COVID-19 vaccine, viral vector-Janssen (Investigational)

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%)

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.

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

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

• Refrigerated: 2-8ºC (36-46ºF) and protect form light; do not freeze
• Room temperature: 9-25ºC (47-77ºF) for up to 12 hr

Opened vials

• Refrigerated: 2-8ºC (36-46ºF) for up to 6 hr, OR
• Room temperature: Maximally 25ºC (77ºF) for up to 2 hr
• Discard if vaccine is not used within these times