Academy Greenlights Federal Actions on Maternal RSV Vaccine

In an expedited evidence review, the executive committee of the Academy’s Commission on Health of the Public and Science recommended Sept. 26 that the Academy support a recommendation from the CDC’s Advisory Committee on Immunization Practices for the use of Abrysvo. AAFP Board Chair Sterling Ransone, M.D., FAAFP, accepted the executive committee’s recommendations.

Earlier in the week, on Sept. 22 ACIP voted 11-1 to recommend seasonal administration of Abrysvo and CDC Director Mandy Cohen, M.D., M.P.H., signed off on the recommendation. 

The vaccine is administered intramuscularly as a single dose to women between 32 and 36 weeks of pregnancy, providing infants a measure of defense in the first few months of life, when they are most vulnerable to severe disease.

“That gives them enough time to build antibody responses through the vaccine and cross through the placenta to give the infant protection when they’re born,” Ransone told USA Today.

According to a CDC update, the vaccine should generally be given between September and January in most of the United States, when RSV infections occur most often. Because RSV seasonality varies, however, health departments may recommend different timing.

The ACIP also voted to include Abrysvo in Vaccines for Children, a federally funded program that provides recommended vaccines and immunizations at no cost to eligible children. The AAFP is monitoring CDC efforts to ensure that Abrysvo will be made available through the program.

The AAFP’s approval comes amid evidence of increased RSV activity in pockets of the southeastern United States dating back to July 2023. The CDC estimates that each year in the United States, 58,000 to 80,000 children younger than age 5 years are hospitalized because of RSV infection, and an analysis of National (Nationwide) Inpatient Sample data indicated acute bronchiolitis due to RSV infection was the leading cause of hospitalizations among infants from January 2009 through December 2019.

It should be noted that the Academy supported several provisions in the Inflation Reduction Act, including a provision, effective Oct. 1, that requires state Medicaid programs to cover all FDA-approved adult vaccines that the ACIP recommends. The FDA approved Abrysvo for use in pregnant patients in August.

In light of this new requirement, the Academy has also provided AFP chapters with resources to urge state Medicaid agencies to review their vaccine coverage and payment policies, and ensure they are facilitating equitable access to adult vaccines in primary care practices.

Abrysvo is one of two therapies on the market designed to protect infants from severe RSV. In August, the CDC recommended the use of nirsevimab (trade name Beyfortus), a long-acting monoclonal antibody, to prevent lower respiratory tract disease due to RSV infection in infants and children up to age 19 months; the AAFP approved the agency’s recommendation Aug. 10. 

There is not enough data to state definitively which therapy offers infants better protection against RSV, meaning that patients should consider their eligibility, insurance coverage and individual preference — and, of course, their family physician’s advice — before determining the best way to proceed.

“I’m sure within a few RSV seasons we will have an answer for that question,” Ransone said.

Family physicians are encouraged to visit the Academy’s RSV Vaccines and Therapeutics webpage for the latest information on vaccines for RSV and other infectious diseases.