RSV vaccines for babies and adults are on the way. Here's what the CDC is saying about them.
A federal advisory committee on Thursday discussed promising results of new vaccines and treatments for RSV while raising some concerns about the products that are currently under Food and Drug Administration review.
Respiratory syncytial virus infects nearly everyone by age 2 and typically causes cold symptoms. But it’s also the leading cause of hospitalizations among newborns and younger children, with the Centers for Disease Control and Prevention reporting between 58,000 and 80,000 hospitalizations per year among those under 5.
RSV also strikes at the other end of life: It causes more than 177,000 hospitalizations and 14,000 deaths among older adults every year.
The CDC's Advisory Committee on Immunization Practices on Thursday weighed recommendations for two RSV vaccines for older adults and pregnant people, and a monoclonal antibody for babies and toddlers.
If approved by the FDA later this year, the CDC panel will have an official vote on recommendations followed by the CDC director's approval.
Here's what we know.
Sanofi’s monoclonal antibody for infants and toddlers
A monoclonal antibody from Sanofi and AstraZeneca, called nirsevimab, helps prevent RSV lower respiratory tract disease in newborns and infants entering or during their first RSV season.
The FDA accepted nirsevimab to review for approval in January. If approved, it would be the second monoclonal antibody on the market for infants. The other option – palivizumab – is only recommended for high-risk infants who were born severely premature at 29 weeks or earlier.
Jon Heinrichs, Sanofi's global head of innovation and emerging sciences, expects the 50-milligram dose of nirsevimab to be available for all infants up to 24 months of age, regardless of whether they were born to term or preterm.
The CDC panel reviewed previous data that found:
The monoclonal was about 80% effective against medically attended RSV lower respiratory tract infections in infants born at 35 weeks or later, according to clinical trial data released this week.
Nirsevimab reduced the incidence of infections by 70% in healthy preterm infants born between 29 and 35 weeks compared to the placebo, per data released in January. Read More