CNBC's Shep Smith reports on the FDA's decision on booster shots. For access to live and exclusive video from CNBC subscribe to CNBC PRO: [ Ссылка ]
The Food and Drug Administration authorized Pfizer and BioNTech’s Covid-19 booster shots for people 65 and older and other vulnerable Americans six months after they complete their first two doses, making many Americans eligible to receive the shots now.
The FDA’s decision largely follows recommendations given Friday by its key vaccine advisory committee at a more than 8-hour agency meeting. The Vaccines and Related Biological Products Advisory Committee voted 16-2 against distributing the vaccines to Americans 16 and older, before unanimously embracing an alternate plan to give boosters to older Americans and those at a high risk of suffering from severe illness if they get the virus.
Though Americans 65 and older make up roughly 17% of the U.S. population, they are the most at risk of dying from Covid, accounting for more than 77% of all Covid deaths, according to the Centers for Disease Control and Prevention.
The FDA granted emergency use authorization to administer Pfizer’s shots to older Americans and people from 18- to 64-years-old with medical conditions that place them at risk of getting severely sick. The agency also included a broad definition of people from 18 to 64 “whose frequent institutional or occupational exposure” to the virus place them at a high risk of developing serious complications from Covid. That leaves enough wiggle room for the CDC to potentially clear third doses for people in nursing homes, prisons, front-line health employees and other essential workers who were among the first Americans who got the initial shots in December.
“The FDA considered the committee’s input and conducted its own thorough review of the submitted data to reach today’s decision,” Dr. Peter Marks, the agency’s top vaccine regulator, said in a statement. “We will continue to analyze data submitted to the FDA pertaining to the use of booster doses of COVID-19 vaccines and we will make further decisions as appropriate based on the data.”
The nonbinding decision by the vaccine advisory committee was expected to be a controversial one as the Biden administration has said it wants to begin offering booster shots to the general public as early as this week, pending authorization from U.S. health regulators.
While the agency hasn’t always followed the advice of its committee, it often does. Still, Marks reminded the panel on Friday that federal regulators did not have to accept its recommendation as written.
“We are not bound at FDA by your vote, just so you understand that. We can tweak this as need be,” he said.
In clearing the shots, which only apply to people who received Pfizer’s original vaccine, the FDA cited a small study provided by the company of about 300 people who received the boosters, data provided by the U.K. as well as more comprehensive, but less rigorous data, from Israeli health authorities.
Some scientists, including at least two at the FDA, had said they weren’t entirely convinced every American who has received the Pfizer vaccine needed extra doses at this time. However, the nation’s top health regulators, including CDC Director Dr. Rochelle Walensky, acting FDA Commissioner Dr. Janet Woodcock and White House chief medical advisor Dr. Anthony Fauci, already endorsed Biden’s booster plan in August.
Friday’s vote put the FDA panel in an “awkward position” as the administration has already announced they would begin distributing boosters to the general public this month, Northwell Health chief of infectious disease Dr. Bruce Farber said prior to the panel’s recommendation.
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