US expects to start Covid-19 vaccination program in early December: Official
Pfizer Inc. and BioNTech SE have submitted to FDA for emergency use authorisation after announcing that the final efficacy analysis of its vaccine candidate, BNT162b2, undergoing phase 3 trial met all of the study’s primary efficacy endpoints.
The United States expects to kick off a Covid-19 vaccination program in early December, the head of the government’s Covid-19 vaccine effort said on Sunday.
Moncef Slaoui, the chief adviser for Operation Warp Speed, a program to facilitate and accelerate vaccination effort, told CNN that the government’s plan is to ship vaccines to the immunisation sites within 24 hours of emergency use authorisation by Food and Drug Administration (FDA).
According to US media reports, FDA vaccine advisors have scheduled a meeting from December 8-10 to discuss approval after Pfizer and Moderna announced that their vaccine candidates are 95 per cent effective.
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Slaoui said that he expects companies to ship the vaccines on the second day of the approval. Pfizer Inc and BioNTech SE have submitted to FDA for emergency use authorisation after announcing that the final efficacy analysis of its vaccine candidate, BNT162b2, undergoing phase 3 trial met all of the study’s primary efficacy endpoints. In a video shared on Friday, Pfizer CEO Albert Bourla said that the request for emergency use authorisation for the Covid-19 vaccine is now in the FDA’s hands.
“This is a historic day, a historic day for science and for all of us. It took just 248 days to get from the day we announced our plans to collaborate with BioNTech to our FDA submission day,” he added.
The Phase 3 trial of Pfizer’s vaccine candidate began on July 27 and as of November 13, as many as 41,135 volunteers have received its second dose. BNT162b2 is an mRNA-based Covid-19 vaccine candidate, the same technology used by Moderna to come up with its mRNA-1273 vaccine candidate. Pfizer Inc. and BioNTech SE expect to produce up to 50 million vaccine doses globally in 2020 and up to 1.3 billion doses by the end of 2021.
“We have operated at extraordinary speed in our clinical development program, from concept to regulatory filing, while always maintaining our focus on safety,” said Bourla.
