Pfizer seeks authorization of boosters for adult beneficiaries

Pfizer and BioNTech on Tuesday asked federal regulators to extend authorization of their coronavirus booster to all adults, a decision c...


Pfizer and BioNTech on Tuesday asked federal regulators to extend authorization of their coronavirus booster to all adults, a decision could significantly increase the number of recipients of this vaccine eligible for the booster.

The Food and Drug Administration is seen as likely to accede to the request, possibly before Thanksgiving, according to people familiar with the situation. The federal government intends to expand the categories of people eligible for additional injections since the first boosters were cleared for emergency use in late September.

An advisory board of experts outside the Food and Drug Administration voted in September against a Similar request from Pfizer to offer shots to the general population. Instead, the committee recommended emergency booster injections for people 65 years of age and older or at high risk of Covid-19 due to their medical condition or employment. These categories were still broad enough to cover at least 60% of the population, administration officials said.

Experts remain divided on whether booster injections are needed for the rest of the population, with many emphasizing that vaccines continue to offer strong protection against serious illness and hospitalization, especially for young people without underlying medical conditions. And there is near-unanimous agreement that vaccinating the roughly 60 million Americans aged 12 and older who have yet to receive their first vaccine should remain the government’s top priority.

For younger, healthy people, the benefits of a booster shot will be marginal, according to Dr. Eric Rubin, a member of the FDA advisory board and assistant professor of immunology at the Harvard TH Chan School of Public Health.

Even so, some leading experts argue that the case for booster shots for the general population is stronger today than it was two months ago. Dr Anthony S. Fauci, the federal government’s top infectious disease expert, said earlier this month that Israel’s most recent data shows that the country’s aggressive recall campaign has significantly limited rates of serious illness, hospitalization and death.

The FDA has the power to change the current emergency use authorization for Pfizer-BioNTech and should not reconvene its advisory committee. Pfizer’s plan to reapply was reported earlier by the Washington Post.

President Biden said in August that he wanted all adults to be eligible for booster shots over fears that vaccine protection against infection could wane over time. The administration aimed to deploy boosters by the third week of September, but was forced to delay after regulators said they needed more time to analyze the data.

At this point, the adult beneficiaries of the Pfizer-BioNTech and the Moderna vaccines are eligible for a third injection six months after their second injection if they are at least 65 years of age or are considered to be at special risk.

All Johnson & Johnson recipients are eligible for a second injection as a booster. And adult recipients of all three vaccines are allowed to choose which vaccine they prefer as a booster vaccine.

Almost 25 million people have received additional injections so far, according to the Centers for Disease Control and Prevention, including those who are eligible due to immune deficiencies. This represents about 14 percent of people who have been fully immunized.

Moderna should also soon request an extension of its emergency use authorization for its booster dose, according to people familiar with the matter. But experts said the request could be more complicated due to concerns about rare cases of myocarditis, or inflammation of the heart muscle, especially in men under 30 who have received two doses of Moderna vaccine.

Similar concerns have been raised about the Pfizer-BioNTech vaccine, but to a lesser extent. One possibility is that the age limit for a Moderna booster could be lowered, but not to 18.

During a White House press briefing earlier this month, Dr. Fauci said new data shows “quite dramatic results” from Israel’s recall campaign with the Pfizer-BioNTech vaccine.

An Israeli study published in the scientific journal The Lancet at the end of October compared about 730,000 people who received a booster dose in August or September with people who received only two doses at least five months earlier. The study included beneficiaries aged 12 and over; the median age was 52 years.

Compared to two-dose recipients, boosted recipients had a 93% lower risk of hospitalization, 92% less risk of serious illness, and 81% less risk of death, according to the study. Boosted recipients were evaluated at least one week after their third dose.

Dr Rubin, a member of the FDA advisory committee, said the Israeli recall data presented to the panel in September was mostly limited to people 60 years and older. Israel’s most recent data is reassuring, he said, because “when they moved on to younger groups, they really didn’t see any significant safety signals.”

Dr Rubin also said that many Americans appear to be getting booster shots, whether or not they are officially eligible, so maintaining complicated eligibility categories may not work anyway. “People vote with their feet,” he said.

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Newsrust - US Top News: Pfizer seeks authorization of boosters for adult beneficiaries
Pfizer seeks authorization of boosters for adult beneficiaries
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