EMA plans rapid approval of vaccines against COVID-19 variants

Article written by Gary Finnegan.

New COVID-19 vaccines against variants of the virus could be approved much more quickly than the first generation of jabs. The European Medicines Agency (EMA) says smaller trials would be accepted in cases where a variant-proof vaccine is only a minor update on existing approved vaccines.

The approach would be similar to that taken in approving new flu vaccines every year. Instead of requiring clinical trials on tens of thousands of people – a process that takes several months – the medicines watchdog allows manufacturaers to tweak their vaccine without starting the clinical development process from scratch.

Existing vaccines are expected to provide some level of protection against the latest variants, but it is still unclear how effective they will be. Scientists also worry that other variants will emerge in future which can evade the immune response generated through vaccination.

In new guidance issued to manufacturers, the EMA says authorised vaccines can be adapted to cope with virus mutations if necessary. It promises an ‘expedited regulatory process’ to ensure vaccine updates can be done without delay.

‘The assumption 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 EMA says. ‘The difference would be in the specific structure (antigen) selected to trigger the immune response in the body.’

The Agency says large-scale safety and efficacy studies are not needed, but immunogenicity studies could be used to show that revamped vaccines protect against variants. Smaller clinical trials could be conducted to demonstrate evidence of an immune response, ideally showing similar results to earlier studies of the parent vaccine.

The effectiveness of a single dose, as a booster shot, in previously vaccinated individuals should also be studied. As usual, post-authorisation studies would continue to monitor long-term safety and effectiveness of variant COVID-19 vaccines.

‘The variant vaccine is expected to be produced by the same manufacturer, and in line with processes and controls used for the parent vaccine,’ according to the new guidance. ‘The manufacturer will need to generate data that show that the quality of the variant vaccine complies with the standards set for the parent vaccine.’ In the case of a multivalent vaccine – one that contains different viral variant strains – additional evidence may be required to ensure the quality of the active substances and the finished product.