalgia (9.9%), headache (6.2%), and fever (3.7% to 7.2%) were reported in pediatric patients 6 to 59 months of age after receiving Afluria. Irritability was reported in 16% to 21% of pediatric patients after receiving Fluarix.[41448] [41685] [52652] Irritability (34.9% to 54%) and abnormal crying (18.6% to 41.2%) were also reported in pediatric patients 6 to 36 months of age after receiving Fluzone.[30823] [54943] Migraine was reported in 1% of adult patients after receiving Fluarix.[41685]

      One large study has shown that the influenza vaccination is safe for both adults and children with asthma, including those with severe disease; the frequency of asthma exacerbations was similar in the 2 weeks after inactivated influenza vaccine administration and after placebo.[26210] Rarely, immediate allergic reactions occur after influenza vaccination in all populations. An allergic reaction may present as urticaria, angioedema, bronchospasm, and/or anaphylactic shock; these reactions are most likely the result of hypersensitivity to residual egg protein. Allergies to thimerosal usually consist of local, delayed-type hypersensitivity reactions. Erythema multiforme, rash, allergic edema of the mouth and throat, throat irritation or tightness, and Stevens-Johnson syndrome have been reported with influenza virus vaccine through postmarketing surveillance; however, no causal relationship has been firmly established.[30823] [41448] [41685] [41686] [47301] [52652] [55717]

      An increased risk of developing the Guillain-Barre syndrome (GBS) after administration of the inactivated influenza virus vaccine was evident in 1976. Subsequent influenza vaccinations during the next few years were not associated with this increased risk. However, during 1993 to 1994 twice the average yearly rate (for the period 1990 to 1995) of influenza vaccine-associated incidences of GBS were reported, representing a risk of slightly more than 1 additional case of GBS per million persons vaccinated. In most cases, symptoms were limited and reversible, but fatalities have occurred. Persons with a history of GBS have a substantially greater likelihood of subsequently developing GBS than persons without such a history. Thus, the likelihood of coincidentally developing GBS after influenza vaccination is expected to be greater among persons with a history of GBS than among persons with no history of this syndrome. It is not known if influenza vaccination is causally associated with this risk for recurrence of GBS.[30823] [41448] [41685] [41686] [47301] [52652] [55717]

      Influenza virus vaccine has rarely been temporally associated with the development of neurological complications, including encephalopathy, optic neuritis, ocular hyperemia, partial facial muscle paralysis, or neuropathic pain in the area of the brachial plexus. No cause and effect has been established in these reports, which have occurred mostly in adults. These adverse neurologic effects can occur as soon as a few hours after administration or as late as 2 weeks after administration. Full recovery is almost always reported. Paresthesias, hypoesthesia, hypokinesia, abnormal gait, dysphagia, dysphonia, tremor, myelitis (including encephalomyelitis and transverse myelitis), confusion, and insomnia have been reported with influenza virus vaccine through postmarketing surveillance; however, no causal relationship has been firmly established.[30823] [41448] [41685] [41686] [47301] [52652] [55717]

      Microscopic polyangitis, vasculitis, and renal vasculitis have been temporally reported with influenza virus vaccination; however, no causal relationship has been firmly established.[30823] [41448] [41685] [41686] [47301] [52652] [60361]

      Febrile seizures have been temporally associated with administration of the inactivated influenza vaccine (IIV). As of December 13, 2010, there were 53 confirmed VAERS reports of febrile seizures in children 6 to 23 months of age after receiving any 2010 to 2011 IIV; 42 of these cases occurred after vaccination with Fluzone (trivalent IIV). The majority of seizures (32 of the 42) were classified as non-serious, and all patients recovered. Of the 42 reports, 36 occurred on the same day or the day after vaccination (median time between vaccination and seizure onset was 10 hours), and 27 received Fluzone at the same time as other vaccines. The elevation in temperature ranged from 100.4 to 104 degrees F.[43210] Over a 3 year period from 2003 to 2006, 35 seizures were reported after influenza vaccination. Seizures occurred in the presence of fever in 21 of the 35 reports, and 29 of the 35 occurred within 2 weeks of vaccination. Five of the 35 seizures occurred in patients with a history of prior seizures.[43209] During the 2006 to 2007 through 2010 to 2011 influenza seasons, increases in reports of febrile seizures occurred in children 6 months to 23 months of age receiving the IIV and PCV7, PCV13, or DTaP-containing vaccines. During the 2014 to 2015 season, administration of IIV with PCV13 also resulted in an increased risk for febrile seizures within days 0 to 1 after vaccine co-administration. Although this observational data may suggest association of the seizure with the simultaneous administration of the vaccines, immunization should not be delayed (e.g., by separating administration across multiple healthcare visits) due to the threat of disease.[47234] [63436]

      Respiratory adverse reactions that have occurred after administration of influenza virus vaccine include rhinitis (1% to 10%), rhinorrhea (2.7% to 11.2%), nasal congestion (1% to 7%), otitis media (1.6% to 2.4%), nasopharyngitis (1.7% to 5%), infectious croup (1.4%), influenza-like illness (1% to 1.6%), cough (more than 1%), sore throat (more than 1%), upper respiratory tract infection (more than 1%), pharyngitis (more than 1%), oropharyngeal pain (more than 1%), and wheezing (1%).[30823] [41448] [41685] [41686] [47301] [52652] [55717] [61129] Dyspnea, stridor, respiratory distress, laryngitis, and asthma have been reported with influenza virus vaccine through postmarketing surveillance; however, no causal relationship has been firmly established.[41685] [52652] [55717]

