Pfizer’s FDA-approved ABRYSVO™ vaccine for the prevention of respiratory syncytial virus (RSV) in infants through the immunization of pregnant patients at 32 to 36 weeks is available at Marshall OB/GYN.
ABRYSVO is the first and only U.S.-approved maternal vaccine to help protect infants at birth through six months of life from lower respiratory tract disease (LRTD) and severe LRTD due to RSV. Also approved by the European Commission, the vaccine is designed to protect against RSV A and B strains and was observed to be safe and effective. The FDA’s decision is based on data from the pivotal phase 3 clinical trial involving more than 14,000 participants, including pregnant individuals and their infants. The results of the randomized, double-blinded, placebo-controlled phase 3 study were published in The New England Journal of Medicine in April 2023.
Marshall University Joan C. Edwards School of Medicine and Marshall Health participated in phases 2 and 3 of the clinical trial from November 2020 through June 2023. Hisham Keblawi, M.D., professor of OB/GYN; Morgan Ruley, OB/GYN research coordinator; and Hillary Salava, RN, research coordinator in the Department of Clinical and Translational Sciences (DCTS), led and coordinated the Marshall team’s involvement in the trial among the Marshall Clinical Research Center (MCRC) and departments of OB/GYN, Pediatrics and DCTS. The multisite trial spanned across 18 countries.
“Clinical trials done at MCRC are essential to promote the well-being of West Virginians and the tri-state area we serve,” said Uma Sundaram, M.D., vice dean of research and graduate education and chair of DCTS.
RSV is a contagious virus and common cause of respiratory illness. It can affect the lungs and make breathing difficult, potentially causing hospitalization or death. In 2022, children’s hospitals locally and nationally saw an unusually high number of RSV cases and hospitalizations.
“RSV can be one of the most serious respiratory illnesses we see in young infants and, until now, we have had few tools to help in the prevention and treatment of RSV,” said Jessie Shields, M.D., pediatrician at Marshall Health and associate professor at the School of Medicine. “The development of this vaccine is an exciting advancement in RSV prevention, and we are thrilled Marshall played an important role in its development.”
For the first three months after birth, the vaccine was proven 82% effective at preventing severe RSV disease and 57% effective at keeping babies from visiting the doctor due to RSV infection. By six months after birth, the vaccine was 69% effective at preventing severe RSV disease and 51% effective at preventing a RSV-related doctor’s visit. The vaccine did not prove to offer additional protection compared to the placebo in keeping six-month-old infants from seeing the doctor for RSV.
The most common maternal side effects were pain at the injection site, headache, muscle pain and nausea. While low birth weight and jaundice were slightly higher for infants in the vaccine group when compared to the placebo group, the FDA could not determine or exclude the vaccine as the cause. No safety concerns were evident in maternal participants or in infants and toddlers up to 24 months.
“Infants under six months are most vulnerable to RSV, and no other vaccine is available for this age,” Keblawi said. “We are currently recommending all pregnant patients seen in our clinic receive the vaccine sometime between 32 and 36 weeks unless their medical history would suggest otherwise.”
The vaccine is available at all Marshall OB/GYN locations by appointment. Call 304-691-1400 to schedule or for more information. For a complete list of clinical trials available at MCRC, visit jcesom.marshall.edu/research.