Dr Scott Gottlieb speaks on Pfizer’s Covid booster approval process



Former Food and Drug Administration commissioner Dr Scott Gottlieb told CNBC he anticipates the Centers for Disease Control and Prevention may soon offer more clarity on who will be eligible for booster doses of Covid.

Pfizer’s board member Gottlieb explained the FDA and CDC boosters approval process in an interview on Tuesday on “The News with Shepard Smith.” The FDA could make a formal decision on Pfizer’s boosters before the CDC begins a series of two-day third-dose meetings on Wednesday and Thursday, where Gottlieb said health officials could develop FDA leadership .

“They provide granular advice to doctors and patients, and they interpret recommendations from the Food and Drug Administration,” Gottlieb said of the CDC. “So, for example, they could say they could list the types of serious conditions that would qualify someone for a recall.”

An FDA advisory committee on Friday rejected a plan that would have allowed third doses for all Americans 16 years and older, expressing concerns about insufficient data and the risk of myocarditis. But the committee then voted unanimously to approve the recalls for medically vulnerable people and anyone 65 and over.

Gottlieb said the process sent mixed messages about who was eligible for recalls, but added that he always believed the FDA would hold two votes to narrow down potential recipients of a third dose of Pfizer.

“I think the meeting created a perception that there might be some conflicting messages. I don’t think there is,” Gottlieb said. “The FDA first voted on boosters for the entire age group 16 and over, eventually moved to a recommendation that boosters should be made available to people 65 and over, and those who are at risk for a serious Covid result, those who are at greater risk for the disease itself. That always seemed to be the administrative guidance from the FDA. “

Former Commissioner of the Food and Drug Administration Dr. Scott Gottlieb speaks at the Skybridge Capital SALT New York 2021 conference in New York, United States, September 15, 2021.

Brendan McDermid | Reuters

Gottlieb added: “I think it created the impression that the agency rejected the boosters before voting for it – it wasn’t. It was more of an administrative action, and I think it was. is where it created some confusion in the public. “

While Pfizer awaits final approval for its boosters, vaccine makers Moderna and Johnson & Johnson have both released data they say supports approval of their own additional doses. J&J said on Tuesday that its Covid boosters are 94% effective when injected two months after the first dose, while Moderna reported a reduction in breakthrough cases among more recently vaccinated participants in a study published on September 15.

More than 2.2 million people in the United States have received a recall since Aug. 13, according to the CDC.

Disclosure: Scott Gottlieb is a contributor to CNBC and serves on the boards of directors of Pfizer, genetic testing startup Tempus, health technology company Aetion, and biotech company Illumina. He is also co-chair of Norwegian Cruise Line Holdings ′ and Royal Caribbean’s Healthy Sail Panel.



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