EsteéoconteúdodoDrugInformationdaElsevier
SARS-CoV-2 Virus (COVID-19) Recombinant Spike Protein Nanoparticle Vaccine
Indications/Dosage
Labeled
General Dosing Information
- The mRNA or Novavax COVID-19 vaccines are preferred, when available, over the Janssen COVID-19 vaccine due to the risk of thrombosis with thrombocytopenia syndrome (TTS) after Janssen COVID-19 vaccination.[66175]
- The Novavax COVID-19 vaccine is covered under an Emergency Use Authorization (EUA) for the 2-dose primary series in patients 12 years and older. The booster dose is authorized in patients 18 years and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate or who elect to receive the Novavax COVID-19 vaccine because they would not otherwise receive a booster.[67669]
- There is no data available on the interchangeability of the COVID-19 vaccines to complete the primary vaccination series. Patients who have received 1 dose of Novavax COVID-19 vaccine should receive a second dose of the same vaccine to complete the primary vaccination series.[66175][67669] In exceptional situations (e.g., first dose of vaccine product cannot be determined or is no longer available), any available mRNA COVID-19 vaccine may be administered at a minimum interval of 28 days between doses. If 2 doses of different COVID-19 vaccine products are administered in these situations or inadvertently administered, no additional doses of either product are recommended.[66175]
- Administer the second dose as close to the recommended interval as possible; do not schedule the second dose appointment earlier than the recommended dosing interval. Patients receiving a second dose up to 4 days before or any time after the recommended date can be considered fully vaccinated. If the second dose of a vaccine is given earlier than the 4-day grace period, the second dose should be repeated. Space the repeat dose the recommended minimum interval after the dose given in error.[66175]
- There is no information on coadministration of the Novavax COVID-19 vaccine with other vaccines.[67669]
- The 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]
Off-Label
- prevention of coronavirus disease 2019 (COVID-19)
For the prevention of coronavirus disease 2019 (COVID-19)†
for the primary vaccination series
Intramuscular dosage
Adults
0.5 mL (5 mcg) IM for 2 doses administered 3 weeks apart.[67669]
Children and Adolescents 12 to 17 years
0.5 mL (5 mcg) IM for 2 doses administered 3 weeks apart.[67669]
for monovalent booster dose
Intramuscular dosage
Adults
0.5 mL (5 mcg) IM at least 6 months after receipt of primary series.[67669]
Therapeutic Drug Monitoring
Maximum Dosage Limits
- Adults
0.5 mL/dose IM.
- Geriatric
0.5 mL/dose IM.
- Adolescents
0.5 mL/dose IM.
- Children
12 years: 0.5 mL/dose IM.
1 to 11 years: 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 indicationReferences
How Supplied
SARS-COV-2 Spike Glycoprotein Vaccine Antigen NVX-COV2373, Quillaja Suspension for injection
Novavax COVID-19 5mcg-50mcg/0.5mL Vaccine Adjuvanted Suspension for Injection (80631-0100) (Novavax, Inc.) nullDescription/Classification
Description
The Novavax COVID-19 vaccine is an investigational vaccine that contains a recombinant spike protein (rS) of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The COVID-19 vaccine is not an FDA-approved vaccine; however, the vaccine has been authorized under an Emergency Use Authorization (EUA) for active immunization for the prevention of coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2. The primary series is authorized in patients 12 years and older; the booster dose is authorized in patients 18 years and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate or who elect to receive the Novavax COVID-19 vaccine because they would not otherwise receive a booster.[67669] The Novavax COVID-19 vaccine is a protein subunit vaccine and was designed with an older technology than the previously approved mRNA and adenovirus COVID-19 vaccines. These types of vaccines are generally considered safe; however, they exhibit low immune response.The Novavax COVID-19 vaccine contains an adjuvant to boost the immune response.[67785] The mRNA or Novavax COVID-19 vaccines are preferred, when available, over the Janssen COVID-19 vaccine due to the risk of thrombosis with thrombocytopenia syndrome (TTS) after Janssen COVID-19 vaccination.[66175] Vaccine efficacy of the Novavax COVID-19 vaccine, defined as prevention of polymerase chain reaction-confirmed symptomatic mild, moderate, or severe COVID-19 from 7 days after the second dose, was 90.4% (95% CI, 83.8% to 94.3%) in patients 18 years and older and 78.29% (95% CI, 37.55% to 92.45%) in patients 12 to 17 years. In clinical trials, the Novavax COVID-19 vaccine has been found to be safe and well-tolerated. The most commonly reported adverse drug reactions include injection site pain, fatigue, muscle pain, headache, and joint pain.[67669]
Classifications
- General Anti-infectives Systemic
- Vaccines
- Pure Vaccines
- SARS-CoV-2 (Covid-19) Vaccines
- Pure Vaccines
- Vaccines
References
Administration Information
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Under the Emergency Use Authorization (EUA), healthcare providers are required to communicate to the patient or caregiver information consistent with the "Fact Sheet for Recipients and Caregivers" prior to the patient receiving the vaccine, including:
- FDA has authorized the emergency use of this vaccine, which is not an FDA-approved vaccine.
