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PCV20 Launch in India: A Single Dose, Science-Driven Approach for Pneumococcal Disease Control - Video

Published On 2025-08-14T12:12:33+05:30  |  Updated On 14 Aug 2025 12:49 PM IST
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Overview

A next-generation pneumococcal conjugate vaccine, PCV20, a single-dose protection is now available in India marking a new milestone in adult immnunisation in India. This approach will aid in adult pneumococcal disease control.

With PCV20, we have single-dose solution that simplifies vaccination regime and expands protection without the need of additional doses in most adults.

India accounts for 23% of the global pneumonia burden—a serious disease causing nearly 6.8 million hospitalizations among older adults worldwide every year1,2. Until now, pneumococcal vaccination involved a 2-dose regimen i.e. priming with PCV13 followed by PPSV23.

PCV20 is a pneumococcal conjugate vaccine that offers broad serotype coverage against 20 serotypes of Streptococcus pneumoniae—the bacteria responsible for pneumonia, meningitis, and bacteremia.

Built on the proven PCV13 platform, PCV20 adds seven additional serotypes3,4 (8, 10A, 11A, 12F, 15B, 22F, and 33F) associated with severe disease, hospitalizations, antimicrobial resistance, and mortality—offering strong and wider protection5-28.

PCV20 uses the same CRM197 carrier protein and manufacturing excellence as PCV13. Immunobridging trials, a regulatory method that infers a new vaccine’s efficacy by comparing its immune response to an approved vaccine, have shown PCV20 to be non-inferior to PCV13 and PPSV23 in immunogenicity in various clinical studies5,29,30. PCV20 was well tolerated and has demonstrated similar safety profile as PCV13.

As per CDC-ACIP and Indian Consensus on Adult Immunisation recommend PCV20 as a single dose for all adults aged ≥50 years and older and those aged 19–49 years with chronic conditions like diabetes mellitus, chronic heart or lung diseases, chronic liver or kidney diseases, and immunocompromising conditions (cancer, HIV, AIRDs etc.)

With PCV20 now available in India, the country joins others worldwide in advancing adult pneumococcal vaccination through a simplified, single dose strategy44.

PCV20 simplifies adult pneumococcal vaccination in India, offering broad protection with a single dose thereby reducing hospitalizations and saving lives.

References:

1. Shi T, et al. J Infect Dis. 2020;222(Suppl 7):S570-S576.

2. Eshwara VK, Mukhopadhyay C, Rello J. Community-acquired bacterial pneumonia in adults: An update. Indian J Med Res. 2020;151(4):287-302.

3. CDC. About pneumococcal vaccines. Available at: https://www.cdc.gov/vaccines/vpd/pneumo/hcp/about-vaccine.html#types-composition. Accessed on: 09 June 2025.

4. European Medicines Agency approves Pfizer’s 20-valent pneumococcal conjugate vaccine against invasive pneumococcal disease and pneumonia in adults. Available at: https://www.pfizer.com/news/press-release/press-release-detail/european-medicines-agency-approves-pfizers-20-valent. Accessed on: 09 June 2025.

5. Prevenar 20 India label: LPDPRV042025, PfLEET number: 2025-0096628 dated 2nd Feb 2025.

6. Méroc E, Fletcher MA, Hanquet G, et al. Systematic literature review of the epidemiological characteristics of pneumococcal disease caused by the additional serotypes covered by the 20-valent pneumococcal conjugate vaccine. Microorganisms. 2023;11(7):1816.

7. Amin-Chowdhury Z, Collins S, Sheppard C, et al. Characteristics of invasive pneumococcal disease caused by emerging serotypes after the introduction of the 13-valent pneumococcal conjugate vaccine in England: A prospective observational cohort study, 2014-2018. Clin Infect Dis. 2020;71(8):e235-e243.

8. Müller A, Kleynhans J, de Gouveia L, et al; for GERMS-SA. Streptococcus pneumoniae serotypes associated with death, South Africa, 2012-2018. Emerg Infect Dis. 2022;28(1):166-179.

9. De Miguel S, Latasa P, Yuste J, et al. Age-dependent serotype-associated case-fatality rate in invasive pneumococcal disease in the autonomous community of Madrid between 2007 and 2020. Microorganisms. 2021;9(11):2286.

