Former Commissioner of the Food and Drug Administration, Dr. Scott Gottlieb told CNBC that he believed the Centers for Disease Control and Prevention could soon provide more clarity on who is eligible for Covid booster doses.
Gottlieb, a Pfizer board member, explained the FDA and CDC approval process for boosters in an interview on Tuesday in The News with Shepard Smith. The FDA could make a formal decision on Pfizer’s boosters before the CDC begins a two-day series of third-dose sessions on Wednesday and Thursday at which Gottlieb said health officials could expand the FDA’s instructions.
“They provide physicians and patients with detailed guidance and interpret the recommendations of the Food and Drug Administration,” Gottlieb said of the CDC. “For example, they could say they could enumerate the types of severe conditions that would qualify someone for a refresher.”
An FDA advisory committee on Friday turned down a plan that would have allowed all Americans 16 and older to take a third dose, with reservations about insufficient data and the risk of myocarditis. But the committee then voted unanimously in favor of the approval of boosters for the medically weak and everyone over 65 years of age.
Gottlieb said the process had given conflicting messages about who should be eligible for boosters, but added that he always thought the FDA was holding two votes to narrow down potential recipients of a third Pfizer dose.
“I think the meeting gave the impression that there could be contradicting messages. I don’t think that is the case,” said Gottlieb. “The FDA initially voted on boosters for the entire age group 16 and over and finally agreed on a recommendation that boosters should be made available for people 65 and over and for those at risk of severe Covid disease, a higher one Risk from the disease itself. That always seemed to be the FDA’s goal, administrative. “
Dr. Scott Gottlieb, former Commissioner of the Food and Drug Administration, speaks during the Skybridge Capital SALT New York 2021 conference in New York City, the United States, on September 15, 2021.
Brendan McDermid | Reuters
Gottlieb added, “I think it gave the impression that the agency voted out Booster before they voted for it – that wasn’t the case. It was more of an administrative measure and I think this has caused some public confusion. “
While Pfizer awaits final approval of its boosters, vaccine makers Moderna and Johnson & Johnson have released data that they believe warrant approving their own add-on doses. J&J said Tuesday that its Covid boosters are 94% effective when injected two months after the first dose, while Moderna reported fewer breakthrough cases in recently vaccinated participants in a study published on Sept. 15.
According to the CDC, more than 2.2 million people in the United States have received a booster vaccination since August 13.
Disclosure: Scott Gottlieb is a CNBC employee and a member of the board of directors of Pfizer, genetic testing startup Tempus, health technology company Aetion, and biotechnology company Illumina. He is also co-chair of Norwegian Cruise Line Holdings ′ and Royal Caribbean’s Healthy Sail Panel.
Comments are closed.