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The Food and Drug Administration on Wednesday approved a vaccine made by Pfizer which protects adults 60 and older from respiratory syncytial virus, a typical pathogen that kills and hospitalizes 1000’s of seniors every year.
Pfizer, in a Wednesday statement, said it expects supplies to be available in the third quarter of this yr ahead of the RSV season. A committee of independent advisers from the Centers for Disease Control and Prevention will meet on June 21 to make recommendations on the use of the vaccine.
Pfizer’s vaccine approval comes just weeks after the FDA authorized the same RSV injection that’s made by GSK.
Two FDA approvals in only one month mark a historic public health milestone after many years of failed attempts to develop vaccines against the virus.
RSV causes mild cold-like symptoms in most individuals, but older persons are more more likely to grow to be severely unwell.
In accordance with the federal Centers for Disease Control and Prevention, the virus kills 6,000 to 10,000 elderly people and hospitalizes 60,000 to 160,000 of them every year.
RSV can also be circulating at the same time as Covid and flu.
The combined burden of the three viruses put significant pressure on the healthcare system late last yr. Two recent RSV vaccines from Pfizer and GSK could help ease that pressure this fall.
Pfizer injection is given in a single dose of 120 micrograms.
The vaccine was about 67% effective against lower respiratory disease with two or more signs or symptoms, and about 86% effective against lower respiratory disease with three signs or symptoms, in keeping with the results of clinical trials.
The FDA’s Committee of Independent Advisors approved Pfizer’s vaccine in February. But several panel members raised safety concerns about the shot.
Two participants in a Pfizer clinical trial developed Guillain-Barre syndrome after receiving the vaccine. Guillan-Barre is a rare neurological disease whose symptoms range from temporary weakness to paralysis.
The FDA believes the two cases of Guillain-Barre are likely related to the vaccine. The agency asked Pfizer to conduct a post-approval safety study to watch the disorder.
Pfizer has also developed a vaccine to guard newborns against RSV.
FDA advisers backed the shot at a gathering earlier this month. The FDA is predicted to make a final decision on this vaccine in August.