FDA Advisors Recommend Booster Vaccine for People 65 Years and Older

(CNN) — Vaccine advisers to the United States Food and Drug Administration (FDA) voted unanimously on Friday to recommend the authorization of emergency use of a booster dose of the Pfizer vaccine against covid-19 six months after the second dose in people 65 years of age or older and in those at high risk of severe disease.

Members of the advisory committee expressed doubts about the safety of a booster dose in young adults and adolescents, and complained about the lack of data on the safety and long-term efficacy of a booster dose.

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Biden administration officials had previously announced a plan to begin giving booster doses to the general population during the week of September 20, pending approval from the FDA and the US Centers for Disease Control (CDC). Some of the advisers have said the process was rushed because of that deadline.

On Friday, several said they wanted to see more data, or that they believed the reinforcements were probably necessary, but for a more limited segment of the population.

“I don’t think a booster dose is going to contribute significantly to controlling the pandemic,” Dr. Cody Meissner, a professor of pediatrics at Tufts University School of Medicine, said during the meeting.

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“It is very important that the main message that we continue to transmit is that we have to give everyone two doses. Everyone has to receive the primary series. This booster dose is not likely to make a big difference in their behavior. pandemic”.

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Pfizer’s vision

During the meeting, Dr. William Gruber, Pfizer’s senior vice president of vaccine research and clinical development, said that several studies indicate that people’s immunity can and does decrease and that giving booster doses restores that immunity, sometimes at levels higher than those seen in the initial vaccination.

Gruber added that while Pfizer’s two-dose vaccine continues to protect well against serious infections, hospitalizations and deaths, there are signs that that could change. The company relied heavily on the Israel data, where vaccinated people began to contract post-vaccination infections.

However, FDA staff and advisers objected to the data available thus far.

Questioning the FDA

Dr. Phil Krause, deputy director of the FDA’s Office of Vaccine Research and Review, noted that Pfizer was using data that had not been peer-reviewed.

“One of the problems with this is that a lot of the data that has been presented and that is being discussed today is not peer-reviewed and has not been reviewed by the FDA,” Krause said at the Vaccine and Products Advisory Committee meeting. Related Biologicals.

Krause, along with another FDA vaccine official, Marion Gruber, signed a Lancet magazine article posted earlier this week arguing that it is too early to start giving reinforcements to people.

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Dr. Michael Kurilla, an infectious disease specialist at the National Center for the Advancement of Translational Sciences, noted that the studies relied heavily on antibody measurements, without examining other important aspects of the immune response.

The FDA noted in its informational documents that the Pfizer vaccine, as well as the vaccines manufactured by Moderna and Johnson & Johnson, continue to provide strong protection against serious illness, hospitalization, and death, even if the antibodies decline over time.

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After the FDA advisory committee makes its recommendation, the FDA will make the decision whether or not to approve the booster dose.

CDC scheduled a meeting of your vaccination advisers by September 22-23, and the CDC must give its go-ahead for the booster doses to be officially administered.

CNN’s Jacqueline Howard and Nadia Kounang contributed to this report.

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