Dr. Scott Gottlieb weighs in on Pfizer’s Covid booster approval course of

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 booster approval process in an interview on Tuesday at “The news with Shepard Smith. “The FDA could make a formal decision via Pfizer’s boosters before the CDC begins a two-day series of meetings 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 rejected a plan on Friday that would have allowed a third dose for all Americans 16 and older, and raised 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. “

As Pfizer awaits final approval of its boosters, vaccine makers will Modern and Johnson & Johnson both released data warranting approval of 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.

Pfizer and BioNtech start the method of searching for full FDA approval for his or her Covid vaccine

Walgreens Doctor Luis S. Solano prepares a dose of Pfizer BioNTec’s Coronavirus Disease (COVID-19) vaccine on February 22, 2021 at the Victor Walchirk Apartments in Evanston, Illinois.

Kamil Krzaczynski | Reuters

Pfizer and German drug manufacturers BioNTech started the process to apply for full approval of the Covid-19 vaccine in the United States. This makes the companies the first to apply for full approval in the nation.

The Food and Drug Administration issued emergency approval for their Covid vaccine at the end of December. Since then, Pfizer has distributed millions of doses in the US, with the goal of dispensing 300 million doses by the end of July. If approved, Pfizer could market its shots directly to consumers and potentially change the pricing of its cans.

It usually takes the FDA about a year or more to determine whether a drug is safe and effective for the general public. Due to the once in a century pandemic that killed nearly 600,000 people in the United States, the FDA allowed the gunshots to be used as part of an emergency clearance.

The permit grants conditional approval based on data for two months. It’s not the same as a biological license application that requires six months of data and ensures full approval. Companies apply for approval on a “rolling filing” basis, which speeds the review process by allowing the FDA to review new data as soon as the company receives it.

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