10. Ramirez J, Furmanek S, Chandler TR, et al, The University Of Louisville Pneumonia Study Group. Epidemiology of pneumococcal pneumonia in Louisville, Kentucky, and its estimated burden of disease in the United States. Microorganisms. 2023;11(11):2813.

11. Menéndez R, Torres A, España PP, et al; CAPA Study Group. Pneumococcal serotypes associated with community-acquired pneumonia hospitalizations in adults in Spain, 2016-2020: The CAPA study. Microorganisms. 2023;11(11):2781.

12. Torres A, Menéndez R, España PP, et al; CAPA Study Group. The evolution and distribution of pneumococcal serotypes in adults hospitalized with community-acquired pneumonia in Spain using a serotype-specific urinary antigen detection test: The CAPA study, 2011-2018. Clin Infect Dis. 2021;73(6):1075-1085.

13. Park DC, Kim SH, Yong D, et al. Serotype distribution and antimicrobial resistance of invasive and noninvasive Streptococcus pneumoniae isolates in Korea between 2014 and 2016. Ann Lab Med. 2019;39(6):537-544.

14. Yun KW, Rhie K, Kang JH, et al. Emergence of serotype 10A-ST11189 among pediatric invasive pneumococcal diseases, South Korea, 2014-2019. Vaccine. 2021;39(40):5787-5793.

15. Griffith A, Golden AR, Lefebvre B, et al. Invasive pneumococcal disease surveillance in Canada, 2021-2022. Can Commun Dis Rep. 2024;50(5):121-134.

16. Cohen R, Levy C, Varon E. The latest news in France before distribution of third-generation pneumococcal conjugate vaccines. Infect Dis Now. 2024;54(5):104937.

17. Ikuse T, Habuka R, Wakamatsu Y, et al. Local outbreak of Streptococcus pneumoniae serotype 12F caused high morbidity and mortality among children and adults. Epidemiol Infect. 2018;146(14):1793-1796.

18. Sleeman KL, Griffiths D, Shackley F, et al. Capsular serotype-specific attack rates and duration of carriage of Streptococcus pneumoniae in a population of children. J Infect Dis. 2006;194(5):682-688.

19. Zulz T, Wenger JD, Rudolph K, et al. Molecular characterization of Streptococcus pneumoniae serotype 12F isolates associated with rural community outbreaks in Alaska. J Clin Microbiol. 2013;51(5):1402-1407.

20. Zivich PN, Grabenstein JD, Becker-Dreps SI, et al. Streptococcus pneumoniae outbreaks and implications for transmission and control: a systematic review. Pneumonia (Nathan). 2018;10:11.

21. Pitts SI, Apostolou A, DasGupta S, et al. Serotype 10A in case patients with invasive pneumococcal disease: a pilot study of PCR-based serotyping in New Jersey. Public Health Rep. 2015;130(1):54-59.

22. Ngamprasertchai T, Ruenroengbun N, Kajeekul R. Immunogenicity and Safety of the Higher-Valent Pneumococcal Conjugate Vaccine vs the 13-Valent Pneumococcal Conjugate Vaccine in Older Adults: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Open Forum Infect Dis. 2025;12(2):ofaf069.

23. Jayaraman R, Varghese R, Kumar JL, et al. Invasive pneumococcal disease in Indian adults: 11 years' experience. J Microbiol Immunol Infect. 2019;52(5):736-742.

24. Varghese R, Daniel JL, Neeravi A, et al. Multicentric Analysis of Erythromycin Resistance Determinants in Invasive Streptococcus pneumoniae; Associated Serotypes and Sequence Types in India. Curr Microbiol. 2021;78(8):3239-3245.

25. Wattal C, Goel N, Byotra SP. Prevalence of pneumococcal serotypes in adults ≥50 years of age. Indian J Med Microbiol. 2017;35(1):95-100.

26. Thomas K, Mukkai Kesavan L, Veeraraghavan B, et al; IBIS Study Group IndiaCLEN Network. Invasive pneumococcal disease associated with high case fatality in India. J Clin Epidemiol. 2013;66(1):36-43.

27. Maeda H, Morimoto K. Global distribution and characteristics of pneumococcal serotypes in adults. Hum Vaccin Immunother. 2025; 21(1):2469424.

