Europe's drugs regulator speeds up the approval process for Pfizer and BioNTech's COVID-19 vaccine

Europe's drugs regulator speeds up the approval process for Pfizer and BioNTech's COVID-19 vaccine
A volunteer receives an experimental vaccination for the coronavirus in a clinical trial at the University of Maryland's medical school.University of Maryland
  • Europe's drugs regulator has fast-tracked the approval process for a COVID-19 vaccine developed by Germany's BioNTech and the US pharmaceutical group Pfizer.
  • The "rolling review" by the European Medicines Agency could speed up authorization of the vaccine.
  • It means the EMA does not have to wait for trials to finish before reviewing data.
  • The decision to begin the review is based on the results of earlier clinical trials that found the vaccine triggered an immune response in humans, the EMA said on Tuesday.

Europe's drug regulator has taken action that could speed up the approval of a COVID-19 vaccine developed by Germany's BioNTech and the US pharmaceutical group Pfizer.

A new "rolling review" launched by the European Medicines Agency on Tuesday will evaluate how effective the vaccine is in real time as data returns from patient trials. This means the agency will not wait for BioNTech and Pfizer to finish their trials and submit all the data at once.

The review could therefore speed up authorization of the vaccine should it ultimately prove safe and effective.
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The agency on Tuesday said it had begun looking at data from laboratory studies on the vaccine. It would continue to assess data until it had enough to make a final decision, it said.

The decision to kick off the rolling review of BioNTech and Pfizer's COVID-19 vaccine is based on the results of earlier clinical trials in adults that found the vaccine triggered an immune response, the agency said.

The vaccine is the second COVID-19 candidate to be approved for a rolling review by the EMA. The agency confirmed on Thursday that it had started a rolling review of the vaccine developed by AstraZeneca and the University of Oxford. This followed a pause in trials of the vaccine, after a participant reported severe neurological symptoms — the UK has resumed trials, while the US is still investigating.
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Pfizer's vaccine is in late-stage studies in the US, Brazil, South Africa, and Argentina.

BioNTech and Pfizer's vaccine could be one of the earliest COVID-19 candidates to be approved in Europe. The race for a vaccine on the continent is becoming ever more urgent as the infection rate rises. The known global coronavirus death toll passed 1 million on September 29.
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