      Gastrointestinal adverse reactions that have occurred after administration of influenza virus vaccine include anorexia (loss of appetite) (1% to 32.3%), vomiting (1.4% to 14.8%), nausea (0.4% to 12%), change in eating habits (10%), upper abdominal pain (1.4%), and diarrhea (1% to 24.2%).[30823] [41448] [41685] [41686] [47301] [52652] [54943] [55717] [60361] [60831] [61129]

      Neck pain (1% to 10%), dysmenorrhea (1.3%), back pain (1.5%), and pain in extremity (1.2%) have been reported in adults after administration of influenza virus vaccine (Fluarix).[41685] [52652] Arthritis and muscle weakness have been reported with influenza virus vaccine through postmarketing surveillance; however, no causal relationship has been firmly established.[55717]

      Thrombocytopenia and lymphadenopathy have been reported with influenza virus vaccine through postmarketing surveillance; however, no causal relationship has been firmly established.[30823] [41686] [55717]

      Red eyes (4% to 7%) have been reported in adult patients after administration of influenza virus vaccine (Flulaval). Conjunctivitis, photophobia, eye pain, eye and eyelid swelling, and eye irritation have been reported with influenza virus vaccine through postmarketing surveillance; however, no causal relationship has been firmly established.[41685] [47301] [52652] [55717]

      Chest tightness has been reported in adult patients after administration of Flulaval (2% to 3%) and Fluvirin (1%). Chest pain (unspecified), sinus tachycardia, syncope, presyncope, dizziness, vertigo, pallor, and flushing have been reported with influenza virus vaccine through postmarketing surveillance; however, no causal relationship has been firmly established.[41685] [41686] [47301] [52652] [52415] [55717]

      Revision Date: 10/02/2020, 04:41:54 PM

      References

      23572 - Govaert TMA, et al. Adverse reactions to influenza vaccine in elderly people: randomised double-blind placebo controlled trial. Br Med J 1993;307:988-90.26210 - The safety of inactivated influenza vaccine in adults and children with asthma. N Engl J Med 2001;345:1529-1536.30823 - Fluzone (influenza virus vaccine) package insert. Swiftwater, PA: Sanofi Pasteur Inc.; 2014 Feb.41448 - Afluria (influenza virus vaccine) package insert. Parkville, Victoria, Australia: CSL Limited; 2021 Jan.41685 - Fluarix trivalent (influenza virus vaccine) package insert. Research Triangle Park, NC: GlaxoSmithKline; 2018 Mar.41686 - Fluvirin (influenza virus vaccine) package insert. Cambridge, MA: Novartis Vaccines and Diagnostics, Inc.; 2014 Nov.43209 - Rosenberg M, Sparks R, McMahon A, et al. Serious adverse events rarely reported after trivalent inactivated influenza vaccine (TIV) in children 6-23 months of age. Vaccine 2009;27:4278-83.43210 - Centers for Disease Control and Prevention (CDC). UPDATE: Vaccine Adverse Event Reporting System (VAERS) Data on Febrile Seizures after Vaccination with Fluzone, a 2010-2011 Trivalent Inactivated Vaccine, in Children Data through December 13, 2010. Retrieved January 26, 2011. Available on the World Wide Web at http://vaers.hhs.gov/resources/VAERSupdate_FebrileSeizures_Children.pdf47234 - Centers for Disease Control and Prevention. Update on febrile seizures in children following vaccination with influenza vaccines and pneumococcal vaccines. Retrieved February 26, 2013. Available on the World Wide Web http://www.cdc.gov/vaccinesafety/concerns/FebrileSeizures.html.47301 - Flulaval (influenza virus vaccine) package insert. Research Triangle Park, NC: GlaxoSmithKline; 2014 May.51849 - Fluzone High-Dose (influenza virus vaccine) package insert. Swiftwater, PA: Sanofi Pasteur Inc.; 2019 Nov.51850 - Fluzone Intradermal (influenza virus vaccine) package insert. Swiftwater, PA: Sanofi Pasteur Inc.; 2014 Feb.52415 - Flucelvax (influenza virus vaccine) package insert. Cambridge, MA: Novartis Vaccines and Diagnostics, Inc.; 2015 Apr.52652 - Fluarix quadrivalent (influenza virus vaccine) package insert. Research Triangle Park, NC: GlaxoSmithKline; 2020 March.54943 - Fluzone Quadrivalent (influenza virus vaccine) package insert. Swiftwater, PA: Sanofi Pasteur Inc.; 2020 Oct.55717 - Flulaval Quadrivalent (influenza virus vaccine) package insert. Research Triangle Park, NC: GlaxoSmithKline; 2020 April.58656 - Fluzone Intradermal Quadrivalent (influenza virus quadrivalent vaccine) package insert. Swiftwater, PA: Sanofi Pasteur Inc.; 2014 Dec.60361 - Fluad (influenza virus, adjuvanted) package insert. Holly Springs, NC: Seqirus Inc.; 2020 Oct.60831 - Flucelvax Quadrivalent (influenza virus vaccine) package insert. Holly Springs, NC: Seqirus, Inc.; 2021 March.61129 - Afluria Quadrivalent (influenza virus vaccine) package insert. King of Prussia, PA: Seqirus, Inc.; 2020 July.63436 - Grohskopf LA, Alyanak E, Broder KR, et al. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices - United States, 2020-2021 Influenza Season. MMWR 2020;69(No. RR-8):1-24.64726 - Fluzone Quadrivalent High-Dose (influenza virus vaccine) package insert. Swiftwater, PA: Sanofi Pasteur Inc.; 2020 July.

