CDC recommends RSV monoclonal antibody for infants, high-risk young children

A panel of advisers to the Centers for Disease Control and Prevention unanimously voted Thursday to recommend wide use among infants and some high-risk children of an antibody designed to protect against RSV, the country’s leading cause of infant hospitalization.

The 10-0 recommendation from the Advisory Committee on Immunization Practices was adopted hours later by CDC Director Mandy Cohen.

“This new RSV immunization provides parents with a powerful tool to protect their children against the threat of RSV,” she said.

The advisers hailed the new antibody, called Beyfortus, as a major advance against a respiratory infection that kills around 100 to 300 children in the U.S. every year and puts between 58,000 and 80,000 in the hospital. Another antibody drug, Synagis, has long been available but is used only for the most vulnerable children, because it is expensive and requires repeated administrations. Beyfortus, approved by the Food and Drug Administration last month, can last the entire RSV season.

At the same time, experts cautioned that rolling the drug out across the country would be difficult. The U.S. has never before tried to give this type of medicine to nearly every infant.

“I think this is life-changing and I’m very excited,” said Helen “Keipp” Talbot, an infectious disease specialist at Vanderbilt University and a member of the ACIP. ”I just hope we can get through the hurdles.”

Some experts on the panel also criticized Sanofi, the company commercializing Beyfortus in the U.S., for its cost. Sanofi indicated to the ACIP it will charge $495 per dose. That is far less than Synagis, and a University of Michigan analysis determined it will likely be cost-effective, given the medical visits and hospitalization Beyfortus is likely to prevent. But it is still far more expensive than a typical vaccine.

“We are extraordinary disappointed with the price setting of the manufacturer,” said Sarah Long, a professor of pediatrics at Drexel University, while calling the drug a “breakthrough” and saying that parents can be “very, very much relieved that they won’t have to be concerned about the likelihood that their child could be hospitalized with RSV.”

Sanofi, in a statement, welcomed the news and noted it would mean the drug will be covered by insurance without co-pays. “Today, we have turned the corner on the threat of RSV to our youngest, most vulnerable population,” said Executive Vice President Thomas Triomphe.

The committee issued two recommendations. The first calls for the drug to be offered to all infants born during the RSV season or to those who are less than eight months of age as they enter their first RSV season.

The second recommendation calls for high-risk children ages 8 to 19 months to receive a dose of Beyfortus before their second RSV season. That includes all the groups who were recommended to receive the older drug — including immunocompromised children and those with chronic lung disease — as well as Native American and Alaska Native children, who have RSV hospitalization rates between four and 10 times that of the general population.

Because these older children will receive two injections, the drug will cost twice as much.

Although people of all ages can be infected with RSV, the risk of a severe infection declines with age. In a randomized controlled trial, Beyfortus appeared to reduce by 70% the risk that a baby would have an RSV infection that required medical care and reduce by 78.4% the risk of an RSV-related hospitalization.

The committee also adopted a third resolution, recommending that Beyfortus be included in Vaccines for Children, the 30-year-old program that assures children of parents without health insurance can be vaccinated for free.

Beyfortus is, notably, not a vaccine. It supplies lab-grown antibodies against the virus, instead of inducing recipients’ immune systems to make their own. But there is no statutory definition for vaccine under the law authorizing the VFC or under the Affordable Care Act, so the CDC determined Beyfortus could be added, said Georgina Peacock, director of the Immunization Services Division.

Including Beyfortus in the VFC will be important “for providing the maximal public health benefit,” said Matthew Daley, a senior investigator at the Institute for Health Research at Kaiser Permanente Colorado.

Sanofi indicated it will charge VFC $395 per dose. The cost-effectiveness model assumed that 50% of patients would receive the drug through VFC and 50% through private insurance, leading to an average price of $445.

Still, that won’t solve all implementation challenges. Even as the CDC is treating Beyfortus as a vaccine for the VFC, doctors will have to explain to patients that it is a drug and have to file adverse events reports as if it’s a drug.

Record-keeping may be difficult, as there isn’t currently a straightforward way of incorporating preventative antibodies into immunization records. And the cost could be prohibitive for hospitals and pediatrician offices, who have to order the product upfront.

“It is not typical for us to think about the pediatricians and family practitioners, who are in small practices, for example, bearing the brunt of the upfront cost and potentially losing money on being able to deliver these preventive interventions,” said Grace Lee, the committee chair and a professor of pediatric infectious diseases at Stanford. “So, as we’re starting to move into these, you know, again, more innovative strategies for prevention, I think this is a plea generally to ask for a reconsideration of where the risk is actually laid.”

The committee was instructed to ignore altogether another major concern with implementation. A new vaccine from Pfizer, designed to induce antibodies pregnant people can pass down to newborns and shown to provide protection in the first months of life, is likely to be approved later this month.

It is not clear yet how pediatricians should strategize using the two interventions. Officials told the committee that another hearing would be called if the Pfizer shot is approved.

This story has been updated with comment from the CDC director.