EU drugs regulator plans to fast track variant-modified COVID vaccines

Europe's medicines regulator is planning to speed up assessments of any Covid-19 vaccines that are modified to protect against variants of the virus, the head of the agency's Covid-19 task-force told Reuters on Friday.

Marco Cavaleri, chair of the vaccine evaluation team at the European Medicines Agency (EMA), said there should be no need for lengthy large-scale trials like those needed to evaluate the first Covid-19 vaccines, since tweaks for new variants can be tested on smaller groups.

"We are working on updated guidelines, assuming that we cannot ask for large Phase III trials. This will allow us to go faster," said Cavaleri.

"We will ask for much smaller trials, with a few hundred participants, rather than 30,000 to 40,000," he told Reuters. He said the EMA would focus primarily on immune response data.

Drugmakers including Pfizer, Moderna and...