FDA says J&J 1-dose shot prevents COVID; final decision soon

FDA says J&J 1-dose shot prevents COVID; final decision soon

SeattlePI.com

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WASHINGTON (AP) — Johnson & Johnson’s single-dose vaccine protects against COVID-19, according to an analysis by U.S. regulators Wednesday that sets the stage for a final decision on a new and easier-to-use shot to help tame the pandemic.

The Food and Drug Administration’s scientists confirmed that overall the vaccine is about 66% effective at preventing moderate to severe COVID-19. The agency also said J&J's shot — one that could help speed vaccinations by requiring just one dose instead of two — is safe to use.

That’s just one step in the FDA’s evaluation of a third vaccine option for the U.S. On Friday, the agency’s independent advisers will debate if the evidence is strong enough to recommend the long-anticipated shot. Armed with that advice, FDA is expected to make a final decision within days.

The vaccination drive has been slower than hoped, hampered by logistical issues and weather delays even as the country mourns more than 500,000 virus-related deaths. So far, about 44.5 million Americans have received at least one dose of vaccine made by Pfizer or Moderna, and nearly 20 million have received the second dose required for full protection.

J&J tested its single-dose option in 44,000 people in the U.S., Latin America and South Africa. Different mutated versions of the virus are circulating in different countries, and the FDA analysis cautioned that it's not clear how well the vaccine works against each variant. But J&J previously announced the vaccine worked better in the U.S. -- 72% effective against moderate to severe COVID-19, compared with 66% in Latin America and 57% in South Africa.

Still, in every country it was highly effective against the most serious symptoms, and early study results showed no hospitalizations or deaths starting 28 days after vaccination.

While the...

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