Another Pfizer vaccine recipient developed Miller Fisher syndrome, which is considered to be a type of Guillain-Barré, eight days after getting the shot. That patient, from Japan, reported double vision and a tingling or burning feeling in her palms and the soles of her feet. Her symptoms were mostly resolved within 41 days, the F.D.A. records said.
The two cases in the Pfizer study put the rate of the condition at about one in 9,000, even though it is typically about one in 100,000, according to Dr. Hana El Sahly, chairwoman of the vaccine advisory committee and a professor of virology at Baylor College of Medicine. “So this is major,” Dr. El Sahly said.
Dr. Marie Griffin, a health policy professor at Vanderbilt University, said the Pfizer vaccine was difficult to evaluate given the low incidence of severe infections among those in the trial.
“I think the benefit for relatively healthy, older people — you have to consider that — is not that great,” Dr. Griffin said. “Compared to a possible high risk of a very severe outcome.”
One recipient of the GSK vaccine, who was 78 and from Japan, also developed Guillain-Barré nine days after getting the vaccine; she went on to spend six months in a rehabilitation hospital. The company and the F.D.A. considered the case to be related to the vaccine.
Two recipients of the GSK vaccine, both 71 and from South Africa, developed acute disseminated encephalomyelitis, a neurological disorder with symptoms including weakness and loss of vision. One case resulted in death. The company and the F.D.A. considered the cases “possibly related” to the vaccine, noting that both patients also received a flu vaccine at the same time as the R.S.V. shot.
Watching the safety of the vaccines after they are approved will be important, said Dr. Henry Bernstein of the Zucker School of Medicine at Hofstra University, and should be considered against the background that the effort to create an R.S.V. vaccine has gone on for years.
Christina Jewett
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