Nirsevimab Frequently Asked Questions

About Nirsevimab

Is nirsevimab a vaccine? 

Nirsevimab is a monoclonal antibody product that is a passive immunization. While not technically a “vaccine” in a traditional sense (active immunization), it is being used in a manner similar to routine childhood vaccines and may be referred to as a vaccine by some entities. Nirsevimab confers long-lasting protection from RSV, with protection expected to last at least 5 months (about the length of a typical RSV season). Nirsevimab is part of the Vaccines for Children program.  

Because nirsevimab is a monoclonal antibody product, who can administer it? 

Nirsevimab comes in a prefilled syringe. In most states, anyone who can administer injections can administer nirsevimab.  

How effective is nirsevimab and how long does the RSV protection conferred by nirsevimab last?

Protection is expected to last at least 5 months, about the length of an RSV season and is expected to reduce the risk of severe RSV disease by about 80%. Data from the 2023-2024 RSV season show that nirsevimab was effective against RSV-associated emergency department encounters and hospitalization among infants in their first RSV season. Specifically, data from the VISION Multi-Site Network of Electronic Health Records of 127 emergency departments and 107 hospitals showed nirsevimab was 77% effective at preventing RSV-associated ED encounters and 98% effective at preventing RSV-associated hospitalization. 

Nirsevimab Ordering and Supply

Should we anticipate limitations in nirsevimab supply for the 2024-2025 RSV season?

A shortage of niservimab is not expected this coming season. The AAP and CDC have been meeting regularly with the manufacturer to review the challenges from last season and plan for the 2024-2025 season.  Nirsevimab is expected to  be broadly available by October 1. 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. 

Given nirsevimab has a shelf life of about 18 months, should I purchase extra doses to have on hand knowing I can always use them next season?

It is noted that data does not currently exist about the impact of temperature excursions on nirsevimab; if temperature excursions occur, you will likely be advised to discard the product, which could have financial implications.

As VFC providers, can we stock VFC nirsevimab without having private stock? 

According to CDC, VFC providers may be allowed a flexible, time-limited ramp-up period to meet the private inventory requirement for nirsevimab. During this time, awardees will not require VFC providers to meet the private inventory minimum requirements for nirsevimab if they do not intend to vaccinate their private pay patients. VFC providers are required to meet the private inventory requirement no later than August 31, 2025. This may vary by state/jurisdiction.   

Can I administer two 50 mg doses to my patient who is > 5 kg instead of a 100 mg dose?

Avoid using two 50 mg doses for infants weighing ≥5 kilograms (≥11 pounds), because 50 mg doses should be reserved for smaller infants who are at increased risk for severe RSV illness because of their smaller airways. Furthermore, providers should be aware that insurers may not cover the cost of two 50 mg doses for an individual infant.

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. 

If nirsevimab supply is limited in my community, what are some other things I can do to protect my patients? 

Continue to use palivizumab for eligible high-risk children and encourage pregnant people to get vaccinated between 32-36 weeks’ gestation with the RSVpreF vaccine.  

Nirsevimab and Palivizumab

If both nirsevimab and palivizumab are available for eligible high-risk patients, which should they receive? 

All infants eligible for nirsevimab should receive nirsevimab.  Palivizumab should be administered to eligible high risk patients if nirsevimab is unavailable.

If an infant received 1 or more doses of palivizumab, can they receive 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 minimum interval between the last dose of palivizumab and the dose of nirsevimab. Because protection from palivizumab wanes after 30 days, nirsevimab should be administered no later than 30 days after the last palivizumab dose, when possible.

If palivizumab was administered in season 1 and the child is eligible for RSV prophylaxis in season 2, the child should receive nirsevimab in season 2.

Nirsevimab Administration, Side Effects/Contradindications, and Timing

Can nirsevimab be co-administered with other routine vaccines?

Yes. In accordance with CDC General Best Practices for Immunizations, simultaneous administration of nirsevimab with age-appropriate vaccines is recommended. Nirsevimab is not expected to interfere with the immune response to other vaccines and had similar safety and reactogenicity profiles to vaccines administered without nirsevimab. 

Are there maximum volumes of injectable vaccine, antibiotic or other products that can be administered into each muscle group for different ages? For example, at the 6-month well-child visit, could an infant receive nirsevimab, COVID-19, influenza, PCV, and DTaP-IPV-HepB-Hib?

