WASHINGTON–The US Food and Drug Administration (FDA) issued a briefing document Tuesday saying the Pfizer-BioNTech Covid-19 vaccine is safe and effective, raising expectations the regulator is poised to grant emergency approval.
An independent committee advising the FDA will meet Thursday on the matter, after Britain became the first country to approve the vaccine last week.
Data from 38,000 US trial participants “suggest a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA (emergency use authorization),” the FDA document said.
It added that the vaccine’s efficacy in preventing Covid-19 was 95 percent, worked uniform…
Keep on reading: Pfizer vaccine raises ‘no specific safety concerns’–US regulator