Members of the Committee on the Environment, Public Health and Food (ENVI) of the European Parliament, exchange with Emer COOKE, Executive Director of the European Medicines Agency (EMA) on vaccine authorisation, availability and deployment. Statements by Peter LIESE (EPP, DE), and Jytte GUTELAND (S&D, SE).

Exchange of views with Emer COOKE, Executive Director of the European Medicines Agency: extracts

https://api.multimedia.europarl.europa.eu/documents/20125/15357757/I201392Chapters%5BSD-EN%5D.srt

Title: Exchange of views with Emer COOKE, Executive Director of the European Medicines Agency: extracts (I-201392)

Interior, Opening of the exchange of views, (1 shot) 

SOUNDBITE (English), Emer COOKE, Executive Director of the European Medicines Agency (EMA), How to ensure that production capacity can be increased, we're looking at different manufacturing options which require chain formal manufacturing changes in order to increase the production capacity. I think you're all aware of the problems with supply identified at a European level due to some of the manufacturing issues. We're working with the companies on these and we very much hope that this will be short lived.

SOUNDBITE (English), Emer COOKE, Executive Director of the European Medicines Agency (EMA), We're seeing a lot of mutated variants of the Coronavirus, and this requires continuous monitoring of the vaccine performance over time to see how they deal with any of the virus mutations. Now, the current available data suggests that both of the MRNA vaccines can elicit significant levels of protection against the new variants, but we still need additional information and further analysis.

SOUNDBITE (English), Emer COOKE, Executive Director of the European Medicines Agency (EMA), As I've also emphasised before, transparency about our scientific reviews is a top priority for us, and we're implementing exceptional measures to ensure that the member states and the public have all the necessary information to safely roll out vaccinations. We're accelerating the publication of our public assessment reports in order to provide an overview of the submitted data and the full rationale behind our assessment and recommendation for authorisation. And as a completely new activity in the context of covid-19 vaccines, we're publishing all approved risk management systems which help to inform the necessary mitigation measures.

SOUNDBITE (English), Emer COOKE, Executive Director of the European Medicines Agency (EMA), We're accelerating the publication of our public assessment reports in order to provide an overview of the submitted data and the full rationale behind our assessment and recommendation for authorisation. And as a completely new activity in the context of covid-19 vaccines, we're publishing all approved risk management systems which help to inform the necessary mitigation measures. 

SOUNDBITE (English), Peter LIESE (EPP, DE), There is a lot of fake news around in Germany. It has been said that the efficacy with the elderly is only eight percent. I think it's nonsense, but there is a problem with the evidence for the elderly in the data that are available.

SOUNDBITE (English), Jytte GUTELAND (S&amp;D, SE), We expect all pharmaceutical companies to honour this contractual agreement with the European Union without further delay. Anything else is unacceptable. The S&amp;D group stands 100 percent with the citizens and the European Commission on this. I would be interested to hear your view on this situation and the company's explanations for not upholding its end of this agreement.

SOUNDBITE (English), Emer COOKE, Executive Director of the European Medicines Agency (EMA), Just to help solve any type of manufacturing issues that do delay the supply, but we don't have an agreement with the companies as to the specific supply for Europe, but the commission is working on this and you will have seen you will have seen how seriously these delays are taken by the European Commission, who is well-placed.

SOUNDBITE (English), Emer COOKE, Executive Director of the European Medicines Agency (EMA), It is possible to to to conclude an authorisation that would focus on a particular age group or it's possible to conclude for a wider age group. Again, I think the importance for us is to be very transparent about what data has been seen, what evaluation has been made to to come to a conclusion on whatever the decision will be and why we are confident that this is the right decision and that.

Exchange of views with Emer COOKE, Executive Director of the European Medicines Agency: extracts

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