Health officials acknowledged growing frustration among pediatricians who are struggling to stock the long-awaited respiratory syncytial virus (RSV) immunization nirsevimab (Beyfortus) and offered advice on managing increasingly limited supplies.
During an AAP webinar Wednesday, officials from the Centers for Disease Control and Prevention (CDC) continued to recommend prioritizing infants at highest risk, referring patients to other providers and encouraging vaccination during pregnancy.
“We are in a really important place right now where we finally have products that protect infants against the No. 1 cause of hospitalization in the United States, and we’re thrilled this is happening, but yet we have this supply issue,” said Manisha Patel, M.D., M.S., M.B.A., chief medical officer for the National Center for Immunization and Respiratory Diseases. “I just want to acknowledge this is a challenge for all of us.”
Sanofi stopped taking new orders for the 100 milligram (mg) doses in October saying supply had exceeded the high demand. In recent days, it also paused ordering for 50 mg doses but plans to reopen them Nov. 16 with limited allocation. Shipping on existing orders of both products will continue into December.
Ayanna Santos, Pharm.D., head of RSV Franchise, U.S. Vaccines for Sanofi, said during the webinar the company is “ensuring there is equitable distribution across the states and across settings, so that includes clinics, birthing hospitals, whether they’re independent or part of a large system.”
Sanofi will contact providers who have allocations assigned this week and next week. Pediatricians also can talk to their field representative or call customer service at 855-BEYFORTUS (855-239-3678).
The CDC also is using an allocation system for the Vaccines for Children (VFC) program and has new allocations every two to three weeks. Pediatricians with questions on VFC distribution should contact their state immunization program.
In late October, the CDC released guidance on managing the shortage of 100 mg doses. The advice officials provided Wednesday followed many of the same themes.
- Prioritize the youngest patients and those with underlying conditions like prematurity, congenital heart disease and chronic lung disease.
- Refer patients to other providers with nirsevimab supply such as health departments.
- Encourage maternal vaccination during 32-36 weeks of pregnancy. The CDC approved a new maternal vaccination in September, and while supplies still are ramping up, they are expected to be sufficient.
- Consider limiting use of nirsevimab for infants who have tested positive for RSV because their risk of a second infection is lower.
- Give available doses now. The RSV season has begun, and infants born later will have an opportunity to benefit from maternal vaccination.
- Don’t use two 50 mg doses for children who need 100 mg. Doing so is not part of the Food and Drug Administration’s approval and may not be covered by insurance. It also would exhaust supply more quickly.
The CDC previously announced flexibilities in the VFC program, including bidirectional borrowing between public and private stock. However, Sarah Meyer, M.D., M.P.H., chief medical officer for the CDC’s Immunization Services Division, cautioned against borrowing from VFC stock if providers are unsure about their next commercial shipment. If they already have borrowed and can’t repay the doses, they should talk to Sanofi or other provider networks to get replacements. If that is not possible, providers should work with their state immunization program to document the borrowing and reimburse it immediately when supply increases, even if that is early next season, Dr. Meyer said.
The CDC also was asked about private insurers, which have a year to start covering the immunization. Charlene Wong, M.D., a senior adviser for health strategy at the CDC, said most of the major commercial insurance companies already indicated they will cover nirsevimab. The CDC is continuing to work with payers to encourage adequate payment for both nirsevimab and palivizumab, another RSV product for high-risk infants.
The Centers for Medicare & Medicaid Services recently announced it has established payment rates for nirsevimab similar to other pediatric immunization administration services.
Strict VFC requirements and payment issues are just a few of the logistical hurdles the AAP had been working to clear long before nirsevimab received final approval.
Supply was not anticipated to be a problem. Dr. Santos said Sanofi and its partner, AstraZeneca, looked at data from previous product launches for children as a guide for supply planning. She apologized for the shortage.
“Obviously, that approach was not sufficient for the demand that we’re seeing for Beyfortus,” she said. “We missed the mark there.”
- Recording of the AAP webinar on nirsevimab supply issues
- CDC guidance on use of nirsevimab while supply is limited during the 2023-’24 season
- AAP RSV resources, including information on ordering, dosing, coding and a visual guide for nirsevimab administration
- VFC operations guide addendum for nirsevimab
- Information for clinicians from the CDC on nirsevimab
- Information for parents from HealthyChildren.org on RSV immunization availability
- Information for parents from HealthyChildren.org on RSV symptoms and when to call a doctor
- Pediatrics in Review article “Implications of Food and Drug Administration Approval of Respiratory Syncytial Virus Prophylactic Medications”