FDA Changes to Vaccine Authorization Allowed Pfizer, Moderna to Apply for Omicron Shot Approval Without Any Clinical Trial Data

🇺🇸💉@COVID19Up: On Monday (August 22), Pfizer asked the U.S. FDA for emergency authorization for the drugmaker’s new Omicron shot. Moderna followed on Tuesday (August 23) with its own application to the FDA for emergency authorization for its Omicron injection.

But unlike previous applications, Pfizer’s 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 COVID-19 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.