Sanofi
Merck / MSD
Pfizer
GlaxoSmithKline
EMA
FDA
FDA
FDA
2022
2025
2023
2023
Not prequalified by WHO
Not prequalified by WHO
2025
Not prequalified by WHO
fully human IgG1κ monoclonal antibody targeting prefusion RSV F protein
fully human IgG1κ monoclonal antibody targeting prefusion RSV F protein
RSV subgroup A prefusion F antigen 60 μg
RSV subgroup B prefusion F antigen 60 μg
RSV Prefusion F3 antigen
120 μg
recombinant Chinese Hamster Ovary cells
recombinant Chinese Hamster Ovary cells
recombinant Chinese Hamster Ovary cells
recombinant Chinese Hamster Ovary cells
None
None
None
AS01
None
None
None
None
Not required
Not required
Water for injections
liquid adjuvant
Liquid: ready to use
Liquid: ready to use
Lyophilised active component to be reconstituted with adjuvant before use
Lyophilised active component to be reconstituted with adjuvant before use
Glass (Type 1) pre-filled syringe containing 50 mg of nirsevimab in 0.5 mL (100 mg/mL) or containing 100 mg of nirsevimab in 1 mL (100 mg/mL).
Glass (Type 1) pre-filled syringe containing 105 mg of clesrovimab in 0.75 mL
Powder for 1 dose in a vial (type 1 glass or equivalent)
Solvent for 1 dose in a pre-filled syringe (type 1 glass) / vial (type 1 glass or equivalent)
Powder for 1 dose in a vial (type I glass)
Suspension for 1 dose in a vial (type I glass)
intramuscular
intramuscular
intramuscular
intramuscular
24 months EU / 18 months US
30 months
3 years
3 years
2-8C
2-8C
2-8C
2-8C
no information available
no information available
no information available
no information available
Single dose in carton of 1
Single dose in carton of 5
Single dose in carton of 1
Single dose in carton of 10
12.1 cm3/dose in the 25 doses pack
no information available
Single dose of 50 mg administered intramuscularly for infants with body weight <5 kg and a single dose of 100 mg administered intramuscularly for infants with body weight ≥5 kg. Beyfortus should be administered from birth for infants born during the RSV season. For others born outside the season Beyfortus should be administered ideally prior to the RSV season.
A single dose of 200 mg given as two intramuscular injections (2 x 100 mg) for children who remain vulnerable to severe RSV disease through their second RSV season. Beyfortus should be administered ideally prior to the start of the second RSV season
Single 105 mg IM dose administered to neonates and infants who are born during or entering their first RSV season.
Infants born during season: dose at birth.
Born before season: dose before season starts.
Additional 105 mg dose recommended post cardiac bypass surgery
Pregnant women - A single dose of 0.5 mL should be administered from 24 weeks gestation.
Individuals 18 -59 years of age who are at increased risk for severe RSV and those 60 years and older - a single dose of 0.5 mL should be administered.
Individuals 50 -59 years of age who are at increased risk for severe RSV and those 60 years and older - a single dose of 0.5 mL should be administered. Not recommended in pregnant women.
no information available
no information available
no information available
no information available
not required
not required
not required
not required
The benefits and risks of nirsevimab use in infants <1 kg should be carefully considered.
There are limited data available in extremely preterm infants (Gestational Age [GA] <29 weeks) less than 8 weeks of age. No clinical data available in infants with a postmenstrual age (gestational age at birth plus chronological age) of less than 32 weeks
The safety and efficacy of nirsevimab in children aged 2 to 18 years have not been established. No
data are available
Can be given alongside routine childhood vaccines, in different syringes & sites
The safety and effectiveness of ENFLONSIA have not been established in children older than 12 months of age.
The safety and efficacy of Abrysvo in children (from birth to less than 18 years of age) have not yet been established. Limited data are available in pregnant adolescents and their infants.
The safety and efficacy of Arexvy in children have not been established
NO
NO
NO
NO
Detailed pricing information for PAHO procurement can be found at: https://www.paho.org/en/documents/revolving-fund-vaccine-prices-2025
Detailed pricing information for PAHO procurement can be found at: https://www.paho.org/en/documents/revolving-fund-vaccine-prices-2025
Detailed pricing information for PAHO procurement can be found at: https://www.paho.org/en/documents/revolving-fund-vaccine-prices-2025
Detailed pricing information for PAHO procurement can be found at: https://www.paho.org/en/documents/revolving-fund-vaccine-prices-2025
1. European Medicines Agency (n.d.). Beyfortus: EU summary of product characteristics [product information document]. Amsterdam: EMA (https://www.ema.europa.eu/en/documents/product-information/beyfortus-ep…, accessed 19 June 2025).
1. U.S. Food and Drug Administration (2025). ENFLONSIA™ (clesrovimab-cfor) injection, for intramuscular use: Highlights of prescribing information. Silver Spring, MD: FDA (https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761432s000lbl…, accessed 19 June 2025).
1. European Medicines Agency (n.d.). Abrysvo: EU summary of product characteristics [product information document]. Amsterdam: EMA (https://www.ema.europa.eu/en/documents/product-information/abrysvo-epar…, accessed 19 June 2025).
2. World Health Organization (n.d.). Abrysvo [online database]. Geneva: WHO (https://extranet.who.int/prequal/vaccines/p/abrysvo, accessed 19 June 2025).
N/A
