The Executive Director of the European Medicines Agency (EMA), Emer Cooke debates with the members of the Environment and Public Health Committee the latest developments in the COVID-19 vaccination campaign (including reviews, authorisations for paediatric use and boosters), as well as recent developments around COVID-19 therapeutics and the general epidemiological situation

Committee on Environment, Public Health and Food Safety

KONEČNÁ, Kateřina (NI, CZ)

LIESE, Peter (EPP, DE)

CLUNE, Deirdre (EPP, IE)

RIES, Frédérique (Renew, BE)

MÉLIN, Joëlle (ID, FR)

RIVASI, Michèle (Greens/EFA, FR)

AUKEN, Margrete (Greens/EFA, DK)

GROOTE, Matthias (S&D, DE)

BUŞOI, Cristian-Silviu (EPP, RO)

European Medicines Agency

BORG, Tonio (MT)

MONTSERRAT, Dolors (EPP, ES)

METZ, Tilly (Greens/EFA, LU)

COLIN-OESTERLÉ, Nathalie (EPP, FR)

TRILLET-LENOIR, Véronique (Renew, FR)

GONZÁLEZ CASARES, Nicolás (S&D, ES)

TÓTH, Edina (NI, HU)

CERDAS, Sara (S&D, PT)

COOKE, Emer (IE)

EU's response to covid-19 (T)

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

SOUNDBITE (English), Cristian-Silviu BU&#350;OI (EPP, RO), Question on the EMA&rsquo;s contingencies plans, particularly in regard of the newly emerged Omicron variant. Furthermore, is it asked to comment on the new medicines that are currently being developed as an alternative to vaccines.

SOUNDBITE (English), Peter LIESE (EPP, DE), Question concerning vaccines patent approval and on the procedure that the EMA is putting in place to accept/reject adapted vaccines coming from already approved producers.

SOUNDBITE (English), Nicol&#225;s GONZ&#193;LEZ CASARES (S&amp;D, ES), Question on the Omicron variant and on vaccination rates across Europe, particularly on how long it will take for the EMA to approve adapted vaccines.

SOUNDBITE (English), Fr&#233;d&#233;rique RIES (Renew, BE), Question on the effectiveness of the so-called &ldquo;booster dose&rdquo; against COVID.

SOUNDBITE (English), Tilly METZ (Greens/EFA, LU), Question addressing the lack of accessible official data on vaccine experimentation for the general-public.

SOUNDBITE (English), KONE&#268;N&#193; Kate&#345;ina (The Left, CZ), Question concerning adapted vaccines and the approval procedure by the EMA.

SOUNDBITE (English), Dolors MONTSERRAT (EPP, ES), Question asking if the agency is planning to regularly accelerate approval procedures for other life-saving medications as it did with COVID vaccines.

SOUNDBITE (French), V&#233;ronique TRILLET-LENOIR (Renew, FR), Question concerning the approval procedure for new COVID vaccines and on the effectiveness of the current EMA&rsquo;s mandate.

SOUNDBITE (French), Mich&#232;le RIVASI (Greens/EFA, FR), Question on the use of the Pfizer vaccine against COVID in the under-10 age groups.

SOUNDBITE (English), Petros KOKKALIS (The Left, EL), Question on methods to stop the spread of COVID and the rise of variants: the procedure to adapt vaccines to better tackle variants and on the global access to COVID medications.

SOUNDBITE (French), Jo&#235;lle M&#201;LIN (ID, FR), Question on the adaptation of vaccines, and on what work is being done by the EMA to prevent future epidemics. Also, alternative therapeutic solutions against COVID are discussed.

SOUNDBITE (English), Deirdre CLUNE (EPP, IE), Question on the adaptation procedure of vaccines and the effectiveness of tests conducted on children.

SOUNDBITE (English), Sara CERDAS (S&amp;D, PT), Question on the EMA&rsquo;s mandate and on how the agency is preparing to face other future health crisis in the aftermath of the current COVID pandemic.

SOUNDBITE (English), Margrete AUKEN (Greens/EFA, DK), Question on the new Clinical Trial Regulation that EMA will present in the coming weeks.

SOUNDBITE (French), Nathalie COLIN-OESTERL&#201; (EPP, FR), Question on the current mandate of EMA and its potentialities and limitations.

SOUNDBITE (English), Edina T&#211;TH (NI, HU), Question asking why the approval of some specific vaccines is being currently slowed down, despite the fact that they are already being widely used globally.

SOUNDBITE (English), Tonio BORG, Answer analyzing the vaccines-approval procedure as well as discussing the pressure that the pandemic put on EMA and also explain how the agency is actually coping. Furthermore, the future developments of the agency are discussed.

SOUNDBITE (English), Matthias GROOTE, Statement calling for more flexibility from institutions, especially when dealing with the rise of the OMICRON variant. Furthermore, the need to speed up vaccinations approval procedures as well as the importance access to medication is discussed.

SOUNDBITE (English), Emer COOKE, EMA Executive Director, Opening remarks presenting the main topics that will be consequently discussed. Particular attention is given to explain how the EMA is prepared to tackle virus mutations, and on how guidance for companies are already in place.

SOUNDBITE (English), Emer COOKE, EMA Executive Director, Answer explaining the preparedness of EMA to tackle the new variant, furthermore the different factors that could affect the spread of the OMICRON variant in Europe are discussed.

SOUNDBITE (English), Emer COOKE, EMA Executive Director, Answer explaining the importance of booster-doses and how EMA is ready preparing to potentially change the current vaccines in order to better adapt to the newly emerged OMICRON variant.

SOUNDBITE (English), Emer COOKE, EMA Executive Director, Answer explaining the importance of the &ldquo;rolling review&rdquo; procedure as well as on the possibility of using it again in future scenarios. Yet it will not always possible to use it.

SOUNDBITE (English), Emer COOKE, EMA Executive Director, Analysis of the EMA&rsquo;s mandate and the resources that agencies is currently able to deploy.

SOUNDBITE (English), Emer COOKE, EMA Executive Director,, Closing remarks.