Many babies should get a shot soon after birth to protect them from RSV, or respiratory syncytial virus, the Centers for Disease Control and Prevention said Thursday. The recommendation clears the way for a new option experts have hailed as a historic advance to curb the leading cause of hospitalizations for American infants.
A panel of the CDC’s outside advisers voted unanimously to endorse giving Sanofi and AstraZeneca’s nirsevimab antibody drug, branded as Beyfortus, to protect babies born into their first RSV season — typically colder months from October through March — when infections typically climb in much of the country.
Some babies who are at increased risk of severe RSV disease will also be recommended to get another dose during their second RSV season.
The votes by the CDC’s Advisory Committee on Immunization Practices, following an hourslong meeting Thursday, is a key step towards requiring insurance coverage for the shots.
“I would be remiss if I didn’t say that today is a historic event. I think that we will look back on this, in a short period of time, and see what a major impact this vote has had on the health and wellbeing of children in the United States. I think that this will mark one of the major accomplishments of the ACIP,” Dr. José Romero, MD, director of the National Center for Immunization and Respiratory Diseases, said in closing the meeting.
CDC Director Dr. Mandy Cohen formally signed off on the recommendations Thursday evening, calling the shots a new “powerful tool” to protect babies from RSV and urging parents to request the shots this fall from their doctors.
“RSV is the leading cause of hospitalizations for infants and older babies at higher risk and today we have taken an important step to make this life saving product available,” Cohen said in a statement.
Beyfortus was first approved by the Food and Drug Administration in July, after results showed a steep reduction in hospitalizations from RSV after infants got the antibody injection. Data suggests the protection could last for at least 5 months.
While virtually all children catch RSV within their first few years of life, the virus poses a higher risk of hospitalization for babies who catch it during their earliest months of life.
CDC survey results presented to the committee suggest 70% of parents were open to getting their newborns the antibody injections to avoid RSV.
Unlike a traditional vaccine, which works to train the body’s own immune defenses against the virus, a shot of the antibody drug works to directly fend off the virus in the body.
It is part of a growing roster of “long-acting” passive immunizations that can quickly offer months of protection against diseases — a key asset for babies who might be exposed to RSV during their most vulnerable first months of life.
“Thanks to advances in biotechnology, we now have the opportunity to prevent infectious diseases with long-acting monoclonal antibodies. When used for passive immunization, these products can provide a level of protection similar to see to that we see with traditional vaccine, but for a limited period of time,” the CDC’s Dr. Melinda Wharton told the panel.
This technicality has posed months of logistical challenges for public health authorities, officials outlined for the committee, as they have worked to adapt policies and systems designed for “vaccines” to cover the new antibody drug.
Similar to other shots, the CDC plans to monitor how well Beyfortus is working in the real world through its ongoing vaccine effectiveness studies. The agency has also drawn up plans to monitor reports of safety issues, as well as tracking the possibility RSV might evolve resistance.
The panel from also voted Thursday to back including Beyfortus in the federal Vaccines for Children program, guaranteeing broad access to the shots for underinsured children.
Beyfortus is also pricier than many other vaccines. Sanofi says the list price of the drug could run as much as $495 before insurance, officials said, with a discounted price of $395 for the the Vaccines for Children program. The hepatitis B vaccine, which is also given to newborns, costs less than $20 per dose.
The drug’s cost could make it harder for some doctors to stock the doses and complicate efforts to set up billing for the doses, officials said, in turn making it harder for some parents to access the shots.
However, the votes Thursday mean Americans will not need to pay an out-of-pocket cost for Beyfortus.
“The recommendation from ACIP to include Beyfortus in the CDC’s Child and Adolescent Immunization Schedule means the cost of Beyfortus will be covered without a co-pay, in accordance with the Affordable Care Act,” a Sanofi spokesperson said.