- The recipient or caregiver has the option to accept or refuse the COVID-19 vaccine.
- The significant known and potential risks and benefits of the COVID-19 vaccine, and the extent to which such potential risks and benefits are unknown.
- Available alternative vaccines and the risks and benefits of those alternatives.
Under the EUA, vaccination providers enrolled in the federal COVID-19 Vaccination Program are required to report all vaccination administration errors, all serious adverse events, cases of myocarditis, cases of pericarditis, cases of Multisystem Inflammatory Syndrome (MIS), and cases of COVID-19 that result in hospitalization or death after administration of the vaccine.[67669]
Route-Specific Administration
Injectable Administration
- Administer intramuscularly. Do not administer intravenously, intradermally, or subcutaneously.
- Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. The Novavax COVID-19 vaccine is a colorless to slightly yellow, clear to mildly opalescent suspension.[67669]
Intramuscular Administration
Preparation
- Do NOT dilute.
- Before withdrawing each dose, swirl vial gently in an upright position. Do NOT shake.
- Inspect the vial for particulate matter and/or discoloration prior to administration; do not use if it is discolored or contains particulate matter.
- Record the date and time of first vial puncture on the vial label.
- Withdraw each 0.5 mL dose using a new sterile needle and syringe.
- Each vial contains 10 doses of 0.5 mL.
- If the amount of vaccine remaining in the vial cannot provide a full dose of 0.5 mL, discard the vial and content; do not pool excess vaccine from multiple vials.
- Storage after vial puncture: Store between 2 and 25 degrees C (36 to 77 degrees F) and use within 6 hours. Discard any vaccine remaining in vial after 6 hours.[67669]
Intramuscular Injection
- After withdrawing the dose, administer as an intramuscular injection.[67669]
Clinical Pharmaceutics Information
From Trissel's 2‚Ñ¢ Clinical Pharmaceutics DatabaseReferences
Adverse Reactions
Mild
- anorexia
- arthralgia
- chills
- fatigue
- fever
- headache
- hypoesthesia
- injection site reaction
- malaise
- myalgia
- nausea
- paresthesias
- pruritus
- urticaria
- vomiting
Moderate
- erythema
- iritis
- lymphadenopathy
Severe
- anaphylactoid reactions
- angioedema
- cardiomyopathy
- cholecystitis
- Guillain-Barre syndrome
- heart failure
- myocarditis
- pericarditis
- pulmonary embolism
- thrombosis
- uveitis
Local injection site reaction was the most commonly reported adverse reaction after COVID-19 vaccine administration during clinical trials. In general, the rates and severity of the reactions were higher after the second dose compared to after the first. After Novavax COVID-19 vaccine administration in patients 12 to 17 years, injection site pain and tenderness (79.8%), erythema or redness (7.7%), and swelling (8.5%) at the injection site were reported. In patients 18 to 64 years, injection site pain and tenderness (82.2%), erythema or redness (7%), and swelling (6.3%) at the injection site were reported. In patients 65 years and older, the incidence of injection site pain and tenderness (63.4%), erythema or redness (4.8%), and swelling (5.3%) was lower compared to younger patients. Injection site pruritus was also reported in 0.1% to 0.2% of patients. After the booster dose, injection site pain and tenderness (81.1%), erythema or redness (6.3%), and swelling (8.4%) at the injection site were reported.[67669]