      Contraindications/Precautions

      Absolute contraindications are italicized.

      • egg hypersensitivity
      • acquired immunodeficiency syndrome (AIDS)
      • agammaglobulinemia
      • anticoagulant therapy
      • breast-feeding
      • coagulopathy
      • fever
      • geriatric
      • Guillain-Barre syndrome
      • hemophilia
      • human immunodeficiency virus (HIV) infection
      • hypogammaglobulinemia
      • immunosuppression
      • intravenous administration
      • neoplastic disease
      • organ transplant
      • pregnancy
      • radiation therapy
      • severe combined immunodeficiency (SCID)
      • subcutaneous administration
      • syncope
      • thrombocytopenia
      • vitamin K deficiency

      Prior to administration, inform the parent, guardian, or responsible adult of the benefits and risks of the vaccine, and provide the Vaccine Information Statement, accessible at the Centers for Disease Control and Prevention (CDC) website. These actions are required by the National Childhood Vaccine Injury Act of 1986.[52653] If a dose of influenza virus vaccine, inactivated has been previously given, question the parent or guardian about previous adverse reactions that may preclude further administration. Report all adverse reactions to the Vaccine Adverse Event Reporting System (VAERS), as well as the manufacturer. The toll-free number for VAERS is 1—800—822—7967. Educate the responsible adult(s) to promptly report any adverse reaction after vaccine administration to a health care provider.[30823]

      Influenza virus vaccine should not be given via intravenous administration or subcutaneous administration, it is for intramuscular (IM) administration only, with the exception of the intradermal Fluzone products. All other formulations should not be given by intradermal administration.[30823] [51850] [58656] Incorrect administration may result in inadequate immunity.

      The decision to administer or to delay vaccination with the influenza virus vaccine because of current or recent febrile illness depends on the severity of symptoms and on the etiology of the disease. Consider delaying vaccinations during the course of a moderate or severe acute illness with or without fever and administer after the acute phase of illness has resolved. All vaccines can be administered to persons with mild illnesses. Persons with moderate or severe febrile illness should be vaccinated as soon as they have recovered from the acute phase of the illness.[65107]

      All formulations of the inactivated influenza vaccine (IIV), with the exception of Flucelvax and Flublok, are contraindicated by the manufacturer for use in persons with a known history of a severe allergic reaction (e.g., anaphylaxis) to the vaccine or any of its components, persons who have had a life-threatening reaction to any previous influenza vaccination, or persons with egg hypersensitivity.[41448] [51849] [51850] [52652] [54943] [55717] [58656] Due to differences in manufacturing processes, Flucelvax and Flublok do not use eggs to propagate the virus; thus, they are only contraindicated in persons with a known history of a severe allergic reaction (e.g., anaphylaxis) to the vaccine or any of its components.[52415] [52915] Flucelvax, however, cannot be considered 100% egg-free because the initial seed virus is created using reference virus stains from the World Health Organization, which have been passaged in eggs. The Advisory Committee on Immunization Practices (ACIP) recommends administering any licensed influenza vaccine (i.e., any IIV, quadrivalent recombinant influenza vaccine (RIV4), or quadrivalent live-attenuated influenza vaccine (LAIV4)) to patients with egg allergy of any severity. Patients who have had symptoms other than urticaria after egg exposure (i.e., angioedema, respiratory distress, lightheadedness, or recurrent emesis) or required emergency medical intervention, may also receive any licensed, age-appropriate influenza vaccine; however, it is recommended that the vaccine only be administered in an inpatient or outpatient medical setting by a health care provider experienced in the recognition and management of severe allergic conditions. Severe allergic reactions to vaccines can occur in patients without a history of previous allergic reaction. A previous severe allergic reaction to influenza vaccine is a contraindication to receiving future influenza vaccines. Although no specific observation time is recommended for egg-allergic patients, ACIP recommends patients be observed for syncope for 15 minutes after vaccination.[53026] [63436] The American Academy of Pediatrics (AAP), the American Academy of Allergy, Asthma, and Immunology (AAAAI), and the American College of Allergy, Asthma, and Immunology (ACAAI) do not recommend any special precautions for egg-allergic recipients, regardless of severity. The AAAAI and ACAAI consider any special precautions (i.e., special observation periods or administration in a specialized medical setting) unnecessary due to the extremely rare risk of anaphylactic reactions after vaccination. They recommend that providers and screening questionnaires not ask about the egg allergy status of the influenza virus vaccine recipient.[62809] [63520] As with any biologic product, the prescriber or health care professional should have procedures in place to manage allergic reactions. The health care professional should have immediate availability of epinephrine (1 mg/mL) injection and other agents used in the treatment of severe anaphylaxis in the event of a serious allergic reaction to the influenza virus vaccine.[41448] [51849] [51850] [52652] [54943] [55717] [60361] [60831]

      Carefully consider the potential benefits and risks of the inactivated influenza vaccine (IIV) for patients who have developed Guillain-Barre syndrome (GBS) within 6 weeks of a previous influenza vaccination.[60831] Influenza immunization is generally not recommended in patients who have developed GBS within 6 weeks of a previous influenza vaccination. However, for most persons with a history of GBS who are at high risk for severe complications from influenza, many experts believe the benefits of the influenza virus vaccine justify yearly vaccination.[53026] [63436] [65107]

