Pfizer’s vaccine against respiratory syncytial virus, or RSV, showed promising results protecting newborns when the shot is administered to mothers during the late stages of their pregnancies, according to new clinical trial data from the company.
In the trial, the vaccine was about 80% effective at preventing severe RSV disease in the infant’s first 90 days of life and nearly 70% effective at protecting against severe illness requiring hospitalizations or breathing assistance in the infant’s first six months of life.
RSV is a common respiratory illness that typically causes coldlike symptoms, but it can be particularly dangerous for infants and older adults. An estimated 58,000 children under 5 years old are hospitalized each year due to an RSV infection, according to the Centers for Disease Control and Prevention.
FLU SEASON OFF TO EARLY START WITH HOSPITALIZATIONS ON THE RISE
“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, senior vice president and chief scientific officer for vaccine research and development at Pfizer. “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.”
Pfizer says it plans to apply for approval for the vaccine with the Food and Drug Administration by the end of 2022, which would make it the first vaccine available for RSV.
The trial included about 7,400 pregnant women ages 49 or younger who were given the vaccine in their late second or third trimester of pregnancy. The mothers were monitored until 6 months after giving birth to assess for any safety concerns, and their babies were followed for at least one year after birth.
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The results offer promise that an RSV vaccine could be on the horizon. Children’s hospitals across the country report an early surge in respiratory diseases, including RSV, is overwhelming their emergency rooms and filling pediatric beds.
