Severe RSV infections can lead to pneumonia, bronchiolitis, or complications in older

adults with underlying health conditions. Adults experiencing difficulty breathing should seek
immediate medical attention.

RSV Vaccines

At present, there is only one RSV vaccine that has been approved for use by Health
Canada, Arexvy (RSVpreF3-AS01E - GSK), and two others that Health Canada is in the process of
reviewing, Renoir (RSV PreF Protein - Pfizer) and ConquerRSV (mRNA-1345 - Moderna).

Arexvy (RSVpreF3-AS01E) is the first RSV vaccine to be authorized for use in Canada for
the prevention of lower respiratory tract disease caused by RSV in adults 60 years of age and
older. NACI is reviewing the use of Arexvy; recommendations and a chapter update are
expected in 2024.
 Efficacy Data to support use: Arexvy was approved for use based on the results of the
RSV Prefusion F Protein Vaccine in Older Adults study published in the NEJM which
compared the vaccine to placebo in adults over the age of 60 years with 39% of the
study population having coexisting conditions known to be associated with an increased
risk of RSV disease. The primary endpoint was effiacy of the vaccine in prevention of RSV
lower respiratory tract disease (LRTD) in adults >60 years in the first season. LRTD was
defined as >2 lower respiratory signs and symptoms (including >1 lower respiratory sign)
or >3 lower respiratory symptoms lasting >24 hours. A single dose of the vaccine was
found to be 82% effective in prevention of LRTD, however, important to note is that the
study was not powered to assess efficacy against hard endpoints such as death or
hospitalization.
 Safety: Side effects with an incidence of >10% include pain at injection site, fatigue and
myalgia similar to most other vaccines
 Formulation: requires reconstitution prior to injection
 Dose: 0.5mL administered IM as a single dose

Renoir is currently under review for the prevention of lower respiratory tract disease
caused by RSV in infants from birth through six months of age by immunization of pregnant
individuals, and the prevention of lower respiratory tract disease caused by RSV in individuals
60 years of age and older.

ConquerRSV is currently under review for the prevention of lower respiratory tract
disease caused by RSV in individuals 60 years of age and older only.

Recommendations for RSV Vaccine Use