Pfizer asks FDA to allow Covid booster injections for all adults

WASHINGTON – Pfizer and BioNTech on Tuesday asked federal regulators to allow their coronavirus booster injection for those 18 and older...


WASHINGTON – Pfizer and BioNTech on Tuesday asked federal regulators to allow their coronavirus booster injection for those 18 and older, a move that would likely make every adult in America eligible for an additional injection.

The Food and Drug Administration is expected to accede to the request, perhaps before Thanksgiving and well before Christmas trips and gatherings. The perspective of everything 181 million adults fully vaccinated in the country, having access to additional fire is a turnaround from two months ago, when an advisory committee of experts from the F.DA. massively not recommended Pfizer-BioNTech’s request to authorize recalls for all adult recipients of this vaccine.

At the time, several committee members raised doubts as to whether young and healthy people needed boosters. But the Biden administration has been rushing to offer largely additional blows since August, when President Biden announced that “The best way to protect yourself” was for every adult to be reminded.

Mr Biden initially wanted Americans to start receiving recalls in late September, but the start of the campaign was delayed after regulators insisted they needed more time to review safety data and efficiency. Some global public health experts have said it would be better to focus on sending initial vaccines to poorer countries with low vaccination rates rather than distributing additional vaccines here so soon.

If regulators approve Pfizer’s request, President Biden will have kept his promise to offer every adult a booster – although the choice would be limited to Pfizer’s vaccine for many.

At this time, only those 65 years of age and older and adults who are particularly at risk because of medical conditions or where they work or live can receive booster shots if they initially received the Pfizer vaccine. BioNTech or Moderna. The FDA has cleared the boosters for all Johnson & Johnson recipients because this vaccine offers less protection. People are allowed to choose which of the three vaccines they want for their additional injection.

So far, nearly 25 million Americans have received boosters, including people with compromised immune systems who became eligible in August. This represents about 14% of people who have been fully vaccinated, a number that could rise sharply if all other adults become eligible for a Pfizer-BioNTech booster. Although the eligibility categories are quite broad, at least 30 to 40 percent of vaccinated adults are still excluded, according to estimates.

Moderna is expected to submit its own application to the FDA soon to expand the eligibility of its booster. Some experts predict the agency could allow wider use of Moderna’s booster but exclude young men, amid concerns about a rare vaccine-related disease that appears to disproportionately affect them. The condition, called myocarditis, is inflammation of the heart muscle.

Some countries in Europe have already authorized booster injections for all adults; Israel offers them every 12 years and over. Tuesday, Authorized Canadian officials a booster dose of Pfizer-BioNTech vaccine for anyone 18 years of age and over.

In the United States, experts are fiercely divided over whether booster injections are needed for the entire population. Many say vaccines continue to offer strong protection against serious illness and hospitalization, especially for young people without underlying medical conditions.

There is near unanimous agreement that vaccinating the roughly 60 million Americans over the age of 11 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.

Despite this, some leading experts argue that the case for booster shots has grown stronger. Dr Nahid Bhadelia, director of the Boston University Center for Emerging Infectious Diseases Policy and Research, said “there is more solid data” now than in September, when the FDA advisory committee rejected Pfizer’s initial request. .

She added: “I think boosters now seem to be able to help prevent serious illnesses for a lot more people than we previously thought.”

Dr Rubin said he was reassured that as Israel began to vaccinate young people, “they really didn’t see any significant safety signals.”

Earlier this month, Dr Anthony S. Fauci, the federal government’s top infectious disease expert, said Israel’s most recent data shows that its aggressive recall campaign has limited rates of serious illnesses, hospitalization and death there. He called the results “rather spectacular”.

Federal officials have followed Israel’s experience closely because its vaccination campaign got off to a quick start and it has a nationalized health system that makes it easier to monitor results than in the United States.

An Israeli study published in the scientific journal The Lancet in late October compared about 730,000 people who had received a booster dose in August or September with people who had only received two doses of the Pfizer-BioNTech vaccine 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, a 92% lower risk of serious illness, and an 81% lower risk of death, according to the study. Boosted recipients were assessed between one week and almost two months after their third dose.

Pfizer and BioNTech said their request was based on data from a clinical trial in the United States and elsewhere that included more than 10,000 volunteers. They said the third injection countered the decrease in vaccine activity over time. After the third injection, the vaccine’s effectiveness rate against symptomatic illnesses was around 95%, they said.

The FDA has the power to change the current emergency use authorization for Pfizer-BioNTech and should not reconvene its advisory committee. Dr Rubin said he was okay with that.

“The FDA got a good idea of ​​what the panel was concerned about, and they are in a good position to pass judgment on their own now,” he said.

Moderna could follow with a request much like that of Pfizer. But getting permission can be trickier due to concerns about rare cases of myocarditis, 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.

If regulators approve Pfizer’s request, that will only formally endorse to some extent what health officials say they already see happen frequently. Many Americans appear to be receiving booster shots, whether officially eligible or not, so maintaining complicated eligibility categories may be futile, some officials have said.

“A decision like this – if supported by the data, which I haven’t seen – is an acknowledgment of this reality,” said Dr. Nirav D. Shah, senior health official for Maine and chairman of the Association of State. and territorial health officials.

“As long as the data shows the boost is worth it, it’s a good decision,” he said.

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Newsrust - US Top News: Pfizer asks FDA to allow Covid booster injections for all adults
Pfizer asks FDA to allow Covid booster injections for all adults
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