      Geriatric persons may develop lower postvaccination antibody titers than healthy young adults and, thus, may remain susceptible to influenza-related upper respiratory tract infection (see Pharmacokinetics). However, even if such persons develop influenza illness despite vaccination, the vaccine can be effective in preventing lower respiratory tract infection or other secondary complications, thereby reducing the risk for hospitalization and death. In a retrospective study of data from 1990—2000, influenza vaccination was associated with significant reductions in the risk of hospitalization for pneumonia or influenza and in the risk of death among community-dwelling patients at least 65 years of age as compared with unvaccinated patients. Specifically, vaccination was associated with a 27% reduction in the risk of hospitalization for pneumonia or influenza and a 48% reduction in the risk of death. Statistically significant reductions in the risk of both hospitalization and death were also found by sensitivity analyses, which modeled the effect of a hypothetical unmeasured confounder that would have caused overestimation of vaccine effectiveness.[33520] In elderly nursing home residents, administration of the flu vaccine annually prior to October should generally be avoided because antibody concentrations can decrease within a few months of immunization.

      No adequate and well-controlled studies have been conducted in pregnant women, and the ability of the vaccine to cause fetal harm or to affect reproductive capacity is unknown. During animal studies, no evidence of impaired fertility or fetal harm was noted with Afluria, Agriflu, Fluarix, Flublok, Flucelvax, FluLaval, Fluvirin, or Fluzone Quadrivalent or Intradermal. Pregnancy may increase the risk of serious medical complications from influenza. Therefore, the Advisory Committee on Immunization Practices (ACIP) recommends that all women who are or will be pregnant (in any trimester) during the influenza season be routinely vaccinated with an inactivated influenza vaccine (vs. live-attenuated influenza vaccine).[63436] Although more data are needed, studies of more than 2,000 pregnant women have demonstrated no adverse fetal effects associated with influenza virus vaccine. Many experts consider influenza vaccination safe during any stage of pregnancy. However, because spontaneous abortion is common in the first trimester and unnecessary drug-exposures have traditionally been avoided during this time, some experts prefer waiting until the second trimester of pregnancy to vaccinate. In addition to benefits to the mother, influenza vaccine administration during pregnancy appears to help protect newborns and infants. Fewer cases of laboratory-confirmed influenza occurred during the first 6 months of life among infants of the 159 mothers who received the inactivated influenza vaccine (6 cases) as compared with infants of 157 mothers who received the pneumococcal polysaccharide vaccine (16 cases). The clinical judgment of the physician is paramount in the determination of whether to vaccinate a pregnant woman. Some manufacturers have established pregnancy registries to monitor pregnancy outcomes and newborn health after vaccination. Patients who receive these vaccines during pregnancy are encouraged to enroll in these registries. For GlaxoSmithKline (GSK) influenza vaccines (e.g., FluLaval and Fluarix), patients are encouraged to contact GSK by telephone at 888-452-9622. For Sanofi Pasteur influenza vaccines (e.g., Fluzone and Flublok), patients are encouraged to contact Sanofi Pasteur at 800-822-2463. For Seqirus influenza vaccines (e.g., Afluria and Afluria Quadrivalent), patients are encouraged to contact Seqirus at 855-358-8966 or us.medicalinformation@seqirus.com.[28647] [30823] [34402] [41448] [41684] [41685] [41686] [47301] [52415] [52652] [52915] [54943] [55717] [65107]

      Data are limited regarding use of the influenza virus vaccine during breast-feeding, and its' excretion in human breast milk is unknown. The Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP) state inactivated virus vaccines pose no risk for mothers or their infants. Additionally, breast-feeding does not adversely affect immunization; limited data suggest breast-feeding may enhance the immune response to certain vaccine antigens. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.[41686] [30823] [41685] [41448] [41684] [47301] [52652] [63520] [65107]

      Patients with thrombocytopenia or a coagulopathy (e.g., hemophilia), vitamin K deficiency, or who are on anticoagulant therapy should be monitored closely when given influenza virus vaccine because bleeding can occur at the IM injection site.[30823]

      Although patients with human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) could have a diminished response, inactivated influenza vaccine (IIV) should be offered to these patients.[34361] [34362] [60092] The CDC recommends immunization of HIV-infected individuals with the IIV, as this measure is safe and may confer protection against influenza.[60092] [63436] One randomized, placebo-controlled trial noted that the administration of IIV was highly effective in preventing hospitalization due to influenza in patients with HIV infection and was not associated with changes in viral load or CD4 counts (mean count 400 cells/mm3).[26272]

      Injectable vaccines, including influenza virus vaccine, have been associated with episodes of syncope and fainting. These events may be accompanied by transient tonic-clonic limb movements, visual disturbances, and paresthesias. Prior to administration, ensure procedures are in place to prevent falls and restore cerebral perfusion. Monitor vaccine recipients after administration of the dose. If syncope occurs, place the patient in a supine or Trendelenburg position to restore cerebral perfusion.[52415]

      Patients with significant immunosuppression may not have an adequate antibody response to the inactivated influenza vaccine (IIV).[41448] Immunosuppressed persons may include patients with severe combined immunodeficiency (SCID), hypogammaglobulinemia, agammaglobulinemia, or an immune system compromised by drug therapy (i.e., corticosteroid therapy with greater than physiologic doses). Short-term (less than 2 weeks) corticosteroid therapy or intra-articular, bursal, or tendon injections with corticosteroids should not be immunosuppressive. Patients vaccinated with IIV within 2 weeks before starting immunosuppressive therapy or while receiving immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after therapy is discontinued if immune competence has been restored. IIV can be administered to patients with major antibody deficiencies and some residual antibody production.[65107]

