<p>Vaccines are a key part of a long-term strategy to bring SARS-CoV-2 under control. It is essential to roll out vaccination rapidly to protect as many people as possible and to lower the opportunities for the virus to evolve further. Any vaccine must be authorised by the European Medicines Agency (EMA).</p>

<p>The European Commission has secured up to 4.4 billion doses of COVID-19 vaccines so far - and negotiations are underway for additional doses. However, countries are facing different challenges around the disinformation or vaccine acceptance. The European Parliament is trying to keep an eye on the purchase and safety of these vaccines. During June plenary the EP adopted a resolution calling for COVID-19 vaccine patent waiver. Parliament proposed negotiations start for a temporary waiver of the WTO TRIPS Agreement on patents to improve global access to affordable COVID-19-related medical products and to address global production constraints and supply shortages. The EP approved also the Digital Green Certificate to facilitate the safe free movement of citizens within the EU during the pandemic.</p>

EU Vaccine Strategy

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

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

EP Plenary session - European Medicines Agency

Vaccination campaign

Press point ' Relocation of the European Medicines Agency '

Milan for EMA puts public health first.

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

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

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

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

During the plenary session (5-8 July 2021) of the European Parliament in Strasbourg, MEPs debate on European Medicines Agency: closing statement by Stella KYRIAKIDES, European Commissioner for Health and Food Safety.

European Medicines Agency: closing statement by Stella KYRIAKIDES, European Commissioner for Health and Food Safety

During the plenary session (5-8 July 2021) of the European Parliament in Strasbourg, MEPs debate on European Medicines Agency.

European Medicines Agency: MEPs debate

Press conference prior to the debate in Plenary on a stronger role for the European Medicines Agency and extending its mandate to prepare for crises and manage medicinal products and medical devices, following lessons learned from the COVID-19 pandemic.

Press conference by Nicolás GONZÁLEZ CASARES (S&D, ES), rapporteur, on reinforcing the mandate of the European Medicines Agency

During the plenary session (5-8 July 2021) of the European Parliament in Strasbourg, MEPs debate on European Medicines Agency: opening statements by Nicolás GONZÁLEZ CASARES (S&D,ES), Rapporteur and by Stella KYRIAKIDES, European Commissioner for Health and Food Safety. This transcription is the result of an automatic process. Please check against delivery.

European Medicines Agency: opening statements by Nicolás GONZÁLEZ CASARES (S&D, ES), Rapporteur and by Stella KYRIAKIDES, European Commissioner for Health and Food Safety

For a drug to be prescribed to a patient, it must first be rigorously tested for efficacy and safety and subsequently be approved by relevant authoritative bodies, such as the European Medicines Agency (EMA). However, the current framework of drug development is heavily ‘drug-focused’ rather than ‘patient-focused’. This means that the end users of the drug, the patients, are not generally placed at the centre of the drug development paradigm. Medical treatment is insufficiently personalised, especially when fighting cancer. In other words, achieving regulatory approval is seen as the ultimate goal, eclipsing somewhat the use of a drug in its real-world setting. This is not helped by the lack of regulatory demands or incentives for gathering such real world data. Restrictions: ©The material may not be edited and must be shown entirely.

EPRS - Tailoring medicine to patient needs

Public health MEPs agree to change the European Medicines Agency’s mandate, to reinforce its role and better equip the EU to manage future health crises. MEPs propose the creation of an interoperable digital EU database to monitor and report on shortages of medicinal products. Statement by Nicolás GONZÁLEZ CASARES (S&D, ES), rapporteur.

Reinforced role for the European Medicines Agency: vote in ENVI Committee and statement by Nicolás GONZÁLEZ CASARES (S&D, ES), rapporteur

Emer COOKE, European Medicines Agency (EMA) Executive Director update MEPs from the Environment, Public Health and Food Security Committee on the state of play in the evaluation and market authorisation of vaccines against COVID-19 and the next steps. And Members of the Budgets Control Committee and the Commission’s Director-General for Health and Food Safety (SANTE), Sandra GALLINA, discuss the current state of the EU’s advance purchase agreement on vaccines against COVID-19.

