FDA, CDC rules Johnson & Johnson COVID vaccine pause can be lifted

The New York Post:

The Centers for Disease Control and Prevention and the Food and Drug Administration said Friday that vaccine providers should resume their use of the Johnson and Johnson jab — after the Advisory Committee on Immunization Practices recommended it was safe to do so. 

The CDC and the FDA said J&J’s one-dose shot should be made available again at vaccine sites after reviewing data showing it will help save lives and prevent hospitalizations despite the risk of extremely rare — but potentially deadly — blood clots.

The chance of clots occurring is “very low,” Janet Woodcock, Acting FDA Commissioner, said at a press conference Friday night.

The rate of cases is 1.9 per one million vaccinated overall, officials said.

All 15 vaccine recipients who developed the rare blood clot were women, most of them under age 50; three died, and seven remain hospitalized.

For women aged 18-49, the rate is seven per one million; for women over age 50 the rate is .9 cases per one million.

“Together both agencies have full confidence that this vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 and older,” Woodcock said.

Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research said the J&J shots should resume “probably by tomorrow morning even.”

Earlier Friday, the APIC voted 10-4 with one abstention that the benefits associated with the vaccine outweigh the risks and said the drug can get back into arms without a new warning label about the rare potential for blood clots. 

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