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Friday, December 3, 2021

US expands COVID booster to all adults, final hurdle ahead

by Lauren Niergaard and Matthew Perrone

WASHINGTON (AP) – US regulators on Friday moved to open up COVID-19 booster shots to all adults, expanding the government’s campaign to bolster safety and overtake rising coronavirus cases that hit the holidays. can be messed with.

Pfizer and Moderna announced the Food and Drug Administration’s decision after at least 10 states began offering the booster to all adults. The latest action is to simplify what has so far been a confusing list of who is eligible to allow anyone age 18 or older to pick up the company’s boosters six months after their last dose — regardless of whether Which vaccine did he have before?

But there’s another step: The Centers for Disease Control and Prevention must agree to expand Pfizer and Moderna Booster to healthy young adults as well. Its scientific advisers were set to debate later on Friday.

If the CDC agrees, millions more Americans could get three doses of protection before the new year. Anyone who has received Johnson & Johnson’s one-dose vaccine may already have received a booster.

All three COVID-19 vaccines used in the US provide strong protection against serious illness, including hospitalization and death without boosters, but protection against infection can diminish over time. Previously, the government approved vaccine boosters from Pfizer and BioNTech as well as a similar Moderna vaccine only for vulnerable groups, including older Americans and people with chronic health problems.

But Pfizer last week asked the FDA to extend that decision to everyone, citing new data from a study of 10,000 people. Ultimately, the FDA decided that there was enough evidence, both from studies and real-world use of the booster, to support the expansion of both Pfizer and Moderna.

“Streamlining the eligibility criteria and making booster doses available to all persons 18 years of age and older will also help to clear up confusion about who can receive a booster dose and ensure that the booster dose is available to all of them.” available for those who may need it,” said FDA vaccine chief Dr. Peter Marx said.

The move to expand comes as new COVID-19 cases have risen sharply over the past two weeks, especially in states where cold weather is driving people indoors.

Because of those worrying trends, some states didn’t wait for federal officials to act. Utah and Massachusetts were the latest states to announce last week that they were opening up boosters to all adults.

A booster for all was the original goal of the Biden administration. But in September, a panel of FDA advisors voted overwhelmingly against that idea based on the vaccines’ continued effectiveness in most age groups. Instead he endorsed an additional Pfizer dose for only the most vulnerable.

Last month, backed by its advisory panel, the FDA approved the Moderna booster — using half the dose that people got with the first two shots — for similar vulnerable groups.

But there has been some frustration inside the White House and among aides of the president that the lengthy and public regulatory process contributed to misinformation and confusion around the booster and potentially meant the nation was better protected during the holiday season. will not be done.

Administration officials, including Dr. Anthony Fauci, continued to push for more widespread use of the booster, noting that even minor infections in younger people can lead to “prolonged COVID” and other complications.

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“I don’t know of any other vaccines where we only worry about keeping people out of hospital,” Fauci said at a briefing on Wednesday.

But the administration had promised that ultimately the decision would fall on the scientists. This time, the FDA did not consult its advisors, saying that the scientific issues surrounding Pfizer and Moderna’s boosters “do not raise questions that would benefit from additional discussion.”

The regulators concluded that the added benefits of protection outweigh the risk of rare side effects from Moderna’s or Pfizer’s vaccines, such as a type of heart inflammation seen mostly in young men.

Pfizer and its German partner BioNTech argued that the widespread boosters could help reduce infections over a critical period.

“In the current situation we have no chance to control the epidemic without providing boosters to everyone,” BioNtech CEO Ugur Sahin told reporters during a visit to Washington last week.

The companies studied 10,000 adults of all ages and found that a booster restored protection against symptomatic infections by about 95%, while increasing the extra-infectious delta variant. It’s too soon to know whether the high level of protection will last longer after the third shot than the second, Sahin said, adding that the companies will track them carefully.

Backing up that evidence, the UK released real-world data showing a similar jump in safety after it began offering boosters to middle-aged and older adults. Israel has credited the sweeping booster for helping that country defeat another wave of the virus.

More than 195 million Americans have been fully vaccinated, defined as receiving two doses of either Pfizer or Moderna vaccines, or a single dose of Johnson & Johnson vaccine. More than 30 million have already received the booster.

Before the expansion, people receiving the Pfizer or Moderna vaccination were eligible for a third dose if they are elderly or at high risk of COVID-19 because of health problems or their job or living conditions. Because no single shot of J&J has been shown to be as effective as its two-dose competitors, any J&J recipient can receive a booster at least two months later.

But people who don’t meet the criteria may score an additional shot because many vaccine sites don’t check eligibility.

The FDA previously ruled that people receiving boosters could receive a different brand from the vaccine they initially received.

Some experts worry that a full focus on boosters could harm efforts to reach the 60 million Americans who are eligible for vaccination but haven’t received the shots. There is also growing concern that richer countries are offering comprehensive boosters when poorer countries have not been able to vaccinate more than a small portion of their population.

“In terms of the No. 1 priority for reducing transmission in this country and around the world, this is getting people their first vaccine series,” said Dr. David Downey from the Johns Hopkins Bloomberg School of Public Health.

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Associated Press writer Zeke Miller contributed.

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The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. AP is solely responsible for all content.

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