FDA Panel Recommends 2 RSV Vaccines for Older Adults
The shots, if approved by the agency would be the first publicly available vaccines against the deadly respiratory virus that kills thousands each year. Some advisors mentioned a slight but identifiable health risk.
According to data provided by GSK to the F.D.A., the GSK vaccine was almost 83 percent effective in lower respiratory tract illnesses in a study of approximately 25,000 patients. Half the patients received the vaccine and the other half received a placebo. There was no R.S.V. Panel members raised concerns about the side effects of each vaccine. One patient who received the Pfizer vaccine developed Guillain Barre syndrome after seven days. This is a condition in which the immune system attacks the nervous systems (but not the spine and brain). F.D.A. considered the case to be life-threatening. Miller Fisher syndrome was a condition that another Pfizer vaccine recipient experienced eight days after receiving the shot. It is a type Guillain Barre. The Japanese patient reported double vision, burning sensations in her hands and feet, and double vision. According to Dr. Hana El Sáhly, who is chairwoman of the vaccine advisory panel and professor of virology at Baylor College of Medicine, the rates of the condition in the two cases from the Pfizer study are about one in 9,000. Dr. Griffin stated that the benefits for older, relatively healthy people are not significant. A GSK vaccine recipient, a 78-year-old Japanese woman, developed Guillain Barre nine days after receiving the vaccine. She spent six months in rehabilitation. Both the F.D.A. and the company agreed that this case was related to GSK vaccine. The case was deemed to be related to the vaccination.