FDA Limits Spend of J&J COVID Vaccine Over Blood Clot Risk

The FDA is limiting who can secure the Johnson & Johnson COVID-19 vaccine thanks to concerns in regards to the risk of a uncommon blood clotting condition.

In a assertion issued Thursday, the FDA stated the J&J vaccine ought to simplest be given to other folks 18 and older who invent now not possess access to other vaccines or for whom other vaccines are now not clinically relevant. Folk 18 and older could presumably additionally catch the J&J vaccine if they believe shut to because they’d now not otherwise secure any vaccine, the FDA stated.

The FDA assertion used to be the same to the recommendation made in December by a CDC committee of experts.

The FDA stated the decision used to be made after more data used to be shared in regards to the incidence of a uncommon blood clotting condition, thrombosis with thrombocytopenia syndrome (TTS), 1 or 2 weeks after other folks obtained the J&J vaccine. The finding “warrants limiting the licensed employ of the vaccine,” the FDA stated.

“We watch that the Janssen COVID-19 vaccine restful has a role in the latest pandemic response in the United States and all over the international neighborhood,” Peter Marks, MD, director of the FDA’s Center for Biologics Overview and Study, stated in the assertion.

“Our motion reflects our updated diagnosis of the risk of TTS following administration of this vaccine and limits the utilization of the vaccine to certain other folks.”

The CDC says 16.9 million other folks are fully vaccinated with the J&J vaccine, in contrast to 76.5 million with Moderna and 126.3 million with Pfizer.

By March 18, the CDC and FDA possess detected 60 confirmed cases of TTS, including nine lethal cases, ABC News reported.

The J&J vaccine used to be granted emergency authorization in February 2021. Correctly being authorities hoped it could maybe perchance presumably abet unfold vaccines all over the nation because it simplest required one preliminary dose and didn’t must be saved at extremely chilly temperatures, unlike the two-dose Pfizer and Moderna vaccines.

But 2 months after authorization, the government paused its employ for 10 days thanks to reports of TTS. Final December, the CDC’s Advisory Committee on Immunization Practices stated the Pfizer and Moderna vaccines were most smartly-appreciated over J&J because J&J carried the uncommon risk of blood clots and bleeding in the brain.

The FDA stated the trigger of the blood clotting is now not identified. However the “identified and skill advantages of the vaccine” outweigh the dangers for these other folks now allowed to secure it, the FDA stated.


FDA: “Coronavirus (COVID-19) Replace: FDA Limits Spend of Janssen COVID-19 Vaccine to Obvious People.”

CDC: “COVID-19 Vaccinations in the United States.”

ABC News: “FDA limits J&J COVID-19 vaccine attributable to uncommon blood clot risk.”

CDC: “Spend of the Janssen (Johnson & Johnson) COVID-19 Vaccine: Updated Intervening time Ideas from the Advisory Committee on Immunization Practices — United States, December 2021.”

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