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Johnson & Johnson Single-dose COVID Vaccine Safe And Effective: FDA

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Drug major Johnson & Johnson's single-shot COVID-19 vaccine is safe and effective as per the trial data submitted for Emergency Use Authorization, the US Food and Drug Administration said. The vaccine, known as Ad26.COV2.S, was found to prevent severe disease and death from Covid.

This confirms the initial results published by Johnson & Johnson last month. The vaccine's EUA will be decided in a vote by FDA's vaccine advisory panel on Friday.

If authorized, Johnson & Johnson's vaccine would be the third COVID-19 vaccine for emergency use in the U.S. - the other two being Pfizer/BioNTech's BNT162b2 and Moderna's mRNA-1273.

As per the document, the vaccine appears to offer protection against COVID-19 requiring medical intervention starting at least 14 days post-vaccination.

JNJ affiliate Janssen Biotech, Inc., which develops the vaccine, submitted EUA request to FDA on February 4, based on the preliminary data from its ongoing multi-national Phase 3 randomized, double-blind and placebo-controlled trials.

In its analysis, the FDA said, "Vaccine efficacy (VE) against central laboratory-confirmed moderate to severe/critical COVID-19 across all geographic areas in which the trial was conducted was 66.9 per cent when considering cases occurring at least 14 days after the single-dose vaccination and 66.1 per cent when considering cases occurring at least 28 days after vaccination."

The vaccine's effectiveness was 85 percent overall in stopping severe cases of disease, while it showed 91.7 percent efficacy among 18 to 59 years old, and 70.3 percent in the 60 plus group. It showed an overall efficacy rate of 72 percent in the U.S.

Johnson & Johnson's single shot vaccine can be stored in normal refrigeration temperatures for three months. In comparison, Moderna and Pfizer vaccines are administered as two doses, and the Pfizer vaccine requires ultra-cold storage.

Meanwhile, Pfizer won't be able to keep its pledge to offer 12 million doses initially for the federal government, once the FDA authorizes the vaccine. Richard Nettles, the vice president of U.S. medical affairs at Janssen Pharmaceuticals, recently informed lawmakers that around four million doses would be ready for shipment following an EUA.

According to Nettles, Johnson & Johnson would supply a total of 20 million doses by the end of March, fewer than its federal commitment. However, the company still expects to supply 100 million doses to the U.S. by the end of June.

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