During clinical trials, fatigue, malaise, and headache occurred after administration of the COVID-19 vaccine. The rates and severity of the reactions were generally higher after the second dose compared to the first dose. After Novavax COVID-19 vaccine administration in patients 12 to 17 years, fatigue and malaise (61.6%) and headache (63.3%) were reported. In patients 18 to 64 years, fatigue and malaise (62%) and headache (52.9%) were reported. In patients 65 years and older, the incidence of fatigue and malaise (39.2%) and headache (29.2%) was lower than that in younger patients. After the booster dose, fatigue and malaise (63.4%) and headache (52.9%) were reported.[67669]
Musculoskeletal adverse reactions were reported during COVID-19 vaccine clinical trials. The rates and severity of the reactions were generally higher after the second dose compared to the first dose. After Novavax COVID-19 vaccine administration in patients 12 to 17 years, arthralgia (19.5%) and myalgia (56.9%) were reported. In patients 18 to 64 years, arthralgia (25.4%) and myalgia (54.1%) were reported. In patients 65 years and older, the incidence of arthralgia (15.4%) and myalgia (30.2%) was lower than that in younger patients. After the booster dose, arthralgia (30.3%) and myalgia (63%) were reported.[67669]
Fever was reported after Novavax COVID-19 vaccine administration in patients 12 to 17 years (16.7%) and in patients 18 to 64 years (6%). In patients 65 years and older, the incidence of fever (2%) was lower than that in younger patients. Chills were also reported in 0.4% of patients. After the booster dose, fever (6.3%) was reported.[67669]
Nausea and vomiting was reported after Novavax COVID-19 vaccine administration in patients 12 to 17 years (23.1%) and in patients 18 to 64 years (15.6%). In patients 65 years and older, the incidence of nausea and vomiting (7.3%) was lower than that in younger patients. Anorexia or decreased appetite was reported in 0.3% of patients receiving the Novavax COVID-19 vaccine during clinical trials. After the booster dose, nausea and vomiting (14.7%) was reported.[67669]
Within 7 days of any dose, hypersensitivity reactions (including urticaria, hypersensitivity, angioedema, and swelling of the face, lips, ear and/or eyelids) were reported by 0.1% of patients receiving the Novavax COVID-19 vaccine and 0.03% of patients receiving placebo. Of these events, 1 reaction (generalized urticaria and facial angioedema lasting for 2 days) was serious and occurred 2 days after Dose 1 of the vaccine. Anaphylactoid reactions were reported during postmarketing experience.[67669]
Lymphadenopathy-related adverse reactions, including lymphadenopathy, lymphadenitis, lymph node pain, and axillary pain, were reported in 0.3% (18 to 64 years) and 0.9% (12 to 17 years) of patients receiving the Novavax COVID-19 vaccine during clinical trials.[67669]
