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Mechanism of Action
US Drug Names
0.5 mL (5 x 1010 vp) IM once.
0.5 mL/dose IM.
Safety and efficacy have not been established.
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
NOTE: On April 13, the CDC and FDA recommended pausing the use of the Janssen COVID-19 vaccine to allow for review of preliminary data for 6 reported U.S. cases of cerebral venous sinus thrombosis (CVST) in combination with thrombocytopenia. All 6 cases occurred among women between the ages of 18 and 48, with symptoms occurring 6 to 13 days after vaccination. More than 6.8 million doses of the Janssen COVID-19 vaccine have been administered in the U.S.
The COVID-19 vaccine is an investigational vaccine that contains a recombinant replication-incompetent adenovirus type 26 vector encoding the viral spike glycoprotein (S) 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 for use under an Emergency Use Authorization (EUA) for active immunization for the prevention of coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in patients 18 years of age and older. There are many clinical trials underway for various COVID-19 vaccines. Within the United States, phase 3 clinical trials currently include mRNA vaccines, viral vector-based vaccines, and protein-based vaccines. Adenoviruses are often used for viral vector vaccines because they elicit a robust immune response. Adenovirus vector vaccines are easy to design and can be produced on a mass scale, making them well suited for pandemic response. In clinical trials, adenovirus COIVD-19 vaccines have been found to be safe and well-tolerated. The most commonly reported adverse drug reactions include injection site pain, headache, fatigue, and muscle pain. The Janssen COVID-19 vaccine is a single dose vaccine. In phase 1a of the vaccination program for COVID-19, the Advisory Committee on Immunization Practices (ACIP) recommends that both health care personnel and residents of long-term care facilities are the first to be offered the vaccine. Next, in phase 1b, frontline essential workers and persons aged 75 years and older will be offered vaccination. Phase 1c will consist of persons aged 65 to 74 years, persons aged 16 to 64 years with high-risk medical conditions, and essential workers not recommended for vaccination in Phase 1b. In the final phase (phase 2), all persons aged 16 years and older not previously recommended for vaccination are eligible.
Janssen Vaccine Trial Data
Efficacy data for the Janssen COVID-19 vaccine included 39,321 patients. Of the study participants who received the Janssen COVID-19 vaccine (n = 19,630), 55.6% were male and 44.3% were female, 62.1% were White, 17.2% were Black or African American, 8.4% were American Indian or Alaska Native, 3.7% were Asian, 0.3% were Native Hawaiian or other Pacific Islander, 5.3% were multiracial, and 3% were unknown or not reported. Additionally, 52.7% were not Hispanic or Latino, 44.8% were Hispanic or Latino, and 2.5% were unknown or not reported. Patients who were immunocompromised and those who had a previous clinical or microbiological diagnosis of COVID-19 disease were excluded, along with pregnant women. Patients with pre-existing stable disease, defined as diseases not requiring significant change in therapy or hospitalization for worsening disease during the 12 weeks before enrollment, were included as were participants with known stable infection with human immunodeficiency virus (HIV). In an interim analysis, there were 116 confirmed moderate to severe/critical COVID-19 cases in the Janssen COVID-19 vaccine group and 348 cases in the placebo group with onset at least 14 days after vaccination (vaccine efficacy of 66.9%). There were 66 confirmed moderate to severe/critical COVID-19 cases in the Janssen COVID-19 vaccine group and 193 cases in the placebo group with onset at least 28 days after vaccination (vaccine efficacy of 66.1%). In general, vaccine efficacy was similar among patients at risk of severe COVID-19 disease including those with 1 or more comorbidities that increase the risk of severe COVID-19 disease (e.g., asthma, BMI 30 kg/m2 or more, chronic pulmonary disease, diabetes mellitus, hypertension). A lower vaccine efficacy against moderate to severe/critical COVID-19 with onset at least 28 days after vaccination was observed for the subgroup of patients 60 years of age and older with comorbidities compared to the overall population, but with an observed trend of increasing vaccine efficacy as the number of cases included in the analysis increased.
