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Doctors Blast FDA Rush to Approve Fourth COVID Vaccine Dose

(AP Photo/Rogelio V. Solis)

The Food and Drug Administration is expected to approve a fourth dose of Pfizer and Moderna's Wuhan coronavirus vaccine this week, despite a lack of clinical data showing they are effective or necessary.


"Drugmaker Moderna asked the Food and Drug Administration on Thursday to authorize a fourth shot of its COVID-19 vaccine as a booster dose for all adults," CBS News reported late last week. "The request is broader than rival pharmaceutical company Pfizer's request earlier this week for the regulator to approve a booster shot for all seniors."

Doctors truly focused on following the science, not political science, are blasting the decision.  

"The FDA’s vaccine regulation is sliding further into the abyss. Last week, Pfizer announced that it would seek emergency-use authorization for a fourth dose of its mRNA vaccine, based on the original Wuhan strain of Covid-19, in people over 65. Meantime, Moderna announced that it was seeking an even larger market share: a fourth dose in anyone over 18, based on its original mRNA vaccine. If the FDA moves forward on authorizing either product, it will cement a dangerous precedent: inadequate evidence being used to justify widespread vaccination for years to come," Dr. Vinay Prasad writes for City Journal. "The data supporting fourth doses aren’t up to medicine’s gold standard: a randomized trial. Instead, we have two observational studies comparing people who rushed to be boosted with those who didn’t."


As noted, a number of longtime FDA officials resigned last fall due to the approval process being rushed and concerns about side effects -- specifically enlargement of the heart in young people -- being ignored. Not to mention the CDC is just now getting around to studying side effects for women who have experienced serious changes in their menstruation cycles. 


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