J&J's one-dose coronavirus vaccine just won a critical thumbs-up from an FDA panel, paving the way for US authorization

  • A panel of experts voted unanimously Friday to recommend Johnson & Johnson’s coronavirus vaccine.
  • US regulators are expected to authorize the single-dose vaccine in the coming days. 
  • J&J has said it will be able to ship nearly 4 million doses following a regulatory OK. 
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Johnson & Johnson’s experimental coronavirus vaccine just passed a critical hurdle, as a group of top doctors and scientists voted unanimously Friday to endorse the shot.

The Food and Drug Administration is now expected to authorize the vaccine to be given widely in the coming days. The FDA typically follows the panel’s advice but isn’t required to do so. An emergency use authorization would likely allow the shot to be given widely to people 18 and older. 

“There is a shortage of vaccines that are currently authorized, and I think authorization of this vaccine will help meet the needs of the moment,” Dr. Archana Chatterjee, the dean of Chicago Medical School and a member of the panel, said.

FDA regulators released their own summary of J&J’s data on Wednesday, finding the shot to be safe and effective.

The healthcare giant ran a study with about 40,000 volunteers, comparing its vaccine with a placebo. That trial found the shot was 66% effective at preventing moderate to severe COVID-19. The first two US-authorized vaccines demonstrated 94% and 95% efficacy at preventing symptomatic cases of COVID-19, though experts cautioned against comparing those figures directly.

A key challenge for J&J’s shot will be explaining to the general public how it compares with the other vaccines, committee members said.

“We have a vaccine now that has good efficacy that everyone is going to compare to the existing vaccines and say it doesn’t look quite as good,” said the panelist Dr. Eric Rubin, an infectious-disease expert and the editor in chief of The New England Journal of Medicine.

J&J has emphasized its vaccine’s ability to prevent the worst outcomes of COVID-19. Starting two weeks after receiving an injection in the study, 31 people were hospitalized with COVID-19: 29 had received the placebo shot and just two had gotten J&J’s vaccine. The study also tallied seven deaths from COVID-19 — all in the placebo group. 

The company has said it will have nearly 4 million doses ready to ship upon emergency authorization and is on track to deliver 100 million doses to the US by the end of June. Beyond the much-needed supply bump, public-health experts are eager to roll out the vaccine for its simplicity: It’s a single-dose vaccination that can be stored at typical refrigerator temperatures for several months.

More than 47 million Americans, or nearly one in five adults in the US, have received at least one dose of a coronavirus vaccine, according to the Centers for Disease Control and Prevention.  

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