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

The Beyfortus shot is expected to be available by this fall and has been shown to reduce the risk of hospitalizations for RSV by 75 percent. Here's what you need to know.
save article
profile picture of Wyndi Kappes
By Wyndi Kappes, Assistant Editor
Updated August 16, 2023
doctor giving a baby a vaccine
Image: LightField Studios | Shutterstock

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.

save article
Article removed.
Name added. View Your List

Next on Your Reading List

doctor listening to 1 month old baby's heart
What to Expect at Baby’s One Month Checkup
Medically Reviewed by Dina DiMaggio Walters, MD
doctor examining one year old baby during 12 month check up
What to Expect at Baby’s 12-Month Checkup
By Anisa Arsenault
doctor giving baby a vaccine
FDA Approves COVID-19 Vaccines for Kids 6 Months and Up
By Wyndi Kappes
close up of doctor putting band aid on baby's leg after flu shot
Should Babies Get the Flu Shot? Here’s What to Know
By Lexi Dwyer
Celebrity Alyssa Milano pictured with children during UNICEF volunteer trip to Kosovo.
Alyssa Milano on Parenting, the Pandemic and Working With UNICEF USA
By Lauren Kay
baby being examined by doctor with stethescope
Tool: Vaccine Planner
By The Bump Editors
nervous woman stands by window
Study Shows Many Parents Still Don’t Trust Routine Childhood Vaccines
By Nehal Aggarwal
mom holding her baby after it had a vaccine
New Technique Makes Vaccines Safe in Warmer Temperatures, Study Finds
By Nehal Aggarwal
city of boston historic buildings
These Are the Best and Worst States for Vaccination Rates, Report Says
By Nehal Aggarwal
sad teddy bear looking out rainy window
Measles Virus Completely Wipes Out Your Immune System, Studies Find
By Nehal Aggarwal
phone screen that shows mock up of vaccine pop up
Facebook and Instagram Debut New Strategy to Combat Vaccine Myths
By Laurie Ulster
two women having serious conversation
How to Talk About Vaccines Without Starting a Fight
By Stephanie Grassullo
new york city's empire state building covered by dots that resemble measles rash
CDC: Measles Cases Have Now Hit a More Than 25-Year High
By Stephanie Grassullo
bar graph showing growth
Report: These Places in the US Have the Highest Risk of a Measles Outbreak
By Stephanie Grassullo
woman's hand holding her phone, which shows instagram icon and a vaccine
Instagram Doubles Down Efforts to Stop the Spread of Misinformation on Vaccines
By Stephanie Grassullo
Q&A: Modified Immunization Schedule?
Q&A: Modified Immunization Schedule?
By Dr. Cheryl Wu
Little boy with bandaid on arm looking at camera
NYC Declares Public Health Emergency, Orders Mandatory Measles Vaccinations
By Stephanie Grassullo
young school children sitting with their arms around each other
Italy Will Now Ban Unvaccinated Kids From School
By Stephanie Grassullo
medical researcher performing tests in a lab
Massive New Study Once Again Proves No Link Between Vaccines and Autism
By Stephanie Grassullo
upset mom scrolls through phone while holding her baby
Social Media Sites Crack Down on Misinformation From Anti-Vax Ads
By Stephanie Grassullo
Article removed.