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RSV vaccine overview:
- Who: The U.S. Food and Drug Administration has approved the first vaccine for use during pregnancy to prevent infant respiratory syncytial virus (RSV).
- Why: Infant RSV is the most frequent cause of lower respiratory tract disease in infants, which can be life-threatening.
- Where: The infant RSV vaccine was approved for use in the United States.
On August 21, the U.S. Food and Drug Administration approved the first vaccine for use during pregnancy to prevent infant RSV (respiratory syncytial virus).
The RSV vaccine is called Abrysvo and is approved for use from 32 through 36 weeks gestational age of pregnancy. It is administered as a single-dose muscle injection.
RSV is a highly contagious virus that causes respiratory infections in people of all ages. It is the most frequent cause of lower respiratory tract disease in infants, according to the FDA.
Infant RSV reportedly poses the greatest risk of lower respiratory tract disease during the first year of life. RSV is the leading cause of infant hospitalization in the country, according to the Centers for Disease Control and Prevention.
“RSV is a common cause of illness in children, and infants are among those at highest risk for severe disease, which can lead to hospitalization,” saidPeter Marks M.D. PhD, the director of the FDA’s Center for Biologics Evaluation and Research.
“This approval provides an option for healthcare providers and pregnant individuals to protect infants from this potentially life-threatening disease.”
RSV vaccine trials showed significant decrease in risk of severe lower respiratory tract disease in infants, FDA says
The FDA explains that the safety and effectiveness of Abryso for the immunization of pregnant women to prevent lower respiratory tract disease in infants born to them was evaluated in ongoing, randomized, placebo-controlled clinical studies.
Of the approximately 3,500 pregnant women who were vaccinated with Abryso, the risk of severe lower respiratory tract disease was reduced by more than 80% within 90 days of birth and by nearly 70% within 180 days after birth when compared to 3,500 pregnant women who received the placebo.
The most commonly-reported Abrysvo side effects included pain at the injection site, headache, nausea, and muscle pain. Pre-eclampsia, a dangerous hypertensive disorder, was reported in 1.8% of individuals who received the Abrysvo vaccine compared to 1.4% who received the placebo.
Low birth rate and jaundice in infants reportedly occurred at a higher rate for those who received the infant RSV vaccine compared to those who received the placebo.
The FDA will require the drugmaker to complete postmarketing research to assess the risk of preterm birth and hypertensive disorders of pregnancy for those who receive the RSV vaccine.
In May, the FDA approved Abrysvo for the prevention of lower respiratory tract infection caused by RSV for those aged 60 and up.
In July, the FDA approved Beyfortus, AstraZeneca’s preventative treatment for infant RSV and children up to 24 months who remain vulnerable to the virus.
What do you think about the new RSV vaccine for pregnant women? Tell us your thoughts in the comments!
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