VACCINE TYPE

• Janssen’s COVID-19 Vaccine is no longer available in the U.S.
  • All remaining U.S. government stock of Janssen COVID-19 Vaccine expired May 7, 2023.
  • Any remaining Janssen COVID-19 Vaccine should be disposed of per local, state, and federal regulations.
• The Janssen COVID-19 vaccine is a suspension 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 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 and older.
  • On May 5, 2022, the FDA revised the criteria for the EUA, limiting the vaccine’s use due to the perceived risk of thrombosis with thrombocytopenia syndrome (TTS) within 1 - 2 weeks after receipt of the vaccine.
    • Use of the Janssen COVID-19 vaccine is limited to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 vaccine because they would otherwise not receive a COVID-19 vaccine.
  • 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 the Janssen vaccine.
    • Vaccine providers must include vaccine information in 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 include death, life-threatening events, inpatient hospitalization/prolonged hospitalization, persistent or significant incapacity, and congenital anomalies/birth defects.
      • Cases of 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 the administration of the Janssen vaccine.
  • The CDC recommended that anyone 18 or older be given a booster shot at least 2 months after the initial dose.
    • Booster doses should be provided with one of the mRNA vaccines (Pfizer BioNTech or Moderna)
    • On March 29, 2022, the CDC recommended that a second booster dose with an available mRNA vaccine be provided 4 months after the initial booster.

INDICATIONS

FORMS

PATHOGEN DIRECTED PROTECTION

• COVID-19

DOSE/ADMINISTRATION

ADVERSE DRUG REACTIONS

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 who 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 on days 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.
• ENSEMBLE 2 is a Phase III, randomized, double-blind, placebo-controlled trial designed to evaluate both the safety and efficacy of a two-dose vaccine series given 8 weeks apart
  • Efficacy increased to 75% against moderate to severe COVID-19 and 94% against severe to critical disease.
  • Full data set pending publication
• After ongoing safety evaluation, the FDA determined the risk of thrombosis with thrombocytopenia syndrome (TTS) to be significant enough that routine vaccine use should be limited and revised the EUA criteria on May 5, 2022.
  • Use of the vaccine should be limited to subjects 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate and for individuals 18 years of age and older who elect to receive the Janssen COVID-19 vaccine because they would otherwise not receive a COVID-19 vaccine.
  • The EUA has been updated with information on the risk of TTS and the development of blood clots within 1 - 2 weeks of receiving the Janssen vaccine.

OTHER INFORMATION

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

• See https://vaers.hhs.gov/reportevent.html for instructions on reporting.

Basis for recommendation

1. Oliver SE, Wallace M, See I, et al. Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine: Updated Interim Recommendations from the Advisory Committee on Immunization Practices - United States, December 2021. MMWR Morb Mortal Wkly Rep. 2022;71(3):90-95.  [PMID:35051137]

   Comment: Due to cases of Guillian-Barre and thrombocytopenia with thrombosis, mRNA vaccines are preferred by ACIP/CDC.
   On December 16, 2021, after reviewing updated vaccine effectiveness and safety data, the Advisory Committee on Immunization Practices made a preferential recommendation for the use of mRNA COVID-19 vaccines over the Janssen adenoviral-vectored COVID-19 vaccine in all persons aged ≥18 years in the United States.
   What are the implications for public health practice?
   Pfizer-BioNTech or Moderna mRNA COVID-19 vaccines are preferred over the Janssen COVID-19 vaccine for primary and booster vaccination. The Janssen COVID-19 vaccine may be considered in some situations, including for persons with a contraindication to receipt of mRNA COVID-19 vaccines.
   

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 16 May 2022

   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--including new May 2022 limitations on use under the EUA. Preliminary analysis of Phase 3 trial data suggests 67% efficacy against SARS-CoV-2 with minimal adverse effects.
   To enhance durability, now an mRNA booster is recommended if not otherwise contraindicated due to severe allergic reactions.
   
   
   

3. Coronavirus (COVID-19) Update: FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals | FDA. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-u... (May 5, 2022)

   Comment: FDA announcement revising EUA criteria for use of the Janssen vaccine. Use is now limited to patients 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine due to the risk of thrombosis with thrombocytopenia syndrome.
   
   
   
   

References

4. Sadoff J, Gray G, Vandebosch A, et al. Final Analysis of Efficacy and Safety of Single-Dose Ad26.COV2.S. N Engl J Med. 2022;386(9):847-860.  [PMID:35139271]

   Comment: The trial performed earlier in the pandemic (pre-Delta and Omicron), saw 52.9% vaccine efficacy regarding severe–critical Covid-19. Protection varied according to variant; higher protection was observed against severe Covid-19, medical intervention, and death than against other end points and lasted for 6 months or longer
   

5. 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.
   

6. 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(9):329-332.  [PMID:33661860]

   Comment: Original ACIP recommendations for the Janssen/JNJ vaccine, now supplanted by newer recommendations.
   

7. Sarkar M, Madabhavi IV, Quy PN, et al. COVID-19 vaccine-induced immune thrombotic thrombocytopenia: A review. Ann Thorac Med. 2022;17(1):1-13.  [PMID:35198043]

   Comment: Rare reports of thrombocytopenia associated thrombosis with features similar to HIT arose with both the Janssen and Astra-Zeneca adenovirus-based vaccines. This review explores what is known and the potential cause.
   

8. CDC. COVID-19 Vaccine Boosters. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/booster-shot.html (accessed June 14, 2023)

   Comment: Detailed recommendations regarding all boosters, but also regarding the Janssen/JNJ vaccine recipients (mRNA recommended).