New FAQ's Added in the Past 30 Days (updated 12/5/2023)
Given the limitations in supply, should we risk stratify beyond what the CDC recommends or is it a first come first serve?
With the start of the RSV season, which is well underway across the US, we encourage pediatricians to use the doses they have on hand now, and not try to conserve them for later in the season, even if that means making difficult decisions about which patients will be able to receive a dose. We advise pediatricians to assess their patient populations to determine which patients are at highest risk for severe RSV disease. It is important to ensure all infants at highest risk for severe RSV as outlined in the HAN get nirsevimab now.
For those who are interested in additional guidance, CDC recommends prioritizing 100 mg doses for infants with underlying medical conditions that place them at increased risk of severe disease; American Indian and Alaska Native infants aged <8 months; and all infants <6 months, who have the highest RSV hospitalization rates. For healthcare settings with limited supply of 50 mg doses, pediatricians should assess which patients are at higher risk for severe RSV disease, due to very young age (such as neonates) or due to underlying conditions (such as prematurity), and therefore should be prioritized for nirsevimab. CDC will continue to monitor the situation and provide additional national guidance if needed.
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, given the current situation of limited supply 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. With a limited number of doses, we need to prioritize those infants at highest risk of severe RSV.
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 limited 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.
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. Additional allocations of 50 mg and 100 mg doses for VFC will be made available to most jurisdictions through the end of December, including additional 50 mg and 100 mg doses. There is a greater quantity of 50 mg doses available this season compared with 100 mg doses. Contact your state immunization program for more details about VFC ordering and anticipated supply for the 23-24 RSV season.
How do I order commercial/private stock nirsevimab? Will I receive any more doses this season?
The 100 mg formulation of nirsevimab is unavailable for new orders through Sanofi. Ordering is not anticipated to re-open during the 23-24 RSV season. Sanofi has indicated that they plan to fulfill all orders that have been successfully placed.
Sanofi re-opened ordering for 50 mg dosage using an allocation system on November 16.
- Customers should have heard about allocated amounts from their regional rep or via their account on VaccineShop.com.
- Customers are able to place a direct order up to their allocation amount for a 30-day period (by December 15).
- If allocations are not accepted/ordered, Sanofi will offer declined doses to those customers without allocations first.
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 (deadline is 12/15)
For information about ordering from Sanofi, please contact your local Sanofi representative or call 1-855-Beyfortus.
What should I do if I have borrowed VFC doses that I am unable to pay back due to the limited supply of nirsevimab?
If you are unable to repay borrowed VFC doses within 30 days, you should contact your state immunization program to discuss.