Medicinal products may only be distributed in Switzerland if they are authorised by Swissmedic. The Swiss Agency for Therapeutic Products, is involved in the entire life cycle of a medicinal products because of its mandated areas of responsibility in the sectors of licensing and the authorisation and monitoring of medicinal products.
Swissmedic updates requirements for authorisation applications for conjugated pneumococcal vaccines
01.06.2025
Taking into consideration the growing experience with the use of conjugated pneumococcal vaccines, Swissmedic has re-evaluated the existing data, including their real-world use in other jurisdictions. As a result, the current requirements for applications for conjugated pneumococcal vaccines were revised to ensure the availability of pneumococcal vaccines for the benefit of the Swiss population. These can be summarised as follows:
- Vaccine efficacy studies continue to be the ‘gold standard’ for assessing the clinical impact of pneumococcal vaccines and are therefore the preferred basis of evidence.
- Due to growing experience with the vaccines, both in Switzerland and in other countries, extrapolation of the efficacy of conjugated pneumococcal vaccines based on immunobridging may be considered as evidence in support of an application.
Rationale for considering an immunobridging approach:
- Experience with conjugated pneumococcal vaccines in countries where these are approved for use in broader age groups than in Switzerland has not revealed any relevant effectiveness and safety issues.
- Efficacy of pneumococcal vaccines has been established in older adults (65 years and older) and children younger than 5 years of age. As older adults typically mount a weaker immune response than younger adults, an adequate immune response and efficacy can also be assumed in younger adults.
- New pneumococcal vaccine efficacy studies would require very large sample sizes, for reasons that include changes in the prevalence of S. pneumoniae serotypes, which limits the feasibility of such studies. In addition, the appropriate study design and consecutive acceptability review/authorisation by local ethics committees would pose a significant challenge due to different vaccination recommendations and vaccine coverage in the countries concerned.
With immediate effect from the data of publication, Swissmedic requests the following for marketing applications for conjugated pneumococcal vaccines and their indication extensions to other age groups:
- Comparative immunogenicity data for different age groups together with a sound justification for the proposed immunobridging strategy, allowing extrapolation of efficacy results to age groups for which no efficacy data are available. Notably, sequential bridging to conjugated pneumococcal vaccines for which efficacy data are available based on demonstrated non-inferior immunogenicity carries the risk of downward drift of the actual efficacy. It is recommended that applicants adequately address this risk, e.g., by using conservative non-inferiority criteria that allow only small differences with the comparator vaccine/age group.
- The need to prevent invasive pneumococcal disease and pneumonia among younger adults (<65 years) and children above 5 years of age is highest in those with immunosuppression or other underlying conditions associated with an increased risk of invasive pneumococcal disease. Therefore, the evaluation of the effect of immunisation with pneumococcal vaccines in this target population is pivotal. To this end, immunogenicity and/or effectiveness data in subgroups of immunosuppressed individuals (e.g., persons living with HIV, severe primary immunodeficiencies, sickle cell disease, solid organ or haematopoietic stem cell transplant, and those receiving immunosuppressive treatments for other conditions) should be provided.
- Applicants should submit an overview of the available (published) effectiveness data of pneumococcal vaccines for age groups for which no efficacy data are available, preferably in the form of a metanalysis, and critically discuss the findings.
- In addition, and if applicable, an overview of planned post-authorisation effectiveness studies should be provided.
Swissmedic invites Applicants to request a “Meeting before application submission” if there is a need to clarify any questions.