Johnson & Johnson COVID-19 Vaccine

Kathryn Dzintars, Pharm.D., BCPS

VACCINE TYPE

  • The Janssen COVID-19 vaccine is a suspension consisting of a replication-incompetent recombinant adenovirus type 26 (Ad26) vector expressing the SARS-CoV-2 spike (S) protein in a stabilized conformation.
    • Single intramuscular (IM) dose to be given to patients 18 years of age and older.
  • The U.S. FDA issued an Emergency Use Authorization (EUA) to permit the emergency use of the Janssen COVID-19 vaccine for active immunization to prevent COVID-19 in individuals 18 years of age and older.
    • Mandatory requirements for the administration of the Janssen vaccine under the EUA are as follows:
      • The vaccine is authorized in patients ≥ 18 years of age.
      • The vaccination provider must give the individual receiving the Janssen vaccine or their caregiver the “Fact Sheet for Recipients and Caregivers” prior to the individual receiving Janssen vaccine.
      • Vaccine providers must include vaccine information to either the state’s or local jurisdiction’s Immunization Information System or other designated systems.
      • Vaccine providers are responsible for reporting certain events to the Vaccine Adverse Events Reporting System (VAERS):
        • Vaccine administration errors whether or not associated with an adverse event
        • Serious adverse events including death, life-threatening adverse events, inpatient hospitalization/prolonged hospitalization, persistent or significant incapacity, congenital anomaly/birth defects
        • Cases of the multisystem inflammatory syndrome (MIS) in children and adults
        • Cases of COVID-19 that result in hospitalization and death
      • Vaccine providers are responsible for responding to FDA requests for information about vaccine administration errors, adverse events, cases of MIS in adults and children, and cases of COVID-19 that result in hospitalization or death following administration of Janssen vaccine to recipients.

INDICATIONS

ACIP RECOMMENDATIONS

  • On February 28, 2021, ACIP voted in favor of the interim recommendation for use of the Janssen vaccine for individuals ≥ 18 years of age.
  • The EUA Fact Sheet for Recipients and Caregivers should be provided to vaccine recipients, and recipients should be counseled on local and systemic reactions.

FORMS

Brand Name

Preparation

Manufacturer

Route

Form

Dosage

Cost

Recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector vaccine, encoding the stabilized prefusion spike glycoprotein of SARS-CoV-2

Janssen

IM

Multidose vials (each vial contains 5 vaccines)

0.5 mL as a single dose

N/A

PATHOGEN DIRECTED PROTECTION

  • COVID-19

DOSE/ADMINISTRATION

Adult PRIMARY SERIES

  • Single-dose, intramuscular injection (0.5mL)
  • Store unpunctured, multidose vials of vaccine at 2ºC to 8ºC (36ºF to 46ºF) and protect from light
    • Vials should not be stored as frozen.
    • Unpunctured vials of the vaccine can be stored at 9ºC to 25ºC (47ºF to 77ºF) for 12 hours.
  • After the first dose has been withdrawn, the vial can be stored at 2ºC to 8ºC (36ºF to 46ºF) for up to 6 hours or at room temperature for 2 hours.

Adult BOOSTER

N/A

Pediatric PRIMARY SERIES

  • This vaccine is only recommended for patients ≥18 years of age.

ADVERSE DRUG REACTIONS

GENERAL

  • In general, the Janssen COVID-19 vaccine is well tolerated.
  • Severe allergic reactions, including anaphylaxis, have been reported following administration of the Janssen COVID-19 vaccine.

COMMON

  • Pain, redness, and swelling at the injection site.
  • Fever
  • Fatigue
  • Headache
  • Chills
  • Diarrhea
  • Muscle and joint pain

VACCINE/DRUG INTERACTIONS

  • No data are available assessing the incidence of drug-drug interactions with the Janssen COVID-19 vaccine.

CONTRAINDICATIONS

  • Do not administer the Janssen COVID-19 vaccine to individuals with a known history of a severe allergic reaction (e.g. anaphylaxis) to any component of the Janssen COVID-19 vaccine.

