The FDA panel recommends Pfizer’s COVID-19 booster for ages 65 and older, but not for the general public

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A group of advisors to the Food and Drug Administration on Friday reformulated a proposed approval of BioNTech and Pfizer’s COVID-19 booster for the general population, recommending approval of an additional dose of the vaccine for people aged 65 and over instead high risk of serious illness.

The decision to recommend a booster vaccination for older adults and those at risk came after the FDA’s Advisory Committee on Vaccines and Related Biological Products voted against broader FDA approval of the BioNTech BNTX.
-3.61%
and Pfizer PFE,
-1.30%
Booster for people who are at least 16 years old and who were vaccinated six months ago.

The FDA is not required to follow the committee’s advice, but it often does.

“I don’t think a booster dose will do much to control the pandemic,” said Dr. Cody Meissner, director of pediatric infectious diseases at Tufts Medical Center and committee member, during Friday’s meeting.

Pfizer shares and BioNTech’s American Depositary Receipts closed 1.3% and 3.6% respectively on Friday, extending losses into the after-hours session.

“I suspect many of us are heading towards the suggestion to limit vaccination at this point,” said Dr. Eric Rubin, Associate Professor in the Department of Immunology and Infectious Diseases at Harvard TH Chan School of Public Health.

Several committee members discussed different age groups to start introducing boosters, including 50, 60 and 65 years of age.

The next step is to wait and see if the FDA decides to approve or approve the booster as the nation moves towards President Joe Biden’s target date, September 20, to begin rolling out additional doses to people those inoculated with the two dose mRNA were shots. If there is FDA approval, the Centers for Disease Control and Prevention will step in too.

Moderna Inc. MRNA,
-2.41%
has also submitted an application for approval of a booster dose. Johnson & Johnson JNJ,
-0.28%
has not yet applied for a booster. Of the three COVID-19 vaccines available in the US, BioNTech and Pfizer are the furthest advanced in the regulatory process.

Why Some Doctors Have Concerns About The COVID-19 Booster Shot

In contrast to the initial approvals of these vaccines, which were widely supported, there has been much more debate among scientists, researchers, and public health experts about whether booster vaccinations are needed at all or at this point in time, or whether they should only be made available to more vulnerable populations like the elderly.

Questions also remain about the clinical data used in Pfizer’s application.

One of the major sticking points for scientists is that most COVID-19 hospital admissions and deaths in the US occur among unvaccinated people. And although the number of groundbreaking cases among those vaccinated is increasing, it still means the vaccines are working.

Regardless, much of the real-world insights the U.S. is relying on comes from Israel, which in recent months has widely distributed a third dose of the Pfizer vaccine to fend off the delta variant that is rising there. (Israel and Pfizer have a data sharing agreement, and Pfizer’s vaccine is the primary vaccine given in Israel.)

“If we hadn’t started the booster at the end of July, we would have reached the capacity of the Israeli hospital capacities,” said Dr. Sharon Alroy Price, the Israeli Ministry of Health’s Director of Public Health Services, during the meeting.

But even with compelling data from Israel, there are some very specific differences between Israel and the US, including the fact that Israel’s definition of major diseases differs from that of the US

In Israel, officials classify an increased respiratory rate or oxygen levels below 94% as a serious illness, according to Sara Oliver, a CDC official who leads the working group on COVID-19 vaccines. In the US, more serious illness is seen in patients who have been hospitalized, treated in an intensive care unit, or died.

Why the COVID-19 booster debate is so complicated

Boosting someone increases their neutralizing antibody titers, an important measure of immunity. That’s what the drug manufacturers behind all three vaccines said.

“T-cell responses really don’t matter when we look at infections,” said Kathrin Jansen, director of vaccine research and development at Pfizer. “It is clear that neutralizing antibodies are responsible for preventing the infection.”

However, there are also concerns that a third dose puts people at risk for rare but serious side effects such as myocarditis, although Israeli officials said only one case of heart disease has been reported in recipients of booster vaccinations.

“I have serious concerns about myocarditis and young people if it is related to the immune response,” Dr. James Hildreth, CEO of Meharry Medical College and temporary voting committee member. “And the booster injections give these people a very strong reaction.”


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