Monday, February 22, 2021 4:28:35 PM
Quote~
"The new guidance, released in a 24-page document on the FDA’s website, would clear the new vaccines as an amendment to a company’s originally approved emergency use application, according to the FDA. The company would need to submit new data that shows the modified vaccine produces a similar immune response and is safe, similar to the process for annual flu vaccines."
"The FDA authorized Pfizer’s and Moderna’s vaccines for emergency use in December, and the two drugmakers have since announced plans to modify their shots to target new variants. The guidance could accelerate the regulatory review process for the vaccines."
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