FDA panel refuses to OK booster shots for most people 16 and over

A Food and Drug Administration advisory panel voted against green-lighting COVID-19 booster shots Friday for most people — throwing up a major hurdle for President Biden’s plan to dole out a third dose to most Americans.

But the independent panel, which reviewed a 23-page FDA briefing document highlighting recent studies,  recommended emergency use of a third dose for Americans over age 65 and those at high risk of severe infection.

The panel said more data is needed before it can okay boosters for people ages 16 and older, and that the two-dose Pfizer regimen is still highly protective against the spread of the super-contagious Delta variant for most people.

“In particular, there is a lack of data on effectiveness and duration,” Dr. Michael Carome, director of Public Citizen’s Health Research Group, said at the meeting Friday.

“Current evidence does not appear to show a need for boosting.”

The FDA is not bound to follow the advice of the independent advisory panel but has followed its guidance so far on COVID-19 vaccinations.

Overall, the panel voted 16-2 not to recommend a third dose for people 16 years and up while unanimously green-lighting it for people 65 years and older.

In coming to its decision, the advisory panel scrutinized several studies to determine whether a booster shot was effective and necessary at least six months after a second dose.

The panel noted research published in the New England Journal of Medicine in July showing that people who have received both doses of Pfizer’s COVID-19 vaccine are still 88 percent protected against getting sick from the Delta variant.

The much-anticipated vote comes after a key member of the panel, Dr. Paul A. Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, last week called third doses “premature.” 

“There is no compelling reason to get a third dose now,” he told the New York Times.

The independent group of experts on Friday also reviewed a Pfizer study of 306 people showing that virus-fighting antibodies jumped threefold after a booster shot was given around six to eight months after the second dose.

But Dr. Meg Seymour, of the National Center for Health Research, argued that the antibody increase wasn’t large enough to be convincing.

“The total safety sample is very small,” she said. “The data provided did not allow us to draw concrete conclusions.”

Another study out of Israel, which was also highlighted by the vaccine maker, tracked about 1 million people age 60 and older and found that a third jab was “roughly 95 percent” effective at protecting against the Delta variant.

The efficacy is comparable to the protection seen shortly after the vaccine’s rollout earlier in the year.

Still, the panel was ultimately not convinced by those studies and others.

The FDA’s reviewers had suggested ahead of the vote that they preferred to focus on research involving Americans, insisting that domestic studies “most accurately represent vaccine effectiveness in the US population.”

Meanwhile, President Biden and the country’s top health advisers insisted last month that booster shots would be needed — and likely available the week of Sept. 20.

Dr. Anthony Fauci, the nation’s top infectious diseases expert, said he was “certain” that Americans would need a booster shot eight months after their second shot.

But not everyone in the scientific community agrees. The World Health Organization recently argued against boosters, saying that rich nations shouldn’t dole out a third dose when poor countries don’t have enough vaccines for their first.

“It is unfortunate the While House announced the need for booster shots prior to the FDA’s assessment of the data,” Seymour admitted at the panel meeting Friday.

Dr. Peter Marks, director of the Center for Biologics Evaluation and Research within the FDA, acknowledged the divisive viewpoints during opening remarks to the advisory panel.

“We know there may be differing opinions in interpreting the data,” he said. “We strongly encourage all the different viewpoints to be voiced and discussed regarding the data, which is complex and evolving.”