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

Dr Scott Gottlieb speaks on Pfizer's COVID booster approval process

Former Food and Drug Administration commissioner Dr Scott Gottlieb told CNBC he hopes the Centers for Disease Control and Prevention can soon provide more clarity on who will be eligible for a COVID booster dose.

Pfizer board member Gottlieb explained the FDA and CDC boosters approval process on Tuesday in an interview on “The News with Shepard Smith.” The FDA could make a formal decision on the Pfizer recall 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 specific advice to doctors and patients, and they interpret recommendations from the Food and Drug Administration,” Gottlieb said of the CDC. “So, for example, they can say they can calculate the critical conditions that would qualify someone for a recall. “

An FDA advisory committee on Friday rejected a plan that would allow a third dose for all Americans 16 and older, expressing insufficient data and the risk of myocarditis. But the committee then voted unanimously to approve the recall for those who are medically infirm and over the age of 65.

Gottlieb said the process was sending mixed messages about who was eligible for a recall, but he always believed the FDA would hold two votes to limit potential recipients of Pfizer’s third dose.

“I think the meeting created the impression that there might be conflicting messages. I don’t think that’s the case, ”Gottlieb said. “The FDA first voted on boosters for the entire age group 16 and over, eventually agreeing to a recommendation that boosters should be made available to people 65 and over, and who are at risk of serious consequences from COVID, who are at higher risk of illness. It always seemed like the FDA was doing it administratively. “

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

Brendan McDermid | Reuters

Gottlieb said: “I think it gave the impression that the agency voted the boosters before they voted – it wasn’t. It was an administrative action, and I think that’s where some public confusion arose.

While Pfizer awaits final approval for its recall, vaccine makers Moderna and Johnson & Johnson have both released data they say warrants 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 a study released Sept. 15 by Moderna recently reported a reduction in success cases among vaccine participants.

According to the CDC, more than 2.2 million people in the United States have received the recall since August 13.

Disclosure: Scott Gottlieb is a CNBC contributor and board member for Pfizer, genetic testing startup Tempus, health tech company Etion, and biotech company Illumina. He is also co-chair of Norwegian Cruise Line Holdings and the Royal Caribbean Healthy Sail Panel.



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