The U.S. Food & Drug Administration (FDA) has updated the emergency use authorization (EUA) of the Johnson & Johnson (Janssen) COVID-19 vaccine to limit the vaccine’s use to individuals 18 years old and older for whom other COVID-19 vaccines are not accessible or clinically appropriate, or for individuals who choose to receive the vaccine because they would otherwise not receive a COVID-19 vaccine.
- People who experienced an anaphylactic reaction after receiving an mRNA COVID-19 vaccine
- People with personal concerns about receiving mRNA vaccines who would otherwise not receive a COVID-19 vaccine
- People who would remain unvaccinated for COVID-19 due to limited access to mRNA COVID-19 vaccines.
This follows action by the Centers for Disease Control and Prevention (CDC) in December 2021, issuing a preferential recommendation for the use of mRNA COVID-19 vaccines over the Janssen COVID-19 vaccine. As part of ongoing vaccine safety monitoring and an updated analysis, the FDA has determined that the risk of thrombosis with thrombocytopenia syndrome (TTS), a syndrome of rare and potentially life-threatening blood clots in combination with low levels of blood platelets with onset of symptoms approximately one to two weeks following administration of the Janssen COVID-19 vaccine, warrants limiting the authorized use of the vaccine. The known and potential benefits of the vaccine for the prevention of COVID-19 outweigh the known and potential risks, according to ongoing analysis.
The Fact Sheet for Healthcare Providers Administering Vaccine has been updated to include revised authorized uses of the vaccine and includes a warning statement now at the beginning of the fact sheet to call out the risk for TTS. This information also has been added to the Fact Sheet for Recipients and Caregivers.
Physicians and other health care professionals should review the updated resources, and ensure all staff administering COVID-19 vaccines understand appropriate use of the vaccine and are prepared to discuss the vaccine’s authorized uses with patients who request the product or ask questions about the product, as well as safety considerations. Physicians and other health care professionals should continue to ensure vaccine recipients know about the signs and symptoms of TTS and when to seek emergency care.
- Fact Sheet for Healthcare Providers Administering Vaccine
- Fact Sheet for Recipients and Caregivers
- Janssen COVID-19 Vaccine Standing Orders for Administering Vaccine to Persons 18 Years of Age and Older
- Interim Clinical Considerations for Use of COVID-19 Vaccines in the United States.
For more information, visit coronavirus.ohio.gov. If you have any questions or issues, please contact the vaccine provider relations team between 8 a.m. and 5:30 p.m. Monday through Friday at 1.844.9ODHVAX (1.844.963.4829) or email COVIDVACCINE@odh.ohio.gov.