Clotting Risks Cause FDA to Restrict Use of J&J Vaccine
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Janssen (Johnson & Johnson 's) COVID-19 vaccine is now limited to certain individuals ages 18 and up after the U.S. Food and Drug Administration downgraded its emergency use authorization (EUA).
The regulator's decision came after finding that some people develop a greater risk of thrombosis with thrombocytopenia syndrome, a rare and possibly life-threatening blood clotting disorder. People with TTS have low blood platelet counts and the onset of symptoms happens around one to two weeks after receiving Janssen's COVID-19 vaccine.
The FDA has already updated the Fact Sheet for Healthcare Providers Administering Vaccine to reflect this change, including a warning statement at the beginning of the guideline to highlight the risk for TTS. The Fact Sheet for Recipients and Caregivers has been revised as well.
"We recognize that the Janssen COVID-19 Vaccine still has a role in the current pandemic response in the United States and across the global community. Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research, in a news release.
The FDA approved Janssen's COVID-19 vaccine for emergency use in February 2021 but then paused its use in April when the Centers for Disease Control and Prevention (CDC) started investigating six cases of TTS post-vaccine.
Approximately two weeks after the pause, the CDC's advisory committee and the FDA lifted the directive but confirmed that there had been 15 TTS cases reported, including the first six mentioned, out of about 8 million doses given. The health agencies then said that the benefits of Janssen's vaccine outweigh the risks for those 18 and older.
However, in December 2021, the CDC's Advisory Committee on Immunization Practices recommended preferential use of the Janssen product in individuals ages 18 years and up in the U.S.
The ACIP noted that the Janssen vaccine may be considered in certain situations, such as if the person is contraindicated to receive mRNA vaccines, if the person would remain unvaccinated because of limited access to mRNA vaccines, and if the person voluntarily chooses to receive the Janssen product despite the identified safety concerns. The directive also applies to booster doses.
"We've been closely monitoring the Janssen COVID-19 Vaccine and occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the EUA. The agency will continue to monitor the safety of the Janssen COVID-19 Vaccine and all other vaccines, and as has been the case throughout the pandemic, will thoroughly evaluate new safety information," Marks added.
The FDA continues to monitor the safety of all COVID-19 vaccines in the market, including those it has already approved and authorized for emergency use. It is working closely with the CDC, the Department of Veterans Affairs, the Centers for Medicare and Medicaid Services and other healthcare groups to ensure the safety and viability of vaccines in circulation.