A child infected with RSV undergoes treatment at Missio children’s clinic Moenchberg in Wuerzburg, Germany, on December 2, 2022.
Heiko Becker | Reuters
An advisory panel to the Centers for Disease Control and Prevention unanimously endorsed the first shot that offers protection against respiratory syncytial virus (RSV) for infants. RSV is the leading cause of hospitalization among infants in the U.S. Branded as Beyfortus, this shot provides families with a simple option to safeguard their babies during the respiratory virus season.
Although CDC Director Dr. Mandy Cohen is not obligated to endorse the panel’s vote, she typically follows their advice.
A spokesperson from Sanofi, one of the manufacturers alongside AstraZeneca, said they are ready to roll out the shot before the upcoming RSV season and do not anticipate any challenges in meeting the demand.
Dr. Sarah Long, a panel member and professor of pediatrics at Drexel University, hailed Beyfortus as a significant milestone, stating it is the first antibody protection against a disease burden in children. She expressed relief on behalf of parents, knowing that their children will have decreased chances of being hospitalized with RSV disease.
If Beyfortus receives CDC endorsement, most insurance plans will be required to cover the shot at no cost to consumers under the Affordable Care Act. The shot is priced at $495.
While Long described the shot as groundbreaking, she expressed disappointment with the price set by Sanofi and AstraZeneca.
It may take some time for insurance plans to update their policies to comply with this requirement.
The CDC advisors also voted unanimously to include Beyfortus in the federal Vaccines for Children Program, which provides shots to financially struggling families.
Beyfortus functions like a vaccine, but it is considered a drug instead because it is an antibody injection. Vaccines stimulate the immune system to produce antibodies that fight viruses, while Beyfortus directly introduces these antibodies into the bloodstream.
Infants below 8 months would receive one dose in their first RSV season, while children aged 8 to 19 months at an increased risk from the virus would receive an additional dose in their second RSV season.
Another option, palivizumab, is already available but primarily used for pre-term babies and those with heart and lung conditions. It is also more challenging to administer, as infants require monthly shots during RSV season.
In contrast, Beyfortus would be widely accessible to all infants, regardless of their health condition. It is administered as a single dose to provide protection throughout the entire RSV season.
An FDA review showed that Beyfortus was up to 75% effective in preventing lower respiratory tract infections requiring medical attention among infants and 78% effective at preventing hospitalization.
The FDA did not identify any safety issues during their review of Beyfortus. While some monoclonal antibodies have been associated with allergic reactions and skin rashes, Beyfortus appears safe.
According to a study published in the medical journal JAMA Network Open in 2022, RSV claims the lives of nearly 100 infants each year. It is also the leading cause of hospitalization among children under the age of one, as stated in a study published in the Journal of Infectious Diseases.
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