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, parent, or caregiver information consistent with the "Fact Sheet for Recipients and Caregivers" prior to the patient receiving the vaccine, including:
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 Multisystem Inflammatory Syndrome (MIS) in adults, and cases of COVID-19 that result in hospitalization or death after administration of the vaccine.
Janssen COVID-19 vaccine
Local injection site reaction was the most commonly reported adverse reaction after COVID-19 vaccine administration during clinical trials. After Janssen COVID-19 vaccine administration, injection pain (33.3% to 58.6% vs. 15.6% to 17.4% placebo), erythema (4.6% to 9% vs 3.2% to 4.3% placebo), and swelling (2.7% to 7% vs 1.6% placebo) at the injection site were the most common reactions. One patient reported severe pain in the injected arm at the time of vaccination that was not responsive to analgesics and was ongoing 74 days after vaccination. All local adverse reactions were reported more frequently in the younger (18 to 59 years) patients compared to the older (60 years and older) patients.
During clinical trials, headache (30.4% to 44.4% vs. 22.1% to 24.8% placebo) and fatigue (29.7% to 43.8% vs. 20.8% to 22% placebo) occurred after administration of the Janssen COVID-19 vaccine. One patient reported severe generalized weakness, fever, and headache, with onset on the day after vaccination and resolution 3 days after vaccination.
Musculoskeletal adverse reactions reported during COVID-19 vaccine clinical trials include myalgia (24% to 39.1% vs. 12.1% to 13.7% placebo).
Nausea (12.3% to 15.5% vs. 8.9% to 10.8% placebo) was reported during COVID-19 vaccine clinical trials.
During clinical trials, fever (3.1% to 12.8% vs. 0.5% to 0.7% placebo) occurred after administration of the COVID-19 vaccine.
Serious allergic reactions, including anaphylactoid reactions, have been reported in Janssen COVID-19 vaccine clinical trials. One case of anaphylaxis was reported in an ongoing, open-label study. Urticaria (all non-serious) was reported in 5 patients receiving the Janssen COVID-19 vaccine and in 1 patient who received placebo in the 7 days after vaccination. Additionally, 1 patient vaccinated with the Janssen COVID-19 vaccine reported urticaria beginning 2 days after vaccination and angioedema of the lips with no respiratory distress beginning 4 days after vaccination.
During Janssen COVID-19 vaccine clinical trials, 1 case of Guillain-Barre syndrome was reported in a patient in the vaccine group compared to 1 case in the placebo group.
Thromboembolic events were reported during Janssen COVID-19 vaccine clinical trials. In vaccinated patients, 6 events of deep vein thrombosis (2 serious; 5 within 28 days of vaccination) were reported compared to 2 events (1 serious; 2 within 28 days of vaccination) with placebo. Four events of pulmonary embolism (3 serious; 2 within 28 days of vaccination) were reported in vaccinated patients compared to 1 event (serious; within 28 days of vaccination) in a placebo patient. One event of transverse sinus thrombosis (serious; within 28 days of vaccination) occurred in a vaccinated patient compared to none in patients receiving placebo. A causal relationship of these events to the COVID-19 vaccine cannot be determined. Six cases of cerebral venous sinus thrombosis (CVST) in combination with thrombocytopenia have been reported after administration of the Janssen COVID-19 vaccine. These adverse reactions appear to be rare; however, preliminary data are being reviewed. All 6 cases occurred among women between the ages of 18 and 48, with symptoms occurring 6 to 13 days after vaccination. The use of heparin to treat this type of thrombosis is not recommended; alternative treatments should be used.
In patients vaccinated with the Janssen COVID-19 vaccine, 4 events of seizures (1 serious; 4 within 28 days of vaccination) were reported compared to 1 event (0 serious; 0 within 28 days of vaccination) in patients receiving placebo. A causal relationship of these events to the COVID-19 vaccine cannot be determined.
In patients vaccinated with the Janssen COVID-19 vaccine, 6 events of tinnitus (0 serious; 6 within 28 days of vaccination, including 3 within 2 days of vaccination) were reported; no events were reported in patients receiving placebo. A causal relationship of these events to the COVID-19 vaccine cannot be determined.
