By Tony Winterburn • 09 December 2020 • 7:45
Pfizer COVID-19 Vaccine Data Wins Backing of U.S. FDA- Approval Draws Near.
Pfizer has cleared the next hurdle the race to get its COVID-19 vaccine approved for emergency use in the United States after the US Food and Drug Administration (FDA) released documents that raised no new issues about its safety or efficacy.
Pfizer and German partner BioNTech submitted their data to the FDA last month about their coronavirus vaccine based on data showing the two-dose regimen was 95 per cent effective against COVID-19 and had no major safety issues.
The vaccine’s efficacy and safety data met its expectations for emergency use authorization, FDA staff said in documents released ahead of a meeting of outside experts to the FDA who will discuss whether to recommend the Pfizer shot for people aged 16 and older. Jefferies analyst Michael Yee said in a research note the documents were “very simple and straightforward, which we think will lead to approval imminently.”
The agency typically follows the recommendations of its advisory panels but is not required to do so. It is not clear how many days or weeks the FDA will take to make a decision, but states are prepping for vaccine deliveries in mid-December.
Deaths from COVID-19 in the U.S. have soared to more than 2,200 a day on average, matching the frightening peak reached last April, and cases per day have eclipsed 200,000 on average for the first time on record, with the crisis all but certain to get worse because of the fallout from Thanksgiving, Christmas and New Year’s.
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