The U.K.’s drugs regulator won’t require further large-scale clinical trials to approve modified coronavirus vaccines against new variants, it said on Thursday.
Instead of waiting to see if vaccinated people become infected, as is usually done, the Medicines and Healthcare products Regulatory Agency (MHRA) will require data that show new versions of approved vaccines induce an immune response through blood tests. These studies will be smaller and faster.
The MHRA has developed guidance for the pharmaceutical industry as part of an international regulatory group, the Access Consortium, that includes Australia, Canada, Singapore and Switzerland. The U.K. has been able to take part since leaving the EU.
Manufacturers must also provide evidence that the vaccine is safe and of high quality, said June Raine, chief executive of the MHRA during a journalists’ briefing.
The guidance is similar to what the European Medicines Agency issued recently and reflects the approach taken with seasonal flu jabs. But Raine also pointed to some differences, saying that the “hallmark of our guidance is scientific flexibility.”
“We will use the best possible science and integrate sources of data commensurate with the urgency of the situation,” she explained.
This approach is “not necessarily faster [than the EMA, but] it could be,” said Christian Schneider, interim chief scientific officer at the National Institute for Biological Standards and Control.
A key difference will be the requirements for immunogenicity. While the EMA and U.S. Food and Drug Administration require data showing the immune response with a new version is at least as good as the original, the consortium is taking a differing approach because it’s “not yet clear” where the exact threshold lies for an immune response, said Schneider, calling it “an arbitrary margin.”
The consortium will instead look at a collection of data, including cellular immune response and cross-reactivity, he said.
Raine said the rolling review process had already begun, but declined to comment on how many or which companies had submitted data for new jabs. Oxford/AstraZeneca, however, has said it has begun making a version of its vaccine against a novel variant.
