Guidance on strain changes in authorised COVID-19 vaccines, MHRA

While developers and other stakeholders are working on testing cross-reactivity of sera from vaccinated people with the new strain in relevant assays, it is important that there is a regulatory approach ready to be implemented should virus mutations at any time make vaccines less efficacious due to insufficient cross-reactivity, and an update of already authorised vaccines is needed. This paper lays out scientific and regulatory considerations. It does not cover unauthorised vaccines currently under development. While the considerations in this paper have been written for vaccines, they may also apply, on a case-by-case basis, for other targeted therapies like monoclonal antibodies. In a most conservative approach, regulators would consider a strain change in an authorised vaccine a new product and require new clinical trials to demonstrate safety, immunogenicity and efficacy. This would result in a considerable delay in getting the new version of the vaccine ready for deployment, since the rate-limiting step is the generation of efficacy data, relying on spontaneous infections, including in a comparator group. This may also be problematic from a public health perspective since delay in updating a vaccine, where needed, bears the risk that the virus is evolving even further, potentially making a new vaccine version outdated at the time of approval again. Therefore, a scientific and regulatory concept should be developed that strikes the right balance between evidence on quali...
Source: Current Awareness Service for Health (CASH) - Category: Consumer Health News Source Type: news