Members of the EP Committee on the Environment, Public Health and Food Safety exchange with Emer COOKE, Executive Director of the European Medicines Agency (EMA). Emer COOKE stressed that people will need to extend the protection againt COVID with a booster again, especially with the threat of the new variant Omicron. Some MEP's pointed out that citizens have the right to be informed and to have access to the clinical trial data.

exchange of views

Committee on Environment, Public Health and Food Safety

RIES, Frédérique (Renew, BE)

BUŞOI, Cristian-Silviu (EPP, RO)

European Medicines Agency

METZ, Tilly (Greens/EFA, LU)

GONZÁLEZ CASARES, Nicolás (S&D, ES)

COOKE, Emer (IE)

EU's response to covid-19 (T)

Exchange of views with Emer COOKE, Executive Director of the European Medicines Agency (EMA): Extracts - ENVI Committee

https://api.multimedia.europarl.europa.eu/documents/20125/15454153/I214864Chapters%5BSD-EN%5D.srt

SOUNDBITE (English), Emer COOKE, Executive Director of the European Medicines Agency (EMA), Even if the new variant becomes more widespread, the vaccines we have will continue to provide protection. Now, the effectiveness of these vaccines is waning over time, and it's becoming increasingly clear that people will need to extend the protection with a booster again, very important with the threat of the new variant.

SOUNDBITE (English), Emer COOKE, Executive Director of the European Medicines Agency (EMA), I have to also stress that we have much more tools to fight this pandemic now than we had last winter. Vaccines are and remain the key to and we have four authorized vaccines and four more currently under review. The vaccine from Novavax could be authorized within a matter of weeks.

SOUNDBITE (English), Cristian-Silviu BU&#350;OI (EPP, RO), Regarding COVID-19 therapeutics, we have promising news indeed, as you mentioned, while the use of outpatient oral antiviral therapeutics are getting new options, and we have seen very encouraging data coming out during the last couple of weeks, this will help us to prevent hospitalisation or one. Well, while some patients will be in the hospital to prevent serious cases and ICU cases.

SOUNDBITE (Spanish), Nicol&#225;s GONZ&#193;LEZ CASARES (S&amp;D, ES), We see this new Omicron variant which is coming to Europe. We don't know the extent. There's a lot of lack of knowledge at the moment, but it's clear that we need to adapt quickly or that we have a route for adapting the vaccines quickly. And some vaccines can be adapted more quickly than others.

SOUNDBITE (French), Fr&#233;d&#233;rique RIES (Renew, BE), The third dose, the booster is clearly the priority. The infection is exploding, Europe has become the world's centre. Hospitals are under pressure and now we have the appearance of this new Omicron variant detected in South Africa.

SOUNDBITE (English), Tilly METZ (Greens/EFA, LU), Taxpayers funds have heavily contributed to research and development of COVID-19 vaccine trials and should have the right to access to the results. However, I note that there is insufficient availability of COVID-19 vaccine trial documents and data. In May, 2021 WHO's report found that out of 86 clinical trials for 20 COVID-19 vaccine, only 12 percent of clinical trials protocol were made publicly available. This is not just an issue of taxpayers funds, but also an issue of trust. Trust in the European institutions can be built by transparency, and citizens have the right to be informed and to have access to the data they have found it.

SOUNDBITE (English), Emer COOKE, Executive Director of the European Medicines Agency (EMA), We know that at some stage there will be a mutation. That means we have to change the current approach. And for that reason, we put in place guidance for companies back in February last year. We haven't had to use that yet. So that's why there are not a lot of vaccines on the market so far, because actually the existing vaccines have shown that they continue to be effective against the circulating variants in Europe. And we don't know whether this will continue with the Omicron variant or not.

SOUNDBITE (English), Emer COOKE, Executive Director of the European Medicines Agency (EMA), But I did want to say specifically on the publication of clinical trial data that we are committed to transparency. For all the COVID vaccines and therapeutics, we have published the clinical trial data. We've done that very quickly following the authorisation and we are committed to doing that.

Cutaways : general view of the meeting room (7 shots)