A drug from AstraZeneca Plc and Sanofi to protect infants against a potentially fatal respiratory illness won backing Thursday from US public health advisers, moving it closer to being administered alongside other childhood immunizations.
In a 10-0 vote, advisers to the Centers for Disease Control and Prevention recommended a dose of the long-acting monoclonal antibody for infants less than eight months old entering their first respiratory syncytial virus season. A separate unanimous vote recommended that vulnerable children eight to 19 months old get a dose as they enter their second RSV season. CDC Director Mandy Cohen adopted the panel’s recommendation late Thursday.
The advisers also voted 11-0 to include the drug in the federally funded Vaccines for Children program, which provides immunizations at no cost for children whose families may be unable to afford them.
RSV causes inflammation of the airways, leading to difficulty breathing, and can be lethal. The drug is among the first medicines available for wide use to protect infants from the illness, which affects most children by the age of two. Called Beyfortus, it was cleared by the US Food and Drug Administration in July.
Beyfortus is meant to be given as a shot at birth if a baby is born either just before or during the RSV season, which normally runs from around October to March in the northern hemisphere.
“Today, we have turned the corner on the threat of RSV to our youngest, most vulnerable population,” said Thomas Triomphe, Sanofi executive vice president for vaccines, in a statement.
Triomphe told investors last week that Beyfortus has strong potential to be a blockbuster drug, a term for hit products that generate sales of at least $1 billion a year for the companies that sell them, though it will take multiple years to reach peak sales. The company wants to ensure “equitable and broad access,” he said, including through the Vaccines for Children program.
The drug will have a list price of $495 a shot, and the company will sell it to the government for $395 a shot for Vaccines for Children, company officials told the panel. The CDC’s recommendation calls for a stronger second-season dose involving two injections, doubling the price.
While panel members raised concerns about the price of the drug and logistics of rolling it out, especially in rural areas, they ultimately backed each of the proposals for its use.
“This really is a huge benefit,” Pablo Sanchez, professor of pediatrics at Ohio State University College of Medicine, said in the meeting. “There are issues of implementation, but I don’t think they’re insurmountable.”
A number of products to fight RSV have been authorized this year after a decades-long search for solutions. Two vaccines for older, more vulnerable adults from GSK Plc and Pfizer Inc. were authorized in May. Pfizer has also filed for authorization of its vaccine for pregnant women to protect their babies.
Sanofi shares rose 1.1% as of 1 p.m. in Paris. Astra shares were little changed in London.
--With assistance from Tim Loh.
(Updates with CDC director’s action in second paragraph)