2024-2025 RSV Prevention Program for infants in Ontario

What are the changes in the 2024-2025 RSV season?
Are both products (Beyfortus and Abrysvo) necessary for an infant? Which product is recommended by the Ministry of Health?
Which infants will receive Beyfortus (Nirsevimab) in primary care and which in the hospital?
Who is considered to be a high-risk infant?
Should premature infants receive Beyfortus (Nirsevimab)?

In addition to supporting their patients with decision-making around RSV prevention, primary care will be involved in administering immunizations (Beyfortus) to infants born outside of RSV season (e.g. January – September 2024) and those born outside a hospital setting.¹

On a case-by-case basis of shared decision making between patient and clinician, Abrysvo (RSVpre-F vaccine) will also be available to pregnant individuals in Ontario, who do not wish to provide or whose infants are unable to receive Beyfortus. Abrysvo is administered during pregnancy (32-36 weeks gestational age). 

No, it is typically only necessary to use one product to prevent RSV.¹ Both the Ontario Ministry of Health and the National Advisory Committee on Immunization (NACI) recommend the use of Beyfortus (Nirsevimab) as it has the strongest evidence of providing immediate protection to infants from RSV. They recommend that infants receive Beyfortus prior to discharge from hospital after birth instead of administering Abrysvo (RSVpre-F vaccine) to pregnant patients. In some circumstances, (e.g., baby is born less than 2 weeks from Abrysvo vaccination or high-risk) infants may benefit from Beyfortus in addition to the Abrysvo vaccine administered in pregnancy.^1,3  

High-risk infants include those with: 

Beyfortus (Nirsevimab) is the recommended monoclonal antibody to prevent RSV in infants born prematurely and should be provided to infants born at less than 37 wGA entering their first RSV season. Those entering their second RSV season who were born at less than 37 wGA and do not have another medical condition should not be routinely offered Beyfortus.³

How does Beyfortus (Nirsevimab) work?
How effective is Beyfortus (Nirsevimab)?
What are the side effects of Beyfortus (Nirsevimab)?
When is Beyfortus (Nirsevimab) contraindicated?
Should infants who have recovered from an RSV infection receive Beyfortus (Nirsevimab) this season?

Beyfortus is a passive immunizing agent, meaning antibodies are given to a person rather than created by their immune system.^3,4 It is an injectable monoclonal antibody, given as an intramuscular injection, that provides immediate protection against RSV in infants. It provides protection for at least six months after immunization. Only one dose of Beyfortus is needed for the RSV season.¹

Beyfortus is highly effective, demonstrating a reduction in hospital admissions associated with RSV by 81-83% and an 80% reduction in medically attended RSV respiratory tract infection in healthy infants.³ Monoclonal antibodies provide protection immediately and through the first months of an infant’s life (if given at birth) when infants are most vulnerable to RSV. Beyfortus is effective through 6 months after administration and may offer protection throughout the entire RSV season.¹  Data collected from Beyfortus administration in the United States and Europe during last RSV season continued to support high efficacy against hospitalizations from RSV.⁵   

Beyfortus has been seen to have a higher efficacy and more immediate effect than Abrysvo (RSVpre-F vaccine). Abrysvo administered in pregnancy resulted in 57% reduction in hospitalizations associated with RSV in infants and reduced medically attended RSV respiratory tract infections in infants by 51% in their first RSV season. Protection from Abrysvo takes some time to develop and it is recommended to allow at least two weeks between administration and birth for transplacental transfer of antibodies.³

No serious events have been seen in studies done on Beyfortus. Adverse events are uncommon following RSV monoclonal antibodies and in randomized controlled trials, adverse events were similar to those receiving a placebo.³ Receiving Beyfortus will not give an infant RSV, as it is an antibody and not the virus that is in the product. 

