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The Food and Drug Administration on Wednesday approved a vaccine made by Pfizer which protects adults 60 and older against respiratory syncytial virus, a common pathogen that kills and hospitalizes thousands of seniors each year.
Pfizer, in a statement Wednesday, said it expects supply to be available in the third quarter of this year 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 the use of the vaccine.
Pfizer’s vaccine approval comes just weeks after the FDA cleared a similar RSV-targeting vaccine that’s made by GSK.
The two FDA clearances in just one month represent a historic milestone for public health, following decades of failed efforts to develop vaccines for the virus.
RSV causes mild symptoms similar to those of a cold in most people, but older people are at higher risk of serious illness.
The virus kills 6,000 to 10,000 seniors and hospitalizes 60,000 to 160,000 every year, according to the federal Centers for Disease Control and Prevention.
RSV also circulates at the same time as Covid and influenza.
The combined burden of the three viruses put tremendous pressure on the healthcare system late last year. The two new RSV vaccines from Pfizer and GSK could help ease some of that pressure this fall.
Pfizer’s vaccine is given as a single dose of 120 micrograms.
The vaccine was about 67% effective against lower respiratory tract diseases 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 committee of independent advisors approved Pfizer’s vaccine in February. But several panel members had expressed concerns about the safety of the shot.
Two participants in the Pfizer clinical trial developed Guillain-Barré syndrome after receiving the vaccine. Guillan-Barré is a rare neurological disorder with symptoms ranging from brief weakness to paralysis.
The FDA considers both Guillain-Barré cases to be 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 newborns from RSV.
FDA advisers backed that shot at a meeting earlier this month. The FDA is expected to make a final decision on this vaccine in August.