In accordance with the CDC’s General Best Practice Guidelines for Immunization, simultaneous administration of nirsevimab with age-appropriate vaccines is recommended.  CDC does not address the issue of maximum volumes that can be injected into each muscle group in different age groups.  CDC has created job aids for healthcare providers to help address the issue and offers the suggested volumes as follows:

• Deltoid:
• Average 0.5 mL (range 0.5–2 mL)
• Vastus Lateralis:
• Average 1–4 mL (range 1–5 mL)

Infants and toddlers would fall at the lower end of the range, whereas adolescents and adults would generally fall on the higher end of the range. Strategies healthcare providers can use to decrease the number/injection volume include:

1. Healthcare providers should always use professional judgement when administering injections. Muscle size can vary greatly from one patient to another.
2. Include an age-appropriate combination vaccine in the facility’s inventory (Pentacel, Pediarix, Vaxellis).
3. Use an alternate route (other than IM) if possible.  IPV (single component, NOT a combination vaccine), MMR (toddlers and infant travelers only), Varicella-containing vaccines (toddlers only), and PPSV23 (high-risk toddlers only) can be administered subcutaneously.
4. Take advantage of recommended age ranges some of the routinely recommended vaccines have.  For example, the 3rd dose of HepB can be given as late as 18 months of age.

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. 

What are the potential side effects of nirsevimab?

CDC published an Immunization Information Statement (VIS-like document) for families. It states that “After getting an RSV preventive antibody, your child might have temporary pain, redness, swelling where the injection was given, or a rash.”  In addition, the nirsevimab package insert has additional information on adverse reactions. “Most common adverse reactions were rash (0.9%) and injection site reactions (0.3%).”

Are there any contraindications to receiving nirsevimab? Can an infant or young child receive nirsevimab when they are sick?

Nirsevimab is contraindicated in infants and young children with a history of serious hypersensitivity reactions, including anaphylaxis, to nirsevimab or to any of its components. Illness or febrile diseases are not contraindications to receiving nirsevimab. The AAP suggests following CDC General Best Practice Guidelines for Immunizations, which recommends that vaccination should be deferred for persons with a moderate or severe acute illness, as this precaution avoids causing diagnostic confusion between the underlying illness and potential adverse effects of immunization. Similar to routine childhood vaccines, mild illness – with or without fever – should not be used as a reason to delay administration of nirsevimab.  

What does "shortly before or during” the RSV season mean?  When should I start administering nirsevimab?

In most of the continental US, “shortly before or during the season” means that administration of nirsevimab should begin on October 1 and conclude on March 31. In tropical climates (southern Florida, Hawaii, Guam, Puerto Rico, US Virgin Islands and US-affiliated Pacific Islands) and Alaska, RSV circulation patterns may differ. Because timing of the onset, peak and decline of RSV activity may vary, providers can adjust administration schedules based on local RSV activity in the community.  The CDC monitors RSV activity in the United States in collaboration with state and county health departments and commercial and clinical laboratories. These data are available from the National Respiratory and Enteric Virus Surveillance System. Information about local epidemiology can be determined by contacting your local, state, tribal, or territorial health department or other local health authority. Optimal timing for nirsevimab administration is shortly before the RSV season begins, however, it may be given to eligible infants and toddlers who have not yet received a dose at any time during the season. 

Per CDC, healthcare providers may choose to give nirsevimab before the start of RSV season if they feel that the child may not return for a visit when nirsevimab would be recommended. For example, a clinician may choose to give nirsevimab to an infant who presented for care in September who has not yet received a dose of nirsevimab and may be unlikely to return for a visit in October or November. Nirsevimab has been shown to protect against severe RSV disease for at least 5 months, and the ideal timing of administration may differ depending on the clinical situation.

How can pediatricians minimize the likelihood of immunization errors?

Vaccine providers who carry both nirsevimab and RSV vaccine products for adults should be especially diligent in following vaccine administration safety procedures to prevent errors. To minimize risk of errors:

• Store nirsevimab and RSV vaccine in their original packaging on different shelves and clearly label the shelves.
• Educate staff about the differences in indication including age for use, preparation, and dosage.
• Confirm with the patient or caregiver the product(s) they are expecting to receive.

Nirsevimab Recommendations

Are there changes to the recommendations for prevention of RSV in infants and young children for the 2024-2025 RSV season?

No changes were made to the original recommendations.  All infants are recommended to be protected by either maternal RSV vaccination or nirsevimab administration for the 2024-2025 season.

Who is recommended to receive nirsevimab?

The AAP recommends nirsevimab, consistent with the Advisory Committee on Immunization Practices (ACIP), for:

• Infants aged <8 months born during or entering their first RSV season whose pregnant parent did not receive RSVpreF vaccine, whose pregnant parent’s RSVpreF vaccination status is unknown, or who were born <14 days after the pregnant parent’s RSVpreF vaccination.
  