      Patients with altered immune states due to generalized neoplastic disease or an immune system compromised by radiation therapy or drug therapy (e.g., chemotherapy or corticosteroid therapy with greater than physiologic doses) may not have an adequate antibody response to the inactivated influenza vaccine (IIV).[41448] Patients with hematological malignancies or solid tumor malignancies, except those receiving anti-B-cell antibodies or intensive chemotherapy (i.e., induction or consolidation chemotherapy for acute leukemia), should receive IIV annually. Patients vaccinated with IIV within 2 weeks before starting immunosuppressive therapy or while receiving immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after therapy is discontinued if immune competence has been restored.[60092] [65107] IIV should not be administered to solid organ transplant (SOT) recipients during intensified immunosuppression, including the first 2 months post-transplant, because of the likelihood of inadequate response. However, IIV can be administered beginning 1 month after transplant during a community influenza outbreak and should be administered 2 to 6 months after SOT. Concerns have been raised that vaccination may trigger rejection; however, clinical evidence indicates that vaccines are not important triggers of rejection episodes and should not be withheld for that reason.[60092]

      Revision Date: 04/02/2021, 10:28:44 AM

      References

      26272 - Tasker SA, Treanor JJ, Paxton WB et al. Efficacy of influenza vaccination in HIV-infected persons. Ann Intern Med 1999;131:430-433.28647 - Centers for Disease Control and Prevention (CDC). Antiviral Agents for the Treatment and Chemoprophylaxis of Influenza: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2011;60:1-26.30823 - Fluzone (influenza virus vaccine) package insert. Swiftwater, PA: Sanofi Pasteur Inc.; 2014 Feb.33520 - Nichol KL, Nordin JD, Nelson DB, Mullooly JP, Hak E. Effectiveness of influenza vaccine in the community-dwelling elderly. N Engl J Med. 2007;357:1373-8134361 - Panel on Opportunistic Infections in HIV-Exposed and HIV-infected Children. Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-exposed and HIV-infected children: Department of Health and Human Services. Accessed Dec 18, 2019. Available at: https://aidsinfo.nih.gov/contentfiles/lvguidelines/oi_guidelines_pediatrics.pdf34362 - Panel on Opportunistic Infections in HIV-Infected Adults and Adolescents. Guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV: recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. Accessed May 26, 2020. Available at http://aidsinfo.nih.gov/guidelines.34402 - Zaman K, Roy E, Arifeen SE, et al. Effectiveness of maternal influenza immunization in mothers and infants. N Engl J Med. 2008;359:1555-6441448 - Afluria (influenza virus vaccine) package insert. Parkville, Victoria, Australia: CSL Limited; 2021 Jan.41684 - Agriflu (influenza virus vaccine) package insert. Cambridge, MA: Novartis Vaccines and Diagnostics, Inc.; 2020 Oct.41685 - Fluarix trivalent (influenza virus vaccine) package insert. Research Triangle Park, NC: GlaxoSmithKline; 2018 Mar.41686 - Fluvirin (influenza virus vaccine) package insert. Cambridge, MA: Novartis Vaccines and Diagnostics, Inc.; 2014 Nov.47301 - Flulaval (influenza virus vaccine) package insert. Research Triangle Park, NC: GlaxoSmithKline; 2014 May.51849 - Fluzone High-Dose (influenza virus vaccine) package insert. Swiftwater, PA: Sanofi Pasteur Inc.; 2019 Nov.51850 - Fluzone Intradermal (influenza virus vaccine) package insert. Swiftwater, PA: Sanofi Pasteur Inc.; 2014 Feb.52415 - Flucelvax (influenza virus vaccine) package insert. Cambridge, MA: Novartis Vaccines and Diagnostics, Inc.; 2015 Apr.52652 - Fluarix quadrivalent (influenza virus vaccine) package insert. Research Triangle Park, NC: GlaxoSmithKline; 2020 March.52653 - National Childhood Vaccine Injury Act of 1986 (42 U.S.C. 300aa-1 to 300aa-34). Retrieved from the World Wide Web December 18, 2012. http://www.hrsa.gov/vaccinecompensation/authorizinglegislation.pdf.52915 - Flublok (influenza virus vaccine) package insert. Meriden, CT: Protein Sciences Corp.; 2018 March53026 - Centers for Disease Control and Prevention. Advisory Committee on Immunization Practices (ACIP) recommended immunization schedules for persons aged 0 through 18 years and adults aged 19 years and older-United States, 2020. MMWR 2020;69(5):130-135.54943 - Fluzone Quadrivalent (influenza virus vaccine) package insert. Swiftwater, PA: Sanofi Pasteur Inc.; 2020 Oct.55717 - Flulaval Quadrivalent (influenza virus vaccine) package insert. Research Triangle Park, NC: GlaxoSmithKline; 2020 April.58656 - Fluzone Intradermal Quadrivalent (influenza virus quadrivalent vaccine) package insert. Swiftwater, PA: Sanofi Pasteur Inc.; 2014 Dec.60092 - Rubin LG, Levin MJ, Ljungman P, et al. 2013 IDSA clinical practice guideline for vaccination of the immunocompromised host. Clin Infect Dis. 2014; 58: e44-100.60361 - Fluad (influenza virus, adjuvanted) package insert. Holly Springs, NC: Seqirus Inc.; 2020 Oct.60831 - Flucelvax Quadrivalent (influenza virus vaccine) package insert. Holly Springs, NC: Seqirus, Inc.; 2021 March.62809 - Greenhawt M, Turner PJ, Kelso JM. Administration of influenza vaccines to egg allergic recipients: A practice parameter update 2017. Ann Allergy Asthma Immunol 2018; 120: 49-52.63436 - Grohskopf LA, Alyanak E, Broder KR, et al. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices - United States, 2020-2021 Influenza Season. MMWR 2020;69(No. RR-8):1-24.63520 - American Academy of Pediatrics Committee on Infectious Diseases. Recommendations for Prevention and Control of Influenza in Children, 2020-2021. Pediatrics. 2020;146(4):e202002458865107 - Kroger AT, Duchin J, Vazquez M. General Best Practice Guidelines for Immunization. Best Practices Guidance of the Advisory Committee on Immunization Practices (ACIP). https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/index.html. Accessed on January 10, 2019.

