A panel of advisers recommended the Centers for Disease Control and Prevention add Pfizer Inc.’s RSV vaccine to the list of shots for pregnant people to protect infants from the sometimes fatal respiratory virus.
The group of medical and public health experts voted 11-1 for the shot, Abrysvo, to be administered to pregnant women between 32 to 36 weeks of gestation. CDC Director Mandy Cohen must now decide whether to make the recommendation official, which would allow the vaccine to be administered as soon as it’s available.
The Food and Drug Administration approved the shot in August, yet with a warning that 5.7% of participants in a vaccine study had pre-term births, versus 4.7% in a group that received a placebo.
Pfizer is following Sanofi and AstraZeneca Plc’s preventive monoclonal antibody for newborns to market. Global sales for RSV protection for both infants and older adults is expected to top $10 billion by 2032. Pfizer and GSK Plc already received CDC recommendations for vaccines for those 60 and older. Moderna Inc. is also working on an injection for RSV using the messenger RNA technology that powers its Covid vaccine.
Pfizer shares fell 0.4% as of 3:36 p.m. in New York.
Decades of Failure
After 60 years of failure to find protection against RSV, the race intensified last year when cases began spiking as Covid social-distancing measures faded. Some 2% to 3% of infants with RSV in the US are at risk of hospitalization, and up to 80,000 children under five end up being admitted each year due to complications related to the virus.
The 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,” said Luis Jodar, Pfizer’s chief medical affairs officer for vaccines.
Pfizer will need to distinguish its maternal vaccine from the competition. It offers protection from the moment a baby is born and is cheaper in price than Sanofi’s antibody, which could help it take market share, Bloomberg Intelligence’s John Murphy said in an analysis in July. Pfizer has said its price for the shot is $295.
But the FDA’s warning may weigh on sales, along with its decision to reduce the time window for its use in pregnant women to weeks 32 to 36 of gestation. The clinical trial was for weeks 24 to 36 of the pregnancy.
“That will definitely impact adoption” of the product, Leerink Partners’ David Risinger said in an interview before Friday’s vote. “That also adds some complexity for providers in their discussions with pregnant women.” He sees sales for Sanofi and Astra’s preventive drug at around $2.3 billion by 2030, versus $560 million for Pfizer’s vaccine.
Members of the CDC advisory group raised the issue of whether insurance coverage for only one form of protection — either the maternal vaccine and the antibody — might pose problems for parents. There was also concern parents would forget whether they’d received the shot, making difficult to verify whether their children were protected.
(Updates with panel members’ comments starting in sixth paragraph.)
