COVID-19 vaccine, viral vector-Janssen

Dosing & Uses

ADULT Dosage Forms & Strengths injection, suspension

5x1010 virus particles/0.5mL (5 doses per vial)

COVID-19 Disease Prevention February 27, 2021: Emergency use authorization (EUA) issued by FDA for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals aged ≥18 years 0.5 mL IM as a single dose Dosing Considerations Limitations of effectiveness: May not protect all vaccine recipients Data unavailable on use of the Janssen COVID-19 vaccine to complete a vaccination series initiated with another COVID-19 vaccine Efficacy against moderate-to-severe/critical COVID-19

No overall differences in safety or efficacy were observed between individuals aged ≥65 yr and younger individuals
Aged 18-59 years
- 14 days post vaccination: 63.7%
- 28 days post vaccination: 66.1%

Aged ≥60 years
- 14 days post vaccination: 76.3%
- 28 days post vaccination: 66.2%

Efficacy against confirmed severe/critical COVID-19

Aged ≥18 years
- 14 days post vaccination: 76.7%
- 28 days post vaccination: 85.4%

Efficacy against severe/critical COVID-19 by variant Data as of February 12, 2021

United States
- 96.4% of strains identified as the Wuhan-H1 variant D614G during the trial
- 28 days post vaccination: 85.9%

Brazil
- 69.4% of strains identified as a variant of the P.2 lineage and 30.6% of strains identified as the Wuhan-H1 variant D614G
- 28 days post vaccination: 87.6%

South Africa
- 94.5% of strains identified as the 20H/501Y.V2 variant (B.1.351 lineage)
- 28 days post vaccination: 81.7%

Adverse Effects

Mandatory for vaccination providers to report to the vaccine adverse events reporting system (VAERS) all vaccine administration errors, serious adverse events, multisystem inflammatory syndrome in adults and children, and hospitalized or fatal cases of COVID-19 following vaccination May submit report online or fax it to VAERS at 1-877-721-0366 >10% 7 days post vaccination; aged 18-59 yr

Injection site pain (58.6%)
Headache (44.4%)
Fatigue (43.8%)
Myalgia (39.1%)
Use of antipyretic or pain medication (26.4%)
Nausea (15.5%)
Fever (12.8%)

7 days post vaccination; aged ≥60 yr

Injection site pain (33.3%)
Headache (30.4%)
Fatigue (29.7%)
Myalgia (24%)
Nausea (12.3%)

1-10% 7 days post vaccination; aged 18-59 yr

Injection site erythema (9%)
Injection site swelling (7%)
Myalgia, Grade 3 (1.4%)
Fatigue, Grade 3 (1.2%)

7 days post vaccination; aged ≥60 yr

Use of antipyretic or pain medication (9.8%)
Injection site erythema (4.6%)
Fever (3.1%)
Injection site swelling (2.7%)

<1% 7 days post vaccination; aged 18-59 yr

Grade 3
- Headache (0.9%)
- Injection site pain (0.4%)
- Injection site erythema (0.3%)
- Fever (0.3%)
- Injection site swelling (0.2%)
- Nausea (0.1%)

7 days post vaccination; aged ≥60 yr

Grade 3
- Fatigue (0.8%)
- Headache (0.4%)
- Injection site pain (0.2%)
- Injection site swelling (0.2%)
- Myalgia (0.2%)
- Injection site erythema (0.1%)
- Fever (0.1%)

Warnings

Contraindications Known history of severe allergic reaction (eg, anaphylaxis) to any component in vaccine Cautions Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have diminished immune response to the vaccine Vaccine may not protect all vaccine recipients Allergic reactions

Appropriate medical treatment used to manage immediate allergic reactions must be immediately available following vaccination
Individuals with histories of severe allergic reaction to vaccines should consult their doctors about the COVID-19 vaccine
Monitor vaccine recipients for immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines

Drug interaction overview

Data are not available to assess concomitant administration with other vaccines

Pregnancy

Data are insufficient to inform of vaccine-associated risks in pregnancy

Women vaccinated with Janssen COVID-19 vaccine are encouraged to enroll in the pregnancy exposure registry

CDC guidelines for vaccination of pregnant or lactating women

Lactation

Data are not available to assess effects on breastfed infants or on milk production/excretion

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Pharmacology

Mechanism of Action Vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector that after entering human cells, expresses the SARS-CoV-2 spike (S) antigen without virus propagation An immune response elicited to the S antigen protects against COVID-19

Administration

IM Preparation Suspension is a colorless to slightly yellow, clear to very opalescent suspension Visually inspect for particulate matter and discoloration; if either of these conditions exists, do not administer Carefully mix vial contents by swirling gently in an upright position for 10 seconds; do NOT shake Each dose is 0.5 mL; each vial contains 5 doses; do not pool excess vaccine from multiple vials IM Administration For IM injection only Storage Receiving shipment

Once received, do not freeze
Initially stored frozen by the manufacturer, then shipped at 2-8ºC (36-46ºF)
If vaccine is still frozen upon receipt, thaw in refrigerator at 2-8ºC (36-46ºF)
If needed immediately, thaw at room temperature (maximally 25ºC/77ºF)
At room temperature, a carton of 10 vials takes ~2 hr to thaw, and an individual vial takes ~1 hour to thaw
Do not refreeze once thawed

Unopened vials