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With someone dying from COVID-19 every 17 seconds according to the World Health Organization (WHO), there are high expectations for coronavirus vaccines that are currently under scrutiny and awaiting EU approval.
The responsibility is heavy and falls on Emer Cooke, the new CEO of the European Medicines Agency (EMA), and her team.
According to the Politico media outlet, she is one of the 28 most important people in Europe today, and she has a lot of work to do to approve a vaccine for citizens in EU member states as quickly and fairly as possible.
“We have two vaccines under active evaluation. We received them on September 1 and we are expected to have a scientific opinion no later than December 29 for Pfizer and BioNTech and by January 12 on the Moderna vaccine,” he said in an interview with Euronews. . via videolink.
The first is currently being rolled out in the UK, the first country in the world to approve the Pfizer vaccine. According to Cooke, the UK moved faster as it was using a temporary authorization process under EU law, but said a robust assessment process was underway in the EU to make sure the 27 countries of the EU had a proper license.
“It is a very robust evaluation process that involves our scientific committee, a peer review process, back and forth to make sure that we have not missed anything and it is at the end of that process that we would conclude if we are satisfied that the The benefits outweigh the risks and the vaccine is of high quality, safety and efficacy, ”he said.
In addition to approving its initial license, Cooke explained that a ‘post-authorization follow-up’ would continue to study safety once it has been used in much larger populations than in clinical trials.
The companies studied about 30,000 subjects during clinical trials, mainly adults and the elderly, but also patients with existing diseases, but Cooke said it is their responsibility to inform the public about the “safety and quality of the vaccine.”
“We are the source of the product data. We know more about this than anyone except the company. And if people are concerned, we want to do everything we can to make sure that they are happy, that they can trust the vaccine,” that’s it. our responsibility, “he said, adding that it might be a” good idea “for him to broadcast it on live television to instill confidence in the vaccine.
Watch the full interview with EMA’s new director Emer Cooke in the media player above
