FDA panel gives nod to Johnson & Johnson booster Covid-19 jabs

A day after recommending Moderna’s Covid-19 booster proposal, an advisory vaccine panel to the Food and Drug Administration endorsed Johnson & Johnson boosters as well, to be offered at least two months after the initial shot.

J&J had asked for flexibility with the booster, saying that the extra dose adds protection against the virus as early as two months after the initial vaccination, but that it could work better if people wait six months. The Vaccines and Related Biological Products Advisory Committee voted unanimously in favor of the booster, but did not set a firm timeline, according to AP.

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Friday’s vote means that the FDA advisers have now green-lit booster jabs for all three vaccines granted emergency use authorization in the US. Pfizer boosters were approved last month, while Moderna’s were given the go-ahead on Thursday. The Centers for Disease Control and Prevention (CDC) still needs to approve both recommendations.

“There are data that suggest the effectiveness of this vaccine is actually less robust than the company’s presentation here,” Dr. Peter Marks, FDA’s top vaccine official, said during the hearing. “And that is a finding of concern particularly because that’s been seen in minority communities potentially and others.”

The panel approved the boosters despite reservations about the J&J data and the lack of time to independently verify it. Among the concerns were that only a “tiny” portion of cases in the booster study involved the delta variant of the coronavirus, and that J&J followed recipients for just over a month, leaving unanswered questions about the durability of protection. 

Dr. Arnold Monto of the University of Michigan, who chairs the panel, said there was “some urgency here to do something,” about protecting the J&J recipients. Only about 15 million Americans took the single-dose vaccine, of the 188 million inoculated in total. 

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The J&J jab rollout was hampered by concerns over “rare but serious” side effects such as blood clots and the Guillain-Barre syndrome, but regulators decided the benefits outweighed the risks. No new safety concerns were flagged with the boosters, the panel said.

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