Respiratory Syncytial Virus

Respiratory Syncytial Virus (RSV) is a common lower respiratory tract infection affecting most children before they reach the age of 2.(1) 

Health Canada has approved several new products for use in the protection of infants. 

  1. nirsevimab (brand name: Beyfortus), a long-acting monoclonal antibody for newborns, most effective for the first 6 months after administration;
  2. RSVpreF, an RSV stabilized vaccine for pregnant individuals, offering both active and passive immunity for newborns.

For most dyads, one of these options is sufficient. NACI recommends nirsevimab as the preferred product to protect infants due to evidence of superior efficacy, duration of protection and available safety data.

Ontario's publicly funded RSV prevention program will provide access to immunizing agents for families with infants and high risk children up to 24 months old.

RSV protection and the Designated Drug Regulation 

With the latest changes to the midwife drug regulation, midwives can prescribe and administer RSVpreF to their pregnant clients as it is an RSV vaccine. Nirsevimab is a monoclonal antibody and not a vaccine; as such, it is excluded from the list of designated drugs and substances. 

The AOM and CMO are working to have the drug list changed to correct this oversight. At present, midwives will need a medical directive to administer nirsevimab to infants in their care or will need to refer clients to other practitioners.

Beyfortus (nirsevimab) administration in community settings: FAQ

How can my client born in the community receive Beyfortus?

Midwives may consider one or more of the following suggestions to facilitate access to Beyfortus for infants born in the community this RSV season: 

  • Seek extension of hospital medical directive to the community setting
  • Refer to general care provider (i.e. GP, NP, Family Health Team, Community Health Centre)
  • Consider referral pathways to existing postpartum programs that may be able to offer vaccination concurrently (i.e. outpatient bilirubin clinic, Healthy Baby Healthy Children (HBHC) programs, Family Health Team that offers tongue-tie release or lactation support services)
  • Obtain a medical directive from a local health-care provider (i.e. pediatrician, GP or NP) to administer in clinic or other out-of-hospital settings*
  • Direct to a regional public health vaccine clinic. Vaccine clinics will serve uninsured and/or unattached clients 

The AOM recognizes that access is more difficult in northern, rural and remote locations where clients may not have the same outpatient services or public health units that offer vaccines locally. In these cases, it may be helpful to collaborate directly with your community partners to develop solutions tailored to your unique circumstances.

*Offering RSV vaccination in out-of-hospital settings relies on the midwife’s knowledge, skills and clinical judgment. Health-care providers administering vaccinations must be knowledgeable about the signs and symptoms of adverse reactions and possess the necessary skills to manage them appropriately.

[September 2024]

Who do I contact at my local public health unit regarding Beyfortus administration?

Midwives should contact the immunization program at your local public health unit. 

To learn which public health unit covers your community, view the list of health units sorted by municipality OR the list of municipalities sorted by health unit. Then, look up the contact information for your public health unit and sub-offices (PDF, 1 MB).

[September 2024]

How do I prepare to manage adverse reactions to Beyfortus in the community setting?

According to the National Advisory Committee on Immunization (NACI) and Ontario Ministry of Health, Beyfortus is safe for most infants. 

RSV prevention products, including the monoclonal antibody or vaccine, may be associated with mild side effects that typically resolve within a few days. Common side effects of Beyfortus (nirsevimab) include localized redness, swelling and/or pain at the injection site. Other mild side effects include rash and low-grade fever. 

Severe reactions, including hives (urticaria), swelling of the mouth or throat (angioedema), difficulty breathing, wheezing or shortness of breath (dyspnea), high fever (pyrexia), seizures or any other serious symptoms, require immediate assessment at the nearest emergency department. 

Offering RSV immunization in community settings relies on the midwife’s knowledge, skills, and clinical judgment. Health-care providers administering immunizations must be knowledgeable about the signs and symptoms of adverse reactions and possess the necessary skills to manage them appropriately. If planning to administer Beyfortus (nirsevimab) under a medical directive, refer to established protocols for guidance on appropriate actions to take in the event of an adverse reaction.

For more comprehensive information on immunizations, visit the Canadian Immunization Guide. To learn more about vaccine safety, including the management of anaphylaxis and other adverse reactions, refer to the section: Anaphylaxis and other acute reactions following vaccination. This section provides essential information on: 

*Anaphylaxis management kits should be readily available wherever vaccines are administered. Never administer an immunization without having an anaphylaxis management kit immediately available.

After immunization, be sure to inform parents about possible side effects and when they should page, visit the nearest emergency department or call 911.

For specific resources on RSV prevention products, including the monoclonal antibody or vaccine, visit:
 

Public Health Agency of Canada: Respiratory syncytial virus (RSV) vaccines

National Advisory Committee on Immunization (NACI): Statement on the prevention of respiratory syncytial virus disease in infants

For detailed information on Beyfortus (nirsevimab) including contraindications and precautions, please refer to the product monograph

Download this information in PDF format.

[September 2024]

What considerations exist for the timing of Beyfortus administration in the community setting?