Myocarditis and/or pericarditis were reported by 2 patients after the Novavax COVID-19 vaccine. The first patient was a 67-year-old male reporting the reaction 28 days after Dose 1 and the second patient was a 20-year-old male reporting the reaction 10 days after Dose 1. Additionally, myocarditis was reported in 2 patients, a 16-year-old patient 2 days after Dose 2 and a 28-year-old male 3 days after a booster dose. The adverse reaction after the booster dose was adjudicated as a non-ST elevation myocardial infarction; however, clinical features were also consistent with myocarditis (chest pain and elevated troponin). No cardiac catheterization or cardiac MRI was performed during the acute presentation. Among the 4 reported events, 3 were reported as resolved and the fourth did not have follow-up available. In a study with a recombinant spike protein COVID-19 vaccine manufactured by a different process than the Novavax COVID-19 vaccine, myocarditis was reported in a 19-year-old male and pericarditis in a 60-year-old female within 10 days of administration of Dose 2 and Dose 1, respectively. Both events were reported as resolved. These reports provide evidence of increased risk of myocarditis and pericarditis after Novavax COVID-19 vaccine administration. Additionally, myocarditis and pericarditis have been reported during postmarketing experience.[67669]
Cardiomyopathy or cardiac failure was reported by 8 patients (0.03%) after the Novavax COVID-19 vaccine compared to 1 patient (less than 0.01%) after placebo. All events were serious. Additionally, an event of congestive heart failure was reported after Novavax COVID-19 vaccination by a patient who was excluded from the safety analysis. Current available information on cardiomyopathy or cardiac failure is insufficient to determine a causal relationship with the vaccine.[67669]
Acute cholecystitis was reported by 6 patients (0.02%) after the Novavax COVID-19 vaccine compared to 2 patients (0.01%) after placebo. All events were serious. Current available information on acute cholecystitis is insufficient to determine a causal relationship with the vaccine.[67669]
A total of 12 non-cardiac, non-neurovascular thrombotic and embolic events were reported by 11 patients (0.04%) after the Novavax COVID-19 vaccine and a total of 7 events were reported by 9 patients (0.03%) after placebo. Events included pulmonary embolism (n = 5), deep vein thrombosis (n = 2), thrombosis (n = 2), and portal vein thrombosis, mesenteric artery thrombosis, and peripheral arterial occlusive disease (n = 1 each). Of the events, 6 were serious including pulmonary embolism (n = 5) and deep vein thrombosis (n = 1). Events after placebo included pulmonary embolism (n = 3), deep vein thrombosis, and peripheral arterial occlusive disease (n = 2 each). Current available information on non-cardiac, non-neurovascular thrombotic and embolic events is insufficient to determine a causal relationship with the vaccine.[67669]
Uveitis, including iritis, uveitis, iridocyclitis, was reported by 3 patients (0.01%) after the Novavax COVID-19 vaccine and 2 patients (0.01%) after placebo. All events were non-serious. One patient had onset of uveitis after Dose 1 of the vaccine which resolved and then recurred after Dose 2. The 2 placebo patients appeared to have a previous history of uveitis and 1 of the Novavax COVID-19 vaccine patients had a history of iritis. Current available information on uveitis is insufficient to determine a causal relationship with the vaccine.[67669]
In a study with a recombinant spike protein COVID-19 vaccine manufactured by a different process than the Novavax COVID-19 vaccine, Guillain-Barre syndrome was reported 9 days after administration of Dose 1 of the vaccine.[67669]
Paresthesias and hypoesthesia were reported during postmarketing use of the Novavax COVID-19 vaccine.[67669]
References
Contraindications/Precautions
Absolute contraindications are italicized.
