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December 12th, 2020 
Awake Goy 
With someone dying from COVID-19 every 17 seconds according to the World Health Organization (WHO), there are high expectations for the coronavirus vaccines currently under scrutiny and awaiting approval by the EU.
The responsibility is a heavy one and it resides with Emer Cooke, the new Executive Director of the European Medicines Agency (EMA), and her team.
According to news outlet Politico, she is one of the 28 most important people in Europe today – and has her work cut out for her to approve a vaccine for citizens in EU member states as quickly as fairly as possible.
“We have two vaccines under active evaluation. We received them on 1 September and we are expected to have a scientific opinion on 29 December at the latest for Pfizer and BioNTech and on 12 January on Moderna vaccine,” she said in an interview with Euronews via videolink.
The former 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 authorisation process under EU law, but she said a robust assessment process was underway in the EU to make sure that the 27 EU countries would have a proper license.
“It is a very robust assessment process involving our scientific committee, a peer review process, back and forth to make sure we have not missed anything and it is at the end of that process that we would conclude whether we are satisfied that the benefits outweigh the risks and the vaccine is of high quality, high safety and efficacious,” she said.
As well as approving its initial licence, Cooke explained that a ‘post-authorisation follow up’ would continue to study the safety once it has been used in much higher populations than it was used in clinical trials.
Some 30,000 subjects were studied by companies during clinical trials, mainly adults and elderly but also patients with existing conditions, but Cooke said it is her responsibility to inform the public about the “safety and quality of the vaccine”.
“We are the source of the data on the product. We know more about this than anybody except the company. And if people are concerned, we want to do whatever we can to make sure you are happy, that you can trust the vaccine, that is our responsibility,” she said, adding that it could be a “good idea” for her to take it on live TV to instill confidence in the vaccine.
Watch the full interview with the new EMA Director Emer Cooke in the media player above
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