New FAQ's Added in the Past 30 Days (updated 1/12/24)
Are there still limitations in supply?
230,000 additional doses of nirsevimab (both 50 mg and 100 mg formulations) will be released in January 2024. This additional quantity will allow for up to 40% of the eligible population to receive nirsevimab during the 23-24 RSV season. Approximately half of the supply will go to VFC, while the other half will be for public/commercial distribution.
On January 5, 2024, CDC issued a COCA Now article recommending that health care providers return to the original recommendations on use of nirsevimab in young children and recommending that infants and children recommended to receive nirsevimab be immunized as quickly as possible.
Questions about ordering VFC doses should be directed to your state immunization program. Questions about private/commercial ordering should be directed to Sanofi at 855-BEYFORTUS.
Can we split a 100 mg manufacturer-filled syringe (MFS) into two 50 mg doses?
No, nirsevimab 100 mg doses are approved for single use.
Manufacturer-filled syringes are prepared with a single dose and sealed under sterile conditions by the manufactures. They do not contain a preservative to help prevent the growth of microorganisms.
They are intended for ONE patient for ONE injection. Never administer medications from the same syringe to more than one patient, even if the needle is changed.
Attempting to split 100 mg MFS into two 50 mg doses is a serious administration error that risks inadvertent contamination and infection transmission.
Should an infant who had a confirmed RSV infection this season still receive nirsevimab?
When supply is adequate, prior infection should generally not be used to determine an infant’s eligibility for nirsevimab. However, if supply is limited, it is reasonable to defer nirsevimab in infants who have had a documented RSV infection as their risk of severe disease is lower with subsequent RSV infections.
What if a young infant is in our office and diagnosed with RSV that day or are within 48 hours of illness onset? Would a dose of nirsevimab be helpful to them to reduce the severity of the illness?
Nirsevimab has not been studied as a treatment in infants with RSV and is not licensed for treatment of RSV disease. Nirsevimab should be given prior to onset of the RSV season or as soon as possible after birth for infants born during the season to prevent severe RSV disease.
If a high-risk child mistakenly received a 100 mg dose of nirsevimab when they should have received a 200 mg dose, should we have them return for the other 100mg?
If a half dose is inadvertently given, another half dose should be administered as soon as possible, but no later than the end of the season (for most of the continental US, this would be through the end of March, unless local guidance is given to administer during a modified time period). This counts as a 200 mg dose.
Given the inconsistent supply of nirsevimab this season, should more pregnant people receive RSV vaccine? What is AAP doing to promote RSV vaccination during pregnancy?
Other existing options for protecting infants against RSV are the maternal RSV vaccination and palivizumab for eligible infants and young children. Providers should encourage pregnant people to receive Pfizer’s maternal RSV vaccine (Abrysvo) during 32–36 weeks’ gestation to prevent RSV-associated lower respiratory tract infection, especially in the context of the current nirsevimab supply constraints. This vaccine should be administered during September through January in most of the continental United States. However, in jurisdictions with seasonality that differs from most of the continental United States (e.g., Alaska, jurisdictions with tropical climates), pediatricians should follow state, local, or territorial guidance on timing of administration. The maternal Pfizer vaccine can be simultaneously administered with other indicated vaccinations. Abrysvo should NEVER be administered to infants.
Similar to nirsevimab, there have been significant implementation challenges with RSV vaccination during pregnancy this season. The AAP collaborated with ACOG and the Society for Maternal-Fetal Medicine on a joint statement on the nirsevimab shortage, which supported RSV vaccination in pregnant people. There are 2 adult RSV vaccines, and only the Pfizer product (Abrysvo) is approved for use in pregnant people. Pfizer has a website to help identify locations that are administering their RSV vaccine.
How do I order nirsevimab through Vaccines for Children (VFC)? Will I receive any more doses this season?
Nirsevimab is being distributed to state immunization programs using an allocation system. CDC determines allocations based on (1) the total amount of product available and (2) each jurisdiction's ordering history for other routine vaccines used in similar age groups. State immunization programs are then responsible for making decisions about how to direct VFC doses to providers within their jurisdiction, as they are most familiar with the providers, patient populations and local needs. States that have reached their allocation limits have the ability to contact the CDC to obtain additional doses. Contact your state immunization program for more details about VFC ordering.
How do I order commercial/private stock nirsevimab? Will I receive any more doses this season?
With the release of an additional 230,000 nirsevimab doses in January, Sanofi is updating their allocations for their customers. This information can be found on VaccineShop.com.
Within VaccineShop.com customer accounts, customers can click on the "View Details" button to see a "Quantity Limit" pop up window with the following information:
- (A) Total Allocation: shipped units + open orders year to date + units remaining to order
- (B) Units Ordered to Date: shipped units + open orders year to date
- (A-B) Units Remaining: units remaining to order
Those without a VaccineShop.com customer account are encouraged to call 1-855-Beyfortus for additional information.
What should I do if I have borrowed VFC doses that I am unable to pay back due to the limited supply of nirsevimab?
Pediatricians who borrowed from VFC stock prior to supply constraints are strongly encouraged to first work directly with the manufacturer and/or their provider network to obtain VFC replacement doses. If that is not possible due to supply constraints, pediatricians must work closely with their state immunization programs to document borrowing that has happened and repay nirsevimab doses to the VFC program immediately when supply chain constraints lift, even if that repayment happens at the beginning of the next RSV season.
If an infant received 1 dose of palivizumab, can they receive nirsevimab?
Yes, if there is an adequate supply of nirsevimab. If palivizumab was administered initially for the season and <5 doses were administered, the infant should receive 1 dose of nirsevimab. No further palivizumab should be administered. There is no minimal interval between the last dose of palivizumab and the dose of nirsevimab. Since protection from palivizumab wanes after 30 days, nirsevimab should be given no later than 30 days after the last palivizumab dose.
In the context of a limited supply of nirsevimab, CDC recommends providers suspend using nirsevimab in palivizumab-eligible children.