A member of staff poses with a phial of Pfizer-BioNTech Covid-19 vaccine at a vaccination health centre on the first day of the largest immunisation programme in the UK’s history on December 8, 2020 in Cardiff, United Kingdom.
Justin Tallis | Getty Images
The Food and Drug Administration said Tuesday data from Pfizer’s coronavirus vaccine trials did not raise any specific safety concerns.
In briefing documents published ahead of an advisory meeting Thursday to review Pfizer’s vaccine, FDA staff also said data submitted was “consistent” with recommendations put forth by the agency for an emergency use authorization.
“As such, FDA has determined that the Sponsor has provided adequate information to ensure the vaccine’s quality and consistency for authorization of the product under an EUA,” the agency wrote in documents posted on its website.
The FDA is expected to decide on whether to authorize Pfizer’s vaccine within days.
The documents posted Tuesday offer a glimpse of the FDA’s view of the vaccine. The FDA is scheduled to convene a meeting of its Vaccines and Related Biological Products Advisory Committee, known as VRBPAC, on Thursday to review Pfizer’s Covid-19 vaccine with German drugmaker BioNTech for emergency use authorization.
If the meeting Thursday goes well and the advisory committee formally votes to OK the vaccine, the FDA could announce its authorization “within days,” Health and Human Services Secretary Alex Azar told ABC News’ “This Week” on Sunday. “But it’s going to go according to FDA’s gold-standard process, and I’m going to make sure it does,” he added.
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