CDC panel recommends new RSV shot for babies and certain toddlers
A federal advisory committee has voted unanimously to recommend a new drug to prevent severe respiratory syncytial virus, or RSV, in babies and certain toddlers ahead of the cold season starting in the fall.
The Advisory Committee on Immunization Practices said Thursday that babies under 8 months old who are entering their first RSV season can get the new monoclonal antibody from Sanofi and AstraZeneca, called Beyfortus. Panel members said the new drug also can be given to those 8 to 19 months old who are at increased risk of severe disease if they're entering their second season of RSV.
The panel also unanimously voted to include the new drug to the federally funded Vaccines for Children program, which would provide Beyfortus at no cost to eligible children whose families are unable to pay.
Panel members said babies can get a shot of the new drug like a vaccine before the RSV season, which typically runs from the fall to the end of spring.
Results from clinical trials show Beyfortus prevents RSV lower respiratory tract disease in infants and children entering or during their first RSV season.
The monoclonal antibody is the first of its kind to be widely available to everyone beyond a small population of immunocompromised children. The other option – palivizumab – is recommended only for high-risk infants who were born severely premature at 29 weeks or earlier.
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Before Beyfortus can become available by the cold season, the CDC director must sign off on the panel's recommendations.
While the panel highlighted the importance of an RSV vaccine for infants, it also expressed concern about the price and implementation challenges, such as safety surveillance by federal adverse reaction reporting systems or whether the new drug would appear on childhood immunization records. An estimated list price mentioned during Thursday's meeting put Beyfortus at $495 a dose.
“Today, we have turned the corner on the threat of RSV to our youngest, most vulnerable population," said Thomas Triomphe, Sanofi's executive vice president of vaccines. "The ACIP’s unanimous recommendations ... and inclusion in the Vaccines for Children program are critical steps toward providing millions of parents in the U.S. with the ability to protect their babies."
In the U.S., about 58,000 children younger than 5 are hospitalized for RSV each year, and several hundred die.
What are other RSV vaccines coming in the fall?
The FDA approved the world’s first RSV vaccine, GSK’s Arexvy, in May to protect adults 60 and older from the worst consequences of the respiratory disease. Walgreens and CVS, the two largest pharmacies in the United States, said they would carry doses of the new vaccine this fall.
GSK, formerly known as GlaxoKlineSmith, shipped its first doses to wholesalers and distributors across the country. They should be available to customers by the end of August at a list price of $280 a dose, according to a company spokesperson.
Another RSV vaccine by Pfizer is awaiting final approval from the regulatory agency and would be used in pregnancy to help prevent severe disease in infants during their first six months of life. The CDC has to provide guidance on its use before it can become available.
Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.
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