Luis Álvarez | Digital Television | beautiful pictures
The Food and Drug Administration on Wednesday approved a vaccine manufactured by Pfizer protect adults 60 years and older from respiratory syncytial virusa common pathogen that kills and hospitalized thousands of seniors each year.
Pfizer, in a statement Wednesday, said it expects supply in the third quarter of this year ahead of the RSV season. The Centers for Disease Control and Prevention’s independent advisory committee will meet on June 21 to make recommendations on vaccine use.
Pfizer’s vaccine approval comes just weeks after FDA approval similar shot RSV targeting is done by GSK.
Two FDA authorizations in just one month mark a historic milestone for public health, after decades of failed efforts to develop a vaccine for the virus.
RSV causes mild symptoms similar to colds in most people, but older adults are at higher risk of serious illness.
The virus kills 6,000 to 10,000 older adults and leaves 60,000 to 160,000 of them hospitalized each year, according to the federal Centers for Disease Control and Prevention.
RSV also circulated at the same time as Covid and influenza.
The combined burden of the three viruses put significant pressure on the healthcare system late last year. Two new RSV vaccines from Pfizer and GSK could help alleviate some of that pressure this fall.
Pfizer’s shot is given as a single dose of 120 micrograms.
The vaccine is about 67% effective against lower respiratory tract disease with at least two signs or symptoms and about 86% effective against this disease with three signs or symptoms, according to clinical trial results.
The FDA’s independent advisory committee endorsed Pfizer’s vaccine in February. But some members of the council spoke out about safety concerns about the shot.
Two Pfizer clinical trial participants developed Guillain-Barre syndrome after vaccination. Guillan-Barre is a rare neurological disorder with symptoms ranging from brief weakness to paralysis.
The FDA considers two Guillain-Barre cases possibly related to the vaccine. The agency asked Pfizer to conduct a post-approval safety study to monitor the disorder.
Pfizer has also developed a vaccine to protect Infant from RSV.
FDA advisers backed that shot in a meeting earlier this month. The FDA is expected to make a final decision on that vaccine in August.
