Nirsevimab and Abrysvo Update for the 2024-2025 Respiratory Season

Respiratory syncytial virus (RSV) is a major cause of childhood illness and the leading cause of bronchiolitis and pneumonia in children under one year of age. RSV infection can cause life-threatening respiratory problems in infants, which frequently require hospitalization, mechanical ventilation, or admission to an ICU. In the United States, RSV is the most frequent reason for hospitalization in a child's first year of life. In some cases, RSV infection in infants is fatal.

All infants should be protected against RSV. This protection can occur via two methods:

1. Maternal RSVpreF (Abrysvo™) vaccination during pregnancy; or
2. Nirsevimab (Beyfortus^®) administration for the infant.

Most infants do not need both forms of protection.

Nirsevimab is a long-acting monoclonal antibody against RSV given to infants to prevent severe disease. Successful implementation of newborn nirsevimab immunization is recommended and has the potential to have a major positive impact on the health of children.

Nirsevimab Availability Through The VFC Program

Nirsevimab for eligible infants and children is available for order through the VFC Program. Once activated for ordering, VFC providers will be able to find nirsevimab vaccine in the VFC RSV order set in the Vaccine Ordering Management System (VOMS).

Beginning in September, Ohio will receive limited biweekly nirsevimab vaccine thresholds of both presentations, 50mg and 100mg, from the CDC. When this occurs, the nirsevimab products will be unrestricted in VOMS and the Immunization Program will send a notification email to VFC providers regarding the availability to order doses of VFC nirsevimab. VFC providers can expect a biweekly email beginning in September 2024 through February 2025 indicating nirsevimab product availability. When a product's availability is exhausted, the product will be restricted from ordering in VOMS until a new biweekly replenishment of vaccine occurs. A message of the day will be added to ImpactSIIS to notify providers of this restricted nirsevimab ordering.

VFC Nirsevimab Ordering Caps

VFC providers will have a calculated biweekly vaccine ordering cap for each Beyfortus^® (nirsevimab) product based on population data submitted with their VFC Provider Profile. These caps may change from month-to-month to align with Ohio's VFC allocation of products from CDC. If a provider requests more than their calculated biweekly ordering cap, the ODH VFC ordering team will reduce the amount accordingly.

Orders will be processed on a first-come, first-served basis until the biweekly threshold is depleted. The ODH VFC order approval staff will evaluate vaccine requests by considering a provider's existing inventory and historical administration of Beyfortus^® (nirsevimab).

Nirsevimab Product Information

• Beyfortus 50mg
  • VOMS Order Set: VFC RSV.
  • Weight Indication: Under 5 kg (under 11 lbs.).
  • Presentation: Single dose vial; 5 pack.
  • Minimum Order Quantity: 5 doses.

• Beyfortus 100mg
  • VOMS Order Set: VFC RSV.
  • Weight Indication: 5+ kg (11+lbs.) and over.
  • Presentation: Single dose vial; 5 pack.
  • Minimum Order Quantity: 5 doses.

Nirsevimab Administration

Providers should administer nirsevimab to the following patients:

• All infants less than eight months of age, born during or entering their first RSV season (typically starting October 1 through March 31 in most of the continental U.S.).
  • Infants born shortly before or during the RSV season should receive nirsevimab within one week of birth. Nirsevimab administration can occur during the birth hospitalization or in the outpatient setting.
  • Only a single dose of nirsevimab is recommended for the infant's first RSV season.
• Children ages eight to 19 months¹ who remain vulnerable to severe RSV disease when entering their second RSV season.

Planning Considerations

• Currently, Ohio's birthing hospitals, like many birthing hospitals throughout the country, are not enrolled as VFC providers. As a result, Ohio's existing network of VFC providers will serve as the main access point to nirsevimab for VFC eligible patients².
• VFC providers will have an opportunity to order nirsevimab products throughout the respiratory season. VFC providers are asked to order conservatively and place off-cycle orders for nirsevimab as needed.
• Redistribution of nirsevimab to other VFC enrolled providers is not allowed. Each enrolled provider should place an order.
• While it is recommended to order early following availability, there will also be future opportunities to order nirsevimab.
• VFC providers are advised to ensure there is adequate vaccine storage space in refrigerators before placing vaccine orders.
• Providers who have existing inventory of VFC nirsevimab remaining from the 2023-2024 respiratory season should not place orders for additional products until their inventory is nearly depleted.
• The ODH vaccine ordering system VOMS is available for providers to place orders 24 hours a day, seven days a week.

