UK, 4 others fast-track modified vaccines

AFP

Regulators in Britain and four other countries have announced new rules to fast-track development of modified COVID-19 vaccines so drugmakers can swiftly target emerging variants.

Previously authorized vaccines that are modified to combat new variants “will not need a brand new approval or ‘lengthy’ clinical studies,” Britain’s Medicines and Healthcare Products Regulatory Agency said on Thursday.

“The clear goal is that future vaccine modifications that respond to the new variants of coronavirus can be made available in the shortest possible time to UK recipients without compromising at any stage on safety, quality or effectiveness,” said Dr June Raine, head of the agency.

The new guidance is based on the model already used to modify the seasonal flu vaccine to keep up with annual changes in the virus and was issued jointly by regulators in the UK, Australia, Canada, Singapore and Switzerland.

The US Food and Drug Administration and European Medicines Agency have issued similar guidance.

Developers will be required to provide “robust evidence” that modified COVID-19 vaccines produce a strong immune response to the variant, as well as data showing they are safe and meet quality standards. This means developers can carry out small-scale trials on a few hundred people, rather than the tens of thousands that were required for initial approval, said Dr Christian Schneider, the MHRA’s chief scientific officer.

“I’d like to emphasize that to date we don’t have evidence that the vaccines in use in the UK are significantly lacking in effectiveness,” Raine said.

The announcement comes amid concerns that the virus may mutate to create new variants that resistant to existing vaccines.