The Ministry of Health requested the Uganda National Technical Advisory group (UNITAG) to review and advise on the Ministry’s scientific consideration (“Pneumosil offers direct protection against serotypes 6A and 19A which are dominant serotypes in Uganda”) to switch PCV products from the currently used PCV10 - Synflorix® to PCV 10 - Pneumosil, 5 dose/ vial, liquid.
In response to this request, UNITAG’s working group on Pneumonia vaccines adopted a specific research question that was utilized to analyze available evidence regarding whether PCV10 – Pneumosil offers superior protection compared to PCV10 – Synflorix and PCV13 – Prevenar in high disease burden countries including those with high seroprevalence of 6A and 19A. Since epidemiological data on circulating serotypes in Uganda from 2011 to 2021 indicated that serotypes 6A, 19A, and 23F continue to circulate in the country following the introduction of PCV10- Synflorix in 2014, the working group developed a recommendation framework that took into account all WHO prequalified PCVs, infants aged 6 weeks up to 2 years in high disease burden countries, and vaccine efficacy/ effectiveness against serotypes 6A and 19A as the outcome.
Evidence showed that all of the capsular antigens included in PCV10 products are also included in the PCV13 product. However, while PCV13 - Prevenar and PCV10 - Pneumosil contain capsular antigens from serotypes 6A and 19A that are not contained in PCV10 – Synflorix, there is evidence that PCV10-Synflorix offers cross-protection against the two serotypes. In addition, the three vaccines contain non-toxic protein carriers, also found in other existing conjugated vaccines in the EPI. Similarly, all the three PCVs were licensed and prequalified (PQ) based on their immunogenicity hence being comparable. In particular, while Prevenar and Synflorix PQ based on their non-inferiority to PCV7 (no longer on the market), Pneumosil was licensed, and PQ based on its non-inferiority to Prevenar and Synflorix that had already received their PQ. Generally, evidence showed that all three PCVs have a comparable safety profile, are efficacious against the circulating serotypes in Uganda and can safely be co-administered with other vaccines in EPI.
Based on the available evidence, UNITAG concluded that all the three WHO prequalified PCVs have comparable safety, efficacy, immunogenicity, and impact on IPD and pneumonia. In addition, the committee concluded that although Pneumosil and Prevenar induce direct antibody response to serotypes 6A and 19A, Synflorix also induces cross-protection against these serotypes.
UNITAG thus recommends that the Ministry of Health should not switch PCV products premised on the vaccine’s serotype constitution as their protective effects against various pneumococcal serotypes are comparable across all three PCV products.
- Pneumococcal disease