  Nirsevimab is not needed for most infants aged <8 months whose pregnant parent received RSVpreF vaccine ≥14 days before giving birth. Nirsevimab may be considered for infants born to a vaccinated pregnant parent in rare circumstances when, based on the clinical judgment of the health care provider, the potential incremental benefit of administration is warranted. These situations include, but are not limited to:
  • infants born to pregnant people who might not have mounted an adequate immune response to vaccination (eg, persons with immunocompromising conditions) or who have conditions associated with reduced transplacental antibody transfer (eg, persons living with HIV infection);
  • infants who might have experienced loss of transplacentally acquired antibodies, such as those who have undergone cardiopulmonary bypass or extracorporeal membrane oxygenation;
  • and infants with substantially increased risk for severe RSV disease (eg, hemodynamically significant congenital heart disease or intensive care admission requiring oxygen at hospital discharge).
• Infants and children 8 through 19 months of age who are at increased risk of severe RSV disease and entering their second RSV season, including those recommended by the AAP to receive palivizumab, regardless of RSV vaccination status of the pregnant parent. This includes the following:
  • Infants and children with chronic lung disease of prematurity who required medical support (chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen) at any time during the 6-month period before the start of the second RSV season.
  • Infants and children who are severely immunocompromised.
  • Infants and children with cystic fibrosis who have manifestations of severe lung disease (previous hospitalization for pulmonary exacerbation in the first year of life or abnormalities on chest imaging that persist when stable) or have weight-for-length that is less than the 10th percentile.
  • American Indian and Alaska Native children.

Should a pregnant person receive maternal RSV vaccine during pregnancy this season if they received maternal RSV vaccine during pregnancy in a previous season?

No.  People who have received a maternal RSV vaccine during pregnancy should not receive additional doses during future pregnancies. Rather, that infant should receive nirsevimab.  Additional data are needed to determine whether additional seasonal doses during subsequent pregnancies are indicated, and ACIP might update recommendations in the future, as data become available.

Should I administer nirsevimab to an infant who is born at the very end of the RSV season? 

Yes. Optimal timing for administration is within 1 week after birth during the RSV season. Administering nirsevimab through the end of the season is important because the risk of severe disease is highest during the first few months of life.

If an infant’s mother has received maternal RSV vaccine, should the infant receive nirsevimab? 

The CDC does not recommend nirsevimab for most infants born to a mother who received maternal RSV vaccine, except for infants where less than 14 days have elapsed between vaccination and birth.   

Nirsevimab can be considered for infants born to a mother who received maternal RSV vaccine when, per the clinical judgement of the healthcare provider, the potential incremental benefit of administration is warranted, including but not limited to the following rare circumstances:

• Infants born to pregnant people who may not mount an adequate immune response to vaccination or have conditions associated with reduced transplacental antibody transfer
• Infants who have undergone cardiopulmonary bypass or extracorporeal membrane oxygenation leading to loss of maternal antibodies
• Infants with substantial increased risk for severe RSV disease (eg, hemodynamically significant congenital heart disease, intensive care admission and requiring oxygen at discharge)

I have a healthy patient who was 7 months old in October. They present to the clinic in November, at 8 months of age. Can they receive nirsevimab at this visit?

No. CDC recommends that only those healthy infants younger than 8 months of age at the time of administration receive nirsevimab.

Can a baby who is 9 months old but corrects to 6.5 months due to prematurity (delivery at 29 weeks gestational age) receive nirsevimab?

In accordance with CDC General Best Practice Guidelines for Immunization preterm infants (infants born before 37 weeks’ gestation), regardless of birth weight, should receive nirsevimab at their chronological age using the same guidance for full-term infants and young children.  

Will infants born during the RSV season receive nirsevimab before they are discharged from the hospital?

It is recommended that infants born shortly before and during the RSV season receive nirsevimab within the first week of life, including in hospital settings. Infants with prolonged birth hospitalizations because of prematurity or other causes should receive nirsevimab shortly before or promptly after discharge. If a hospital has been unable to implement administration of nirsevimab, the infant should receive nirsevimab in an ambulatory setting as soon as available. Currently, few hospitals participate in the VFC program, and additional advocacy to support hospital participation is ongoing. Timely and well-coordinated communication between birth hospital and the medical home is important. Equitable access to nirsevimab will require those in a community to work together. 

Which children should receive a dose of nirsevimab in their second RSV season? 

