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FDA advisory panel rejects widespread Pfizer booster shots | News – Kansas City, Missouri

Kansas City, Missouri 2021-09-17 15:42:26 –

Washington (AP) —Influential Federal Advisory Board has categorically rejected plans to provide most Americans with Pfizer booster shots against COVID-19.

Friday’s 16-2 vote hit the Biden administration’s efforts to increase people’s protection against the virus among the highly contagious delta mutants.

During a few hours of discussion, members of the Food and Drug Administration panel of outside experts complained that Pfizer provided little data on the safety of additional doses.

And they complained that the data provided by Israeli researchers about their booster campaign might not be suitable for predicting the US experience.

This is the latest news update. The previous story of AP is as follows.

Washington (AP) — The Biden administration’s embarrassed plan to distribute COVID-19 booster shots to most Americans was Friday as the government’s advisory board actively discussed whether to support additional doses of the Pfizer vaccine. Faced the first big hurdle.

Scientists inside and outside the government have recently disagreed on the need for boosters and who should get them, and the World Health Organization says that when poor countries don’t have enough vaccines, rich countries Their first strongly opposes giving a third inoculation.

A panel of outside experts advising the Food and Drug Administration was less important than the clear case: studies show that the immune level of vaccinated people declines over time, and boosters reverse it. Although suggesting that it can be done, the Pfizer vaccine is still very protective against serious illness and death, even with the prevalence of highly contagious delta variants.

FDA experts were planning to vote on one basic question. Does the evidence show that Pfizer boosters are safe and effective for people over the age of 16? If voted in favor, the FDA is expected to promptly approve Pfizer’s shot boosters.

But that’s just one step in the process. The more annoying question of who should be shot when will be discussed by an advisor to the Centers for Disease Control and Prevention on Wednesday. The CDC typically adopts group recommendations for setting policies for US vaccination campaigns.

The CDC says it is considering boosters for the elderly, nursing home residents, and front-line healthcare professionals, rather than all adults.

People who receive Moderna or J & J shots will need separate decisions from the FDA and CDC to get boosters.

At the meeting on Friday, FDA panelists heard a full discussion of the need for boosters from both Pfizer and Israeli health officials. Israel began providing boosters to its citizens in July.

Sharon Alroy-Israel Health Department Preis said booster doses improve protection against infections in people over the age of 60 by a factor of 10.

“It’s like a fresh vaccine,” she said, returning protection to its original level and helping Israel “mitigate the serious cases of the fourth wave.”

Pfizer representatives also argued that it was important to strengthen immunity before the defense against severe illness began to decline. According to a company survey of 44,000 people, the efficacy against symptomatic COVID-19 was 96% 2 months after the second dose, but decreased to 84% in about 6 months.

Both Pfizer and Israeli representatives faced backlash from panelists. Some skeptics about Israel’s experience and its relevance to the United States complicate the Commission’s decisions. No one knows yet the level of antibodies that are unlikely to be infected and require booster immunization.

“This is a great way to monitor if you really need booster shots,” said James Hilldress, President of Meharry Medical College.

Dr. Philip Klaus, an FDA vaccine reviewer, has asked many questions about the reliability of one of the major studies showing that Pfizer has weakened immunity.

Another concern was whether the third dose exacerbated serious side effects.

Dr. Cody Meissner of Tufts Medical Center said he was worried about additional doses to the younger age group given the risk of heart inflammation seen in most young men after the second dose. This condition is very rare, but it is not clear if the risk increases with different doses, he said.

Pfizer pointed out Israeli data from nearly 3 million boosters, suggesting that side effect rates are similar to those seen after the second dose.

Dr. Paul Offit, a vaccine expert at the Philadelphia Children’s Hospital, said he was likely to support the approval of a third dose for adults over the age of 60 or 65, but for anyone up to the age of 16. “I really have a problem,” he said.

Extra shots may reduce mild or asymptomatic cases at least temporarily, but “the question is what will be the effect of it on the pandemic arc, but it may not be so many. “Hmm,” said Mr. Ofit.

The Biden administration said vaccination of people was a priority in the first place, but the growing crisis urged efforts to strengthen Americans’ protection against the virus by giving them booster shots. Gave.

President Joe Biden’s top health advisors, including the FDA and CDC heads, first announced plans for a wide range of booster shots a month ago, with the week of September 20 as an almost certain start date. The booster will be dispensed eight months after the second dose of the Pfizer and Moderna vaccines.

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

Earlier this week, two top FDA vaccine reviewers joined a group of international scientists and published an editorial denying the need for boosters for healthy people. Scientists say ongoing research shows that shots work well despite the delta variant.

On Friday, U.S. Surgeon President Vivek Murthy added that the Biden administration was not trying to pressure regulators to act when announcing its booster program, but instead was transparent to the public. He said he was preparing for the shot if it was approved.

“We have always said that this initial plan relies on independent assessments by the FDA and CDC,” Mercy said.

The Biden program also raised major ethical concerns about the poorest parts of the world seeking vaccines. However, the government argued that the plan was not ours or their choice and pointed out that the United States is supplying large quantities of vaccine to other parts of the world.

The United States has already approved Pfizer and Modana boosters for certain people with weakened immunity, such as cancer patients and transplant recipients.

Some Americans, healthy or unhealthy, could get boosters simply by appearing and asking for shots. And some healthcare systems are already providing additional doses to high-risk people.

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The Associated Press’s Department of Health Sciences is supported by the Department of Science Education at the Howard Hughes Medical Institute. AP is solely responsible for all content.



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