Pfizer’s vaccine, designed to protect newborns and infants from severe respiratory syncytial virus infections, won a recommendation from the Centers for Disease Control and Prevention on Friday, but only for seasonal use.
The vaccine is Pfizer’s bivalent RSVpreF vaccine, called Abrysvo, which is given to pregnant women in the third trimester (32-36 weeks).
RSV (respiratory syncytial (sin-SISH-uhl) virus) is the leading cause of infant hospitalization in the United States. Each year, 1.5 million children seek outpatient treatment for RSV, of which 58,000 to 80,000 are hospitalized and 100 to 300 tragically die from the infection.
The CDC’s Advisory Committee on Immunization Practices voted 11-1 Friday to recommend the vaccine, which has been shown to be 91 percent effective in preventing severe RSV during the first three months of life in infants. , it was shown to have a preventive effect of 76.5%. Get seriously ill in the first 6 months. He was demonstrated to be 57% effective in preventing hospitalizations in the first six months.
Although the vaccine appeared to increase the rate of preterm birth compared to placebo, the increase was not statistically significant.
Ultimately, the committee recommended that the vaccine be used only seasonally, between September and January, to protect infants born between October and March, when RSV infection typically peaks. Recommended. (There are exceptions for pregnant people who live in areas of the United States where RSV is prevalent year-round, such as Hawaii and Gaum.)
Vaccination is not recommended for pregnant women planning to give birth between February and August. Instead, those babies have the following options: Monoclonal antibody immunization Sanofi’s Nilsevimab (Bayfortas) is available to protect against RSV in the run-up to seasonal infections. Antibodies are shown below. Approximately 80% effective in preventing severe RSV More than 5 months.
One of the dissenting votes on the CDC panel was Vanderbilt University School of Medicine professor Helen Cape Talbot, who questioned the complexity of the recommendation and the need for another option, given the availability of antibodies. did. However, other members emphasized the benefits of him having two options.
Shortly after the advisory committee’s vote, CDC Director Mandy Cohen endorsed the recommendation.
“This is another new tool we can use to save lives this fall and winter,” Cohen said in a statement. “We encourage parents to talk to their doctors about how to protect young children from serious RSV disease by getting the vaccine during pregnancy or by giving the baby RSV vaccine after birth.”
Both options are expensive. Pfizer plans to charge $295 for the vaccine, while Sanofi will sell its monoclonal shot for $495.