IMMUNE RESPONSE

  • Neutralizing-antibody titers against wild-type virus were detected in 90% or more of all participants on day 29 after the first vaccine dose (geometric mean titer [GMT], 224 to 354), regardless of vaccine dose or age group

CLINICAL EFFICACY

  • An ongoing, multinational, placebo-controlled, double-blind safety and efficacy trial in individuals ≥ 18 years of age were randomized 1:1 to receive either placebo or the Janssen COVID-19 vaccine.
    • 43,783 subjects enrolled in this study, of whom 21,985 received the Janssen vaccine
      • Randomized subjects were stratified by age (18 - 59 years, > 59 years) and the presence/absence of comorbidities.
    • Primary efficacy analysis was the first occurrence of moderate to severe/critical COVID-19 infection with an onset of symptoms at day 14 and day 28.
      • The median length of follow-up was 8 weeks, with 24 months planned duration.
      • At 14 days post-vaccination in the vaccine group, there were 95 cases of COVID-19 in the 18-59 age group (63.7% efficacy) and 21 cases in the > 59 years age group (76.3% efficacy), compared to 260 cases of COVID-19 in the placebo group aged 18-59 years and 88 cases of COVID-19 in the placebo group aged > 59 years. This translates to an overall efficacy of 66.9% among all subjects
      • At 28 days post-vaccination in the vaccine group, there were 52 cases of COVID-19 in the 18-59 age group (66.1% efficacy) and 14 cases in the > 59 years age group (66.2% efficacy) compared to 152 cases of COVID-19 in the placebo group aged 18-59 years and 41 cases of COVID-19 in the placebo group aged > 59 years. This translates to an overall efficacy of 66.1% among all subjects.
    • Subgroup analyses evaluating vaccine activity in countries with different circulating SARS-CoV-2 variants are pending.

OTHER INFORMATION

It is MANDATORY for vaccination providers to report to the Vaccine Adverse Event Reporting System (VAERS) all vaccine administration errors, all serious adverse events, cases of multisystem inflammatory syndrome (MIS) in adults and children, and hospitalized or fatal cases of COVID-19 following vaccination with the Janssen COVID-19 vaccine.

References

  1. Sadoff J, Le Gars M, Shukarev G, et al. Interim Results of a Phase 1-2a Trial of Ad26.COV2.S Covid-19 Vaccine. N Engl J Med. 2021.  [PMID:33440088]

    Comment: Multicenter, placebo-controlled, phase 1/2a trial healthy adults between the ages of 18 and 55 years (cohort 1) and those 65 years of age or older (cohort 3) were randomly assigned to receive the Ad26.COV2.S vaccine at a dose of 5×1010 viral particles (low dose) or 1×1011 viral particles (high dose) per milliliter or placebo in a single-dose or two-dose schedule. Neutralizing-antibody titers against wild-type virus were detected in 90% or more of all participants on day 29 after the first vaccine dose (geometric mean titer [GMT], 224 to 354), regardless of vaccine dose or age group. The incidence of adverse effects was similar between groups.

  2. Fact sheet for healthcare providers administering vaccine for the Emergency Use Authorization (EUA) of the Janssen COVID-19 vaccine to prevent COVID-19. https://www.fda.gov/media/146304/download. Accessed 6 March 2021.

    Comment:
    Information on the Janssen COVID-19 vaccine, including instructions for providers, dosage and administration instructions, and a summary of the current clinical data that is available. Preliminary analysis of Phase 3 trial data suggests 67% efficacy against SARS-CoV-2 with minimal adverse effects.


  3. Oliver SE, Gargano JW, Scobie H, et al. The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Janssen COVID-19 Vaccine — United States, February 2021. MMWR Morb Mortal Wkly Rep 2021;70:329–332. DOI: http://dx.doi.org/10.15585/mmwr.mm7009e4

    Comment: ACIP recommendations for the use of the Janssen COVID-19 vaccine, a single dose, intramuscular, recombinant vaccine against the spike protein of the SARS-CoV-2 virus.


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Last updated: March 11, 2021