The Centers for Disease Control and Prevention (CDC) is recommending that all infants under eight months old should get a new antibody shot aimed to protect the body against severe cases of respiratory syncytial virus (RSV). The agency’s Advisory Committee on Immunization Practices (ACIP) voted unanimously on August 3 to recommend the injection to protect babies beginning this fall.
In July, the Food and Drug Administration approved nirsevimab, which is the first long-acting medication to protect babies and toddlers from RSV. The lung-attacking virus sends about 58,000 children under five to the hospital, and kills 100 to 300 infants every year in the United States. RSV season typically lasts from November through March.
CDC director Mandy Cohen signed off on the recommendation and it will be added to the CDC’s childhood immunization schedule. ACIP also unanimously recommended that certain infants between the ages of eight to 19 months should receive a second dose of nirsevimab to help them stay healthy during their second RSV season if they have any underlying health issues that put them at a higher risk of hospitalization.
“As we head into respiratory virus season this fall, it’s important to use these new tools available to help prevent severe RSV illness,” Cohen said in a statement. “I encourage parents of infants to talk to their pediatricians about this new immunization and the importance of preventing severe RSV.”
In a second unanimous vote, ACIP also recommended that certain infants ages eight to 19 months get a second dose of nirsevimab to help them through their second RSV season, if they have underlying health issues that put them at higher risk for hospitalization.
Vaccines for older adults were FDA approved in May, but there are currently no vaccines for babies. The FDA is expected to make a decision on an RSV vaccine for pregnant people, with the goal of passing along protection on to newborns, later in August.
Importantly, nirsevimab is not a vaccine for RSV. It is a lab-made antibody for babies that helps their immune systems fight off the virus and is also the first first form of passive immunization added to the routine childhood immunization schedule. Passive immunizations do not require the body to manufacture antibodies against pathogens the way that vaccines do. Instead, they sent protective antibodies to attack the virus.
ACIP voted to add the antibody shot to the federally funded Vaccines for Children Program. This program provides free immunizations to children who may have difficulty accessing them.
Nirsevimab was developed by AstraZeneca and Sanofi and is expected to be ready for the fall RSV season and will be sold under the brand name Beyfortus. Sanofi reportedly said that if this shot is recommended for all infants, it will cost $495 per dose for private payers and $395 through Vaccines for Children.
The cost of the drug could make it difficult for some doctors to stock up on nirsevimab and complicate billing. However, getting this recommendation from ACIP means that families will not pay an out-of-pocket cost due to the Affordable Care Act. It may take up to 18 months for this coverage to kick-in, as insurers have a year to add implement coverage of new treatments that will then take effect in the new plan year.
According to CBS News, director of the National Center for Immunization and Respiratory Diseases José Romero closed the meeting by saying, “I would be remiss if I didn’t say that today is a historic event. I think that we will look back on this, in a short period of time, and see what a major impact this vote has had on the health and wellbeing of children in the United States. I think that this will mark one of the major accomplishments of the ACIP.”