The COVID-19 vaccine is contraindicated in patients with a history of a severe allergic reaction to any component of the vaccine. 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. A known polysorbate allergy is a contraindication to the Janssen COVID-19 vaccine. Polyethylene glycol (PEG) is an ingredient in both mRNA COVID-19 vaccines and polysorbate 80 is an ingredient in the Janssen COVID-19 vaccine; cross-reactive hypersensitivity between these compounds may occur. Patients with a contraindication to 1 type of COVID-19 vaccine (i.e, adenovirus) have a precaution to the other (i.e., mRNA). However, because of potential cross-reactive hypersensitivity between the ingredients in both vaccines, consider evaluation by an allergist-immunologist in patients with a known allergy to these ingredients before they receive 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. 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.
Immunocompromised patients, including patients with immunosuppression or receiving immunosuppressive therapy, may not have an adequate immune response to 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. 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.
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.  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. 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 chemotherapy or treatment with other immunosuppressive drugs. Vaccination should be delayed 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.
Clinical trials for the vaccine were expanded to include patients with chronic, stable human immunodeficiency virus (HIV) infection. Efficacy information for the COVID-19 vaccine is not yet available in this patient population 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. 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.
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.  Additionally, cerebral venous sinus thrombosis (CVST) in combination with thrombocytopenia has been reported after administration of the Janssen COVID-19 vaccine. These adverse reactions appear to be rare; however, preliminary data are being reviewed. Advise patients who develop a severe headache, abdominal pain, leg pain, or shortness of breath within 3 weeks of Janssen COVID-19 vaccine administration to contact their health care provider. The use of heparin to treat this type of thrombosis is not recommended; alternative treatments should be used.
Available data are insufficient to inform vaccine-associated risks during pregnancy. It is unknown whether administration of the COVID-19 vaccine can cause fetal harm or affect the reproductive system. The adenovirus vector used in the Janssen COVID-19 vaccine has been used for other Jannsen vaccines that have included pregnant patients vaccinated during any trimester, including a large-scale Ebola vaccination trial. No adverse pregnancy-related outcomes, including infant outcomes, were determined to be related to the vaccines in these trials. Experts believe that COVID-19 vaccines are unlikely to pose a risk to the pregnant patient or fetus. There are no recommendations for routine pregnancy testing before COVID-19 vaccination. Patients who are trying to become pregnant do not need to avoid pregnancy after COVID-19 vaccination. There is no evidence that any of the COVID-19 vaccines affect future fertility. A pregnancy exposure registry is available that monitors pregnancy outcomes in women exposed to Janssen COVID-19 vaccine during pregnancy. Encourage women vaccinated with the Janssen COVID-19 vaccine to enroll in the registry by visiting https://c-viper.pregistry.com. In a reproductive developmental toxicity study, 1 mL of Janssen COVID-19 vaccine was administered to female rabbits by the IM route on 3 occasions. No vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported.
There are no data regarding use of the COVID-19 vaccine during breast-feeding and its excretion in human breast milk is unknown. If a breast-feeding infant experiences an adverse event possibly related to a maternally administered vaccine, health care providers are encouraged to report the adverse event to the FDA.
The Janssen COVID-19 vaccine is a monovalent vaccine composed of a recombinant replication-incompetent human adenovirus type 26 (Ad26) vector, constructed to encode the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) spike (S) protein. After binding of the Ad26 vector to cellular receptors and transduction of the cell, episomal vector DNA drives cellular production of the transgene encoded S protein. The S protein is then expressed on the cell membrane resulting in humoral and cellular immune responses directed against the SARS-CoV-2 S protein.
The COVID-19 vaccine is administered intramuscularly. Vaccination does not ensure immunity.
Affected cytochrome P450 isoenzymes: none
Neutralizing antibody titers against wild-type virus were detected in 96% of participants aged 18 to 55 years and 96% of participants aged 65 years and older by Day 29. Neutralizing antibody concentrations were maintained in patients aged 18 to 55 years up to at least Day 85 and up to at least Day 87 for patients 65 years and older.
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