The Centers for Disease Control and Prevention on Thursday recommended use of a monoclonal antibody to protect infants and some older babies from respiratory syncytial virus, or RSV, endorsing the advice of an expert committee that had backed the drug earlier in the day.
Called Beyfortus and developed by partners Sanofi and AstraZeneca, the shot is expected to be available in time for the start of the typical RSV season this fall. It won Food and Drug Administration approval in July
The CDC recommends one dose of Beyfortus for all infants under 8 months old who are born during or entering their first RSV season. The agency is also advising that children between 8 months and 19 months who are at increased risk of severe RSV disease receive a dose in their second season.
The expert panel, known as the Advisory Committee on Immunization Practices, or ACIP, voted unanimously in support of both uses.
“We do believe this is a breakthrough,” said ACIP chair Sarah Long, a professor of pediatrics at Drexel University College of Medicine and an infectious disease physician.
Most infants are likely to be infected by RSV before their second birthday. Typically, the virus causes mild symptoms similar to that of a cold. But it can be more dangerous in some young babies, and is the leading cause of hospitalization for infants under one year old. Several hundred children under 5 years old die from RSV infections each year.
The CDC committee also voted 11-0 to include the shot in Vaccines for Children, a federally funded program that provides vaccines to children whose families might otherwise not be able to afford them.
“The ACIP’s unanimous recommendations for routine use of Beyfortus 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 through their first RSV season, when they are most susceptible to severe RSV disease,” said Thomas Triomphe, executive vice president of vaccines at Sanofi, in a statement.
Sanofi will charge $495 per dose in the commercial market, according to slides presented at Thursday’s meeting. The CDC’s recommendation, alongside Beyfortus’ inclusion in the Vaccines for Children program, will allow the drug to be covered by insurance without a copay. Still, insurance coverage may take some months to be put in place.
Beyfortus’ dosing is determined by an infant’s weight. Babies can receive either a 50 milligram, 100 milligram or 200 milligram dose. Pricing will be the same across dosage strengths, Sanofi said.
While Beyfortus is being included in children’s vaccine initiatives, it is an antibody shot that provides passive immunization. Members of the committee noted how, because Beyfortus is a preventive “treatment” rather than a vaccine, parents will need to be educated to support uptake and counter hesitancy.
A CDC-conducted survey, presented at the meeting, showed that 70% of respondents would “definitely” or “probably” give their newborns an RSV antibody treatment if it was safe and effective.
Beyfortus is the only RSV antibody approved by the FDA for all infants under 18 months. Another antibody, Synagis, is available, but its use is limited to only certain infants who are high risk.
Pfizer has developed a vaccine, named Abrysvo, that earlier this year won approval to prevent RSV infection in adults 60 years and older, who are also considered vulnerable to severe disease. The pharmaceutical giant is expecting a decision from the FDA soon on whether the vaccine could be used in pregnant people as a passive immunization for newborns.
Committee members questioned whether it would be safe for an infant to later receive Beyfortus if their mother had previously been given Pfizer’s vaccine. Representatives for Sanofi deferred comment on any interaction between the two drugs.
Should Pfizer’s shot be cleared for use during pregnancy, another ACIP meeting will be held to determine whether it’s safe for the vaccine and antibody to be used together.
The European Medicines Agency backed Abrysvo for maternal use in July. An ongoing Phase 3b study is ongoing to further evaluate its safety and efficacy in infants, with more data one year after initial dosing.
Wall Street analysts expect RSV vaccines and antibodies to eventually earn billions of dollars in yearly sales — a lucrative market that’s drawn other would-be competitors like Moderna.