- acquired immunodeficiency syndrome (AIDS)
- agammaglobulinemia
- anticoagulant therapy
- breast-feeding
- chemotherapy
- coagulopathy
- corticosteroid therapy
- hemophilia
- human immunodeficiency virus (HIV) infection
- hypogammaglobulinemia
- immunosuppression
- neoplastic disease
- pregnancy
- radiation therapy
- severe combined immunodeficiency (SCID)
- syncope
- thrombocytopenia
- vitamin K deficiency
The COVID-19 vaccine is contraindicated in patients with a history of a severe allergic reaction to any component of the vaccine.[67669] The CDC considers an immediate allergic reaction (occurring within 4 hours of administration) of any severity to a previous dose of COVID-19 vaccine or any of its components or a severe allergic reaction (i.e., anaphylaxis) after a previous dose or to a component of the COVID-19 vaccine a contraindication to COVID-19 vaccination. Administration of antihistamines is not recommended for allergic reaction prophylaxis prior to vaccination as they can mask cutaneous symptoms and delay the diagnosis and management of anaphylaxis. As with any biologic product, the prescriber or healthcare professional should have procedures in place to manage allergic reactions. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and immediately discontinue administration of the vaccine. The healthcare 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 vaccine.[66175][67669] When vaccinating patients with allergies, a 30 minute observation period is recommended for patients with a history of an immediate allergic reaction of any severity to a vaccine or injectable therapy, patients with a history of anaphylaxis due to any cause, or patients with a contraindication to a different COVID-19 vaccine than the 1 they are receiving. A 15 minute observation period is recommended for all other patients.[66175]
Immunocompromised patients, including patients with immunosuppression or receiving immunosuppressive therapy, may not have an adequate immune response to the COVID-19 vaccine.[67669] Patients with autoimmune conditions may receive the COVID-19 vaccine. Counsel patients about the unknown vaccine safety profile and effectiveness in immunocompromised patients, the potential for reduced immune responses, and the need to continue following precautions to avoid exposure to the SARS-CoV-2 virus. 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. COVID-19 vaccines may be administered without regard to timing of corticosteroid treatment, including topical or intraarticular treatment, bursal, or tendon injection.[65107] [66175] Ideally, COVID-19 vaccination should be completed at least 2 weeks before initiation of immunosuppressive therapies. When it is not possible to administer the COVID-19 vaccine in advance, people on immunosuppressive therapy can still receive COVID-19 vaccination. Antibody testing is not recommended to assess for immunity after COVID-19 vaccination. Re-vaccination is not recommended after immune competence is regained in patients who received the COVID-19 vaccine during treatment with immunosuppressive drugs. For patients receiving antibody therapies not specific to COVID-19 treatment (e.g., intravenous immunoglobulin, RhoGAM), there is no recommended minimum interval between these therapies and administration of COVID-19 vaccines. Administration of the COVID-19 vaccine either together or at any interval before or after receipt of an antibody-containing product is unlikely to substantially impair the development of a protective antibody response.[66175]
