Pfizer’s vaccine against respiratory syncytial virus, a common disease that injures and kills thousands of seniors annually, was approved by the Food and Drug Administration on Wednesday.
In a statement released on Wednesday, Pfizer stated that it anticipates having supplies available prior to the RSV season in the third quarter of this year. On June 21, a committee of independent advisors from the Centers for Disease Control and Prevention will meet to discuss how to use the vaccine.
Pfizer’s RSV vaccine received FDA approval just weeks after GSK’s RSV vaccine received FDA approval.
After decades of unsuccessful efforts to develop vaccines for the virus, the two FDA authorizations within a month represent a historic milestone for public health.
Most people with RSV experience mild symptoms similar to those of a cold, but older adults are more likely to experience severe illness.
According to the federal Centers for Disease Control and Prevention, the virus annually injures 60,000 to 160,000 older adults and kills 6,000 to 10,000 of them.
Covid and flu are also present at the same time as RSV.
The consolidated weight of the three infections put significant squeeze on the medical services framework before the end of last year. This fall, the two brand-new RSV vaccines from Pfizer and GSK might help alleviate some of that pressure.
Pfizer’s shot is managed as a solitary 120-microgram portion.
According to the findings of a clinical trial, the vaccine was approximately 67% effective against lower respiratory tract infections with at least two signs or symptoms and approximately 86% effective against these infections with three signs or symptoms.
Pfizer’s vaccine was approved by the FDA’s committee of independent advisors in February. However, a number of panelists had raised safety concerns regarding the shot.
After receiving the vaccine, Guillain-Barre syndrome struck two Pfizer clinical trial participants. Guillan-Barre is a rare neurological condition characterized by short-term weakness and paralysis.
The FDA sees the two Guillain-Barre cases as perhaps connected to the antibody. Pfizer has been asked to carry out a post-approval safety study to keep an eye out for the disorder.
Additionally, Pfizer has developed a vaccine to protect infants from RSV.
During a meeting earlier this month, the FDA’s advisors supported that strategy. In August, the FDA is expected to make a final decision regarding that vaccine.