Recent updates on pneumococcal vaccination

India accounts for 23% of pneumococcal disease worldwide and 36% within the WHO regional context.¹ Pneumococcal pneumonia leads to an estimated 4–5 million cases in India annually, with hospitalization rates ranging from 10%–30% overall and soaring to 60%–70% among the elderly.²

Current regime: 1 dose of PCV13 followed by PPSV23 1 year later ³

• Above 50 years: PCV 13 followed by PPSV23, 1 year later
• At-risk: PCV 13 followed by PPSV23, 1 year later and 2^nd dose of PPSV23 5 years later
• High-risk: PCV 13 followed by PPSV23, 8 weeks later and 2^nd dose of PPSV23 5 years later

New regime: PCV20 are recommended for adults ³

• Above 50 years: 1 dose of PCV20 only
• At-risk: 1 dose of PCV20 only
• High-risk: 1 dose of PCV20 only

Unmet Need:

Despite availability of pneumococcal vaccines, a significant proportion of pneumococcal disease in India remains unaddressed. Recent global serotype surveillance data indicates that non-PCV13 serotypes (11A, 15B) are contributing to significant disease prevalence. ^4,5 Additionally, evidence suggests that these emerging serotypes are increasingly causing invasive pneumococcal disease including meningitis and are responsible for Anti-microbial resistance (AMR). ^4,5

Long standing use of PPSV23 has not closed this gap either. Evidence with PPSV23 shows limited and inconsistent protection against non-invasive pneumococcal disease, waning immunity requiring revaccination at ~5 years intervals and lack of durable memory response. ^6,7,8,9 As a result, the incidence of invasive pneumococcal disease and community acquired pneumonia due to PPSV23 unique serotypes continues to rise, especially in older and at-risk/high risk adults. ⁶

PCV20: Scientific Evidence

The introduction of PCV20, with its single-dose regimen and broad serotype coverage, addresses many of these barriers by simplifying the vaccination process, reducing the need for follow-up visits, and making it easier for both providers and patients to achieve full protection against pneumococcal disease.

• PCV20 is a 20-valent pneumococcal conjugate vaccine approved in India for active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14,15B, 18C, 19A, 19F, 22F, 23F, 33F in individuals 18 years of age and older.
• Administered as a single intramuscular dose, Prevenar 20 may be administered concomitantly with seasonal influenza vaccine (QIV; surface antigen, inactivated, adjuvanted) and COVID-19 mRNA vaccine (nucleoside modified). ¹⁰
• PCV20 helps protect against 20 serotypes, including the 13 covered by PCV13 and seven additional serotypes (8,10A, 11A, 12F, 15B, 22F, 33F).⁴

These serotypes together account for a significant share of adult pneumococcal disease globally and in India, particularly in invasive disease, meningitis and antimicrobial resistant infections.^11-18

According to India data, these serotypes are increasingly responsible for invasive pneumococcal disease (IPD) in India, especially 15B/15C and 11A, which are not covered by PCV13.¹⁹

Coverage comparison in India:

PCV20 provides an additional 10% coverage compared to PCV13, enhancing protection against invasive pneumococcal disease in adults.

The tables below compare serotype coverage rates for PCV13 and PCV20 across age groups, based on findings from two major studies of invasive and non-invasive pneumococcal disease in adults.

A) Invasive disease (IPD)²⁰

B) Non- Invasive disease (CAP)²¹

IMMUNOBRIDGING:

Immunobridging is a globally endorsed regulatory strategy to infer vaccine efficacy when direct clinical efficacy data is unavailable. Leading authorities—including the World Health Organization (WHO), European Medicines Agency (EMA), United States Food and Drug Administration (U.S. FDA), and Central Drugs Standard Control Organization (CDSCO)—support this approach for pneumococcal conjugate vaccines. ^22-25

PCV20 is built upon the established PCV13 platform¹⁰, which has demonstrated its efficacy in preventing pneumococcal disease (PD) through several trials, including CAPITA and the Louisville Trial.^25,26 Given the similar platform, adjuvant, manufacturing process, and immunological non-inferiority to PCV13, it is reasonable to expect comparable efficacy and/or effectiveness of PCV20 to that of PCV13. Importantly, PCV20 offers the added advantage of seven additional serotypes in conjugated form, which expands protection against pneumococcal disease beyond the coverage of PCV13.

STUDIES SNAPSHOT

Immunobridging studies showed non-inferior opsonophagocytic activity (OPA) responses for all 13 shared serotypes and 6 of the 7 additional serotypes compared to PPSV23.

PCV20 was well tolerated and immunogenic regardless of age or prior vaccination history. ^27-28 Non-inferiority was demonstrated in both healthy adults and in patients with chronic medical conditions.³⁰ PCV20 was well tolerated and highly immunogenic in Indian adults aged 18 and above, including those ≥50 years. The vaccine demonstrated a strong safety profile and induced robust functional antibody responses against all 20 serotypes. ²⁷

CDC-ACIP and API Indian Consensus Recommendations: ^32,3

As per CDC-ACIP and Indian Consensus Guidelines (developed by API and 13 medical societies), need for adult pneumococcal vaccination is especially critical among individuals with at-risk/high-risk conditions.