Patients with altered immune states due to generalized neoplastic disease or an immune system compromised by radiation therapy or chemotherapy may not have an adequate immune response to the COVID-19 vaccine. Data suggest immune response to COVID-19 vaccination may be reduced in patients receiving chemotherapy for cancer, patients with hematologic cancers (i.e., chronic lymphocytic leukemia), patients receiving stem cells or organ transplants, and in patients receiving certain medications that may blunt the immune response to vaccination (e.g., mycophenolate, rituximab, azathioprine, anti-CD20 monoclonal antibodies, Bruton tyrosine kinase inhibitors).[65107] [66175] [67669] Counsel patients about the unknown vaccine safety profile and effectiveness in immunocompromised patients, the potential for reduced immune responses, and the need to continue following precautions to avoid exposure to the SARS-CoV-2 virus. Ideally, complete COVID-19 vaccination at least 2 weeks before initiation or resumption of immunosuppressive therapies, but timing of COVID-19 vaccination should take into consideration current or planned immunosuppressive therapies and optimization of both the patient's medical condition and response to vaccine. Serologic testing or cellular immune testing to assess for immunity after COVID-19 vaccination, outside the context of research studies, is not recommended.[66175] Delay vaccination for at least 3 months after hematopoietic cell transplantation (HCT) or engineered cellular therapy (e.g., CAR-T cells) to maximize vaccine efficacy. For patients with hematologic malignancies receiving intensive cytotoxic chemotherapy (e.g., cytarabine/anthracycline-based induction regimens for AML), delay vaccination until absolute neutrophil count (ANC) recovery. For patients with solid tumor malignancies undergoing major surgery, separate date of surgery from vaccination by at least a few days to allow symptoms (e.g. fever) to be correctly attributed to surgery vs. vaccination. For more complex surgeries (e.g. splenectomy or surgery that may lead to an immunosuppressive state) surgeons may recommend a wider window (+/- 2 weeks) from the time of surgery.[66335]
Efficacy information for the COVID-19 vaccine is not yet available in patients with chronic, stable human immunodeficiency virus (HIV) infection and although patients with HIV infection or acquired immunodeficiency syndrome (AIDS) could have a diminished response, the COVID-19 vaccine should be offered to patients with chronic, stable HIV.[65107] Counsel patients about the unknown vaccine safety profile and effectiveness in immunocompromised patients, the potential for reduced immune responses, and the need to continue following precautions to avoid exposure to the SARS-CoV-2 virus.[66175]
The COVID-19 vaccine is administered by intramuscular (IM) injection only. Carefully consider the risks and benefits in patients at increased risk for bleeding after an intramuscular injection, such as thrombocytopenia, bleeding disorders (e.g., hemophilia), coagulopathy, vitamin K deficiency, and those receiving anticoagulant therapy. Caution and appropriate precautions to minimize the risk of bleeding or hematoma formation are advised.[65107] [67669]
The available data regarding use of the Novavax COVID-19 vaccine during pregnancy is insufficient to inform a vaccine-associated risk. Animal data did not reveal evidence of impaired fertility or harm to the fetus when administered at doses containing the same quantity of SARS-CoV-2 recombinant spike protein (5 mcg), one-fifth the quantity of adjuvant (10 mcg), and inactive ingredients contained in a single dose of the Novavax COVID-19 vaccine. A pregnancy exposure registry is available that monitors pregnancy outcomes in women vaccinated with the Novavax COVID-19 vaccine during pregnancy. Encourage women vaccinated during pregnancy to enroll in the registry by going to https://c-viper.pregistry.com.[67669]
There are insufficient data to assess the effects of the Novavax COVID-19 vaccine during breast-feeding, on milk production, and excretion in human breast milk.[67669]
