Where FDA full approval process stands on SARS-CoV2

[Deminpenn]

vaccines.

Found a good article in Science Magazine on where the process stands: https://www.sciencemag.org/news/2021/07/when-will-covid-19-vaccines-be-fully-approved-and-does-it-matter-if-they-are

When might the vaccines be approved?

On 16 July, FDA accepted Pfizer’s application “under priority review”—meaning it will move faster than during standard reviews, which typically take at least 10 months; the agency now has until January 2022 to review the materials. That seems like a long time, but last week an FDA official told CNN that the decision is likely to come within 2 months. “The review … has been ongoing, is among the highest priorities of the agency, and the agency intends to complete the review far in advance of the [January] Date,” an FDA press officer confirmed to Science in a statement.

FDA has not formally accepted Moderna’s application, possibly because the company has not yet submitted all the required materials.

But worth the whole read.

[CaliforniaPeggy]

1. I am glad to read this. Getting the FDA to approve this is the highest priority. n/t