FDA limits J&J COVID vaccine as dose shortage looms

The US Food and Drug Administration (FDA) yesterday severely restricted use of the Johnson & Johnson (J&J) COVID-19 vaccine as federal budget documents herald a vaccine shortage this fall if second boosters are widely encouraged.Blood clots with the J&J vaccineIn the 14 months after gaining an emergency use authorization, the J&J one-dose vaccine yesterday hit another, when the FDA limited its use to certain individuals, citing rare but serious blood clotting events following vaccination.The FDA said the agency has now identified 60 confirmed cases of thrombosis with thrombocytopenia syndrome (TSS), including 9 fatal cases, among 18 million recipients of the vaccine.

The agency now recommends that only people who would not get a COVID-19 vaccine otherwise, or who may be allergic to mRNA vaccines, receive the J&J shot."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, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, in an FDA press release.The adenovirus-based vaccine was once considered a game-changer, as it was easier to administer and store than the mRNA vaccines, and required only one visit to a vaccine provider.

But with weeks of gaining FDA authorization last spring, the agency said they were aware of 9 cases of TSS. Use of the vaccine was then paused for 10 days, and the vaccine quickly fell out of favor with Americans—200 million of which have received either the Pfizer or Moderna vaccine products.The Centers for