Beyfortus may be kept at room temperature (20 - 25°C) for a maximum of eight hours and must be discarded if not used within that time limit.  

Given these storage and disposal requirements, midwives may find the day one or two visit a more reasonable time for administration than immediately after the birth in home or community settings.

If planning to administer Beyfortus in the community setting, the midwife must be knowledgeable about the signs and symptoms of adverse reactions and possess the necessary skills to manage them appropriately.

[September 2024]

 

Resources for midwives

resource icon

Toolkits, fact sheets and instructions 

RSV Symptoms, Treatment, Prevention and Risks 
Health Canada provides a summary of RSV symptoms and effective prevention measures as well as specific information on what healthcare providers need to know. 

Protecting Infants and High-Risk Children during RSV Season: For Healthcare Providers
This PCMCH fact sheet available in English and French supports healthcare providers in understanding the changes associated with the recent expansion of Ontario’s RSV prevention program for infants and high-risk children. 

2024-2025 RSV Prevention Program for infants in Ontario
This toolkit, created by the Centre for Effective Practice includes patient resources, conversation guides, eligibility guides and more to support primary care through Ontario’s new RSV Prevention Program for infants in the 2024-2025 RSV season.   

McMaster Children's Hospital Implementation Toolkit
This toolkit, developed by McMaster Children's Hospital at Hamilton Health Sciences, includes a sample medical directive, an eLearning pdf and quiz, sample workflows and information for families.

Respiratory Syncytial Virus (RSV) prevention program: Eligibility criteria 
Information from the Ministry of Health outlining eligibility criteria for the RSV prevention program. 

BORN RSV Data Collection 
The BIS is changing to capture the new data about infant RSV protection.  As of November 2024, four new data elements will be included. More information can be found in the RSV Data Elements List and the BORN RSV Data Collection FAQ

RSVpreF administration instructions
Review safety and administration instructions for the RSV stabilized vaccine for pregnant individuals.

 

guide.png

 

Guidance 

NACI Statement on the prevention of RSV disease in infants
This statement from the National Advisory Committee on Immunization focuses on the protection of infants and children from RSV disease highlighting two immunization products. It provides independent advice and recommendations for immunization providers. 

Infant and High-Risk Children RSV Prevention Program Guidance for Health Care Providers - Beyfortus (August 8, 2024)
This guidance document provides information on Beyfortus administration schedule, reporting side effects, cold chain and storage requirements as well as detailed administration instructions. 

Infant and High-risk Children RSV Prevention Program Guidance for Health Care Providers - Abrysvo (August 8, 2024)
This guidance document provides information on Abrysvo administration, eligibility, reporting adverse events, cold chain requirements and detailed administration instructions. 

 

client handout icon

 

Client Handouts

Protecting your child from RSV: For Parents and Expectant Parents 
This fact sheet for clients available in English and French from PCMCH includes essential tips and recommendations for safeguarding infants and high-risk children from RSV, with a focus on the monoclonal antibody medication.

webinar image

Webinars

Infant and High-Risk Children Respiratory Syncytial Virus (RSV) Prevention Program
This webinar from the Association of Ontario Midwives and Ministry of Health provides an overview of the latest updates on the RSV prevention program, covering both monoclonal antibodies and vaccination strategies. The session will highlight the importance of early protection and provide essential information on eligibility criteria and the timing of administration to ensure infants are safeguarded throughout the RSV season. AOM staff shared information on the advocacy efforts taken so far to address the oversight in the Designated Drug Regulation as it pertains to Beyfortus as well as key clinical resources for midwives.

For links to additional resources, view the webinar's slide-deck (PDF, 1 MB) 
 

Updates in Pediatric RSV Prevention for Midwifery Practice with Dr. Jasleen Kaur Grewal
This recorded webinar from the Canadian Association of Midwives (CAM) provides midwives with information regarding the changing landscape of pediatric RSV prevention in the Canadian context, including a comprehensive overview of RSV, its impact on public health and an understanding of new developments in RSV prevention including vaccines and monoclonal antibodies.

 

 

apps.png

Mobile Apps

RM Rx: Resource for Midwives
The Rm Rx mobile app has been updated to include drug cards on both Abrysvo, the vaccine for pregnant people and Beyfortus, the newborn monoclonal antibody. Available on the App Store and Google Play.

 

 

References

1. Health Canada. Respiratory syncytial virus (RSV): For health professionals. June 21, 2024. Accessed at: https://www.canada.ca/en/public-health/services/diseases/respiratory-syncytial-virus-rsv/health-professionals.html 

2. Abrams E., Doyon-Plourde P., Davis P., et al. Burden of disease of respiratory syncytial virus in infants, young children and pregnant women and people. Canada Communicable Disease Report Volume 50-1/2, January/February 2024. Accessed at: https://www.canada.ca/en/public-health/services/reports-publications/canada-communicable-disease-report-ccdr/monthly-issue/2024-50/issue-1-2-january-february-2024/burden-disease-rsv-infants-children-pregnant-women-persons.html