New 25-Valent Pneumococcal Vaccine Shows Promise in Global Disease Coverage

The newly developed, 25-valent pneumococcal conjugate vaccine (PCV25) shows promise in addressing the global burden of pneumococcal disease, according to a study in Vaccine.¹ With an acceptable safety profile and immunogenicity among healthy adults, PCV25 also has potential to specifically address burdens among infants and patients from low- and middle-income countries (LMICs).

“The first PCV—PCV7—containing 7 capsular polysaccharides individually conjugated to the carrier protein CRM197 (a nontoxic mutant of diphtheria toxin) was introduced for use in infants and young children in 2000 in the US and subsequently replaced by vaccines with higher valency,” wrote the authors of the study. “As of May 2025, 170 of 194 WHO member states have introduced PCVs for infant vaccination, and 15 more are planning to do so because of their significant reduction of morbidity and mortality in children and the indirect protection observed in the wider population.”

The development of a new pneumococcal conjugate vaccine, known as PCV25 or IVT PCV-25, recently reached a significant milestone with the completion of 2 randomized, double-blind clinical trials in Canada. These studies, designated CVIA 096 and CVIA 105, demonstrated that multiple formulations of PCV25 are both safe and immunogenic in healthy, vaccine-naive adults.^1,2

READ MORE: Pneumococcal Vaccination Significantly Reduces IPD Mortality

This vaccine candidate, developed by the biotechnology company Inventprise with support from the Bill & Melinda Gates Foundation, represents a vital effort to reduce the global burden of pneumococcal disease.^3,4

A New Territory for Pneumococcal Vaccines

Pneumococcus remains a leading cause of mortality, responsible for approximately 300,000 deaths annually in children under 5, particularly through life-threatening conditions like pneumonia, meningitis, and sepsis.^3,4 Although existing vaccines approved for children and older adults currently cover between 10 and 20 serotypes, PCV25 expands this protection to include 7 additional emerging and deadly serotypes—including 2, 6C, 9N, 15A, 16F, 24F, and 35B.^1,3

For pharmacists, who are often the most accessible members of the health care team, understanding these clinical advancements is essential for improving public health outcomes. Research indicates that patients visit their local community pharmacist twice as often as their primary care physician, yet pharmacists continue to face significant barriers to increasing pneumococcal immunization rates.⁵

A study involving South Carolina pharmacists revealed that many professionals have limited knowledge regarding complex and frequently changing vaccination guidelines, correctly identifying recommendations in only a fraction of patient cases.

PCV25 aims to address some of these challenges by utilizing a patented hydrazide-polyethylene glycol-hydrazide (Hz-PEG-Hz) linker technology. This innovative platform, which was originally explored during the development of a vaccine for Haemophilus influenzae type A, allows for an increased number of serotypes without the typical drop in potency or the immune interference often seen with carrier proteins like CRM197.⁴

Furthermore, Inventprise has implemented highly automated manufacturing processes in Washington State to ensure this complex vaccine remains affordable for LMICs where the disease burden is most severe.^3,4

Details of the CVIA 096 and CVIA 105 Trials

The Canadian clinical trials, conducted in collaboration with organizations such as the Canadian Center for Vaccinology and the Vaccine Evaluation Center, compared PCV25 with the licensed PCV20 control.^1,3 Results showed that PCV25 has a safety and tolerability profile similar to current standards, with common reactions including injection site pain, fatigue, and headache.¹

These findings are consistent with the safety information provided in CDC Vaccine Information Statements, which also remind providers to report adverse events to the Vaccine Adverse Event Reporting System (VAERS) and inform patients about the National Vaccine Injury Compensation Program.⁶ Although adult immunogenicity is not fully predictive of the response in infants, the robust antibody responses observed for all 25 serotypes support the next phase of development in pediatric populations.¹

Pharmacists can help bridge the current immunization gap by using tools like the PneumoRecs VaxAdvisor and addressing barriers such as patient eligibility and insurance coverage.⁵ By staying informed on the pipeline of vaccines, which has been known to confuse some professionals in the pharmacy space, pharmacists remain critical to the global mission of reducing preventable mortality.^3,5

The next step for IVT PCV-25 is reaching its target infant population.

“IVT PCV-25 had an acceptable safety profile and was immunogenic in healthy adults,” concluded the authors of the current study.¹ “Further development will include assessment of safety and immunogenicity of all current formulations in the target infant population with a goal to identify a well-tolerated formulation likely to meet non-inferiority criteria for currently licensed strains in addition to providing expanded coverage against novel serotypes.”

READ MORE: Pneumococcal Resource Center

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REFERENCES

1. Langley JM, Sadarangani M, Ockenhouse C, et al. Safety and immunogenicity of a 25-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive healthy adults: results from 2 randomised, controlled clinical trials. Vaccine. 2026;75:128236. https://doi.org/10.1016/j.vaccine.2026.128236

2. Study to evaluate a 25-valent pneumococcal conjugate vaccine (IVT PCV-25). Clinicaltrials.gov. August 30, 2023. Accessed March 12, 2026. https://clinicaltrials.gov/study/NCT05540028

3. Inventprise completes vaccination of participants in a phase 2 dose ranging study of its 25 valent pneumococcal vaccine candidate. News Release. Inventprise. January 2, 2024. Accessed March 12, 2026. https://inventprise.com/2024/01/02/inventprise-completes-vaccination-of-participants-in-a-phase-2-dose-ranging-study-of-its-25-valent-pneumococcal-vaccine-candidate/

4. Datta A, Kapre K, Andi-Lolo I, et al. Multi-valent pneumococcal conjugate vaccine for global health: from problem to platform to production. Hum Vaccin Immunother. 2022 Nov 30;18(4):2117949. doi: 10.1080/21645515.2022.2117949.

5. Davies A, Schreiber D, Carey C, et al. Community pharmacists’ pneumococcal vaccine knowledge and perceived barriers to vaccination. Vaccine. 2025;53:126930. https://doi.org/10.1016/j.vaccine.2025.126930

6. Pneumococcal conjugate vaccine: what you need to know. CDC. Accessed March 12, 2026. https://www.cdc.gov/vaccines/hcp/current-vis/downloads/pcv.pdf