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FDA panel issues narrow recommendation for Covid vaccine booster doses – Boston, Massachusetts

Boston, Massachusetts 2021-09-17 16:14:27 –

Click for an archived version of the live coverage of the FDA’s Advisory Board hearing here..

NSn Friday’s Food and Drug Administration advisory board recommended that most Americans at this time oppose booster vaccination with the Covid-19 vaccine. This is a big condemnation of the Biden administration, but it has unanimously passed a recommendation for Americans over the age of 65. ..

The FDA does not have to follow the advisory board’s recommendations, but usually does. If the FDA and the US Centers for Disease Control and Prevention adopt this recommendation, US policy will be on par with countries like the United Kingdom.

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After seven hours of deliberation, members of the Vaccine and Related Biopharmaceutical Advisory Board voted against the proposal to administer a third dose of the vaccine developed by Pfizer and BioNTech to individuals 16 years and older. .. The vote to recommend boosters to people over the age of 65 and those at risk of severe Covid was 18-0.

It was not immediately clear who was considered high risk. It may be left to the Immunization Implementation Advisory Board, the CDC Advisory Board, to materialize it.

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Panelists acknowledged that the data showed that the protection given to vaccinated people weakened over time, but the overwhelming number of vaccinated people needed hospitalization. He claimed that he had sufficient protection to deal with the infection without risking death.

“The vaccine may eventually be applied to the general public, but I don’t think it’s there yet,” said Ofer Levy, head of the Boston Children’s Hospital precision vaccine program. ..

Peter Marks, head of the FDA Biopharmaceutical Center, which decides to approve the vaccine, voted to recommend booster vaccination.

“It’s no secret here that there is still debate about the need for an additional Covid-19 vaccine at this stage of the pandemic,” he said. “But new evidence, such as from an Israeli colleague, is very helpful, and we also know that the United States is experiencing breakthrough infectious diseases, including severe ones.”

Voting puts the FDA in a difficult position. In August, President Biden, government commissioner, Janet Woodcock, and other executive branch supreme health officials say booster doses will be granted to most Americans before the FDA and CDC review the data. I took an unusual measure.

In the last few weeks Many outside experts did not support the decision.. The World Health Organization is also very critical of the idea that most people in developing countries will boost in wealthy countries while they have not yet been vaccinated.

Another ACIP meeting is scheduled for next week. While the FDA makes a decision on whether to approve the vaccine, ACIP advises the CDC on whether to recommend the use of FDA-approved vaccines.

Most experts believe that booster doses may eventually be needed. When is the problem?

“I think this would be a much better vaccine with a late boost,” said a vaccine made by Moderna and many other producers when he was Deputy Director of the National Vaccine Research Center. Barney Graham, who designed the structure, said the Institute of Health STAT in a recent interview..



FDA panel issues narrow recommendation for Covid vaccine booster doses Source link FDA panel issues narrow recommendation for Covid vaccine booster doses

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