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Monday, November 29, 2021

US Distributes COVID Boosters To All Adults, Final Hurdle Ahead

Laurent Niergaard and MATTHEW PERRON

WASHINGTON (AP) – US regulators on Friday offered to vaccinate against COVID-19 for all adults, expanding the government’s campaign to strengthen protection and outpace the rise in coronavirus cases, which could worsen with the holidays.

Pfizer and Moderna announced the FDA’s decision after at least 10 states have already begun offering boosters for all adults. The latter move is intended to simplify what has so far been a convoluted list of eligible vaccines, allowing anyone 18 years of age or older to choose to revaccinate any company six months after their last dose – regardless of which vaccine they got first.

But there’s one more step: The Centers for Disease Control and Prevention must agree to extend the Pfizer and Moderna boosters even to healthy young adults. His scientific advisers were scheduled to hold the debate on Friday.

If the CDC agrees, tens of millions more Americans can receive three doses of protection before the new year. Anyone who has received a single Johnson & Johnson vaccine can already receive a booster shot.

All three COVID-19 vaccines used in the United States provide robust protection against serious illness, including hospitalization and death without booster, but protection against infection may weaken over time. Earlier, the government approved Pfizer and BioNTech vaccine boosters, as well as a similar vaccine, Moderna, only for vulnerable groups, including older Americans and people with chronic health problems.

But last week, Pfizer asked the FDA to extend the decision to everyone, citing new data from a 10,000-person study. Ultimately, the FDA decided that there was enough evidence from research and actual use of boosters to support expansion for both Pfizer and Moderna.

“Optimizing acceptability criteria and providing booster doses to all individuals 18 years and older will also help remove confusion over who can receive a booster dose and ensure that booster doses are available to anyone who may need one,” said the FDA’s vaccine chief. dr. said Peter Marks.

The move towards expansion is due to the fact that the number of new cases of COVID-19 has been steadily increasing over the past two weeks, especially in states where colder weather is forcing people to leave for their homes.

Due to these alarming trends, some states did not wait for federal action. Utah and Massachusetts were the latest states to announce last week that they are opening boosters to all adults.

The original goal of the Biden administration was to motivate everyone. But in September, a group of FDA advisers voted overwhelmingly against the idea, based on the consistent effectiveness of vaccines in most age groups. Instead, they approved an additional dose of Pfizer only for the most vulnerable.

Last month, with the support of its advisory group, the FDA approved Moderna boosters – using half the dose people got with their first two shots – for the same vulnerable groups.

But there was some frustration within the White House and among the president’s allies that the lengthy and public regulatory process has contributed to misinformation and confusion around accelerators and potentially means the nation will not be optimally protected ahead of the holiday season.

Administration officials, including Dr. Anthony Fauci, continued to push for increased use of boosters, noting that even milder infections in young people can cause “long-term COVID” and other complications.

Read Also:  Friday COVID-19 update: 35 more deaths in Minnesota and 3,378 new cases

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

But the administration has promised that ultimately the decision will remain with scientists. This time, the FDA did not consult with its advisers, saying the scientific issues surrounding the Pfizer and Moderna boosters “do not raise questions that would benefit from further discussion.”

Regulators have concluded that the overall benefits of additional protection outweigh the risks of rare side effects from Moderna or Pfizer vaccines, such as heart inflammation, seen mostly in younger men.

Pfizer and its German partner BioNTech argued broader boosters could help fight infections during critical times.

“In the current situation, we have absolutely no chance of controlling the pandemic without providing all the accelerators,” 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 the booster restored protection against symptomatic infections by up to about 95%, even when the extra-infectious delta variant increased. It’s too early to tell whether this high level of protection will last longer after the third shot than after the second, which Sahin said the companies will be closely monitoring.

Corroborating this evidence, the UK has released real-world data showing the same leap in protection when it began offering boosters for middle-aged and older people. Israel believes widespread launch vehicles have helped suppress another wave of the virus in that country.

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

Prior to expansion, people who received the Pfizer or Moderna vaccine were eligible for a third dose if they are elderly or at high risk for COVID-19 due to health, work, or living conditions. Because J&J’s single shot hasn’t been as effective as its two-dose competitors, any J&J recipient can get a booster shot in at least two months.

But people who do not meet the criteria can get an extra shot because many vaccination sites do not test for qualifications.

The FDA previously ruled that people getting boosted can receive a different brand of vaccine than the one they originally received.

Some experts fear that the focus on boosters could hurt efforts to reach the 60 million Americans who qualify for the vaccine but have not received the vaccine. There is also growing concern that rich countries are offering widespread booster vaccinations when poor countries have been unable to vaccinate more than a small fraction of their populations.

“As far as priority # 1 to reduce transmission in this country and around the world, it continues to give people their first batch of vaccines,” said Dr. David Dowdy of Johns Hopkins Bloomberg School of Public Health.


Associated Press writer Zeke Miller contributed.


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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