GSK
Serum Institute of India (SII)
Biomanguinhos
Pfizer
Sinergium
Beijing Minhai (Kangtai group)
Walvax
Nanolek
Biological E
Merck/MSD
Pfizer
EMA (EU)
CDSCO/DCGI (India)
ANVISA (Brazil)
EMA (EU)
ANMAT (Argentina)
NMPA (China)
NMPA (China)
Russian Federation
CDSCO/DCGI (India)
EMA
FDA (USA)
2009
2020
2020 (for the 4 doses vial presentation)
2009
2016
2021
2019
2021
2022
2022
2023
2009
2019
Not prequalified by WHO
2010
Not prequalified by WHO
Not prequalified by WHO
Not prequalified by WHO
Not prequalified by WHO
Not prequalified by WHO
Not prequalified by WHO
Not prequalified by WHO
serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F
serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F, 23F
serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F
serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F
serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F
serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F
serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F
serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F
serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F
serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F
serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B/C, 22F, 33F
Each polysaccharide undergoes a separate bacterial fermentation followed by conjugation to a carrier protein: protein D, a surface protein derived from Haemophilus influenzae.
Each polysaccharide undergoes a separate bacterial fermentation followed by conjugation on CRM197, a non-toxic mutant of diphtheria toxin.
Each polysaccharide undergoes a separate bacterial fermentation followed by conjugation to a carrier protein: protein D, a surface protein derived from Haemophilus influenzae.
Each polysaccharide undergoes a separate bacterial fermentation followed by conjugation on CRM197, a non-toxic mutant of diphtheria toxin.
Each polysaccharide undergoes a separate bacterial fermentation followed by conjugation on CRM197, a non-toxic mutant of diphtheria toxin.
Capsular polysaccharide antigen serotypes 1, 5, 6A, 9V, 19A, 19F and 23F are combined with tetanus toxoid, and capsular polysaccharide antigen serotypes 3, 4, 6B, 7F, 14 and 18C are combined with diphtheria toxoid.
Each polysaccharide undergoes a separate bacterial fermentation followed by conjugation on tetanus toxoid
Each polysaccharide undergoes a separate bacterial fermentation followed by conjugation on CRM197, a non-toxic mutant of diphtheria toxin.
Each polysaccharide undergoes a separate bacterial fermentation followed by conjugation on CRM197, a non-toxic mutant of diphtheria toxin.
Each polysaccharide undergoes a separate bacterial fermentation followed by conjugation on CRM197, a non-toxic mutant of diphtheria toxin.
Each polysaccharide undergoes a separate bacterial fermentation followed by conjugation on CRM197, a non-toxic mutant of diphtheria toxin.
Aluminium phosphate
Aluminium phosphate
Aluminium phosphate
Aluminium phosphate
Aluminium phosphate
Aluminium phosphate
Aluminium phosphate
Aluminium phosphate
Aluminium phosphate
Aluminium phosphate
Aluminium phosphate
2-phenoxyethanol (only in 4 doses vial)
Thiomerosal (in multidose vials)
2-phenoxyethanol (onyl in 4 doses vial)
2-phenoxyethanol (only in 4 doses vial)
2-phenoxyethanol (only in 4 doses vial)
None
None
None
2-phenoxyethanol
None
None
None
None
None
None
None
None
None
None
None
None
None
Liquid, ready to use
Liquid, ready to use
Liquid, ready to use
Liquid, ready to use
Liquid, ready to use
Liquid, ready to use
Liquid, ready to use
Liquid, ready to use
Liquid, ready to use
Liquid, ready to use
Liquid, ready to use
1 dose vial of 0.5ml
2 doses vial of 1ml
4-doses vial
Pre-filled syringe of 0.5ml (not PQed)
1 dose vial of 0.5ml
5 dose vial of 2.5ml
10-dose vial of 5ml
1 dose vial of 0.5ml
4 doses vial of 2ml
1 dose vial of 0.5ml
4-dose vial of 2ml
Pre-filled syringe of 0.5ml (Not PQed)
0
Pre-filled syringe of 0.5ml
1 dose vial of 0.5ml
Pre-filled syringe of 0.5ml
0
5 dose vial of 2.5ml
0
Pre-filled syringe of 0.5ml
Intramuscular
Intramuscular
Intramuscular
Intramuscular
Intramuscular
Intramuscular
Intramuscular
Intramuscular
Intramuscular
Intramuscular
Intramuscular
48 months
36 months
36 months (4 doses vial) 48 months (1 dose vial)
36 months
36 months
24 months
24 months
36 months
24 months
36 months
24 months
2-8°C
2-8°C
2-8°C
2-8°C
2-8°C
2-8°C
2-8°C
2-8°C
2-8°C
2-8°C
2-8°C
Type 30
Type 30
Yes (type unknown)
Type 30
None
None
None
None
Yes (type unknown)
None
None
10/11.5/58 (1 dose)
4.8 (2 doses)
2.4 (4 doses)
14.06/17.57 (1 dose)
3.51 (5 doses)
2.11 (10 doses)
No information available
12 (1 dose)
3.5/3.6 (4 doses)
No information available
No information available
No information available
No information available
No information available
No information available
No information available
The primary infant series consists of three doses with the first dose usually given at 2 months of age and with an interval of at least 1 month between doses. The first dose may be given as early as 6 weeks of age.
