An additional 230,000 doses of respiratory syncytial virus (RSV) immunization nirsevimab (Beyfortus) will be released in January, officials announced Thursday.
The additional supplies will include both 50 milligram (mg) and 100 mg doses and will be distributed through the Vaccines for Children program and the private market, according to Sanofi.
A Sanofi spokesperson said the additional doses are “from supply originally intended for the Southern Hemisphere RSV season, which will be replenished before that season starts.” They come on top of 77,000 doses of the 100 mg formulation that were expedited for release in November.
The company said it would update providers on their order status and potential availability of new doses. It did not provide further guidance on ordering. Customers with questions can contact their representative or call 855-BEYFORTUS.
The long-awaited monoclonal antibody product to protect infants from RSV, the leading cause of hospitalization for this age group, received approval from the Centers for Disease Control and Prevention (CDC) in early August. However, it has been in short supply.
Sanofi said Thursday it had to finalize its launch supply in March 2023 and aimed to provide enough immunization for 30% of the birth cohort within six months of launch, which was higher than the initial uptake of rotavirus and pneumococcal conjugate vaccines. The company noted implementation barriers like commercial payer coverage and coding issues resolved more quickly than expected, and orders quickly exceeded planned available doses.
Thursday’s announcement of extra doses came after several meetings between Biden administration officials, Sanofi and its partner, AstraZeneca. The AAP also has been meeting with Sanofi and health officials on this issue. With the additional doses, there would be enough for 1.4 million babies or about 40% of the eligible population this season, the company said. It plans to launch a process in February to support providers in planning for the 2024-’25 RSV season.
The CDC released a health advisory Thursday urging people to get vaccinated against RSV, flu and COVID-19 as respiratory illnesses increase. Hospitalizations increased by 200% for influenza, 51% for COVID-19 and 60% for RSV over the past four weeks, according to the alert. At least 12 children have died of flu this season. The CDC also is seeing an increase in cases of multisystem inflammatory syndrome in children following SARS-CoV-2 infection.
Vaccination rates have been lagging. About 38% of children under 18 years have received a flu vaccine, and just under 8% of children have received an updated COVID-19 vaccine. Everyone 6 months and older is eligible for these two vaccines. Infants under 8 months and some high-risk toddlers ages 8 months through 19 months are eligible for nirsevimab. During supply shortages, the CDC has recommended prioritizing those most at risk including infants under 6 months, infants with certain underlying conditions and children who are American Indian or Alaska Natives. An RSV vaccine also is available for pregnant people at 32 through 36 weeks’ gestation and for adults 60 years and older.
- CDC health advisory urging vaccination for respiratory viruses, including a conversation guide for health care providers
- 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
- AAP News article “How to use new CPT codes for administration of RSV immunizations”
- 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”
- AAP policy Recommendations for Prevention and Control of Influenza in Children, 2023-2024
- Information from the AAP on COVID-19 vaccines