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News: Adapting COVID-19 vaccines to SARS-CoV-2 variants: guidance for vaccine manufacturers
CHMP, Last updated: 25/02/2021
EMA has issued guidance outlining the requirements for manufacturers planning to modify their COVID-19 vaccines in order to address coronavirus (SARS-CoV-2) variants.
Currently, three vaccines are authorised for use in the EU: Comirnaty, COVID-19 Vaccine Moderna and COVID-19 Vaccine AstraZeneca. Viruses typically mutate and several variant strains of SARS-CoV-2 have already been identified worldwide. The three authorised vaccines provide protection against the variants that are currently prevalent across Europe. However, it appears that with continued mutations and new variants emerging, authorised vaccines may need to be adapted, in time to ensure continued protection. Initial data indicates that some of these variants may have an impact on the level of protection provided by COVID-19 vaccines against infection and disease.
Therefore, it is an urgent public health priority to define an expedited regulatory process for the adaptation of vaccines to protect against current or future variants. There are ongoing discussions at international level on how to approach variants and vaccines in a coordinated way.
EMA’s human medicines committee (CHMP) has adopted a reflection paper which details the laboratory (non-clinical), clinical, quality and manufacturing data needed to support the approval of such ‘variant’ vaccines.
The assumption behind the CHMP’s guidance is that a new variant vaccine would largely rely on the same technology and platform as the ‘parent’ vaccine – a vaccine already approved in the EU for the prevention of COVID-19. The difference would be in the specific structure (antigen) selected to trigger the immune response in the body…
Reflection paper on the regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2 (PDF/240.55 KB) (new)