Is there still an emergency?
An FDA change to vaccine authorization allowed Pfizer and Moderna to apply for BA.5 booster approval without key data
But unlike previous applications, Pfizer and Moderna's filings are missing one piece of information: clinical trial data of their vaccines.
That’s deliberate. In June, the FDA asked vaccine manufacturers to start developing BA.4 and BA.5 boosters for a fall vaccination campaign. To help the drugmakers hit that fall deadline, the FDA said the companies did not need to include data from a clinical trial.
https://www.msn.com/en-ca/health/medical/an-fda-change-to-vaccine-authorization-allowed-pfizer-and-moderna-to-apply-for-ba-5-booster-approval-without-key-data/ar-AA112B9b?cvid=2d89786706304ecf9ae123f4e0076ae4
No trial data. No worries. As long as it’s recommended.
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