Update of purchase, evaluation and authorization of COVID-19 vaccines: extracts from the exchanges of views with Sandra GALLINA, Director-General of DG SANTE (CONT) and with Emer COOKE, EMA Executive Director (ENVI)

Members of the Committee on the Environment, Public Health and Food Safety (ENVI) exchange views on the update of evaluation and authorization of COVID-19 vaccines, with Emer COOKE, Executive Director of the European Medicines Agency's (EMA), in the European Parliament in Brussels. Opening statements by Pascal CANFIN, ENVI Chair, and Emer COOKE. This transcription speech is the result of an automatic process. Check against delivery.

Update of evaluation and authorization of COVID-19 vaccines - Exchange of views with Emer COOKE, EMA Executive Director: opening statements by Pascal CANFIN, ENVI Chair, and Emer COOKE

Members of the Committee on the Environment, Public Health and Food Safety (ENVI) exchange views on the update of evaluation and authorization of COVID-19 vaccines, with Emer COOKE, Executive Director of the European Medicines Agency's (EMA), in the European Parliament in Brussels. Questions & answers

Update of evaluation and authorization of COVID-19 vaccines - Exchange of views with Emer COOKE, EMA Executive Director: questions & answers

Members of the Committee on the Environment, Public Health and Food Safety (ENVI) exchange views on the update of evaluation and authorization of COVID-19 vaccines, with Emer COOKE, Executive Director of the European Medicines Agency's (EMA), in the European Parliament in Brussels. Closing statements by Pascal CANFIN, ENVI Chair, and Emer COOKE.

Update of evaluation and authorization of COVID-19 vaccines - Exchange of views with Emer COOKE, EMA Executive Director: closing statements by Pascal CANFIN, ENVI Chair, and Emer COOKE

The Environment, Public Health and Food Security Committee (ENVI) hold a debate on COVID-19 variants and how effective vaccines are against them with representatives from the European Medicine Agency (EMA), the European Centre for Disease Prevention and Control (ECDC) and the World Health Organisation (WHO). Following this meeting, Pascal CANFIN (RE, FR), ENVI Chair, gives a statement on a faster authorisation process for updated vaccines and on the role of vaccination certificates.

COVID-19 variants and the vaccines' efficacy: statement by Pascal CANFIN (Renew, FR), ENVI Chair

Members of the EP Committee on Environment, Public Health and Food Safety exchange their views on COVID-19 variants and the vaccines' efficacy. Opening statements by Pascal CANFIN (Renew, FR), ENVI Chair, Marco CAVALERI, Head of Biological health threats and vaccines strategy and Chair of the COVID-19 Emergency Task Force, EMA, Bruno CIANCO, Head of Surveillance section, ECDC and Katherine O’BRIEN, Department of Immunization, Vaccines and Biologicals Director, World Health Organization, (WHO)

Exchange of views on COVID-19 variants and the vaccines' efficacy: opening statements by Pascal CANFIN (Renew, FR), ENVI Chair, Marco CAVALERI (EMA), Bruno CIANCO (ECDC) and Katherine O’BRIEN (WHO)

Emer COOKE, Executive Director of the European Medicines Agency, answers questions posed by the members of the Committee on the Environment, Public Health and Food Safety on vaccine authorisation, availability and deployment.

Exchange of views with Emer COOKE, Executive Director of the European Medicines Agency EP Committee on the Environment, Public Health and Food Safety: questions/answers with the MEPs

Emer COOKE, Executive Director of the European Medicines Agency, exchanges with the members of the Committee on the Environment, Public Health and Food Safety on vaccine authorisation, availability and deployment .

Exchange of views with Emer COOKE, Executive Director of the European Medicines Agency EP Committee on the Environment, Public Health and Food Safety: opening statement

The Committee on Environment and Public Health (ENVI) discuss how to ensure fast approval of safe COVID-19 vaccines and treatments in the EU with Guido RASI, Executive Director of the European Medicines Agency (EMA), in the European Parliament in Brussels.

EMA’s activities on COVID-19 and prospects for the future: extracts from the exchange of views with Guido RASI, Executive Director of European Medicines Agency (EMA)

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