FDA meeting jeopardizes Biden plan to fight virus

FDA meeting jeopardizes Biden plan to fight virus

A key part of President Joe Biden’s plan to fight COVID is under threat as the Food and Drug Administration’s vaccine advisory committee debated and voted on Friday on Pfizer and BioNTech’s request to offer booster shots to the General public. Meets.

The agency’s Vaccines and Related Biologics Advisory Committee vote – scheduled for around 2:30 p.m. ET – comes as some scientists, including at least two from the FDA, say they are completely protecting every American. Not sure if someone who has received the Pfizer vaccine needs additional doses at this time.

In documents released before the advisory committee meeting, FDA scientists declined to take a position in support of the third move, saying US regulators used all available data to support the booster’s use. Has not independently reviewed or verified. They also seemed skeptical of some of the data they provided, including the widely cited efficacy figures in Israel, where the researchers published observational studies showing the effectiveness of the Pfizer vaccine against infection over the wire. time.

This sets the stage for a tense meeting on Friday as the Biden administration said it wanted to start offering recalls to the general public as early as next week, pending FDA clearance. The move is part of the administration’s broader plan to tackle the high number of Covid cases in the United States due to the rapidly spreading delta variant.

The country’s leading health regulators, including CDC Director Dr Rochelle Valensky, Acting FDA Commissioner Dr Janet Woodcock and White House Chief Medical Advisor Dr Anthony Fauci, have already backed Biden’s stimulus package in August. While the FDA hasn’t always followed the advice of its committee, it often does. The agency stunned investors and the public earlier this year when it bypassed the advice of its independent panel of external experts to approve Biogen’s Alzheimer’s drug.

If the committee does not cast a favorable vote, it could force the Biden administration to shift gears on its plan, possibly limiting third shots to certain groups of Americans, such as those 65 and older. People known to be at high risk of severe exposure. Lawrence Gostin, director of the Center on Disease, National and Global Health Law at the World Health Organization.

The FDA group could give Biden’s stimulus package a “good reception,” Gostin said. “While there is good evidence for a potential weakening of vaccine immunity, the two doses of mRNA hold up in preventing serious illness, hospitalizations and death.”

The vote puts the committee in a “strange position” as the administration has already announced it will begin handing out boosters in the week of September 20, said Dr Bruce Farber, head of infectious diseases at Northwell Health.

“I’m sure they won’t be unanimous in what they said because we already know they are not unanimous,” he said.

Scientists and other health experts were already criticizing Biden’s decision to promote all Americans 16 and older when senior health officials presented the plan last month. Scientists and other experts said the data cited by federal health officials did not force the administration to request a premature recall.

Outlining plans to begin booster distribution early next week, administration officials cited three CDC studies that showed the safety of COVID vaccines had weakened over several months. The administration plan tells people to take their third dose of Pfizer or Moderna vaccine eight months after their second injection. Biden has since said scientists are examining whether to extend the third shot by three months. U.S. health officials have said they need more data on Johnson & Johnson’s vaccine before recommending boosters for those injections.

Pfizer and Moderna also published their own analyzes, showing that the incidence of breakthrough cases of COVID, which occur in fully vaccinated people, was lower among clinical trial participants who had recently received the vaccine in the United States. , suggesting the safety of COVID vaccines overtime. In separate documents released on Wednesday, Pfizer said an observational study in Israel showed that a third dose of the COVID vaccine six months after the second injection restored protection against infection by 95%.

Still, some scientists argue that booster shots are no longer necessary for the general public.

A group of leading scientists published an article in the medical journal The Lancet on Monday, saying that available data suggests that vaccine protection against serious illness persists, albeit against mild illness, over time. efficiency is reduced. The authors, including two senior FDA officials and several scientists from the World Health Organization, said it was “not appropriate” to widely distribute booster shots to the general public at this time.

There is currently no consensus in the biomedical community on boosters for the general public, said Dan Barouch, immunologist at Harvard Medical School. “There are seasoned experts who come from different sides of the debate. “

Professor of Molecular Microbiology and Immunology at the Bloomberg School of Public Health at Johns Hopkins University, Dr Arturo Casadeval supports Booster for the General Public.

He said a third injection would boost immunity and reduce the risk of breakthrough infection, including a variety of strains. “For all vaccines, immunity wanes over time and COVID-19 vaccines are no different,” he said.

Akiko Iwasaki, an immunologist at the Yale School of Medicine, disagrees with the widespread distribution of boosters in the United States, saying we should focus on the world’s first injection before moving on to doses of reminder.

Nonetheless, she said, booster shots are still needed for some of the most vulnerable, as rupture cases lead to serious illness and hospitalization.

These serious cases occur “mainly in the elderly and adults 65 and over,” she said. “I think giving it to superiors really makes sense to me right now.”

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