FDA advisors must grapple with confusing research on booster shots.


Advisors to the Food and Drug Administration must face a series of mind-boggling scientific questions Friday before deciding whether to allow booster shots for coronavirus vaccines — and if so, to whom.

Three major research projects came in this week. On Monday, an international team of scientists analyzed dozens of studies in the journal The Lancet and concluded that boosters are not yet necessary for the general population, and that the world would be better served by using vaccine doses to protect the billions of people who remain unvaccinated.

Two of the authors are vaccine experts at the FDA itself, and both had already announced plans to resign due to what they believe was undue pressure from the Biden administration to approve booster shots.

On Wednesday, the agency’s scientists posted a review online hinting that they, too, are not convinced there is enough evidence that boosters are needed. Overall, data indicates that current US licensed or authorized Covid-19 vaccines still protect against severe Covid-19 illness and death in the United States. management summary.

White House officials have said they are particularly concerned about data from Israel, where officials have said vaccinated people are seeing a declining immune response and higher infection rates. Alarmed by the increase in cases, Israeli officials offered third doses of the vaccine to anyone over the age of 12.

Researchers from Israel published early results from that rollout in the New England Journal of Medicine on Wednesday — but few outside scientists found the findings convincing.

The team collected data on the effects of booster shots from the health records of more than 1.1 million people over the age of 60. At least 12 days after the booster, the infection rates were 11 times lower – and the number of serious illnesses nearly 20 times lower – in those who received a booster compared to those who received only two doses, the researchers found.

The results aren’t surprising, experts said, and don’t indicate long-term benefits.

Credit…Amr Alfiky/The New York Times

“We’ve known for some time that the vaccines elicit less strong immune responses in the elderly,” said Dr. Celine Gounder, an infectious disease specialist at the Bellevue Hospital Center and a former adviser to the Biden administration. “Recommending additional doses of vaccine for the elderly is not controversial.”

Vaccination remains potently protective against serious illness and hospitalization in the vast majority of people in all studies published to date, experts say. But the vaccines seem less potent against infections in people of all ages, especially those exposed to the highly contagious Delta strain.

The cumulative data to date suggests that only older adults need boosters — and maybe not. But White House officials have said they don’t want to wait for hospitalizations to rise — if they ever do — among the vaccinated before taking action.

The Biden administration has said booster doses could be rolled out soon, should the FDA and Centers for Disease Control and Prevention deem it necessary. A CDC advisory committee will meet next week to consider the question.

British scientists have recommended giving third doses to adults over 50 and other medically vulnerable people. France, Germany, Denmark and Spain are also considering or have already started administering boosters for older adults. Israel is already considering a fourth dose for its population.

But recent history leaves many experts suspicious of adding the United States to the list.

dr. Luciana Borio, a former acting chief scientist at the FDA, criticized the Biden administration for announcing a plan for boosters before federal scientists could review the evidence.

The Trump administration pressured FDA scientists to allow, for example, hydroxychromoquine and restorative plasma, without sufficient evidence to support either treatment. “It seems to me that there has been a process error in the way we make those decisions,” said Dr. borio.

“We need an FDA that has people who make these decisions and who maintain the ability to make those decisions independently and based only on science. If this changes, we’ll all lose.”

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