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 vaccine

In 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 Disease Control and Prevention (CDC) COVID Data Tracker shows 66.3% of Americans are fully vaccinated against COVID-19, 77.7% have received at least one dose of vaccine, and 45.9% of those eligible have received their first booster dose.

The US reported 72,158 new COVID-19 cases yesterday, and 242 deaths, according to the Johns Hopkins COVID-19 tracker. The 7-day average of new daily cases is 67,827, with 286 daily deaths, according to the Washington Post tracker.

Possible Sep 1 cutoff for vaccines

In funding news, budget documents indicate that the Biden administration could run out of COVID-19 vaccines by Sep 1 if it moves forward with plans to encourage all adults to get a second booster shot, Stat reports.

Currently, adults 50 and older and those immunocompromised are recommended to get a second booster—or four shots total for mRNA vaccines—but many experts believe that recommendation will widen before this fall.

In other federal news, over 260 travel industry and business organizations are calling on the Biden administration to end its COVID-19 testing requirement for vaccinated international passengers entering the country, Axios reports.

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