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Pfizer vaccine data wins backing of U.S. FDA

Published Dec 08, 2020 02:18PM ET Updated Dec 08, 2020 02:30PM ET
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Pfizer (NYSE:PFE) cleared the next hurdle in the race to get its COVID-19 vaccine approved for emergency use in the U.S. after the Food and Drug Administration on Tuesday released documents that did not raise any new issues about its safety or efficacy.

The analysis, conducted by FDA staff, affirmed that the coronavirus vaccine, developed by Pfizer and its German partner BioNTech, was 95% effective in preventing COVID-19 after two doses.

The results also show some protection begins even after the first dose. Though the agency's staff noted that more data would be needed to assess the potential of a single shot.

The Food and Drug Administration posted its analysis online ahead of a meeting on Thursday in which outside experts plan to discuss the documents and whether Pfizer's shot should be authorized for emergency use.

This comes as Britain on Tuesday began a vaccination drive using the Pfizer-Biontech vaccine, making Britons the world's first recipients outside of clinical trials.

Meanwhile back in the U.S., concerns are growing about vaccine supplies and timelines for inoculating Americans after the New York Times reported that the Trump administration had the opportunity over the summer to buy more doses of Pfizer's vaccine but declined.

Meaning, according to the report, that Pfizer might not be able deliver more than the initial deal promised until June of next year.

The Trump administration is pushing back on the report, saying the U.S. made other supply deals with other companies, when those vaccines get approved.

One administration official told Reuters the White House is still confident the U.S. will be able to accommodate any American who wants to be vaccinated by the middle of next year.

Pfizer vaccine data wins backing of U.S. FDA

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