FDA Approves New Shot to Protect Babies and Toddlers Against RSV

Federal regulators have given their approval for a new shot that aims to protect healthy babies and some vulnerable toddlers against respiratory syncytial virus (RSV), the leading cause of hospitalization among young children in the United States. The preventive shot, named Beyfortus, functions in a similar way to a vaccine by providing temporary protection against the virus for a single winter season. It is composed of laboratory-made antibodies that prevent the virus from entering cells.

Beyfortus can be administered to infants at birth if they are born during the RSV season, or it can be given to babies in a pediatrician’s office before their first winter respiratory virus season. The shot is also approved for high-risk children up to the age of 2. Developed by Sanofi and AstraZeneca, Beyfortus is not the first preventive antibody treatment for RSV, but it is the first to offer protection to all healthy babies. Previous monthly shots were only available to high-risk preemies or babies with underlying heart or lung conditions.

In a large clinical trial, a single shot of Beyfortus demonstrated both safety and effectiveness in preventing babies from developing severe illness that required medical attention or hospitalization. “Today’s approval addresses the great need for products to help reduce the impact of RSV disease on children, families, and the health care system,” said John Farley, director of the FDA’s Center for Drug Evaluation and Research.

While Beyfortus provides important protection against RSV, there may be challenges in integrating it into pediatric care. Since it is technically a drug and not a vaccine, doctors and parents may require some time to familiarize themselves with its use. Additionally, coverage by insurers is uncertain, although under the Affordable Care Act, preventive care should be covered within a year of a product being recommended.

The pricing information for Beyfortus has not yet been released, but Sanofi expects it to be priced similarly to a new pediatric vaccine series. The cost-effectiveness of the shot is still debatable, with some health economists questioning whether it provides enough value to be used in all infants. The CDC will provide recommendations on how the shot should be incorporated into health care, and if the RSV vaccine for pregnant women by Pfizer is also approved, it may create competition in the market.

RSV is a respiratory virus that typically causes mild cold-like symptoms in most people. However, it can lead to severe illness in young children, resulting in numerous hospitalizations and even deaths. Last year, there was a significant increase in RSV cases, with children under 5 being hospitalized at double the rate of previous seasons. The approval of Beyfortus marks a breakthrough in RSV prevention, following decades of unsuccessful attempts to develop a vaccine.

In addition to Beyfortus, two vaccines for adults 60 and older have recently been approved to protect against RSV. They will be available alongside flu and COVID-19 shots for older adults during the fall vaccination season. Another vaccine developed by Pfizer, designed to be given during pregnancy and provide protection to newborns, is currently being considered by the FDA, with a decision expected later this year. This vaccine offers similar protection to Beyfortus.

It is hoped that the approval of Beyfortus and the progress made in RSV prevention will significantly reduce the impact of the virus on vulnerable populations. However, there are potential hurdles, including logistical, educational, and financial challenges that need to be addressed before the drug can be widely distributed in time for this year’s RSV season.