FDA endorsed Johnson & Johnson’s one-time COVID-19 vaccine, one step away from approving its use in the United States

Johnson & Johnson’s single-dose vaccine provides protection against COVID-19, according to an analysis by US regulators on Wednesday that paves the way for a final decision on a new, easier-to-use injection to contain the pandemic.

Scientists from the Food and Drug Administration (FDA) confirmed that, in general, the vaccine is approximately 66% effective in preventing moderate to severe COVID-19The agency also said the J&J injection – which could speed up vaccinations by requiring just 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.Armed with that advice, the FDA is expected to make a final decision in the coming days.

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

Yet it was in all countries highly effective against the most severe symptoms, and the initial results of the study showed that there were no hospitalizations or deaths from 28 days after vaccination

While the overall efficacy figures may suggest that the J&J candidate is not as potent as its two-dose competitors, all COVID-19 vaccines in the world have been tested differently, making comparisons nearly impossibleAlthough it would not be surprising if one dose turned out to be slightly weaker than twopolicymakers will decide whether it is an acceptable trade-off to get more people vaccinated faster.

J&J was on track to become the world’s first single-dose option, until Mexico announced earlier this month that it would be using a one-off version of Chinese company CanSino.

The United States vaccination campaign was slower than expected, hampered by logistical problems and weather delays, even as the country mourns more than 500,000 virus-related deaths. So far, about 65 million Americans have received at least one dose of the vaccine from Pfizer or Moderna, vaccines that require two doses several weeks apart for complete protection.

If the FDA approves the use of the J&J vaccine in the US, the supply of vaccines will not immediately increase significantlyOnly a few million doses are expected to be ready for shipment in the first week. However, J&J told Congress this week that it is expected 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 approximately 1 billion doses by the end of the year.

(With AP information)

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