Monday, October 18, 2021

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    FDA meeting jeopardizes Biden’s plans to fight the virus

    An important part of the president Joe BidenPlans to fight Covid are at stake as the Food and Drug Administration’s Vaccine Advisory Board meets on Friday for debate and voting. Pfizer When BioNTechAn application for providing booster shots to the general public.

    Voting by the institution’s Vaccine and Related Biopharmaceutical Advisory Board (scheduled around 2:30 EST) will take place as some scientists, including: At least two in the FDA, Says that not all Americans who have been vaccinated with Pfizer are completely convinced that they need additional doses at this time.

    In a document released prior to the advisory board meeting, FDA scientists Refused to take a stance US regulators say they haven’t independently reviewed or validated all the data available to support the use of boosters, and whether they support third shots. They also seemed skeptical about some of the data provided. Effectiveness figures widely quoted from IsraelResearchers there have published observational studies showing that the effectiveness of the Pfizer vaccine against infection has diminished over time.

    The Biden administration has said it wants to wait for FDA approval and start offering booster shots as early as next week, so it’s ready for a tense meeting on Friday.This move is part of the administration Broader plan Confront more Covid cases in the United States supported by the rapidly expanding delta variant.

    Top U.S. health regulators, including CDC director Rochelle Walensky, FDA commissioner Janet Woodcock, and White House chief medical advisor Anthony Fauci, have already announced in August that Biden Approved booster plan. The FDA does not always follow the advice of the Commission, but it does. The agency surprised investors and the general public earlier this year, away from the advice of an independent committee of outside experts to approve Biogen’s drug for Alzheimer’s disease.

    If the Commission does not vote in favor, the Biden administration may be forced to shift gear according to plan, perhaps for Americans over the age of 65 who are known to be at serious risk. Limit third shots to specific groups The illness was said by Lawrence Gostin, director of the World Health Organization Center on National and World Health Law.

    Gostyn said the FDA Group could give Biden’s booster program a “cool reception.” “There is ample evidence that vaccine immunity can be compromised, but preventing serious illness, hospitalization, and death ensures that two mRNA doses are maintained.”

    Dr. Bruce Farber, Head of Infectious Diseases at Northwell Health, has announced that the government will begin distributing boosters in the week of September 20, putting the commission in a “troublesome position” by voting. He said he would be taken.

    “I already know they aren’t unanimous, so I’m sure they won’t be unanimous in what they say,” he said.

    Scientists and other health professionals were already critical Biden’s move to boost All Americans over the age of 16 who were outlined by health officials last month. Scientists and other experts said the data quoted by federal health officials were unconvincing and characterized the government’s promotion of boosters prematurely.

    Overview of the plan to start Distribute boosters as early as next week, Government officials cited three CDC studies that showed that vaccine protection against Covid was reduced over the course of several months.The administration’s plan is to give people a third dose of Pfizer or Modana Vaccine will be given 8 months after the second vaccination. Biden has said scientists have been considering moving the third shot up three months since then.U.S. health officials said more data needed Johnson & Johnsons Vaccines before they can recommend boosters for those shots.

    Pfizer and Moderna have also been released respectively Unique analysis The incidence of breakthrough Covid cases in fully vaccinated people indicates less frequent cases in recently vaccinated clinical trial participants, suggesting that Covid vaccine protection declines over time. doing. In another document released Wednesday, Pfizer showed that an observational study in Israel showed a third dose of the Covid vaccine six months after the second injection restored protection from infection to 95%. Said that.

    Still, some scientists claim that booster shots for the general public are not needed for now.

    A major group of scientists Published a treatise The data available on Monday’s medical journal, The Lancet, said the data available show that vaccine protection against severe illness continues, even though its effectiveness against mild illness diminishes over time. The author, including two FDA officials and several scientists from the World Health Organization, said the widespread distribution of booster shots to the general public was “inappropriate” at this time.

    Dan Barouch, an immunologist at Harvard Medical School, said there is currently no consensus in the biomedical community regarding boosters for the general public. “There are senior experts who fall into various aspects of the debate.”

    Dr. Arturo Casa de Bar, Chairman of Molecular Microbiology and Immunology, Johns Hopkins University Bloomberg School of Public Health, supports boosters for the general public.

    He said third shots should boost immunity and reduce the likelihood of breakthrough infections, including mutant strains. “For all vaccines, immunity declines over time, and the Covid-19 vaccine is no exception,” he added.

    Akiko Iwasaki, an immunologist at Yale School of Medicine, disagrees with the widespread distribution of boosters in the United States. She said she should focus on giving everyone in the world the first shot before moving on to booster doses.

    Still, she said, booster shots are now needed for more vulnerable people, as breakthrough cases have led to serious illness and hospitalization.

    These severe cases are “mainly found in the elderly and older people, such as those aged 65 and over,” she said. “I think it really makes sense for me to give it to my seniors.”

    FDA meeting jeopardizes Biden’s plans to fight the virus

    Source link FDA meeting jeopardizes Biden’s plans to fight the virus

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