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He told CNBC the studies, which have not yet been peer-reviewed, are too small to generate real conclusions before Pfizer and Moderna provide data from their clinical trials.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 least as good or better as the original vaccines in generating an immune response, particularly to [Omicron subvariants] BA.4/BA.5 and other newer variants,” Marks said, referring to temporarily increased antibodies, not longer-term immunity or better protection against severe outcomes
It’s not clear Marks has been privy to the latest Pfizer data. Politico reported Thursday afternoon the drugmaker was “slated” to give unidentified Biden administration officials bivalent efficacy data that day, continuing a year-old pattern of the White House leading the FDA in vaccine decisions. Pfizer published a press release Friday claiming the booster “elicited approximately 4-fold higher neutralizing antibody titers against Omicron BA.4/BA.5 sublineages compared to the original COVID-19 vaccine” above age 55, without providing full trial data to date.
Titers rose 13.2-fold from “pre-booster levels” in that age group a month after boosting, compared to a 2.9-fold increase for the original booster. The bivalent increase was 9.5-fold in ages 18-55.
“Based on […]
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