These promising coronavirus vaccines could be approved sooner than expected – but not in the US

[Chris Smith]

• The UK has accelerated the review of the three coronavirus vaccine frontrunners: AstraZeneca, Moderna, and Pfizer.
• The country's government is conducting rolling reviews, which allow it to see data in real-time and potentially hasten emergency use approval for the vaccine candidates that prove to be safe and effective.
• The US FDA has strict requirements for emergency approvals, making it impossible for any of the three drugs to be approved before the presidential election.
• Pfizer seems to be the closest to having its drug approved in the US.

The UK is reportedly accelerating the review process for three coronavirus vaccine frontrunners, and it might issue approvals even before the rest of Europe does. AstraZeneca/Oxford, Moderna, and Pfizer/BioNTech are the three experimental drugs that are nearing the end of Phase 3 trials. The FDA made it clear that none of these vaccines will be able to seek emergency use authorization (EUA) in the US before the presidential election, as the agency wants safety data for at least two months for at least half of the volunteers in each study.

Of the three efforts, Pfizer seems the most likely to get a EUA this year in the US, but the company announced earlier this week that it has no early vaccine efficacy data to share with the public as it’s still waiting for a milestone to be reached. All companies are blinded to their COVID-19 vaccine studies, and only independent review boards get to see the partial data. Pfizer will receive the first information about the drug’s efficacy once 32 people out of the 42,000 registered volunteers get a positive COVID-19 diagnosis.

But if the UK and Europe do approve any of the drugs before America does, it would imply that the drugs have shown efficacy and safety, making it only a matter of time before the FDA issues its own approvals.

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These promising coronavirus vaccines could be approved sooner than expected – but not in the US originally appeared on BGR.com on Sun, 1 Nov 2020 at 11:24:22 EDT. Please see our terms for use of feeds.

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