FDA panel recommends 2 RSV vaccines for older adults

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Another Pfizer vaccine recipient developed Miller Fisher syndrome, which is thought to be a variant of Guillain-Barré, eight days after getting the shot. That patient from Japan reported double vision and a tingling or burning sensation in the palms and soles of the feet. FDA records state that her symptoms mostly resolved within 41 days.

The two cases in the Pfizer study put the rate of the condition at about one in 9,000, even though it is usually about one in 100,000, according to Dr. Hana El Sahli, chair of the vaccine advisory committee and professor of virology at Baylor College of Medicine. “So this is key,” said Dr. El Sahli.

Dr. Mary Griffin, a professor of health policy at Vanderbilt University, said Pfizer’s vaccine was difficult to evaluate given the low incidence of serious infections among those involved in the trial.

“I think the benefit for relatively healthy, older people — you have to consider it — isn’t that great,” Dr. Griffin said. “Compared to the potentially high risk of very serious consequences.”

One recipient of the GSK vaccine, who was 78 years old and from Japan, also developed Guillain-Barre nine days after receiving the vaccine; She went on to spend six months in a rehabilitation hospital. The company and the FDA have considered the matter related to the vaccine.

Two recipients of the GSK vaccine, both 71 and one from South Africa, developed acute disseminated encephalomyelitis, a neurological disorder characterized by weakness and loss of vision. Death occurred in one case. The company and the FDA consider the cases “possibly related” to the vaccine, noting that both patients received a flu vaccine along with the RSV shot.

Seeing the safety of vaccines once approved will be important, said Dr. Henry Bernstein of the Zucker School of Medicine at Hofstra University, and should be considered against the backdrop that efforts to create an RSV vaccine have gone on for years.

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