28. Huang L, Wasserman M, Grant L, et al. Burden of pneumococcal disease due to serotypes covered by the 13-valent and new higher-valent pneumococcal conjugate vaccines in the United States. Vaccine. 2022;40(33):4700-4708.

29. Prevenar 13[summary of product characteristics]. Kent, UK: Pfizer Ltd; 2017

30. Pfizer Limited. Annual report 2018–19. Available at: https://www.pfizerltd.co.in/files/pfizer_limited_annual_report_2018_19.pdf. Accessed on 19 Jun 25.

31. Gruber MF, Rubin S, et al. Approaches to demonstrating the effectiveness of filovirus vaccines: Lessons from Ebola and COVID-19. Front Immunol. 2023;14:1109486.

32. Cruz P, Lam JM, Abdalla J, et al; Global Immunocompromised Health Coalition. Immunobridging Trials: An Important Tool to Protect Vulnerable and Immunocompromised Patients Against Evolving Pathogens. Vaccines (Basel). 2024;13(1):19.

33. WHO. Recommendations to assure the quality, safety, and efficacy of pneumococcal conjugate vaccines, Annex 3, TRS No 977. Available at: Recommendations to assure the quality, safety and efficacy of pneumococcal conjugate vaccines, Annex 3, TRS No 977. Accessed on: 09 June 2025.

34. EMA. Guideline on clinical evaluation of vaccines. Available at: Guideline on clinical evaluation of vaccines. Accessed on: 09 June 2025.

35. FDA. Summary basis for regulatory action, Available at: June 8, 2021 Summary Basis for Regulatory Action - PREVNAR 20. Accessed on: 09 June 2025.

36. CDSCO. Draft regulatory guidelines for the development of vaccines with special consideration for the COVID-19 vaccine. Available at: Regulatory_guidelines_for__development_of_Vaccine.pdf. Accessed on: 09 June 2025.

37. Essink B, Sabharwal C, Cannon K, et al. Pivotal phase 3 randomized clinical trial of the safety, tolerability, and immunogenicity of 20-valent pneumococcal conjugate vaccine in adults aged ≥18 years. Clin Infect Dis. 2022;75(3):390398.

38. Cannon K, Elder C, Young M, et al. A trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in populations of adults ≥65 years of age with different prior pneumococcal vaccination. Vaccine. 2021;39(51):7494–7502.

39. Cannon K, Cardona JF, Yacisin K, et al. Safety and immunogenicity of 20-valent pneumococcal and quadrivalent influenza vaccine coadministration: A phase 3 trial. Vaccine. 2023;41(13):2137–2146.

40. NLM. A Study to Learn About the Safety and Immune Response of 20vPnC in Adults in India- Study details. Available at: https://clinicaltrials.gov/study/NCT05875727?locStr=India&country=India&cond=Pneumococcal%20Vaccines&rank=6. Accessed on: 18 July 2025.

41. Centers for Disease Control and Prevention. Pneumococcal vaccine timing for adults. October 2024. Accessed November 13, 2024. https://www.cdc.gov/pneumococcal/downloads/Vaccine-Timing-Adults-JobAid.pdf

42. Centers for Disease Control and Prevention. Pneumococcal Vaccine for Adults Aged ≥19 Years: Recommendations of the Advisory Committee on Immunization Practices, United States, 2023. Available at https://www.immunize.org/wp-content/uploads/acip/rr7203a1-H.pdf. Accessed on: 22 May 2025.

43. Indian Consensus Guideline on Adult Immunization. Available at: https://apiindia.org/reader/Indian%20Consensus%20Guideline%20on%20Adult%20Immunization. Accessed on: 09 June 2025.

44. UNICEF. Vaccine market update PCV. Available at: https://www.unicef.org/supply/media/18906/file/UNICEF-VIC2023-Session15-PCVupdate-UNICEF-2023.pdf. Accessed on: 09 June 2025

Speakers

Dr. Bhumika Maikhuri

Dr Bhumika Maikhuri is an orthodontist with 2 years of clinical experience. She is also working as a medical writer and anchor at Medical Dialogues. She has completed her BDS from Dr D.Y. Patil Medical College and Hospital and MDS from Kalinga Institute of Dental Sciences. She has a few publications and patents to her credit. Her diverse background in clinical dentistry and academic research uniquely positions her to contribute meaningfully to our team.
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