      Mechanism of Action

      Influenza virus vaccine imparts immunity against the influenza virus by stimulating production of antibodies that are specific to the disease. Vaccine recipients develop immunity only to those strains of the virus from which the vaccine was prepared. Influenza viruses are recognized by the surface antigens they carry, and two such antigens, hemagglutinin (H) and neuraminidase (N) have been identified and are used to classify the various viruses. Subtypes of these strains (H1, H2, H3, N1, N2) are associated with influenza A virus and have been recognized to cause disease in humans. Immunity to these surface antigens increases resistance to infection and decreases the severity of the disease if infection occurs. Eventually, antigenic variation can occur, and immunity to one strain may no longer impart immunity to distantly related subtypes of the virus. Influenza B viruses also exhibit antigenic variation, and new variants of both types of viruses continue to cause widespread epidemics of respiratory disease.[41448]

      Revision Date: 07/14/2016, 09:33:46 PM

      References

      41448 - Afluria (influenza virus vaccine) package insert. Parkville, Victoria, Australia: CSL Limited; 2021 Jan.

      Pharmacokinetics

      The inactivated influenza virus vaccine (IIV) is usually administered intramuscularly; intradermal vaccines are also available. The vaccine usually imparts a protective effect within 10 to 14 days of administration. Post-vaccine antibody titers are generally high enough in healthy young adults and children to provide resistance against infection by strains found in the vaccine as well as related strains. A hemagglutination-inhibiting antibody titer of at least 1:40 may be protective against influenza infection in up to 50% of people. Among 1007 patients 18 to 64 years of age who got Afluria, 94.2 to 99.9% had a postvaccination titer of at least 1:40. The duration of immunity imparted by the influenza vaccine generally lasts 6 to 12 months.[41448]

      Special Populations

      Pediatrics

      Infants and Children 6 to 47 months

      Three clinical studies evaluated the immunogenicity of Fluvirin in healthy patients (n = 285) and those at increased risk for influenza complications (n = 41). Patients at increased risk were vaccinated with two 0.25 mL doses. After vaccination, 49% or more demonstrated at least a 4-fold increase in HI antibody titers to all strains, with titers >= 1:40 in 71% or more of patients. A lower immune response was demonstrated for Fluvirin in 2 clinical studies when the vaccine was compared to 2 other spilt vaccines in patients 6 to 47 months of age, with the greatest differences demonstrated in those less than 36 months of age. Due to these differences, Fluvirin must only be used in patients 4 years of age or older.[41686]

       

      Infants and Children 6 months to 8 years

      The immunogenicity of Fluzone was evaluated in a multi-center study during which 68 infants and children 6 to 35 months of age were given 2 doses of 0.25 mL 26 days apart and 120 children 3 to 8 years were given 2 doses of 0.5 mL 30 days apart. Influenza vaccine was given during the previous flu season to 54.4% of those in the 6 to 35 months age group and 27.5% in the 3 to 8 years age group. One month after the last dose of the vaccine, HI antibody titers >= 1:40 in the younger age group occurred in 92.6% of patients (95% CI 83.7 to 97.6) for A (H1N1), 100% (94.7; 100) for A (H3N2), and 20.6% (11.7; 32.1) for the B strain. In the older age group, titers >= 1:40 developed in 99.2% (95.4; 100) for A (H1N1), 100% (97; 100) for A (H3N2), and 58.3% (49; 67.3) for the B strain.[30823]

       

      Children and Adolescents 3 to 17 years

      A randomized, controlled, double-blind study assessed the immune response to the Fluarix quadrivalent vaccine (n = 791) compared to 2 different formulations of the trivalent Fluarix vaccine, TIV-1 (n = 818) and TIV-2 (n = 801). The quadrivalent vaccine demonstrated non-inferiority to the trivalent formulations at evaluation 28 days after the last vaccination. Seroconversion was defined as a pre-vaccination HI titer of < 1:10 with a post-vaccination titer >= 1:40 or >= at least a 4-fold increase in serum HI titer over baseline to >= 1:40. Seroconversion occurred in the following percentages of patients for each strain: A/California/7/2009 (H1N1) 91.4% quadrivalent vs. 89.9 to 91.6% trivalent; A/Victoria/210/2009 (H2N2) 72.3% vs. 70.7 to 71.9%; B/Brisbane/60/2008 (Victoria lineage) 70% vs. 29.6 to 68.5%; B/Brisbane/3/2007 (Yamagata lineage) 72.5% vs. 37 to 70.8%. The additional B virus strain in the quadrivalent vaccine did not demonstrate immune interference with the other strains present in the vaccine.[52652]

