Biden must sort out the FDA’s foot-dragging over vaccine booster shots
Coronavirus,Booster Shots,World,Coronavirus Vaccine
While Israel’s seen dynamite data from its third vaccine shots and England is set to follow suit, America could be held hostage to a brewing Beltway booster battle.
The Food and Drug Administration just refused to recommend approval of Pfizer’s application to give the general public third COVID-vaccine doses. Team Biden wants to start its booster campaign next week — but doesn’t seem willing to shake the FDA out of its return to business-as-usual hypercaution to do it.
The FDA released a report Wednesday — two days before an outside panel considers Pfizer’s request — concluding it didn’t have enough information to give the go-ahead. “Overall, data indicate that currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death in the United States,” it said. “There are many potentially relevant studies, but FDA has not independently reviewed or verified the underlying data or their conclusions.”
So the agency won’t even trust the three studies from the Centers for Disease Control and Prevention that President Joe Biden cited in calling for a booster campaign. One, from New York, found that vaccine efficacy against infection dropped from 92 to 80 in under three months. Another saw Pfizer’s efficacy go from 76 to 42 percent over a few months.
Pfizer’s clinical trial showed subjects given a third jab had significant increases in antibodies that neutralize the virus, putting them back up to the 90 to 95 percent protection following a second dose. The FDA admitted it judged this third dose a safe and effective vaccine. It’s already given the OK for boosters among the moderately to severely immunocompromised.
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