FDA panel recommends Pfizer boosters for those over 65 years of age or at high risk for severe Covid

FDA panel recommends Pfizer boosters for those over 65 years of age or at high risk for severe Covid

A key advisory body to the Food and Drug Administration overwhelmingly opposed the recommendation of Pfizer booster vaccinations for most recipients of the company’s coronavirus vaccine, and instead only endorsed it for those 65 or older or at high risk for severe Covid-19 19 have.

The vote – the first on boosters in the United States – was a blow to the Biden government’s strategy of providing additional vaccinations to most fully vaccinated adults in the United States eight months after receiving a second dose. The broader rollout should begin next week.

Committee members seemed to reject the argument that the general population needed booster vaccinations, saying the data from Pfizer and elsewhere still seemed to show two vaccinations that protected against serious illness or hospitalization and did not prove a third vaccination was preventing the spread contain the infection. Some also criticized the lack of data that an additional injection is safe for younger people.

“It is unclear that everyone needs topping except for a subset of the population who would clearly be at high risk for serious illness,” said Drs. Michael G. Kurilla, a committee member and officer for the National Institutes of Health.

But the panel’s final recommendation left some space for the White House to argue that the core of its booster strategy remains intact. Depending on how “high risk” is defined, It is conceivable that tens of millions of Americans could be eligible for additional vaccinations from the Pfizer vaccine.

The panel of largely external experts voted 16-2 against a Pfizer booster for people aged 16 and over after a tense, day-long public discussion in which the divisions within the agency and administration were publicly displayed. Officials from the Centers for Disease Control and Prevention and the National Institutes of Health, along with infectious disease experts and doctors, voted against additional shots for such a broad population.

Dr. Paul Offit, a committee member and director of the Vaccine Education Center at Children’s Hospital of Philadelphia, asked if additional shots would go much further in changing the arc of the pandemic. “We all agree that we have to vaccinate the unvaccinated if we really want to influence this pandemic,” he said.

However, the panel unanimously passed a fallback position to limit additional admissions to the elderly and others at high risk of severe Covid disease. Then, following an informal survey conducted by a senior FDA official, committee members determined that health care workers, emergency responders, and others whose jobs put them at particular risk should also be eligible for the booster. The official – Dr. Peter Marks, who oversees the FDA’s vaccines division – said the at-risk group would also include teachers.

Biden staff noted that under the White House plan to offer booster syringes eight months after the second injection, the same group would come first as they were vaccinated earliest.

The FDA has the final say in approving vaccines, and while it is not required to follow the committee’s recommendations, it usually does. The agency is expected to make a decision early next week.

A CDC advisory committee is due to meet on Wednesday and Thursday to discuss booster injections before this vaccine policy-making agency makes recommendations on who should get them.

Critics of the government’s booster strategy as too far-reaching or premature said the advisory committee acted as a necessary check on Friday.

The meeting “put the FDA back in the driver’s seat,” said Dr. Luciana Borio, a former acting chief scientist at the agency. The panel of experts, she said, “should retain its scientific independence. She understands that the data presented has significant limitations and that the FDA must carefully review the data before making a decision. “

Apoorva Mandavilli and Sheryl Gay Stolberg contributed the reporting.

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Rachel Meadows

Rachel Meadows

Trending topics news writer who enjoys cooking, walking her dog and travel.

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