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The FDA is getting feisty as a cascade of early research on the effectiveness of COVID-19 bivalent boosters, which were authorized without human data, intersects with embarrassing headlines about “rebound” infections for highly inoculated federal officials.
Public health officials stand to get even more defensive amid revelations that Pfizer is sharing undisclosed booster efficacy data with the White House and that boosters may actually weaken immune systems’ ability to fight COVID.
Center for Biologics Evaluation and Research Director Peter Marks, the FDA’s vaccines chief and face of its “Just a Minute” video series , publicly challenged Columbia and Beth Israel Deaconness preprint research that found the Omicron-targeting boosters did not meaningfully outperform the original Wuhan-strain boosters.
He told CNBC the studies, which have not yet been peer-reviewed, are too small to generate real conclusions before Pfizer and Moderna provide data from their clinical trials.The studies nonetheless show bivalents are “generally at […]
Read the rest of this story here: justthenews.com
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