FDA advisory panel rejects plan to offer Pfizer COVID-19 booster shots to most Americans

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An advisory panel for the US Food and Drug Administration on Friday voted to reject Pfizer-BioNtech’s plan to offer booster doses of the COVID-19 vaccine to Americans, saying the boosters are safe. More data is needed to determine whether and not they are effective.

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The vote was 16-12 by a committee of outside experts gathered by the Food and Drug Administration, with members expressing disappointment that Pfizer had provided little data on the safety of additional supplements. Many also raised doubts about the value of mass boosters rather than targeting specific groups.

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In an extraordinary move, both FDA leaders and the panel indicated they were likely to take a second vote Friday afternoon on recommending booster shots for older Americans and other high-risk groups.

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It would help salvage part of the Biden administration’s campaign, but would be a major step back from the broader plan proposed by the White House a month ago, offering booster shots of both vaccines to Pfizer and Moderna to nearly all Americans eight months later. His second dose.

During several hours of vigorous debate on Friday, panel members questioned the value of giving boosters to nearly everyone.

“I don’t think a booster dose will make a significant contribution to controlling the epidemic,” said Dr. Cody Meisner from Tufts University. “And I think it’s important that the main message we transmit is that we all have to get two doses.”

Dr. Amanda Cohn of the Centers for Disease Control and Prevention said: “It is clear at this time that unvaccinated transmission is occurring in the United States.”

Panel members also complained that the data provided by Israeli researchers about their booster campaign may not be suitable for predicting the American experience.

The US has already approved an additional dose of both Pfizer or Moderna vaccines for people who have weakened immune systems, or those with severely weakened immune systems.

meeting Being livestreamed online for public viewing, and is lasts till noon.

The need for boosters and who should get them has been the subject of debate in recent days among scientists within and outside the government, and The World Health Organization has strongly objected To give third-round shots to rich countries when poor countries do not have enough supplies of their first vaccine.

The FDA is also not obliged to follow the advice of its independent panel. But if the agency dismisses its own experts, it could lead to public confusion as President Joe Biden and his top health advisers launch a booster campaign they hoped to start next week. .

US health officials are urgently looking at protecting Americans against the virus amid the highly contagious Delta variant, which has not seen US COVID-19 cases and deaths since last winter.

related: Hospitals in several states are rationing health care amid crushing COVID-19 surge

If the FDA decides that the additional shot is safe and raises immunity levels, the US Centers for Disease Control and Prevention must decide who should get a second dose. The CDC has scheduled a meeting of its own advisors for next week and indicated it is considering boosters for some people — such as older adults, nursing home residents and front-line health workers — in general. instead of population.

Receiving the booster would require separate FDA and CDC decisions for people receiving the Moderna or J&J shots. It is not clear how soon this could come.

FILE – A nurse prepares to administer the Pfizer COVID-19 booster shot at UCI Medical Center on Thursday, August 19, 2021 in Orange, Calif. (Photo by Jeff Gritchen/MediaNews Group/Orange County Register via Getty Images)

In opening remarks for the advisory panel on Friday morning, Dr. Peter Marks – the FDA’s top vaccine regulator – acknowledged the sharp disagreement.

“We know that there can be differing opinions in interpreting the data,” Marx said. “We strongly encourage you to voice and discuss all the different perspectives about data, which is complex and evolving.”

Israel is already giving boosters to its citizens, and Britain this week announced plans to start giving them to people over 50 and some other vulnerable groups six months after their second dose.

In the first presentation of the day to the panel, British researcher Jonathan Stern pointed out a number of problems with ongoing studies showing how effective vaccines are at different times in different countries.

“We must be very mindful of the obvious short-term benefits of vaccination,” he said.

Israeli health officials presented data from their experience of offering additional doses to nearly 3 million adults since late July. The government launched the effort after indications that the safety of the Pfizer vaccine fell from 97% earlier this year to 85% by July in people previously vaccinated.

Sharon Alroy-Preis of Israel’s Ministry of Health told the panel that the booster dose improved protection against infection tenfold in people 60 and older.

“It’s like a new vaccine,” bringing protection back to original levels and helping Israel “reduce severe cases in the fourth wave,” she said.

Pfizer was expected to present data suggesting immunity to its vaccine. A Pfizer study of 44,000 people found the effectiveness against symptomatic COVID-19 was 96% two months after the second dose, but dropped to 84% by about six months.

related: Study: 80% of COVID-19 patients have 1 or more long-term effects

on Wednesday, The FDA Posted a Lot of Evidence That panel is considering and has struck a decidedly neutral tone on the justification of the booster. The agency’s reviewers have suggested that they research primarily how vaccines are working among Americans, saying it “may most accurately represent vaccine effectiveness in the US population.”

Overall, the data shows that Pfizer and other US-authorized COVID-19 vaccines “still provide protection against serious COVID-19 illness and death in the United States,” the agency said, summarizing the evidence.

Anna Durbin of the Johns Hopkins School of Public Health said it is important to understand the FDA’s decision whether an additional dose is safe and does what it promises – to increase immunity levels.

The broader issue: “What’s really going to control the delta variant is vaccinating without a vaccine, not a booster,” Durbin said.

To date, 63.5% of Americans eligible for the shots have been fully vaccinated, according to CDC data – meaning more than a third of the eligible population is still not protected.

related: COVID-19 booster: FDA strikes neutral tone on additional shots ahead of panel meeting

For the average person, the CDC says that real-world data shows that protection against serious illness, hospitalization, and deaths is strong. But in a recent study, protection from infection slipped as the delta variant hits: It was 91% in the spring but 78% in June and July. The CDC also indicated that for people age 75 and older, there was a slight drop in safety from hospitalization in the summer.

Moderna has also asked the FDA to allow booster doses of its vaccine, and posted its study of weakened immunity on Wednesday.

President Joe Biden’s top health advisers, including the heads of the FDA and CDC, first announced plans for widespread booster shots a month ago, targeting the week of September 20 as the start date. He said boosters would be given eight months after the second dose of Pfizer and Moderna Vaccines.

But before that FDA staff scientists had completed their assessment of the data. Some experts questioned whether Biden was breaking his pledge to “follow the science” on COVID-19 by overtaking government scientists.

earlier this week, Two top FDA vaccine reviewers join a group of international scientists In publishing an editorial dismissing the need for boosters in healthy people. The scientists said continued studies show the shots are working well, regardless of the delta version.

related: COVID-19 booster not needed yet, says health experts’ group

While the US has already approved booster shots for some people with weakened immune systems, such as cancer patients and transplant recipients, some healthy Americans have managed to get boosters as well. In some cases, they have simply shown up and asked for a shot, and the health system is already offering additional doses to those at high risk.

The US booster plan has also raised ethical concerns about the fate of people in poorer parts of the world. But the administration has argued that the plan is not to us or their choice, given that the US is supplying vast quantities of the vaccine to the rest of the world.

related: COVID-19 booster: WHO chief urges countries to hold off extra shots for rest of 2021

This was reported from Cincinnati.


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