EXCLUSIVE-EU drugs regulator plans to fast track variant-modified COVID vaccines - (NASDAQ via NewsPoints Desk)

  • The European Medicines Agency (EMA) plans to speed up assessments of COVID-19 vaccines modified to protect against variants of the virus, Marco Cavaleri, chair of the agency’s vaccine evaluation team, said on Friday, as reported in NASDAQ.

  • Cavaleri said there should be no need for lengthy large-scale trials since tweaks for variants can be tested on smaller groups. "We will ask for much smaller trials, with a few hundred participants, rather than 30,000 to 40,000," he said, adding that the EMA would focus primarily on immune response data.

  • The FDA said last week that it is considering a rapid review process for the quick turnaround of new COVID-19 booster shots if vaccines do not provide protection against variants that emerge.

  • Pfizer and BioNTech, as well as AstraZeneca and Moderna have said they are preparing for the possibility that variants will emerge that could require tweaks to their vaccines.

  • "We will also try to streamline regulatory procedures doing something similar to what happens with flu vaccines. In short, without the drugmakers having to submit all the preliminary data again", Cavaleri said.

  • He added that the agency is aware that it may soon be no longer possible to conduct clinical trials with placebo for categories such as the elderly, due to rollout of current COVID-19 vaccines. "In that case we could think about a head-to-head comparison with an already approved vaccine", he said.

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