Alternatively, a 2-doses primary schedule can be used with the first dose may be given as early as 6 weeks of age with a second dose administered 2 months later.
Three-dose primary series at 6,10,14 weeks of age or 2,3 and 4 months of age or 2,4 and 6 months of age. Alternatively, a two-dose primary series with booster dose. The first dose may be administered from the age of 6 weeks, with a second dose at age of 14 weeks.
0
Prmary series consists of three primary doses with the first dose may be given as early as 6 weeks of age, with a minimum of 4 weeks between doses.
Alternatively, a two dose primery series with a booster schedule may be considered. The first dose may be given from the age of 2 months, with a second dose 2 months later.
Prmary series consists of three primary doses with the first dose may be given as early as 6 weeks of age, with a minimum of 4 weeks between doses.
Alternatively, a three-dose schedule may be considered. The first dose may be given from the age of 2 months, with a second dose 2 months later.
Adults above 18 can be administered one single dose. The need for revaccination with a subsequent dose of Prevenar 13 has not been established
Two doses starting at 6 weeks of age wiwth a 2 months interval followed by a booster dose
Three-dose primary series at 2,4 and 6 months of age or 3,4 and 5 months of age. Both followed by a fourth (booster dose).
Primary series of three doses with start 2–6 months with at least 4 weeks intervals followed by a booster dose. Alternatively 2 two primary doses with start at 7-11 months with 4 weeks interval plus a booster dose
Three-dose primary series at 6,10,14 weeks of age
The first dose is given as early as 6 weeks of age, with a second dose administered 8 weeks later and a booster dose. Alternatively, three doses are administered with the first dose given as early as 6 weeks of age, with an interval of 4 to 8 weeks between doses in the primary series, followed by a booster dose.
The primary infant series consists of three doses, with the first dose usually given at 2 months of age and with an interval of at least 4 weeks between doses followed by a booster dose. The first dose may be given as early as 6 weeks of age.
Once a PCV vaccination programme has been initiated, product switching is not generally recommended unless there are substantial changes in the epidemiological, programmatic, or financial situation that determined the original choice of product. Switching to another WHO-prequalified vaccine demonstrating similar immunogenicity to the currently used PCVs may be acceptable based on cost-saving considerations. If the series cannot be completed with the same vaccine, the available PCV product can be used. Restarting a series with a different PCV is not recommended, even for the primary series.
Once a PCV vaccination programme has been initiated, product switching is not generally recommended unless there are substantial changes in the epidemiological, programmatic, or financial situation that determined the original choice of product. Switching to another WHO-prequalified vaccine demonstrating similar immunogenicity to the currently used PCVs may be acceptable based on cost-saving considerations. If the series cannot be completed with the same vaccine, the available PCV product can be used. Restarting a series with a different PCV is not recommended, even for the primary series.
Once a PCV vaccination programme has been initiated, product switching is not generally recommended unless there are substantial changes in the epidemiological, programmatic, or financial situation that determined the original choice of product. Switching to another WHO-prequalified vaccine demonstrating similar immunogenicity to the currently used PCVs may be acceptable based on cost-saving considerations. If the series cannot be completed with the same vaccine, the available PCV product can be used. Restarting a series with a different PCV is not recommended, even for the primary series.
