UK – ACCESS Consortium guidance on strain changes in authorised COVID-19 vaccines

A regulatory approach for updating authorised coronavirus vaccines should mutations at any time make them less efficacious due to insufficient cross-reactivity.

This document 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.

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.

Rather, a regulatory approach like for seasonal updates for influenza vaccines can be taken. 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)…