      Geriatric

      The efficacy of Afluria in 206 healthy elderly patients (mean age of 72 years, range 65 to 93 years) was assessed by determining the percentage of patients with seroconversion, which was defined as a 4-fold increase in post-vaccination hemagglutination-inhibiting antibody titer if the pre-vaccination titer was at least 1:10 or an increase in titer to at least 1:40 if the pre-vaccination titer was less than 1:10. The mean seroconversion rate ranged from 34% to 45.6% for the 3 vaccine strains. After vaccination, 77.7 to 99.5% had a hemagglutination-inhibiting antibody titer of at least 1:40.[41448] The efficacy of the influenza virus vaccine among older patients was also examined in another study. Receipt of a single dose of the 2003/2004 influenza vaccine to patients either older or younger than 60 years on hemodialysis led to a significant increase from baseline in the percentage of patients with an antibody titer for each of the 3 vaccine strains of at least 1:40, which is considered protective against infection. Fewer older patients obtained a protective antibody titer. For example, 1 month after the dose, 94.7% of 19 patients 60 years of age or younger and 66.7% of 39 patients older than 60 years of age had protective antibody titers against the H1N1 component. The effect of a second dose given a month after the initial dose was examined. The percentage of patients with protective antibody titers did not significantly increase after a second dose. Further, geometric mean titers did not significantly increase after the second dose in either the younger or older patients. The strains in the 2003/2004 influenza vaccine were B/Hong Kong/330/2001(B), A/New Caledonia/20/99 (A/H1N1), and A/Panama/2007/99 (A/H3N2).[33455] In contrast to results obtained after a second dose, more adults at least 65 years of age seroconverted after receipt of Fluzone High-Dose (180 mcg influenza virus hemagglutinin) as compared with receipt of Fluzone (45 mcg influenza virus hemagglutinin). Among the Fluzone High-Dose recipients, 41.8% to 69.1% seroconverted as compared with 23.1% to 50.7% of Fluzone recipients. In another study, administering Fluzone High-Dose to patients 65 years of age and older (n = 15,892) was found to be statistically superior to Fluzone (n = 15,911) in reducing the number of laboratory confirmed influenza cases [1.43% (n = 227) vs. 1.89% (n = 300); 95% CI, 24.2 (9.7; 36.5)].[51849]

      Revision Date: 07/14/2016, 10:11:41 PM

      References

      30823 - Fluzone (influenza virus vaccine) package insert. Swiftwater, PA: Sanofi Pasteur Inc.; 2014 Feb.33455 - Tanzi E, Amendola A, Pariani E, et al. Lack of effect of a booster dose of influenza vaccine in hemodialysis patients. J Med Virol 2007;79:1176-9.41448 - Afluria (influenza virus vaccine) package insert. Parkville, Victoria, Australia: CSL Limited; 2021 Jan.41686 - Fluvirin (influenza virus vaccine) package insert. Cambridge, MA: Novartis Vaccines and Diagnostics, Inc.; 2014 Nov.51849 - Fluzone High-Dose (influenza virus vaccine) package insert. Swiftwater, PA: Sanofi Pasteur Inc.; 2019 Nov.52652 - Fluarix quadrivalent (influenza virus vaccine) package insert. Research Triangle Park, NC: GlaxoSmithKline; 2020 March.

      Pregnancy/Breast-feeding

      pregnancy

      No adequate and well-controlled studies have been conducted in pregnant women, and the ability of the vaccine to cause fetal harm or to affect reproductive capacity is unknown. During animal studies, no evidence of impaired fertility or fetal harm was noted with Afluria, Agriflu, Fluarix, Flublok, Flucelvax, FluLaval, Fluvirin, or Fluzone Quadrivalent or Intradermal. Pregnancy may increase the risk of serious medical complications from influenza. Therefore, the Advisory Committee on Immunization Practices (ACIP) recommends that all women who are or will be pregnant (in any trimester) during the influenza season be routinely vaccinated with an inactivated influenza vaccine (vs. live-attenuated influenza vaccine).[63436] Although more data are needed, studies of more than 2,000 pregnant women have demonstrated no adverse fetal effects associated with influenza virus vaccine. Many experts consider influenza vaccination safe during any stage of pregnancy. However, because spontaneous abortion is common in the first trimester and unnecessary drug-exposures have traditionally been avoided during this time, some experts prefer waiting until the second trimester of pregnancy to vaccinate. In addition to benefits to the mother, influenza vaccine administration during pregnancy appears to help protect newborns and infants. Fewer cases of laboratory-confirmed influenza occurred during the first 6 months of life among infants of the 159 mothers who received the inactivated influenza vaccine (6 cases) as compared with infants of 157 mothers who received the pneumococcal polysaccharide vaccine (16 cases). The clinical judgment of the physician is paramount in the determination of whether to vaccinate a pregnant woman. Some manufacturers have established pregnancy registries to monitor pregnancy outcomes and newborn health after vaccination. Patients who receive these vaccines during pregnancy are encouraged to enroll in these registries. For GlaxoSmithKline (GSK) influenza vaccines (e.g., FluLaval and Fluarix), patients are encouraged to contact GSK by telephone at 888-452-9622. For Sanofi Pasteur influenza vaccines (e.g., Fluzone and Flublok), patients are encouraged to contact Sanofi Pasteur at 800-822-2463. For Seqirus influenza vaccines (e.g., Afluria and Afluria Quadrivalent), patients are encouraged to contact Seqirus at 855-358-8966 or us.medicalinformation@seqirus.com.[28647] [30823] [34402] [41448] [41684] [41685] [41686] [47301] [52415] [52652] [52915] [54943] [55717] [65107]

      breast-feeding

      Data are limited regarding use of the influenza virus vaccine during breast-feeding, and its' excretion in human breast milk is unknown. The Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP) state inactivated virus vaccines pose no risk for mothers or their infants. Additionally, breast-feeding does not adversely affect immunization; limited data suggest breast-feeding may enhance the immune response to certain vaccine antigens. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.[41686] [30823] [41685] [41448] [41684] [47301] [52652] [63520] [65107]

