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MPs told of ‘urgent need’ to regulate updated vaccines

Oxford team already planning small trials on updated vaccines targeting coronavirus variants

MPs have been told there is an “urgent need” for early engagement with medical regulators to ensure that updated Covid-19 vaccines targeted at new variants are approved in a speedy manner.

Scientists are already working on designing and testing tweaked vaccines they hope will be able to tackle new and emerging variants of the coronavirus, but they have said that rapid approval for use requires early engagement with regulators.

“There will need to be a conversation with regulatory bodies—the Medicines and Healthcare products Regulatory Agency, the European Medicines Agency, etc—about a fast-track process similar to what is used for flu to update vaccines based on a much shorter period, so that we don’t need to go through a full-blown clinical trial every time there’s a strain change,” said Wendy Barclay, head of the department of infectious diseases at Imperial College London.

“That should be straightforward, but I don’t think the pathway is yet sorted out with those regulatory bodies, and that’s an urgent need.”

The comments were made on 24 February to the House of Commons Science and Technology Committee, which questioned several academics and officials on the progress of the UK’s Covid-19 vaccination programme.

Small clinical trials

Sarah Gilbert, professor of vaccinology at the University of Oxford, who leads the Oxford/AstraZeneca vaccine work, said her team is working on producing a new version of the vaccine with small clinical trials to start in the early summer. It is not yet certain that updated vaccines will be needed, she said, but added that the team wants to be ready just in case.

“We have been discussing with regulators the approach we will need to take for a strain change,” she said, adding that she expected the process would be similar to the one that exists for flu and would not require any further large efficacy trials on tens of thousands of people, but only smaller trials involving hundreds of people.

“The exact plans for those clinical trials and what the regulators will need to see are still being finalised, and discussions are being held,” Gilbert said.

She added that her team was designing the trials for tweaked vaccines in talks with various regulators, not just the UK’s MHRA.

“We want to be able to work with regulatory bodies around the world…we want to have a strategy that will work with other regulatory authorities as well, and the World Health Organization.”

Barclay said Covid-19 had “revolutionised” the whole vaccine field. She called for “conversations with regulatory bodies about what can be learned from the current, very fast delivery, and how we can trim that even more, but at the same time emphasising safety. There is a limit to how quickly we can go because you must perform safety studies properly.”