Once a PCV vaccination programme has been initiated, product switching is not generally recommended unless there are substantial changes in the epidemiological, programmatic, or financial situation that determined the original choice of product. Switching to another WHO-prequalified vaccine demonstrating similar immunogenicity to the currently used PCVs may be acceptable based on cost-saving considerations. If the series cannot be completed with the same vaccine, the available PCV product can be used. Restarting a series with a different PCV is not recommended, even for the primary series.
Once a PCV vaccination programme has been initiated, product switching is not generally recommended unless there are substantial changes in the epidemiological, programmatic, or financial situation that determined the original choice of product. Switching to another WHO-prequalified vaccine demonstrating similar immunogenicity to the currently used PCVs may be acceptable based on cost-saving considerations. If the series cannot be completed with the same vaccine, the available PCV product can be used. Restarting a series with a different PCV is not recommended, even for the primary series.
No infornation available
No infornation available
No infornation available
No infornation available
Infants and children who have begun immunisation with another pneumococcal conjugate vaccine may switch to Vaxneuvance at any point in the schedule
No infornation available
Following a 3-doses primary series, a booster (fourth) dose is recommended at least 6 months after the last primary dose and may be given from the age of 9 months onwards (preferably between 12 and 15 months of age).
For a 2-doses primary series, A booster (third) dose is recommended at least 6 months after the last primary dose and may be given from the age of 9 months onwards (preferably between 12 and 15 months of age.
Note: Manufacturer schedules may differ from current WHO or national recommendations.
Depending on recommended dosing schedule, a booster dose (4th dose) can be administered at 9-10 or 12-15 months of age. The minimum interval between doses should be 4 weeks. For the 2+1 schedule, the booster (third) dose is recommended between 9-18 months of age. If a booster dose is given, it should be at least 6 months after the last primary dose.
Note: Manufacturer schedules may differ from current WHO or national recommendations.
Depending on recommended dosing schedule, a booster dose (4th dose) can be administered at 9-10 or 12-15 months of age. The minimum interval between doses should be 4 weeks. For the 2+1 schedule, the booster (third) dose is recommended between 9-18 months of age. If a booster dose is given, it should be at least 6 months after the last primary dose.
Following a 3-doses primary series, a fourth, booster dose is recommended after the first birthday.
With a 2-doses primary series, a third (booster) dose is recommended between 11 to 15 months of age.
Note: Manufacturer schedules may differ from current WHO or national recommendations.
Followoing a 3-doses primary series, a fourth, booster dose is recommended after the first birthday.
With a 2-doses primary series, a third (booster) dose is recommended between 11 to 15 months of age.
A booster dose is adminstered aftrer 12 momths of age.
A booster dose is adminstered at 12-15 momths of age.
In the three-doses primary schedule the booster dose is administered at 11–15 months. In the alternative (late start) schedule the booster dose is administered in the second year.
None
The booster dose is recommended between 11 through 15 months of age in both primary seriers. For the 3 doses primary series, the booster dose should be administered at least 2 months after the third dose.
The fourth (booster) dose is recommended between 11 and 15 months of age.
The safety and efficacy of Synflorix in children below 6 weeks and over 5 years of age have not been established
The safety and effectiveness in children below the age of 6 weeks has not been established.
The safety and efficacy of Synflorix in children below 6 weeks and over 5 years of age have not been established
The safety and effectiveness in children below the age of 6 weeks has not been established.
The safety and effectiveness in children below the age of 6 weeks has not been established.
The safety and efficacy in children below 6 weeks and over 5 years of age have not been established
The safety and efficacy in children below 6 weeks and over 5 years of age have not been established
The safety and efficacy in children below 6 weeks and over 5 years of age have not been established
The safety and efficacy in children below 6 weeks and over 5 years of age have not been established
The safety and effectiveness in children below the age of 6 weeks has not been established.
The safety and effectiveness in children below the age of 6 weeks has not been established.
YES
YES
NO
YES
NO
NO
NO
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
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
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] World Health Organization (WHO) (2010). Synflorix™ prequalification. World Health Organization. Available at: https://extranet.who.int/prequal/vaccines/p/synflorix-0
(accessed 16 September 2025).
