FDA advisers support RSV vaccine for pregnant women

This is huge. I wrote about it in a previous newsletter but things have moved along significantly. A new vaccine that would be given to pregnant women to protect their infants from respiratory syncytial virus (RSV) just received the endorsement of FDA vaccine experts. “If the vaccine actually lives up to data we’ve seen today, I can guarantee that many infants and their parents will breathe easier in the coming years,” said Jay M. Portnoy, M.D., a member of the Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC). All 14 voting members agreed data are adequate to support efficacy and safety of the vaccine. The FDA is expected to decide whether to approve the vaccine in the next few months. The vaccine from Pfizer is made up of RSV recombinant stabilized prefusion F proteins and is referred to as an RSVpreF vaccine (Abrysvo). If approved by the FDA and Centers for Disease Control and Prevention (CDC), it would be given to pregnant women at 24-36 weeks’ gestation to protect their infants up to 6 months after birth. RSV can cause severe lower respiratory tract disease such as bronchiolitis or pneumonia and is the leading cause of hospitalization in U.S. infants. There are about 58,000 to 80,000 hospitalizations and 100 to 300 deaths per year in children under 5 years.  There are currently no vaccines to protect infants from RSV, although the FDA is reviewing a monoclonal antibody from AstraZeneca and Sanofi that would be given to this age group. An FDA committee met June 8 to discuss that product. Another monoclonal antibody, palivizumab, is available to protect high-risk infants and toddlers, but only about 5% of infants are eligible.


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