Infant RSV shot faces final hurdle at CDC, could be available by fall

Americans may soon have access to a shot that protects babies from respiratory syncytial virus, or RSV, the leading cause of hospitalization among infants in the U.S.

A panel of advisors to the Centers for Disease Control and Prevention will meet Thursday to review the data and vote on how the drug, branded under the name Beyfortus, should be administered. It is one of the last hurdles before doctors can start administering shot.

CDC Director Mandy Cohen is not obligated to endorse the vote of the advisors, though the head of the agency usually follows the panel’s advice.

Beyfortus, also called nirsevimab, is set to become the first shot in the U.S. that protects all infants from RSV. Sanofi has said the companies are prepared to roll the shot out before RSV season this fall and do not foresee any challenges meeting demand.

If Beyfortus receives CDC backing, most insurance plans will be required to cover the shot at no cost to consumers due to requirements under the Affordable Care Act. The shot has a list price of $495.

Although Beyfortus works like a vaccine, the shot is considered a drug, not a vaccine, because it is an antibody injection. This has raised concerns about whether Beyfortus will be included in the federal Vaccines for Children program that provides shots at no cost to families that are struggling financially.

Advisors are also voting Thursday on whether Beyfortus should be included in the Vaccines for Children program, making the votes a crucial step for the drug.

Another option, called palivizumab, is already on the market but it is primarily used for pre-term babies and those with congenital heart and lung conditions. It is also more difficult to administer because infants have to receive a shot monthly during RSV season.

Beyfortus, on the other hand, would be broadly available for all infants regardless of whether they have a health condition. It is also administered as a single dose to protect babies during the entire RSV season.

Beyfortus was up to 75% effective at preventing lower respiratory tract infections that required medical attention among infants and 78% effective at preventing hospitalization, according to an FDA review.

The FDA did not identify any safety issues when it reviewed Beyfortus. Some monoclonal antibodies have been associated with allergic reactions and skin rashes.

RSV kills nearly 100 infants every year, according to a study published in the medical journal JAMA Network Open in 2022. It is also the leading cause of hospitalization among children less than a year old, according to a study published in the Journal of Infectious Diseases.

Children’s hospitals were overwhelmed last year by a surge of RSV infections at the same time that flu and Covid were also circulating.

The wave of illness strained hospitals so much that they called on the Biden administration to declare a public health emergency in response. The White House ultimately did not declare one.