The most commonly occurring adverse reactions among Beyfortus clinical trial subjects were⁶:  

Data collected from Beyfortus administration in the United States and Europe during last RSV season continued to support that there are no increased signals of significant adverse reactions from Beyfortus.⁵  

Clinicians should exercise clinical judgement while considering response to side effects such as fever. The Chief Medical Officer of Health suggests that primary care may employ a standard response like with fever after other immunizations. If there is fever after Beyfortus administration, it can be monitored for 24-48 hours if the infant is otherwise well (i.e. feeding, diapering, no apparent distress). Infants over 2 months may take Tylenol for their fever.  High fever (over 40°C) should be managed emergently, even post-administration.² 

Individuals with known hypersensitivity or a history of a severe allergy to any other humanized monoclonal antibodies or component of the product, including non-medicinal ingredients or materials in the product’s packaging, should not receive Beyfortus.³ Individuals who have a moderate or severe acute illness, with or without fever, do not need to wait until they have recovered before receiving Beyfortus.²

Beyfortus is typically not required or advised for an infant who has already had a confirmed RSV infection during the current RSV season. The benefit of administering Beyfortus after the infant has recovered from RSV is uncertain and likely minimal, as the risk of rehospitalization within the same season is very low. However, it may be worth considering for infants with severe immunodeficiencies who may not develop a sufficient immune response to the RSV infection. There is no specific waiting period recommended between an RSV infection and the administration of Beyfortus.²

What is the role of primary care in RSV prevention?
How do I check if an infant has received their Beyfortus (Nirsevimab) dose?
How to obtain Beyfortus (Nirsevimab) for your primary care practice
Storage and handling information
At what dose should Beyfortus (Nirsevimab) be given?
Can Beyfortus (Nirsevimab) be given with other immunizations? Can it be given at other scheduled appointments?
Is Beyfortus (Nirsevimab) covered by OHIP?
Can parents access Beyfortus (Nirsevimab) privately for children outside of the RSV Prevention Program eligibility?
Checklist
Patient resources
Talking to patients about RSV prevention

Primary care has a multifaceted role to play in Ontario’s RSV Prevention Program for infants. This includes:¹ 

If infants received their dose of Beyfortus in hospital, it will be recorded in the BORN Information System and on the patient’s discharge summary. It is recommended to confirm with parents that their infant received Beyfortus in hospital.⁵

Primary care can order Beyfortus through their usual vaccine source (i.e., local public health unit or OGPMSS) in the same manner as any routine immunization product.⁵ Product will be obtained via cold chain delivery systems with orders picked up by the facility or delivered by a PHU approved courier. PHUs will release a one-month supply of product, similar to vaccine ordering. It is recommended that primary care review lists of infants born since January 2024 to determine an appropriate amount of Beyfortus that may be needed. Contact your local public health unit for further information regarding processes and ordering time as it may vary by PHU.² 

Beyfortus (Nirsevimab) comes as a single pre-filled syringe (50 mg or 100 mg). It should be stored in its original container to protect it from light and should be kept between 2° C and 8° C. Do not freeze.⁶

The usual dose of Beyfortus varies by age and weight⁶:  

For high-risk children entering their second RSV season who weigh less than 10 kg, a single dose of 100 mg may be considered at clinical discretion.³ If a child is undergoing cardiac surgery, they may be given an additional dose of Beyfortus after the procedure, see product monograph for more details.⁶ 

Yes, Beyfortus can be given at the same time, before or after other routine childhood immunizations, including influenza. It is a passive immunizing agent specifically targeted against RSV whose monoclonal antibodies do not interfere with the immune response to other immunizations.³

Beyfortus can be administered at visits you may already have scheduled with your patients. Here are some opportunities for infant visits in which you may choose to include Beyfortus administration, based on the infant’s month of birth.²

Beyfortus can be billed using fee code G538, which provides renumeration for administering immunizations that are not explicitly listed. For more information about billing and RSV prevention, see OMA’s guidance.¹ 

No. Beyfortus will not be available for the private market in Canada.²  

Consider using the PrOTCT framework to help you approach conversations about RSV prevention with patients.  It can help support collaborative decision making as you share information and build trust with parents in your practice.  

Pr: Presume they will get the immunization with positive statements.  

O: Offer to share your knowledge about the facts and experience with the immunization.  

T: Tailor the recommendation to their specific health concerns.  

C: Address specific concerns (should not be the bulk of the conversation). 

T: Talk through a specific plan for where and when to get the vaccine. 

For more support and information about approaching conversations with your patients about vaccine hesitancy, see the OMA’s Vaccine Hesitancy resource.  

PrOTCT Framework modified with permission from the Centre for Effective Practice. (December 2021) Constantinescu, Ivers. N., Grindrod. K. PrOTCT Framework: Ontario. Toronto: Centre for Effective Practice.