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  • Full assessment report available for first authorised COVID-19 vaccine
    COVID-19 vaccine - Comirnaty - marketing authorisation slider
    COVID-19 |Vaccine

    Full assessment report available for first authorised COVID-19 vaccine

  • Full assessment report available for first authorised COVID-19 vaccine
    COVID-19 vaccine - Comirnaty - marketing authorisation slider
    COVID-19 |Vaccine

    Full assessment report available for first authorised COVID-19 vaccine

    EMA has published the assessment report for Comirnaty, the first COVID-19 vaccine to be authorised in the EU, together with the product information in all official EU languages.

  • Second public meeting on COVID-19 vaccines
    second public meeting
    COVID-19 |EVENT

    Second public meeting on COVID-19 vaccines

  • Second public meeting on COVID-19 vaccines
    second public meeting
    COVID-19 |EVENT

    Second public meeting on COVID-19 vaccines

    Apply now to ask a question during our virtual meeting on Thursday 8 January. The event will be broadcast, with updates on the assessment, approval and roll-out of COVID-19 vaccines.

  • Management Board: Highlights of December 2020 meeting
    Management Board meeting highlights
    Management Board |Highlights

    Management Board: Highlights of December 2020 meeting

  • Management Board: Highlights of December 2020 meeting
    Management Board meeting highlights
    Management Board |Highlights

    Management Board: Highlights of December 2020 meeting

    The Board focused in particular on the Agency’s activities in response to the COVID-19 pandemic. It also adopted EMA’s budget for 2021.

  • Development, evaluation and monitoring of COVID-19 vaccines
    COVID-19 vaccines tier 2 slider
    COVID-19 |VACCINES

    Development, evaluation and monitoring of COVID-19 vaccines

  • Development, evaluation and monitoring of COVID-19 vaccines
    COVID-19 vaccines tier 2 slider
    COVID-19 |VACCINES

    Development, evaluation and monitoring of COVID-19 vaccines

    Read about how EMA is ensuring vaccines for COVID-19 meet the highest standards of quality, safety & efficacy while their development and approval is sped up due to the public health emergency.

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Latest news

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    23/12/2020

    IT systems temporarily unavailable from 31 December 2020 to 1 January 2021

    Several European Medicines Agency (EMA) information technology (IT) systems will be temporarily unavailable between 08:00 on Thursday 31 December 2020 and 18:00 on Friday 1 January 2021 (Central European Time, CET). This is due to essential...

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    22/12/2020 COVID-19

    EMA organises a second public meeting about the new COVID-19 vaccines

    EMA will organise a second public meeting on 8 January 2021 to inform European citizens about the assessment, approval and roll-out of new COVID-19 vaccines. Together with the EU medicines regulatory network, EMA has been working around the clock to...

  • List item
    22/12/2020

    Cyberattack on EMA - update 3

    The ongoing investigation of the cyberattack on EMA, carried out by the Agency in close collaboration with law enforcement and other relevant entities, has revealed that the data breach was limited to one IT application. The perpetrators primarily...

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    21/12/2020 COVID-19

    EMA recommends first COVID-19 vaccine for authorisation in the EU

    Update: Comirnaty is now authorised across the EU. This follows the granting of a conditional marketing authorisation by the European Commission on 21 December 2020. EMA has recommended granting a conditional marketing authorisation for the vaccine...

  • List item
    18/12/2020

    Cyberattack on EMA - update 2

    EMA has engaged a specialised third-party service provider to support the full investigation that is currently being carried out in close cooperation with law enforcement and other relevant entities. This company will contribute to the additional...

  • List item
    18/12/2020 COVID-19

    EMA Management Board: highlights of December 2020 meeting

    The December 2020 meeting of the Management Board was Emer Cooke’s first Board meeting as EMA's Executive Director since she took up leadership of EMA in November. Update on COVID-19 The Management Board was updated that evaluation of applications...

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