Monoclonal antibodies
|
Vaccines
|
||
---|---|---|---|
Beyfortus (Nirsevimab)
|
Enflonsia (Clesrovimab)
|
Abrysvo (RSVpreF)
|
Arexvy (RSVPreF3-AS01)
|
Sanofi
|
Merck / MSD
|
Pfizer
|
GlaxoSmithKline
|
EMA
|
FDA
|
FDA
|
FDA
|
11/04/2022
|
06/09/2025
|
03/31/2023
|
03.05.2023
|
07/17/2023
|
06/09/2025
|
03/31/2023
|
03.05.2023
|
11/04/2022
|
N/A
|
08/24/2023
|
06/06/2023
|
N/A
|
N/A
|
03/12/2025
|
N/A
|
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 Prefusion F3 antigen |
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
|
Water for injections
|
Liquid ready to use
|
Liquid ready to use
|
Powder
|
Powder
|
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) |
Powder 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
|
N/A
|
N/A
|
N/A
|
N/A
|
Single dose in carton of 1 |
Single dose in carton of 1 |
12.1 cm3/dose in the 25 doses pack |
? |
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. |
Single 105 mg IM dose administered to neonates and infants who are born during or entering their first RSV season. |
Pregnant women - A single dose of 0.5 mL should be administered between weeks 24 and 36 of gestation |
Adults older than 50 (if at risk of RSV) or older than 60 in single dose of 0.5 mL. |
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
The benefits and risks of nirsevimab use in infants <1 kg should be carefully considered. |
Can be given alongside routine childhood vaccines, in different syringes & sites |
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
|