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The Biden administration’s decision to start authorizing third doses of Covid-19 vaccine in September is being met with bafflement, concern, and even anger from a number of immunologists, vaccinologists, and people steeped in the normal way such decisions are made.

Many flat-out challenged the need for booster doses at this time. Others questioned the morality of administering third shots to Americans when most people on the planet haven’t received one. And some worried that a decision had been made before the Food and Drug Administration had ruled on the need for a booster or a key vaccine advisory committee had evaluated the data — typically the way vaccine policy is set.

The government’s top public health officials on Wednesday pointed to data showing that the mRNA vaccines developed by Pfizer-BioNTech and Moderna are no longer protecting as well against mild and moderate Covid-19 infections as evidence that “could” signal a decline in protection against serious disease.

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But “could is not a very strong word … especially to make a policy decision on,” Norman Baylor, president and CEO of Biologics Consulting and a former head of the FDA’s Office of Vaccines, told STAT.

Anna Durbin, a vaccines researcher at Johns Hopkins University, said the vaccines continue to be highly effective in preventing hospitalizations, severe infections, and deaths among most vaccinees.

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That they may not work as well over time in preventing mild illnesses among those vaccinated isn’t necessarily a sign the vaccines are failing, said Durbin, who insisted that people are going to need to accept that fact. “We cannot keep [boosting] and say: ‘We’re going to prevent colds in everybody,’ ” she said.

The decision to boost so early in the country’s use of the vaccines isn’t science-based, in Durbin’s view. “I think there’s this tidal wave building that’s based on anxiety. And I don’t think it’s based on scientific evidence that a booster is needed.”

To many experts, including Baylor, the sequencing of the decisions being made is also out of whack. While U.S. health officials said booster shots could start being offered the week of Sept. 20, the Food and Drug Administration has not even ruled yet on Pfizer’s application for approval of a third shot; it was filed only Monday. Moderna hasn’t yet asked the agency to authorize a third shot at all.

At present, the extra dose policy only applies to the Pfizer-BioNTech and Moderna vaccines; people who received the one-dose Johnson & Johnson vaccine continue to wait for guidance about whether they need another dose.

Meanwhile the Advisory Committee on Immunization Practices — which reviews data on vaccines and makes recommendations on their use to the Centers for Disease Control and Prevention — is set to meet next week to look at the data for a third dose. Before Wednesday’s announcement, there was no suggestion a vote might be taken next Tuesday; the group may need additional sessions to address the question.

Surgeon General Vivek Murthy insisted the booster dose program would only go ahead if sanctioned by the FDA and the ACIP, as the CDC advisory committee is known. But the fact that there is a fixed date for the start of the booster program led some to wonder if the outcome had already been decided.

“How did you pick the week of September 20?” asked Baylor. “Since this meeting hasn’t occurred and you don’t know what they’re going to say — this is an independent body — suppose they say: ‘We don’t think so.’ Then what are you going to do with that?”

Grace Lee, professor of pediatrics at Stanford University School of Medicine and ACIP chair, insisted the group will conduct the review the way it always does — in sessions that are open to the public.

“When we can review that data, when we can review it with the public, when we can deliberate on the decisions, we’ll provide our best scientific advice and opinions,” she told STAT. “We will give our best possible advice based on what we see.”

Jesse Goodman, a former chief scientist at the FDA who is now a professor of medicine at Georgetown University, was concerned about the administration’s decision to announce the plan before that process has played out. Goodman believes booster shots will eventually be needed, and that it is prudent to plan for that eventuality. But “I’m not sure we had enough [data] to pull the trigger right now,” he said.

“In the heat of the moment and when we’re all dealing with a real public health emergency, it becomes almost doubly important that we continually reassess and have the normal processes in place. And I do worry that we not put the cart before the horse,” said Goodman.

“I would have preferred that this had been vetted a little bit more,” said Paul Offit, a vaccine expert from Children’s Hospital of Philadelphia, who is on an expert committee that advises the FDA on vaccines. “This just seems to be a declaration without the kind of vetting you would like to have seen.”

Like Goodman, Offit thinks boosters may eventually be needed. But he’s not convinced they are needed now. Almost all the evidence to date suggests protection against severe disease is still holding and may well last several years, he said.

“So the notion that we are trying to get ahead of it by boosting after eight months I think is premature,” he said, also arguing that using more doses in the U.S. will inevitably slow vaccination in low-income countries.

Scott Hensley, a vaccines researcher at the University of Pennsylvania’s Penn Institute for Immunology, shared those concerns.

“Anyone who thinks that vaccinating Americans with a third dose is not going to come at the expense of getting the vaccine to other places in the world — if that’s what you think, you’re just kidding yourself,” he said.

Hensley suggested the vaccines still appear to be doing what they were designed to do, even if some vaccinated people are having mild infections.

“A year and a half ago if someone told you you could have a vaccine that’s 90%, 95% effective at keeping you out of the hospital and keeping you alive, you would have jumped at that,” he said.

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