FDA Confirms Single Dose of Johnson & Johnson Vaccine Protects Against COVID-19
Washington. Johnson & Johnson's (J&J) single-dose vaccine protects against COVID-19, according to an analysis by U.S. regulators on Wednesday that sets the stage for a final decision on a new, easier-to-use vaccine to help eradicate the pandemic.
Scientists from the Food and Drug Administration (FDA) confirmed that overall, the vaccine is approximately 66% effective in preventing moderate to severe COVID-19. The agency also said the injection from Janssen, J & J's pharmaceutical division, is safe to use.
That's just one step in the FDA's evaluation of a third vaccination option for the United States.
This coming Friday, the agency's independent advisers will debate whether the evidence is strong enough to recommend the long-awaited shot. Armed with that advice, the FDA is expected to make a final decision in a matter of days.
J&J tested its single-dose option on 44,000 people in the United States, Latin America, and South Africa. Because different mutated versions of the virus are circulating in different countries, the researchers analyzed the results geographically.
J&J previously announced that the vaccine worked better in the United States: 72% effective against moderate to severe COVID-19, compared to 66% in Latin America and 57% in South Africa.
However, in all countries it was highly effective against the most severe symptoms, and the first results of the study showed no hospitalizations or deaths from 28 days after vaccination.
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