Pfizer booster shots recommended only for 65+ after FDA advisory meeting

TAMPA, Fla. - Booster shots of the COVID-19 vaccine are recommended only to seniors and those at high risk instead of everyone, following an intense FDA advisory committee meeting Friday.

The decision puts a snag in President Biden’s plan to roll out booster shots to everyone starting Sept. 20. Doctors on the panel voted 16 to 2 approving third doses of the Pfizer vaccine through emergency use to be recommended to people 65 years old and older and individuals who are at high risk of severe COVID-19. Those shots would come at least 6 months after the second dose.

"I would say I would like to see more data before I recommend it for a younger age group," said Dr. Archana Chatterjee, an FDA advisory committee member.

Lack of evidence for all ages was the main hold up. Scientists heard a breakdown of Israel’s study on booster shots, but several advisors raised concerns that it only showed data to support how well the dose worked in older people. Several doctors also had problems with the size of the study. 

RELATED: FDA advisory panel OKs Pfizer COVID-19 booster for 65 and older, votes no for younger

"Even with the data sets that they provided that Pfizer provided, you can't really make a really strong statement that these show safety because it's 300 people. It's a very, very small group," said Dr. Michael Teng, a USF Health virologist who watched Friday’s meeting. "You have to know that it's safe. When you have a group of only 300, that's not really enough safety data."

Teng said Friday’s vote shows why it’s important to follow the regulatory process. In August the Biden administration announced plans to roll out boosters to everyone on Sept. 20 before the FDA and CDC approved a third dose. 

"That was the big problem with the Biden administration announcing this a month ago that boosters are going to be available to everybody on the 20th that they really got ahead of themselves," said Teng. "You start losing credibility when you say something's going to happen and it's clearly just not going to happen at this point."

Boosters are already approved for those with weakened immune systems. While Friday’s vote only extends a third dose to seniors and high risk right now, scientists said one thing was clear from the intense discussion for people who get the vaccine.

"From the data that were shown today, the two-dose regime for the Pfizer vaccine is extremely still extremely effective at preventing hospitalizations and deaths even over a longer period of time," said Teng. "If you're not medically frail, if you're not over 65, I think the question will be then it's not necessary to go out and get a booster, that your immunity's doing pretty well. It's just those people who really should not get infected because they have bad outcomes."

While the vote is influential, the committee is a group of independent advisors. The FDA commissioner can decide to go against their recommendation. 

"If she chooses to go against the advisory committee, it wouldn't be the first time this year because there's that Alzheimer's drug, which is a big fiasco as well," said Teng.

The panel also suggested including healthcare workers and others with high-risk exposure jobs in the booster shot group; however, who falls within the group is expected to be ironed out in the CDC’s advisory committee meeting set for next week.