Private Supply Inventory Considerations

• VFC providers will be allowed a flexible, time-limited ramp-up period to meet the private inventory requirement for nirsevimab. During this time, ODH 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.

Nirsevimab Borrowing Allowances

• Ohio VFC providers must use the Vaccines for Children (VFC) Borrowing Form to document borrowed doses.
• Borrowed nirsevimab doses must be repaid within one month. Doses borrowed are to be replaced dose-for-dose and administered to the appropriate population (i.e., if VFC vaccine is borrowed for a privately insured patient and then repaid to VFC inventory, the repaid dose must be administered to a VFC-eligible child).
• If a provider borrows VFC doses for privately insured patients, they must maintain documented proof of privately purchased doses which includes the number of doses, lot numbers, and documentation that authenticates doses repaid were administered to the VFC eligible children2.

Abrysvo Availability Through the VFC Program

Abrysvo for VFC-eligible pregnant women is now available through the VFC Program. Ordering has been activated in VOMS. Abrysvo ordered through the VFC Program is to be administered to appropriate individuals who meet the ACIP recommendation eligibility and VFC eligibility criteria².

Abrysvo Prodcuct Information:

• Abrysvo
  • VOMS Order Set: VFC-Abrysvo.
  • Indication: Pregnant women.
  • Presentation: Single dose vials.
  • Minimum Order Quantity: 1 dose.

Abrysvo Administration to Pregnant Women

Abrysvo vaccine, made by Pfizer, Inc., is the only RSV vaccine authorized for use during pregnancy; specifically, during gestational weeks 32 and zero days through 36 weeks and six days. Do NOT administer Abrysvo to infants. The receipt of this vaccine is an option for pregnant women instead of having their infant receive an injection with nirsevimab during their first week of life for RSV prevention. This vaccine will help reduce the severity of RSV illness for the infant when born during the active RSV season.

Eligibility for one dose of VFC dose of Abrysvo (pregnant vaccine recipient must meet all of the following criteria):

• Time of year: Sep. 1 through Jan. 31 in Ohio.
• Gestational age: between 32 weeks and 0 days through 36 weeks and 6 days of gestation.
• Vaccination history: no history of a previous dose of any RSV vaccine.
• Maternal preference: either maternal Abrysvo vaccination or nirsevimab preventive antibody administration to the infant is recommended. Infants do not generally need both forms of protection.
• Meets VFC eligibility criteria².
• Abrysvo can be given at the same visit or at any time before or after other recommended vaccines (e.g., Tdap, influenza, or COVID-19 vaccine), using different anatomic sites.

Thank you for your partnership and efforts to prevent serious illness, hospitalization, and death from vaccine preventable diseases. For questions about the VFC Program, please call the ODH Immunization Program at 1-800-282-0546.

1. Nirsevimab: Eight- to 19-Month-Old Eligibility Criteria.

• Children with chronic lung disease (CLD) of prematurity who required medical support during the six months (diuretics, oxygen, chronic steroids) before the start of the second RSV season.
• Children who are severely immunocompromised.
• 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 10th percentile. 
• American Indian and Alaska Native children (note that this is a new group for whom second-season prophylaxis is recommended in contrast to the current palivizumab recommendations). 

2. VFC Vaccine Eligibility.

Children through age 18 years who meet at least one of the following four criteria are considered federally vaccine-eligible and therefore eligible for vaccine through the VFC program:

• Medicaid eligible: A child who has health insurance covered by a state Medicaid program.
• Uninsured: A child who has no health insurance coverage.
• American Indian or Alaska Native: As defined by the Indian Health Care Improvement Act (25 U.S.C. 1603).
• Underinsured: Underinsured children are eligible to receive VFC vaccine only through a federally qualified health center (FQHC), rural health clinic (RHC), or a public health department that receives deputized authority from a FQHC or RHC.

For the purposes of VFC, underinsured includes:

• Children who have commercial (private) health insurance, but the coverage does not include vaccines.
• Children whose insurance covers only selected vaccines (VFC eligible for non-covered vaccines only).
• Children whose insurance caps vaccine coverage at a certain amount (once that coverage amount is reached, these children are categorized as underinsured).

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