The committee voted 7 to 4 on safety and 7 to 4 on effectiveness, according to an announcement from Pfizer. The vaccine candidate is currently under FDA review for the prevention of acute respiratory disease and lower respiratory tract disease caused by RSV in adults 60 years of age and older.
Weinstein said Pfizer’s RSV vaccine now has to go through the FDA approval panel and appears likely to get approved. The vaccine showed approximately 85% effectiveness during its phase 3 clinical trial.
“This advisory board gives a green light to move forward to the full panel,” Weinstein said. “Typically they follow the recommendations of the advisory board, though that’s not always the case.”
The role of the advisory committee is to provide recommendations to the FDA, but these recommendations are not binding. The FDA’s decision on whether or not to approve the RSV vaccine for the prevention of acute respiratory disease and lower respiratory tract disease caused by RSV in individuals 60 years of age and older is expected by the Prescription Drug User Fee Act goal date in May 2023.
“In older adults, RSV can result in serious illness, hospitalization, or even death, so there is a significant need to protect this at-risk population,” said Annaliesa Anderson, senior vice president and chief scientific officer of vaccine research and development at Pfizer. Among older adults in the U.S., RSV infections account for approximately 60,000 to 160,000 hospitalizations and 6,000 to 10,000 deaths each year, according to the Centers for Disease Control.
Dr. Roberto Colon, chief medical officer of Miami Valley Hospital, said RSV typically presents like a cold for most people who get the virus.
“For most of us, it doesn’t end up being very severe. There are some more unfortunate individuals, particularly the very old and the very young, who are going to be much more susceptible to getting severe forms of the disease, and in some cases, it could be fatal,” Colon said.
Pfizer’s RSV vaccine is being targeted at the older population from getting severely sick from RSV, and a recent clinical trial from Pfizer revealed positive results. Colon said a trial involving the vaccine and 34,000 participants—including 17,000 individuals receiving the vaccine and 17,000 receiving a placebo—showed Pfizer’s RSV vaccine was “very effective at preventing severe forms of the disease and also had significant impact at being able to prevent people from getting sick and having those symptoms associated with the disease.”
A possible side affect of the vaccine was noted as Guillain-Barre syndrome, which is a rare neurological disorder where your immune system attacks part of the peripheral nervous system—the network of nerves located outside of the brain and spinal cord—according to the National Institute of Neurological Disorders and Stroke.
There were two Guillain-Barre cases among 19,942 vaccinated participants in the clinical studies for the RSV vaccine, according to the FDA. The FDA said this was within the context of a background rate of one and a half to three cases occurring per 100,000 people per year for Guillain-Barre syndrome in the U.S. among adults greater than 60 years of age.
“The important thing to realize is that Guillain-Barre can happen in the general population,” Colon said. “What they find when they look at the number of individuals that got Guillain-Barre in this study, when they compared it to what would be expected in the general population, it does not appear to be an increased risk.”
Pfizer is also working on an RSV vaccine for infants from birth up to six months of age by immunization of pregnant individuals during their pregnancy. A decision from the FDA on this vaccine is expected by August, according to Pfizer.
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