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More booster-shot data needed, Pfizer told

Many US experts, including President Biden’s chief medical adviser for the pandemic, have said there is insufficient evidence yet that boosters are necessary
The high-level online meeting, which lasted an hour and involved Pfizer’s chief scientific officer briefing virtually every top doctor in the federal government, came on the same day Israel started administering third doses of the Pfizer-BioNTech vaccine to heart transplant patients and others with compromised immune systems.

Sheryl Gay Stolberg, Sharon LaFraniere   |   Washington   |   Published 14.07.21, 12:15 AM

Representatives of Pfizer met privately with senior US scientists and regulators on Monday to press their case for swift authorisation of coronavirus booster vaccines, amid growing public confusion about whether they will be needed and pushback from federal health officials who say the extra doses are not necessary now.

The high-level online meeting, which lasted an hour and involved Pfizer’s chief scientific officer briefing virtually every top doctor in the federal government, came on the same day Israel started administering third doses of the Pfizer-BioNTech vaccine to heart transplant patients and others with compromised immune systems. Officials said after the meeting that more data — and possibly several more months — would be needed before regulators could determine whether booster shots were necessary.

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The twin developments underscored the intensifying debate about whether booster shots are needed in the US, at what point and for whom. Many American experts, including Dr Anthony S. Fauci, President Biden’s chief medical adviser for the pandemic, have said there is insufficient evidence yet that boosters are necessary.

Some, though, say Israel’s move may foreshadow a government decision to at least recommend them for the vulnerable.

Pfizer is gathering information on antibody responses in those who receive a third dose, as well as data from Israel, and expects to submit at least some of that to the Food and Drug Administration in the coming weeks in a formal request to broaden the emergency authorisation for its coronavirus vaccine.

But the final decision on booster shots, several officials said after the meeting, will also depend on real-world information gathered by the Centers for Disease Control and Prevention about breakthrough infections — those occurring in vaccinated people — that cause serious disease or hospitalisation.

And any recommendations about booster shots are likely to be calibrated, even within age groups, officials said. For example, if booster shots are recommended, they might go first to nursing home residents who received their vaccines in late 2020 or early 2021, while elderly people who received their first shots in the spring might have a longer wait.

And then there is the question of what kind of booster: a third dose of the original vaccine, or perhaps a shot tailored to the highly infectious Delta variant, which is surging in the US.

“It was an interesting meeting. They shared their data. There wasn’t anything resembling a decision,” Dr Fauci said in a brief interview Monday evening, adding, “This is just one piece of a much bigger puzzle, and it’s one part of the data, so there isn’t a question of a convincing case one way or the other.”

Amy Rose, a Pfizer spokeswoman, said in a statement, “We had a productive meeting with US public health officials on the elements of our research programme and the preliminary booster data.”

The department of health and human services, which convened the meeting, issued its own statement reiterating the administration’s stance. “At this time, fully vaccinated Americans do not need a booster shot,” it said.

With less than half of the US population fully vaccinated, some experts said on Monday that the country needed to remain focused on getting all Americans their first dose. The Food and Drug Administration’s most important task, they said, is to increase public confidence by granting full approval to the coronavirus vaccines in use, which for now are authorised on an emergency basis.

“At this point, the most important booster we need is to get people vaccinated,” said Dr Carlos del Rio, an infectious disease expert at Emory University in Atlanta. The booster doses in Israel, he added, “will help us answer some questions, but at the end of the day I don’t agree with what they’re doing. I think it’s awfully premature.”

Within the administration, some fear that if Americans are convinced that coronavirus vaccines provide only short-lived immunity before requiring a booster, they will be less likely to accept a shot.

New York Times News Service



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