Injectable vaccines, including the Novavax COVID-19 vaccine, have been associated with episodes of syncope and fainting. Prior to administration, ensure procedures are in place to prevent falls and manage syncopal reactions. Patients should remain seated or lying down during the observation period to decrease the risk for injury. If syncope develops, observe patients until symptoms resolve.[66175] [67669]
References
Mechanism of Action
The Novavax COVID-19 vaccine contains purified, full-length recombinant spike (rS) protein. It uses a combination of spike proteins that are tethered to the surface of a particle, called nanoparticles, and an adjuvant to boost the immune response. The vaccine produces an immune response to the rS protein, which protects against COVID-19.[67669][67783]
Revision Date: 07/14/2022, 10:46:44 AMReferences
Pharmacokinetics
The COVID-19 vaccine is administered intramuscularly. Vaccination does not ensure immunity.[67669]
Affected cytochrome P450 isoenzymes: none
Route-Specific Pharmacokinetics
Intramuscular Route
Noninferior immune responses were demonstrated by geometric mean titers (GMTs) and seroconversion rates (SCR) in a comparison of patients 12 to 17 years to patients 18 to 25 years. Noninferior immune responses were demonstrated by the GMT ratio of neutralizing antibody titers (MN50) after the booster dose compared to the primary series. Fourteen days after dose 2 of Novavax COVID-19 vaccine, the neutralizing GMTs were 3,859.6 (95% CI, 3,422.8 to 4,352.1) for patients 12 to 17 years and 2,611.8 (95% CI, 2,367.4 to 2,881.5) for patients 18 to 25 years. The geometric mean ratio (GMR) was 1.47 (95% CI, 1.26 to 1.72) in patients 12 to 17 years/18 to 25 years. Fourteen days after dose 2 of Novavax COVID-19 vaccine, the SCR was 98.7% (95% CI, 97% to 99.6%) for patients 12 to 17 years and 99.8% (95% CI, 98.7% to 100%) for patients 18 to 25 years. In patients 18 years and older, the neutralizing antibody geometric titers (MN50) at 28 days after a booster dose were 5,075.6 (95% CI, 4,448.3 to 5,791.4) and 1,505.7 (95% CI, 1,244.1 to 1,822.3) 14 days after completion of the primary series.[67669]
References
Pregnancy/Breast-feeding
pregnancy
The available data regarding use of the Novavax COVID-19 vaccine during pregnancy is insufficient to inform a vaccine-associated risk. Animal data did not reveal evidence of impaired fertility or harm to the fetus when administered at doses containing the same quantity of SARS-CoV-2 recombinant spike protein (5 mcg), one-fifth the quantity of adjuvant (10 mcg), and inactive ingredients contained in a single dose of the Novavax COVID-19 vaccine. A pregnancy exposure registry is available that monitors pregnancy outcomes in women vaccinated with the Novavax COVID-19 vaccine during pregnancy. Encourage women vaccinated during pregnancy to enroll in the registry by going to https://c-viper.pregistry.com.[67669]
breast-feeding
There are insufficient data to assess the effects of the Novavax COVID-19 vaccine during breast-feeding, on milk production, and excretion in human breast milk.[67669]
References
Interactions
Level 3 (Moderate)
- Abatacept
- Abemaciclib
- Abrocitinib
- Acalabrutinib
- Adalimumab
- Ado-Trastuzumab emtansine
- Afatinib
- Alectinib
- Alemtuzumab
- Alpelisib
- Altretamine
- Aminolevulinic Acid
- Amivantamab
- Anakinra
- Anifrolumab
- Antithymocyte Globulin
- Arsenic Trioxide
- Asciminib
- Asparaginase Erwinia chrysanthemi
- Avacopan
- Avapritinib
- Axicabtagene Ciloleucel
- Axitinib
- Azacitidine
- Azathioprine
- Belantamab mafodotin
- Belatacept
- Belimumab
- Belinostat
- Belumosudil
- Bendamustine
- Benralizumab
- Betamethasone
- Bevacizumab
- Bexarotene
- Binimetinib
- Bleomycin
- Blinatumomab
- Bortezomib
- Bosutinib
- Brentuximab vedotin
- Brexucabtagene Autoleucel
- Brigatinib
- Brodalumab
- Budesonide
- Budesonide; Formoterol
- Budesonide; Glycopyrrolate; Formoterol
- Busulfan
- Cabazitaxel
- Cabozantinib
- Calaspargase pegol
- Canakinumab
- Capecitabine
- Capmatinib
- Carboplatin
- Carfilzomib
- Carmustine, BCNU
- Ceritinib
- Certolizumab pegol
- Cetuximab