[2] European Medicines Agency (EMA) (2023). Synflorix™ EPAR – Product Information. European Medicines Agency. Available at: https://www.ema.europa.eu/en/documents/product-information/synflorix-ep…
(accessed 16 September 2025).
[1] World Health Organization (WHO) (2019). PNEUMOSIL® prequalification. World Health Organization. Available at: https://extranet.who.int/prequal/vaccines/p/pneumosilr
(accessed 16 September 2025).
[1] Ministério da Saúde (Brasil) (2022). Comunicado nº 09 de agosto de 2022: fornecimento da vacina pneumocócica 10-valente (conjugada). Ministério da Saúde. Available at: https://www.gov.br/saude/pt-br/vacinacao/rede-de-frio/comunicados/comun… (accessed 16 September 2025).
[1] World Health Organization (WHO) (2016). Prevenar 13 Multidose Vial. World Health Organization. Available at: https://extranet.who.int/prequal/vaccines/p/prevenar-13-multidose-vial (accessed 16 September 2025).
[2] European Medicines Agency (EMA) (2023). Prevenar 13 EPAR – Product Information. European Medicines Agency. Available at: https://www.ema.europa.eu/en/documents/product-information/prevenar-13-… (accessed 16 September 2025).
[1] Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) (2016). Disposición N° 2156/16: autorización de comercialización de la vacuna neumocócica conjugada 13-valente. ANMAT. Available at: https://boletin.anmat.gob.ar/marzo_2016/Dispo_2156-16.pdf (accessed 16 September 2025).
[1] Walvax Biotechnology Co., Ltd. (2021). Package insert of 13-valent pneumococcal polysaccharide conjugate vaccine (PCV13-TT). Walvax Biotechnology Co., Ltd. Available at: https://en.walvax.com/media/upload/product/Package%20Insert%20of%20PCV1… (accessed 16 September 2025).
[1] Shenzhen Kangtai Biological Products Co., Ltd. (2021). 13-valent pneumococcal polysaccharide conjugate vaccine (TT/DT). Shenzhen Kangtai Biological Products Co., Ltd. Available at: https://en.biokangtai.com/Product_Details/16.html (accessed 16 September 2025).
[1] Nanolek (2023). Pnemotex 13-valent pneumococcal conjugate vaccine package insert. Nanolek. Available at: https://nanolek.ru/assets/pdf/IMP_Pnemotex_12_01_2023.pdf (accessed 16 September 2025).
[2] Russian State Register of Medicines (GRLS) (2021). Pnemotex (13-valent pneumococcal conjugate vaccine) registration details. Russian State Register of Medicines. Available at: https://grls.pharm-portal.ru/grls/8606a1ad-6250-42a6-aced-f38e15ebb153#… (accessed 16 September 2025).
[1] Central Drugs Standard Control Organization (CDSCO) (2018). Summary of Product Characteristics: 14-valent pneumococcal conjugate vaccine (Bio E Ltd). Central Drugs Standard Control Organization. Available at: https://www.cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadSm… (accessed 16 September 2025).
[1] European Medicines Agency (EMA) (2021). Vaxneuvance: European Public Assessment Report (EPAR). European Medicines Agency. Available at: https://www.ema.europa.eu/en/documents/product-information/vaxneuvance-… (accessed 16 September 2025).
[1] European Medicines Agency (EMA) (2022). Prevenar 20 (previously Apexxnar): European Public Assessment Report (EPAR). European Medicines Agency. Available at: https://www.ema.europa.eu/en/documents/product-information/prevenar-20-… (accessed 16 September 2025).
N/A
N/A
Formulation, filling & finishing of Synflorix - commercialisation limited to Brazil.
Prevenar 13 has marketing authorisation for adult population (older than 18 years of age in US and EU).
Formulation, filling & finishing of Prevnar13 - commercialisation limited to Argentina and Latin America.
N/A
N/A
N/A
Marketing Authorisation has been issued but no commercialisation is recorded in India. Phase III trial completed in 2024. The vaccine does not appear yet in the Biological E list of available vaccines.
Vaxneuvance has marketing authorisation for adult population (older than 18 years of age in US and EU).
Prevnar 2020 has marketing authorisation for adult population (older than 18 years of age in US and EU).
