FDA Panel Votes to Recommend Johnson & Johnson’s Coronavirus Vaccine for Emergency Authorization

by Andrew Trunsky


The Food and Drug Administration’s vaccine advisory panel voted Friday evening to recommend Johnson & Johnson’s coronavirus vaccine for emergency approval, clearing the way for its authorization, distribution and administration nationwide.

The vote followed hours of the panel live-streaming its process of scouring over data from the pharmaceutical company in order to reaffirm that the vaccine was safe for the millions of Americans who will receive it. The FDA also released the vaccine’s clinical trial data on Wednesday showing that the vaccine was effective in fighting the virus itself.

Though the panel’s decision is merely advisory, the FDA has said that it will follow its recommendation, meaning that Johnson & Johnson’s vaccine could be approved as soon as Saturday if it follows the timeline of Pfizer and Moderna. If authorized, it will be the third coronavirus vaccine approved.

Johnson & Johnson’s clinical data showed that its vaccine was overwhelmingly effective in combatting coronavirus cases and reducing its spread. The drugmaker said in January that its vaccine was 72% effective against the virus in the United States and 86% effective in preventing severe cases, though it was slightly less effective in South Africa, where a mutated, more contagious strain has become dominant.

The company applied for emergency use from the FDA on Feb. 4.

Once approved, experts believe that it could vastly mitigate supply shortages reported by states and localities across the country. The Johnson & Johnson vaccine can be stored in normal refrigerators instead of ultra-cold freezers, and unlike Pfizer and Moderna’s vaccines, requires only one dose.

But even with the vaccine’s approval, its supply could be limited at first. Dr. Richard Nettles, the vice president of U.S. medical affairs at Janssen Pharmaceuticals, the drug development arm of Johnson & Johnson, said Tuesday that it was ready to ship approximately four million doses once authorized, just one-third of what the company originally said it was prepared to distribute by the end of February.

Nettles added that Johnson & Johnson could manufacture 20 million doses by the end of March and has a contract to deliver 100 million doses by the end of June.

While the U.S. initially got off to a slow start at administering the vaccines, the rate has accelerated over the past month, with daily vaccinations averaging well over one-million a day, according to the CDC.

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Andrew Trunsky is a reporter at Daily Caller News Foundation.





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