Infants and children 8 through 19 months of age who are at increased risk of severe RSV disease and entering their second RSV season, including those recommended by the AAP to receive palivizumab, regardless of RSV vaccination status of the pregnant parent. This includes the following:

• Infants and children with chronic lung disease of prematurity who required medical support (chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen) at any time during the 6-month period before the start of the second RSV season.
• Infants and children who are severely immunocompromised.
• Infants and children with cystic fibrosis who have manifestations of severe lung disease (previous hospitalization for pulmonary exacerbation in the first year of life or abnormalities on chest imaging that persist when stable) or have weight-for-length that is less than the 10th percentile.
• American Indian and Alaska Native children.

If a patient was born towards the end of March and did not receive nirsevimab, can they receive nirsevimab in October?

Yes. Per AAP’s guidance, healthy infants born at the end of their first RSV season who did NOT receive nirsevimab and are <8 months of age entering their second RSV season may receive one dose of nirsevimab.

Why are infants 8-12 months old ineligible to receive nirsevimab (unless they are considered high-risk)?

The highest risk for severe RSV is in children under 6 months of age.  Infants 8 months and older will be entering their second RSV season and have likely already experienced their first RSV infection and will not receive the full benefits of nirsevimab.  

Should American Indian and Alaska Native infants and young children from birth – 19 months of age receive palivizumab if nirsevimab is unavailable?

If nirsevimab is unavailable, only those high-risk American Indian and Alaska Native infants and young children who meet current criteria for palivizumab should receive it. American Indian or Alaska Native heritage is not an indication for first or second season palivizumab.

What is the guidance for high risk infants who are 19-24 months of age, particularly given nirsevimab has been FDA approved for infants and toddlers 24 months of age and younger who are at high risk for severe RSV illness?

A dose of nirsevimab is recommended for some children aged 8 through 19 months who are at increased risk for severe RSV and who are entering their second RSV season (note this is inclusive of 19 months). Nirsevimab provides at least 5 months of protection and should be offered to eligible children when entering the RSV season.

Nirsevimab is not recommended for any child who is age 20 months and older. Children ages 20 months and older have likely already experienced two RSV seasons and been infected with RSV, and thus are less likely to benefit from nirsevimab. 

Should an infant who had a confirmed RSV infection this season still receive nirsevimab?

Prior infection should generally not be used to determine an infant’s eligibility for nirsevimab. 

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.

Coding and Payment

Is nirsevimab financially feasible for my practice? What flexibilities are available when I implement nirsevimab in my practice?

• There is no minimum order size. Nirsevimab is packaged as five single dose prefilled syringes per carton in both formulations.
• Nirsevimab is fully returnable upon expiration. Sanofi offers credit (credit based on exact amount returned and the invoice purchase price that is net of prompt pay or other discount(s)) upon expiration on all full and open box Sanofi product(s) directly purchased from Sanofi that are returned within 1 year after the expiration date. 

How do I code and bill for nirsevimab? Will I be paid appropriately?

See current coding and billing recommendations, including Coding Vignettes, on the nirsevimab Coding and Payment page. 

Does nirsevimab require insurance prior authorization, as palivizumab does?  

In most instances,nirsevimab does not require insurance preauthorization. Please report any payer concerns or hassles to the AAP Coding Hotline. 

Reporting

If a patient has an adverse reaction to nirsevimab, where should it be reported? 

Adverse events when giving nirsevimab alone should be reported to the  FDA’s MedWatch Adverse Event Reporting Program.  

If an adverse event occurs while co-administering nirsevimab with a vaccine, it should be reported to the Vaccine Adverse Event Reporting System.  

Do I need to report nirsevimab administration to my state immunization information system (IIS)? 

Yes. You should report nirsevimab administration to the state IIS in accordance with state policies for reporting of vaccine administration.  

Talking to Families

Will there be a Vaccine Information Statement (VIS) available for nirsevimab?  

CDC has developed a “VIS-like” document – called an Immunization Information Sheet on nirsevimab. You are encouraged to share this document with parents/families when administering nirsevimab. You can download a copy on the CDC site.   

What resources are available for talking to families about RSV immunization?   

Please visit www.healthychildren.org/rsv for resources on talking about RSV immunization with families.  In addition, AAP has a patient brochure on RSV that is available in various languages.  

How can families prevent RSV infection?  

Families should take preventative measures to stop the spread of RSV and other respiratory illnesses, including washing hands, covering coughs and sneezes, cleaning frequently touched surfaces, and staying home when sick. 

Expectant parents should talk with their healthcare provider about receiving the RSV vaccine (Abrysvo, Pfizer) during pregnancy to protect their infant from severe RSV. CDC recommends that all infants are protected against RSV through either vaccination of the mother with RSV vaccine during pregnancy or giving the infant nirsevimab after birth. 

Parents should talk with their healthcare provider about whether nirsevimab is available for their infant.