The AAP Recommends New RSV Shot for Babies and Calls for Equal Access

The American Academy of Pediatrics (AAP) is joining forces with the Centers for Disease Control (CDC) and the Food and Drug Administration (FDA) to recommend the first-ever RSV shot for all babies under 8 months old.

Protection against severe respiratory syncytial virus, or RSV, is expected to be within reach for babies across America starting this fall. Less than a month after the FDA officially approved the Beyfortus shot, the CDC added it to their childhood immunization schedule, and the AAP has followed suit, issuing a statement on August 15 calling for nationwide adoption and equitable access.

“Pediatricians are sadly familiar with the dangers of RSV and its devastating consequences for some families,” AAP President Sandy Chung, MD, FAAP, said in the press release. “We are eager to offer all infants this protection and urge federal officials to see that it is made available and affordable in all communities.”

Currently, there is no infrastructure in place to ensure all children can access to Beyfortus, which Chung called “alarming.” Without significant structural changes, families living in lower-income and under-resourced communities, as well as those with infants at greatest risk for severe RSV illness, may face challenges accessing it.

The CDC and the AAP are in agreement that all babies under 8 months and high-risk kids under 19 months should get the nirsevimab or Beyfortus shot before or during their first RSV season (November through March).

While most children will get RSV at some point, around 80,000 children each year are sent to the hospital with a severe case—making RSV the leading cause of hospitalization for kids under 1. The Beyfortus shot can has been shown to reduce the risk of these hospitalizations and healthcare visits for RSV by 75 percent in clinical trials.

Here’s what you need to know about the new shot and how it could keep your newborn safe and out of the hospital this winter.

How Does The RSV Shot for Babies Work?

Developed by AstraZeneca and Sanofi, Beyfortus is a monoclonal antibody shot. “Antibodies are part of our immune system and help us fight infections. Monoclonal antibodies are man-made proteins that mimic the antibodies that our bodies naturally produce,” the CDC explained in a press release.

“Making this immunization available means that babies will be able to receive antibodies to prevent severe RSV disease, providing a critical tool to protect against a virus that is the leading cause of hospitalization among infants in the U.S.” Only one shot is needed and can be given to children prior to or during RSV season.

Is RSV Shot for Children Safe?

The FDA has deemed the RSV shot safe and effective for children under 2 years old. Agency advisers considering the antibody shot for infants cast a unanimous vote in June in favor of approving the treatment for infants.

The FDA and Agency advisors reviewed the results from three different clinical trials in which more than 3,200 infants were given the shot. No major safety concerns were seen. No serious adverse reactions were reported, and no safety concerns have been documented. Side effects, including pain at the injection site, rash and fever were uncommon and similar to what babies that were given a placebo experienced.

What About Other RSV Shots?

Other companies outside of AstraZeneca and Sanofi are also diligently working on RSV vaccinations. Earlier this year, Pfizer’s vaccine obtained a vote of confidence from the independent agency that advises the FDA. It is currently waiting to be approved.

Unlike Beyfortus, Pfizer’s vaccine would be given to expectant mothers before their newborn’s arrival. In conjunction with this form of injection, a small increase in preterm births has been reported. Officials at the FDA reported that the difference was not statistically significant—meaning that the difference was not large enough to be attributed to the vaccine and could instead have been due to chance or other factors during the mother’s pregnancy. However, Pfizer has said if the drug were approved by the FDA, it would still conduct further studies and monitor preterm births and other possible problems.

The CDC recommends that parents talk to their pediatricians about the new shot and the importance of preventing severe RSV. You can learn more about RSV and the other two respiratory illnesses that made up this past winter’s “tripledemic” here.

Please note: The Bump and the materials and information it contains are not intended to, and do not constitute, medical or other health advice or diagnosis and should not be used as such. You should always consult with a qualified physician or health professional about your specific circumstances.