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The Food and Drug Administration on Wednesday approved a vaccine made by Pfizer that protects adults ages 60 and older from respiratory syncytial virus, a standard pathogen that kills and hospitalizes hundreds of seniors every yr.
Pfizer, in a press release Wednesday, said it expects to have supply available within the third quarter of this yr ahead of the RSV season. The Centers for Disease Control and Prevention’s committee of independent advisors will meet on June 21 to make recommendations on using the vaccine.
The approval of Pfizer’s vaccine comes just weeks after the FDA cleared an analogous shot targeting RSV that’s made by GSK.
The 2 FDA authorizations inside only a month represent a historic milestone for public health, after many years of failed efforts to develop vaccines for the virus.
RSV causes mild symptoms just like a chilly in most individuals but older adults face a better risk of severe illness.
The virus kills 6,000 to 10,000 older adults and hospitalizes 60,000 to 160,000 of them every yr, in line with the federal Centers for Disease Control and Prevention.
RSV also circulates similtaneously Covid and flu.
The combined burden of the three viruses put substantial pressure on the health-care system late last yr. The 2 recent RSV vaccines from Pfizer and GSK could help ease a few of that pressure this fall.
Pfizer’s shot is run as a single 120-microgram dose.
The vaccine was about 67% effective against lower respiratory tract illness with not less than two signs or symptoms, and about 86% effective against this illness with three signs or symptoms, in line with clinical trial results.
The FDA’s committee of independent advisors endorsed Pfizer’s vaccine in February. But several members of the panel had voiced safety concerns concerning the shot.
Two participants in Pfizer’s clinical trial developed Guillain-Barre syndrome after receiving the vaccine. Guillan-Barre is a rare neurological disorder with symptoms starting from temporary weakness to paralysis.
The FDA views the 2 Guillain-Barre cases as possibly linked to the vaccine. The agency has asked Pfizer to conduct a post-approval safety study to observe for the disorder.
Pfizer has also developed a vaccine to guard newborns from RSV.
The FDA’s advisors backed that shot in a gathering earlier this month. The FDA is predicted to make a final decision on that vaccine in August.