For a vaccine using a viral vector, antibodies against the viral vector should be measured. Regulatory Authorities request bridging data on immunogenicity from a sufficient number of individuals an immunogenicity and reactogenicity study may include both vaccine-naïve and subjects already vaccinated with the current vaccine version. From a clinical perspective, clinical efficacy studies prior to approval are not required.
From a non-clinical perspective, non-clinical immunogenicity data, both humoral and cellular, in a relevant animal model can be of support for an application.From a pharmaceutical quality perspective, details of the virus sequence, its history and any updates to the already established manufacturing process should be provided, supported by appropriate batch analyses and stability data.It is considered that, in a rapidly evolving pandemic and public health need, international harmonisation of both the definition on key virus variants and regulatory requirements are desirable but not a prerequisite for moving ahead in effective and enabling regulation of vaccine updates.Evidence gathered by the large pivotal clinical studies for initial authorisation and by mass vaccination campaigns is a strong foundation for this approach, as is ongoing research on the "correlate of protection" (i.e., what immunological readouts correlate with clinical protection from COVID-19 disease). Rather, a regulatory approach like for seasonal updates for influenza vaccines can be taken.On public health and scientific considerations, Regulatory Authorities do not consider an updated coronavirus vaccine to be an entirely novel product with the resulting requirement for lengthy full-blown clinical studies.It is only applicable to COVID-19 vaccines which have already been authorised, based on adequate data on pharmaceutical quality, safety and efficacy from pivotal clinical trials.This Points to Consider document lays out a regulatory approach for updating authorised coronavirus vaccines should mutations at any time make them less efficacious due to insufficient cross-reactivity.Future outlook: Considerations for future novel coronaviruses unrelated to SARS-CoV2 (pandemic preparedness).Considerations for COVID-19 vaccines under development.Guidance for adapting authorised COVID-19 vaccines for SARS-CoV2 mutations in an ongoing pandemic.Regulatory concepts for influenza virus vaccines.
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