FDA Likely to Report Pfizer-BioNTech COVID-19 Vaccine is Safe and Effective, Push to EUA

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As Pfizer and BioNTech’s COVID-19 vaccine candidate, BNT162b2, starts to begin distribution in the UK, scientists from the U.S. Food and Drug Administration ((FDA) have released company data ahead of this week’s advisory committee review appearing to confirm the vaccine’s safety and efficacy. The FDA’s endorsement of the vaccine’s effectiveness and safety represents a crucial step toward distributing the vaccine across the U.S.

The document prepared and released by FDA staff indicates scientists from the agency plan to tell the advisory committee on Thursday that the available clinical trial data are adequate to support its safe and effective use in public immunization programs.

Approximately 38,000 participants 16 years of age and older were fully dosed with the vaccine candidate in the Pfizer and BioNTech Phase III trial. Participants were randomly assigned to either placebo or the vaccine. All patients had a median of two months of follow-up after the second vaccine dose to determine the safety profile. No safety concerns that would prevent an Emergency Use Authorization (EUA) were identified.

In the study, only eight cases of COVID-19 were observed in the vaccine arm versus 162 cases in the placebo group, indicating the Pfizer and BioNTech’s COVID-19 vaccine has an approximately 95% efficacy rate.

But the possible announcement from the FDA doesn’t necessarily mean the agency will authorize it for mass distribution. On Thursday, an advisory committee meeting comprising independent experts will discuss the data and vote on whether the vaccine should be recommended for an EUA.

Authorization of the vaccine, if deemed effective and safe by the advisory committee, will be welcomed news for the U.S., which has seen more than 280,000 deaths attributed to COVID-19 since the beginning of the pandemic. It’s likely that the first doses of the Pfizer and BioNTech COVID-19 vaccine could roll out across the U.S. within 24 hours following EUA approval from the FDA.

And while the Trump administration has assured citizens that the U.S. would have enough vaccine doses available for the country, a recent report from The New York Times said the administration passed on the opportunity to purchase additional doses of BNT162b2. The Trump administration, under Operation Warp Speed, initially purchased 100 million doses of the vaccine in July in a $1.95 billion deal. These 100 million doses will protect only 50 million out of the 328 million people in the U.S., considering the vaccine requires two doses to be effective.

Additionally, the news report in the Times noted that it’s unlikely Pfizer and BioNTech will have a new batch of doses to offer the U.S. until the summer of 2021. The current available additional doses have already been acquired by governments from other global regions, including the United Kingdom and the European Union.

To make up for the lack of additional BNT162b2 doses, the Department of Health and Human Services said the U.S. government could acquire additional vaccine doses from Moderna, whose vaccine has also been demonstrated as 95% effective at protecting against infection. The FDA will review the Moderna vaccine data on Dec. 17, in addition to other vaccine candidates from Novavax, AstraZeneca and Johnson & Johnson (J&J), according to the Times report. Combined, the U.S. government has contracts for up to 3 billion doses of the Moderna, Novavax, AstraZeneca and J&J vaccines.

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