November 1, 2022 – Pfizer’s RSV vaccine is ready to submit for FDA approval by the end of the year.
In the trial, Pfizer gave 7,400 pregnant women the vaccine and studied the presence and effectiveness of antibodies passed to the babies. The vaccine was 82 percent effective at preventing severe RSV in hospitalized babies for the first three months of life. After six months, it was 70 percent effective.
If approved, this would be the first RSV vaccine and the first new product related to the infection in over two decades.
“We are thrilled by these data as this is the first-ever investigational vaccine shown to help protect newborns against severe RSV-related respiratory illness immediately at birth,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research & Development, Pfizer. “These data reinforce Pfizer’s resolve to bring our expertise in the research and development of innovative vaccines to address critical public health needs using new approaches and technologies. We look forward to working with the FDA and other regulatory agencies to bring this vaccine candidate to expectant mothers to help protect their infants against severe RSV during their most vulnerable first six months of life, which has the highest burden of RSV illness in infants.”