FDA restricts use of Johnson & Johnson COVID-19 vaccine
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The FDA has restricted the use of Johnson & Johnson’s COVID-19 vaccine based on an updated analysis of the risk for a rare but potentially deadly blood-clotting syndrome.
The vaccine will be available only to people aged 18 years or older “for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate” or “who elect to receive the [vaccine] because they would otherwise not receive a COVID-19 vaccine,” the FDA said.
The FDA said it based the restrictions on an updated analysis of the risk for thrombosis with thrombocytopenia syndrome (TTS), a rare disorder that occurs around 1 to 2 weeks after vaccination.
The CDC and FDA paused the rollout of the Johnson & Johnson vaccine last year over six cases of TTS that occurred out of the first 6.8 million doses of the vaccine administered in the United States. They lifted the pause after a couple of weeks.
The FDA’s most recent analysis of cases found that TTS occurs at a rate of 3.23 per million doses of Johnson & Johnson vaccine administered. The reporting rate of TTS deaths is 0.48 per 1 million doses of the vaccine administered, the analysis found.
The risk “warrants limiting the authorized use of the vaccine,” the FDA said, although it also found that the benefits of the vaccine outweigh the risks for adults who would otherwise not be able to receive one of the other COVD-19 vaccines.
“We recognize that the [vaccine] still has a role in the current pandemic response in the United States and across the global community,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release announcing the restrictions. “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.”
At the time the FDA authorized the vaccine in February 2021, it was heralded as a potential “game-changer” for the U.S. response because of its single-dose schedule and more forgiving transport and storage requirements. However, only around 3.2% of the more than 577 million doses of COVID-19 vaccine administered as of May 5 were the Johnson & Johnson shot, which was developed by the company’s subsidiary, Janssen.
In October, the FDA and CDC recommended that people who received the vaccine get a booster shot at 2 months, and in December the CDC’s Advisory Committee on Immunization Practices recommended the messenger RNA vaccines made by Pfizer-BioNTech and Moderna over the Johnson & Johnson shot because of the risk for TTS.
References:
CDC. COVID-19 vaccinations in the United States. https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total. Accessed May 6, 2022.
Perspective
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Sandra Adamson Fryhofer, MD, MACP, FRCP
As promised, the FDA has continued to monitor safety concerns linking Janssen’s viral vector vaccine to rare, unusual and life-threatening blood clots caused by TTS. The FDA authorized and approved COVID-19 vaccines using mRNA technology do not carry this risk.
Janssen’s viral vector vaccine still has a role in the pandemic response, including across the global community. The FDA’s announcement now limiting emergency use to those aged 18 years or older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate demonstrates careful oversight and transparency and should reassure the public.
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