FDA Vaccines Advisory Committee Member: Biden Administration ‘Marginalized’ FDA and CDC on Boosters

On Friday’s broadcast of CNN’s “Situation Room,” FDA Vaccines and Related Biological Products Advisory Committee member Dr. Paul Offit stated that “in many ways, the FDA and CDC were marginalized” by the Biden administration’s handling of coronavirus vaccine boosters, but the administration did eventually “let this process play out the way it should have played out at the beginning.” Offit also argued that labeling cases with mild or no symptoms as breakthrough infections “created an expectation for this vaccine that, frankly, was unfair.”

Offit said, “Well, the way the process works is you identify a problem. You pose a solution to the problem, which in this case would be a booster dose, and then it goes to the FDA, which is a regulatory body, as Dr. Gupta said. And then that regulatory body listens to their advisers and then you move from there to the CDC, which is a public health agency that makes a recommendation. That whole process was really skipped, and in many ways, the FDA and CDC were marginalized, which is never a good idea. But, I think finally, the administration stepped back and let this process play out the way it should have played out at the beginning.”

He added, “I think the biggest mistake we’ve made communications-wise is labeling asymptomatic infection or mildly symptomatic infection breakthrough infections. That’s not a breakthrough infection. A breakthrough infection is despite being fully vaccinated, you’re hospitalized or worse. And I just think we created an expectation for this vaccine that, frankly, was unfair.”

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