- Chlorambucil
- Ciltacabtagene Autoleucel
- Cisplatin
- Cladribine
- Clofarabine
- Cobimetinib
- Copanlisib
- Corticosteroids (systemic)
- Cortisone
- Crizotinib
- Cyclophosphamide
- Cyclosporine
- Cytarabine, ARA-C
- Dabrafenib
- Dacarbazine, DTIC
- Daclizumab
- Dacomitinib
- Dactinomycin, Actinomycin D
- Daratumumab
- Daratumumab; Hyaluronidase
- Dasatinib
- Daunorubicin
- Daunorubicin Liposomal
- Daunorubicin Liposomal; Cytarabine Liposomal
- Decitabine
- Decitabine; Cedazuridine
- Deflazacort
- Denileukin Diftitox
- Denosumab
- Deucravacitinib
- Dexamethasone
- Dinutuximab
- Docetaxel
- Dostarlimab
- Doxorubicin
- Doxorubicin Liposomal
- Dupilumab
- Duvelisib
- Eculizumab
- Efgartigimod Alfa
- Elotuzumab
- Emapalumab
- Enasidenib
- Encorafenib
- Enfortumab vedotin
- Entrectinib
- Epirubicin
- Erdafitinib
- Eribulin
- Erlotinib
- Estramustine
- Etanercept
- Etoposide, VP-16
- Everolimus
- Fam-Trastuzumab deruxtecan
- Fedratinib
- Fingolimod
- Floxuridine
- Fludarabine
- Fludrocortisone
- Fluorouracil, 5-FU
- Fostamatinib
- Gefitinib
- Gemcitabine
- Gemtuzumab Ozogamicin
- Gilteritinib
- Glasdegib
- Golimumab
- Guselkumab
- Hydrocortisone
- Hydroxyurea
- Ibritumomab Tiuxetan
- Ibrutinib
- Idarubicin
- Idecabtagene Vicleucel
- Idelalisib
- Ifosfamide
- Imatinib
- Immunosuppressants
- Inebilizumab
- Infigratinib
- Infliximab
- Inotuzumab Ozogamicin
- Iobenguane I 131
- Irinotecan
- Irinotecan Liposomal
- Isatuximab
- Ivosidenib
- Ixabepilone
- Ixazomib
- Ixekizumab
- L-Asparaginase Escherichia coli
- Lapatinib
- Larotrectinib
- Leflunomide
- Lenvatinib
- Lisocabtagene Maraleucel
- Lomustine, CCNU
- Loncastuximab Tesirine
- Lorlatinib
- Lurbinectedin
- Lutetium Lu 177 dotatate
- Margetuximab
- Mechlorethamine, Nitrogen Mustard
- Melphalan
- Melphalan Flufenamide
- Mepolizumab
- Mercaptopurine, 6-MP
- Methotrexate
- Methoxsalen
- Methylprednisolone
- Midostaurin
- Mitomycin
- Mitotane
- Mitoxantrone
- Mobocertinib
- Mogamulizumab
- Moxetumomab pasudotox
- Mycophenolate
- Nanoparticle Albumin-Bound Paclitaxel
- Nanoparticle Albumin-Bound Sirolimus
- Natalizumab
- Naxitamab
- Necitumumab
- Nelarabine
- Neratinib
- Nilotinib
- Niraparib
- Obinutuzumab
- Ocrelizumab
- Ofatumumab
- Olaparib
- Olaratumab
- Omacetaxine
- Omalizumab
- Osimertinib
- Oxaliplatin
- Ozanimod
- Paclitaxel
- Palbociclib
- Panitumumab
- Panobinostat
- Pazopanib
- Pegaspargase
- Pegcetacoplan
- Pemetrexed
- Pemigatinib
- Pentostatin
- Pertuzumab
- Pertuzumab; Trastuzumab; Hyaluronidase
- Pexidartinib
- Plicamycin
- Polatuzumab Vedotin
- Ponatinib
- Ponesimod
- Porfimer
- Pralatrexate
- Pralsetinib
- Prednisolone
- Prednisone
- Procarbazine
- Radium-223 Dichloride
- Ramucirumab
- Ravulizumab
- Regorafenib
- Reslizumab
- Ribociclib
- Ribociclib; Letrozole
- Rilonacept
- Ripretinib
- Rituximab
- Rituximab; Hyaluronidase
- Romidepsin
- Rucaparib
- Ruxolitinib
- Sacituzumab Govitecan
- Sarilumab
- Secukinumab
- Selinexor
- Selpercatinib
- Selumetinib
- Siltuximab
- Siponimod
- Sirolimus
- Sonidegib
- Sorafenib
- Sotorasib
- Spesolimab
- Streptozocin
- Sunitinib
- Tacrolimus
- Tafasitamab
- Tagraxofusp
- Talazoparib
- Talimogene Laherparepvec
- Tazemetostat
- Tebentafusp
- Temozolomide
- Temsirolimus
- Teniposide
- Tepotinib
- Teriflunomide
- Tezepelumab
- Thioguanine, 6-TG
- Thiotepa
- Tisagenlecleucel
- Tisotumab Vedotin
- Tivozanib
- Tocilizumab
- Tofacitinib
- Topotecan
- Tositumomab
- Trabectedin
- Tralokinumab
- Trametinib
- Trastuzumab
- Trastuzumab; Hyaluronidase
- Tretinoin, ATRA
- Triamcinolone
- Trifluridine; Tipiracil
- Trilaciclib
- Tucatinib
- Ublituximab
- Umbralisib
- Upadacitinib
- Ustekinumab
- Vandetanib
- Vedolizumab
- Vemurafenib
- Venetoclax
- Vinblastine
- Vincristine
- Vincristine Liposomal
- Vinorelbine
- Vismodegib
- Voclosporin
- Vorinostat
- Zanubrutinib
- Ziv-Aflibercept
References
Monitoring Parameters
- laboratory monitoring not necessary
US Drug Names
- Novavax COVID-19
