FDA advisors narrowly voted for Pfizer’s RSV vaccine for the elderly, despite possible safety concerns.


Vaccine consultants at the US Food and Drug Administration narrowly voted in favor of Pfizer’s RSV vaccine for adults over 60 on Tuesday, paving the way for approval of the first national RSV vaccine despite some safety concerns.

Committee members voted 7 to 4, with one abstention, that there is sufficient evidence to support the safety and efficacy of the Pfizer vaccine for preventing respiratory syncytial virus lower respiratory disease in the elderly.

The FDA, which usually follows independent committee recommendations, should decide on vaccine approvals by May, before the typical winter RSV surge. The US Centers for Disease Control and Prevention must then recommend the vaccine before it becomes generally available.

Pending these moves, Pfizer’s vaccine — along with the GSK vaccine candidate voted on by the FDA’s advisory committee on Wednesday — will become the first approved RSV vaccine for adults 60 and older.

RSV is a highly contagious virus that causes a flu-like illness in people of all ages, the severity of which increases with age. It is estimated to be responsible for 177,000 hospitalizations and 14,000 deaths per year among adults aged 65 and over. CDC.

The Pfizer vaccine was 66.7% effective in preventing mild lower respiratory disease with two or more symptoms and 85.7% in preventing disease with three or more symptoms. FDA White Paper.

While a majority of committee members voted in favor of the vaccine, some members expressed concern about the “important potential risk” of the vaccine: Guillain-Barré syndrome. Two adults out of 20,000 vaccine recipients in Pfizer’s Phase 3 clinical trial developed symptoms consistent with a rare neurological disorder within nine days of vaccination.

“It seems to me that one case is a wake-up call. Two cases are very disturbing and I am concerned that Pfizer does not believe there are any security issues,” the doctor said. Marie Griffin, a professor of health policy at Vanderbilt University Medical Center, voted that the data showed the vaccine was effective but unsafe.

The FDA recommended that Pfizer conduct a safety study to further evaluate Guillain-Barré disease and other immune-mediated demyelinating conditions following a potential vaccine approval, and the company agreed.

Dr. Daniel Feikin, a respiratory consultant who voted for the vaccine’s safety and efficacy, said post-marketing safety surveillance would be “critical.”

Some vaccine advisers wanted to see more data on efficacy against hospitalization or death, especially among people at high risk, such as the elderly or people with other medical conditions.

“I think the data supports the effectiveness of this vaccine. It’s just that the population was underrepresented by people who could have benefited the most from the vaccine,” Griffin said.

The available safety and efficacy data from Pfizer’s clinical trials are for the first of two seasons of RSV. Some of the experts said that the vote is premature and that they would like to see more data.

“I desperately want a vaccine that works against RSV. It has been a terrible disease throughout my career. I would like to see it. There is no doubt about that,” the doctor said. Jay Portnoy, professor of pediatrics at the University of Missouri-Kansas City, voted that the data showed the safety of the vaccine, but not its effectiveness.

Portnoy says that waiting for the second season of data will provide more reliable numbers and a fuller analysis.

“This is not an emergency use permit. We may take the time to complete research and obtain the necessary information before licensing this product in the future. So I remain a bit skeptical given the data we have.”

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