The Centers for Disease Control and Prevention on Friday recommended pregnant people get Pfizer Inc.’s
maternal vaccine to protect babies from respiratory syncytial virus.
In an 11-to-1 vote, a CDC advisory committee recommended that the shot be seasonally administered to pregnant people at 32 through 36 weeks’ gestation. CDC director Dr. Mandy Cohen finalized the recommendation late Friday.
RSV affects the lungs and breathing passages and can be particularly risky for babies and for older adults. The virus hospitalizes 58,000 to 80,000 children under 5 years of age annually, according to the CDC, with those at greater risk including premature infants and children with weakened immune systems.
The maternal vaccine “is another new tool we can use this fall and winter to help protect lives,” Cohen said in a statement Friday.
The Pfizer shot, Abrysvo, last month became the first maternal RSV vaccine approved by the Food and Drug Administration. It is designed to protect babies through the first six months of life.
The committee’s recommendation “reinforces the wide-ranging impact vaccines can have, including helping protect infants immediately at birth from the potentially severe and life-threatening complications that can develop from RSV,” Luis Jodar, Pfizer’s chief medical officer for vaccines medical development, said in a statement.
The maternal vaccine has a list price of $295 per dose.
The CDC has previously recommended nirsevimab, a monoclonal antibody jointly developed by AstraZeneca PLC
for all infants younger than 8 months born during or entering their first RSV season.
In most cases, babies only need protection from either the monoclonal antibody or the maternal vaccine, but not both, the CDC said Friday. But doctors may recommend nirsevimab for babies born less than two weeks after maternal immunization, the agency said.
A Sanofi spokesperson noted that nirsevimab, marketed under the brand name Beyfortus, is the only choice for babies born outside RSV season and provides protection directly to infants that extends through 5 months. CDC advisers on Friday “continued to recognize the value and demonstrated clinical efficacy and safety of Beyfortus,” the spokesperson said.
Pfizer’s Abrysvo was also approved earlier this year to protect older adults from RSV. The company has said it expects peak revenues of about $2 billion from Abrysvo, including the uses in both older adults and pregnant people.
Pfizer shares fell 0.5% Friday and have dropped 36% in the year to date, while the S&P 500
has gained 12.5%.