Note:

For adults who has received PCV13 at any age and PPSV23 at age ≥65 years: Shared clinical decision-making is recommended. If a decision to administer PCV is made, a single dose of PCV20 is recommended ≥5 years after the last pneumococcal vaccine dose

^# Immunocompromising conditions: Chronic renal failure, nephrotic syndrome, immunodeficiency, iatrogenic immunosuppression, generalized malignancy, HIV infection, Hodgkin disease, leukemia, lymphoma, multiple myeloma, solid organ transplant, congenital or acquired asplenia, or sickle cell disease or other hemoglobinopathies.

* Chronic medical conditions: Alcoholism; chronic heart disease, including congestive heart failure and cardiomyopathies; chronic liver disease; chronic lung disease, including chronic obstructive pulmonary disease, emphysema, and asthma; cigarette smoking; or diabetes mellitus

Indian Consensus guidelines on adult immunization recommendations on pneumococcal vaccination for adults:

• The guidelines recommend the use of single dose of PCV20 to all adults with age 50 years and above regardless of underlined risk factors and to 18- 49 years of age with underlined at-risk and/or high-risk conditions. ^$

^$High Risk individuals: CKDs, Immunocompromised conditions (HIV, Autoimmune Rheumatic Disease), Malignancies (Solid and Hematological), Solid organ transplant, Functional or Anatomical Asplenia, Hodgkins Disease, Nephrotic Syndrome, Down Syndrome, CSF Leak, Cochlear Implant

^$At-Risk individuals: Age ≤2 years, ≥50 years, Chronic Respiratory Disorders, Diabetes Mellitus, Chronic Heart Disease, Chronic Liver Disease

Note:

For HSCT patients: 3 – 6 months after transplant, 3 dose of PCV 20, 4-6 weeks apart followed by one booster dose 6 months later.^33,34

References:

1. Ghoshal AG. Burden of pneumonia in the community. J Assoc Physicians India. 2016;64:8–11.
2. Koul PA, Vora AC, Jindal SK, et al. Expert panel opinion on adult pneumococcal vaccination in the post-COVID era (NAP- EXPO Recommendations-2024). Lung India. 2024;41(4):307–317.
3. Indian Consensus Guideline on Adult Immunization | API [Internet]. Available from: https://apiindia.org/reader/Indian%20Consensus%20Guideline%20on%20Adult%20Immunization
4. Grewal R, Hillier K, Deeks SL, Yeung AH, Wilson SE, Wijayasri S, Harris TM, Buchan SA. Invasive Pneumococcal Disease Epidemiology and Serotype Replacement After the Introduction of the 13-Valent Pneumococcal Conjugate Vaccine in Ontario, Canada, 2007-2022. Open Forum Infect Dis. 2024 May 15;11(6):ofae275. doi: 10.1093/ofid/ofae275. PMID: 38868312; PMCID: PMC11167672.
5. ICMR - Antimicrobial Resistance Surveillance Network. Annual report: January 2021 to December 2021. 2021. https://main.icmr.nic.in/sites/default/files/upload_documents/AMR_Annual_Report_2021.pdf
6. Ladhani SN, Collins S, Djennad A, Sheppard CL, Borrow R, Fry NK, et al. Rapid increase in non-vaccine serotypes causing invasive pneumococcal disease in England and Wales, 2000-17: a prospective national observational cohort study. Lancet Infect Dis. 2018 Apr;18(4):441-51. doi:http://dx.doi.org/10.1016/s1473-3099(18)30052-5.
7. Latifi-Navid H, Latifi-Navid S, Mostafaiy B, Jamalkandi SA, Ahmadi A. Pneumococcal disease and the effectiveness of the PPV23 vaccine in adults: a two-stage Bayesian meta-analysis of observational and RCT reports. Sci Rep. 2018 Jul;8(1):11051. doi:http://dx.doi.org/10.1038/s41598-018-29280-2.
8. Niederman MS, Folaranmi T, Buchwald UK, Musey L, Cripps AW, Johnson KD. Efficacy and effectiveness of a 23-valent polysaccharide vaccine against invasive and noninvasive pneumococcal disease and related outcomes: a review of available evidence. Expert Rev Vaccines. 2021 Mar;20(3):243-56. doi:http://dx.doi.org/10.1080/14760584.2021.1880328.
9. Falkenhorst G, Flamaing J. Vaccination against pneumococcal disease in the European Union, with particular focus on Germany. In: Michel JP, Maggi S, editors. Adult vaccinations: practical issues in geriatrics. Springer, Cham; 2019. https://doi.org/10.1007/978-3-030-05159-4_11. Accessed August 27, 2021
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20. Jayaraman R, Varghese R, Kumar JL, Neeravi A, Shanmugasundaram D, Ralph R, Thomas K, Veeraraghavan B. Invasive pneumococcal disease in Indian adults: 11 years' experience. Journal of Microbiology, Immunology and Infection. 2019 Oct 1;52(5):736-42.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: 12 June 2025.
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