      Revision Date: 04/02/2021, 10:28:44 AM

      References

      28647 - Centers for Disease Control and Prevention (CDC). Antiviral Agents for the Treatment and Chemoprophylaxis of Influenza: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2011;60:1-26.30823 - Fluzone (influenza virus vaccine) package insert. Swiftwater, PA: Sanofi Pasteur Inc.; 2014 Feb.34402 - Zaman K, Roy E, Arifeen SE, et al. Effectiveness of maternal influenza immunization in mothers and infants. N Engl J Med. 2008;359:1555-6441448 - Afluria (influenza virus vaccine) package insert. Parkville, Victoria, Australia: CSL Limited; 2021 Jan.41684 - Agriflu (influenza virus vaccine) package insert. Cambridge, MA: Novartis Vaccines and Diagnostics, Inc.; 2020 Oct.41685 - Fluarix trivalent (influenza virus vaccine) package insert. Research Triangle Park, NC: GlaxoSmithKline; 2018 Mar.41686 - Fluvirin (influenza virus vaccine) package insert. Cambridge, MA: Novartis Vaccines and Diagnostics, Inc.; 2014 Nov.47301 - Flulaval (influenza virus vaccine) package insert. Research Triangle Park, NC: GlaxoSmithKline; 2014 May.52415 - Flucelvax (influenza virus vaccine) package insert. Cambridge, MA: Novartis Vaccines and Diagnostics, Inc.; 2015 Apr.52652 - Fluarix quadrivalent (influenza virus vaccine) package insert. Research Triangle Park, NC: GlaxoSmithKline; 2020 March.52653 - National Childhood Vaccine Injury Act of 1986 (42 U.S.C. 300aa-1 to 300aa-34). Retrieved from the World Wide Web December 18, 2012. http://www.hrsa.gov/vaccinecompensation/authorizinglegislation.pdf.52915 - Flublok (influenza virus vaccine) package insert. Meriden, CT: Protein Sciences Corp.; 2018 March54943 - Fluzone Quadrivalent (influenza virus vaccine) package insert. Swiftwater, PA: Sanofi Pasteur Inc.; 2020 Oct.55717 - Flulaval Quadrivalent (influenza virus vaccine) package insert. Research Triangle Park, NC: GlaxoSmithKline; 2020 April.63436 - Grohskopf LA, Alyanak E, Broder KR, et al. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices - United States, 2020-2021 Influenza Season. MMWR 2020;69(No. RR-8):1-24.63520 - American Academy of Pediatrics Committee on Infectious Diseases. Recommendations for Prevention and Control of Influenza in Children, 2020-2021. Pediatrics. 2020;146(4):e202002458865107 - Kroger AT, Duchin J, Vazquez M. General Best Practice Guidelines for Immunization. Best Practices Guidance of the Advisory Committee on Immunization Practices (ACIP). https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/index.html. Accessed on January 10, 2019.

      Interactions

      Level 2 (Major)

      • Ofatumumab
      • Satralizumab

      Level 3 (Moderate)

      • Ocrelizumab
      • Siponimod
      Ocrelizumab: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination. [43236] [61838] Ofatumumab: (Major) Administer all needed non-live vaccines according to immunization guidelines at least 2 weeks before initiation of ofatumumab. Ofatumumab may interfere with the effectiveness of inactivated vaccines due to its actions, which cause B-cell depletion. [43236] [60092] [65850] Satralizumab: (Major) Administer all non-live vaccines according to immunization guidelines at least 2 weeks before initiation of satralizumab. [43236] [60092] [65841] Siponimod: (Moderate) Administer all non-live vaccines at least 4 weeks before siponimod initiation, whenever possible. Vaccines may be less effective if given during siponimod treatment and for 1 month after discontinuation of siponimod treatment. [64031]
      Revision Date: 10/02/2020, 02:38:00 AM

      References

      43236 - National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC). General recommendations on immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2011;60(2):1-64.60092 - Rubin LG, Levin MJ, Ljungman P, et al. 2013 IDSA clinical practice guideline for vaccination of the immunocompromised host. Clin Infect Dis. 2014; 58: e44-100.61838 - Ocrevus (ocrelizumab) injection package insert. South San Francisco, CA: Genentech, Inc.; 2020 Dec.64031 - Mayzent (siponimod) tablets package insert. East Hanover, NJ: Novartis Pharmaceutical Corporation; 2021 Jan.65841 - Enspryng (satralizumab-mwge) injection package insert. South San Francisco, CA: Genentech, Inc.; 2020 Aug.65850 - Kesimpta (ofatumumab) injection package insert. East Hanover, NJ: Novartis Pharmaceutical Corporation; 2020 Aug.

      Monitoring Parameters

      • laboratory monitoring not necessary

      US Drug Names

      • Afluria
      • Afluria Quadrivalent
      • Agriflu
      • Alfuria
      • FLUAD
      • FLUAD Quadrivalent
      • Fluarix
      • Fluarix Quadrivalent
      • Flublok
      • Flublok Quadrivalent
      • FLUCELVAX
      • FLUCELVAX Quadrivalent
      • Flulaval
      • Flulaval Quadrivalent
      • Fluogen
      • Flushield
      • Fluvirin
      • Fluzone
      • Fluzone High-Dose
      • Fluzone Intradermal
      • Fluzone Quadrivalent