FDA committee votes to authorize booster shots for 65-plus, high-risk

Sep. 18—In the continued effort to combat the spread and severity of COVID-19, members of a Food and Drug Administration advisory committee voted unanimously on Friday to authorize Pfizer booster shots for use in people 65 and older and high-risk patients.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) met for more than eight hours to discuss the necessity of booster shots. The decision could be amended to possibly include health care workers and others who face a high risk of exposure.

The vote by the committee followed a previously failed vote to approve the third set of shots for anyone 16 and older.

In that earlier vote, 16 out of 18 VRBPAC members voted no to authorization citing concerns over lack of data, a small sample size for safety and absolutely no data on boosters in kids age 16 and 17.

During the meeting, the committee questioned related booster shot studies from Israel.

"The data is not as compelling as what is being presented," said Bi-County Health Officer Dr. Phuong Luu. "One big deal, how they define a severe case — post fully vaccinated breakthrough case as a severe case — is very different than what we define as a severe case. So, you're not really comparing apples to apples. So, that's a big red flag. When you look at studies, you really want to compare apples to apples."

Luu said how Israel defines severe fully vaccinated breakthrough cases is much different than how the CDC does.

"Since we're not even starting from the same foundation, it's very hard to parse out the validity of the data ... compared to the United States," said Luu. "... Right now you cannot fully compare Israel and the United States because of that big foundational difference as how they define severe disease and if you're not using the same definition, you can't come to the same result, comparison wise."

After the failed vote, the committee altered the measure to include specifics on age group and risk factors. They also changed from voting to recommend approval of the boosters to giving the shots emergency use authorization.

"In a subsequent vote, based on data that was presented ... they did vote to recommend that the FDA authorize a booster dose to those 65 years and older and those at high risk of severe disease and hospitalization," said Luu. "So that second category of high risk still needs to be determined."

An emergency use authorization authorization allows the use of medical products under emergency circumstances, but a full FDA approval is more rigorous and considered the gold standard.

"The FDA technically does not have to accept the expert panel's recommendations, but they usually do," said Luu. "So we should expect to hear from the FDA sometime this weekend, maybe as soon as tomorrow morning."

The vote by VRBPAC does not mean boosters are available. Another committee, the Advisory Committee on Immunization Practices (ACIP), which is convened by the Centers for Disease Control and Prevention, is set to meet next week.

"The CDC is also waiting ASIP's deliberation on Pfizer booster doses and whether ASIP would recommend something similar, different than the FDA expert panel," said Luu.

ACIP will discuss the rollout and decide if boosters should be offered to any additional groups. Once that is done, CDC Director Dr. Rochelle Walensky will need to sign off before eligible Americans can get a third dose.

Luu said the need for a booster shot is based on its risks versus any given reward.

"The data needs to be whether we are seeing a significant drop in vaccine efficacy against severe disease," said Luu. "... We want to make sure when we tell you, hey this is our recommendation ... we have carefully reviewed the data to make sure that the benefit really truly outweighs the risk of any potential side effect, adverse effect, etc."

Even as the delta variant of COVID-19 continues to ravage the country, vaccine effectiveness is still very strong for severe disease, said Luu.

"We're not promising you and we cannot ever promise you that even after you're fully vaccinated, you won't get infected and/or you also won't get mild to moderate symptoms," said Luu. "But, the data continues to fully support strong protection against severe disease. And that is the marker that we are carefully monitoring and at any one point it drops for sub-population, such like those who are elderly, then that's when we would say, OK, it won't be for general population at this time ... but all the while we are always gathering data."

Luu said science is never static and through more studies and discussion, recommendations could change.

The Boston Herald contributed to this story.