The FDA brushed aside those reservations and didn't even wait for its own advisory committee to evaluate the performance of new boosters before issuing emergency use authorizations for Pfizer and Moderna products on Monday.
Sen. Ron Johnson blasted the FDA for withholding safety data, based on its "Empirical Bayesian data mining" of the Vaccine Adverse Events Reporting System, by invoking ongoing Freedom of Information Act litigation.
The FDA's Vaccines and Related Biological Products Advisory Committee is scheduled to meet next month.
Over the weekend, critics noted the FDA greenlit Moderna's next version of Spikevax - its non-EUA vaccine - for marketing while labeling it an "Unapproved drug," possibly as a defensive maneuver against litigation, two weeks ago.
The agency defines unapproved as posing "Significant risks to patients." "This is typical obfuscation that we have seen for the Covid vaccines," Yale University epidemiologist Harvey Risch told Just the News.
VRBPAC member Paul Offit, the 72-year-old director of the Vaccine Education Center at Children's Hospital of Philadelphia and himself a vaccine inventor, said he's planning to skip a second consecutive booster because of his good health and hybrid immunity.
Weill Cornell's Moore, who expressed early skepticism that bivalent boosters were an improvement, told KFFHN the new formulations are "Not remotely a game changer." He criticized "Editorial FOMO" - fear of missing out - for media hyping the threat of new variants such as the "Nothingburger" variant BA.2.
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