from Childrens Health Defense:
The FDA, meanwhile, has been busy handing out “Breakthrough Therapy” designations to Pfizer as if they were papal dispensations, signaling a regulatory willingness to speed up approval not only for Pfizer’s RSV vaccine but also for a maternal Group B Streptococcus (GBS) vaccine the company is developing.
To this expedient end, the FDA allowed Pfizer to “stop the [RSV] study short,” halting enrollment at about 7,400 participants — though the trial was supposed to involve 10,000 pregnant women.