Pfizer to Seek Emergency Use Approval of Their COVID Vaccine Today
On Wednesday, Pfizer said that a final analysis of clinical-trial data showed that the vaccine is 95% effective.
Pfizer and BioNTech will be seeking emergency use approval for their COVID-19 vaccine on Friday, 20 November, the company announced on its Twitter handle.
This comes two days after Pfizer announced on Wednesday that a final analysis of clinical-trial data from its COVID-19 vaccine trial shows that the shot is 95 percent effective and that the vaccine also protects older people from the infection. The company had also said that there had been no significant safety problems so far in a trial which included almost 44,000 participants.
“The Phase 3 study of our COVID-19 vaccine candidate has met all primary efficacy endpoints. The study reached 170 confirmed cases of COVID19, with the vaccine candidate BNT162b2 demonstrating 95 percent efficacy beginning 28 days after the first dose,” a statement from the company read.
Wednesday’s announcement had opened the way for Pfizer to apply for the first US regulatory authorisation for a coronavirus vaccine.
In a statement, the companies had announced that the safety milestone required by the US FDA for Emergency Use Authorisation (EUA) has been achieved and that they would submit a request within days to the FDA.
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