The FDA approved Johnson & Johnson’s single-dose COVID-19 vaccine, a step after it was approved for use in the United States

Johnson & Johnson’s single-dose vaccine provides protection against COVID-19, according to an analysis by U.S. regulators Wednesday that sets the stage for a final decision on a new, easier-to-use injection to help control the pandemic.

Scientists from the Food and Drug Administration (FDA) confirmed that in general, the vaccine is about 66% effective in preventing moderate to severe COVID-19. The agency also said that the J&J injection – which could help speed up vaccinations by requiring only one dose instead of two – is safe to use.

On Friday, the agency’s independent advisers will debate whether the evidence is strong enough to recommend the long-awaited vaccine.. Based on this advice, the FDA is expected to make a final decision in the coming days.

J&J has tested its single-dose option on 44,000 people in the United States, Latin America and South Africa. Since different mutated versions of the virus are circulating in different countries, the researchers analyzed the results geographically. J&J had previously announced that the vaccine worked best in the United States, with 72% effectiveness against moderate to severe COVID-19, compared to 66% in Latin America and 57% in South Africa..

Even so, in all countries it was very effective against the most severe symptoms, and the first results of the study showed that there was no hospitalization or death from 28 days after vaccination.

While the overall efficacy figures may suggest that candidate J&J is not as potent as its two-dose competitors, all of the world’s COVID-19 vaccines have been tested differently, making comparisons nearly impossible. Even if it would not be surprising that one dose turns out to be a little lower than two, policymakers will decide whether this is an acceptable compromise to get more people vaccinated faster.

J&J was set to become the world’s first single-dose option until earlier this month Mexico announced it would use a single-dose version from Chinese company CanSino.

The vaccination campaign in the United States has been slower than expected, hampered by logistical problems and weather delays, even as the country mourns more than 500,000 deaths linked to the virus. So far, some 65 million Americans have received at least one dose of the vaccine manufactured by Pfizer or Moderna, vaccines that require two doses several weeks apart for full protection.

If FDA clears J&J vaccine for use in the United States, it will not significantly increase vaccine supply immediately. Only a few million doses should be ready to ship within the first week. However, J&J told Congress this week that it plans to deliver 20 million doses by the end of March and 100 million by the summer.

European regulators and the World Health Organization are also studying the J&J vaccine. Globally, the company aims to produce around 1 billion doses by the end of the year.

(With AP information)

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