Is Johnson & Johnson’s Janssen COVID-19 vaccine safe?

Yes. Although use of the J&J vaccine was temporarily paused in April 2021, following a thorough safety review, U.S health officials determined that the recommended pause should be lifted and use of the vaccine should resume.

The two agencies have determined the following:

  • Use of the Janssen COVID-19 Vaccine should be resumed in the United States.
  • The FDA and CDC have confidence that this vaccine is safe and effective in preventing COVID-19.
  • The FDA has determined that the available data show that the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older.
  • At this time, the available data suggest that the chance of TTS occurring is very low, but the FDA and CDC will remain vigilant in continuing to investigate this risk.
  • Health care providers administering the vaccine and vaccine recipients or caregivers should review the Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Fact Sheet for Recipients and Caregivers, which have been revised to include information about the risk of this syndrome, which has occurred in a very small number of people who have received the Janssen COVID-19 Vaccine.

CDC’s independent Advisory Committee on Immunization Practices met to discuss the latest data on TTS, hearing from the vaccine manufacturer Janssen and the COVID-19 Vaccine Safety Technical (VaST) Subgroup, as well as a risk benefit analysis. ACIP is committed to be vigilant and responsive to additional information that could impact the risk benefit analysis of any of these vaccines. Vaccine safety monitoring will continue and any new information about TTS will be brought to ACIP as needed.

Update December 16, 2021

The Missouri Department of Health and Senior Services updated the standing orders for the Janssen COVID-19 vaccine to indicate that either authorized mRNA COVID-19 vaccines (Pfizer or Moderna) are preferred over the Janssen COVID-19 vaccine for the prevention of COVID-19 in individuals ages 18 years and older due to the risk of thrombosis with thrombocytopenia or Guillain-Barre (GBS) following vaccination. Clients medically unable to receive the mRNA COVID-19 vaccine or would otherwise not be vaccinated against COVID-19 may request the Janssen vaccine, and a CCPHC nurse may determine if the client is eligible for the vaccine.

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1. Are the available COVID-19 vaccines safe and effective?
2. Is it safe to get my child vaccinated?
3. Why did it take so long for the FDA to make a decision about vaccines for children under 5?
4. Is it safe to get vaccinated if I am pregnant or breastfeeding?
5. How was the vaccine developed so quickly?
6. What ingredients are used in the vaccines?
7. What are the possible side effects of a COVID-19 vaccine?
8. Who is NOT recommended for each vaccine?
9. Can I get COVID-19 from the vaccine?
10. Is Johnson & Johnson’s Janssen COVID-19 vaccine safe?
11. Does the Johnson & Johnson/Janssen vaccine require special precautions?