Dit is een belangrijke dag voor Europa.
Het is een dag van echte Europese solidariteit in actie. Na maanden werk levert onze EU-vaccinatiestrategie resultaat op: toegang tot veilige, doeltreffende en betaalbare vaccins tegelijkertijd voor alle lidstaten. Vandaag zien we wat collectief kan worden bereikt wanneer we samenwerken in een sterke Europese gezondheidsunie. Een zorgzaam en ondersteunend Europa. Een Europa dat geen enkele mogelijkheid onbenut laat.”
BioNTech en Pfizer hebben op 1 december een formele aanvraag ingediend voor een voorwaardelijke vergunning voor het in de handel brengen van het vaccin. De aanvraag kwam er nadat het EMA op 6 oktober al was gestart met een voortschrijdende evaluatie van de gegevens naarmate deze beschikbaar werden gemaakt.
Santa comes early with EMA approval of coronavirus vaccine - but so does new mutation
Published 3 months ago
Welcome, welcome, to the last European Alliance for Personalised Medicine (EAPM) update of the year, as Christmas approaches. It has been one of the strangest, hardest years in a generation, but EAPM is looking forward to the end of COVID-19 in 2021 as well as the establishment of the European Health Union supported by the EU4Health funding mechanism,
writes EAPM Executive Director Denis Horgan.
A big thank you
As Christmas looms, now is the time for EAPM to thank all of its stakeholders and the EU health institutions for their support during this very difficult year, it is very much appreciated. In addition, we wish all of our collaborators the very best for 2021 and look forward to collaborating on the many policy issues that we will have on our doorsteps in January. From a regulatory/policy perspective, chief among these are the EU Health Data Space, Pharma Strategy,
12/21/2020 | Press release | Distributed by Public on 12/22/2020 01:47
Europa-Kommissionen godkender den første sikre og effektive vaccine mod COVID-19
Today, the European Commission has granted a conditional marketing authorisation (CMA) for the COVIDâ19 vaccine developed by BioNTech and Pfizer, making it the first COVID-19 vaccine authorised in the EU. This authorisation follows a positive scientific recommendation based on a thorough assessment of the safety, effectiveness and quality of the vaccine by the European Medicines Agency (EMA) and is endorsed by the Member States.
The President of the European Commission, Ursula
von der Leyen, said: Today we add an important chapter to a European success story. We approved the first safe and effective vaccine against COVID-19. More vaccines will come soon. Doses of the vaccine approved today will be available for all EU countries, at the same time, on the same conditions. The upcoming European vaccination days will also
Having drilled the first bolts of its ambitious EU health agenda, the European Commission is now called to the challenging task of creating a trustworthy, patient-centred European health data space.
Expectations are high for this cornerstone of health digitalisation that will seek to make good use of healthcare data for research and innovation, but also for policymaking and regulatory purposes.
In 2021, the Commission is planning a legislative initiative that will be part of the European Health Union, which is intended to reshape the way health is dealt with in the EU.
Investments in the European health data space will be supported by the newly established EU4Health programme, as well as common data spaces and digital health-related innovation under the Horizon Europe and the Digital Europe programmes.
EU Reporter
Coronavirus: Commission puts forward rules on rapid antigen tests and secures 20 million tests for member states
Published 3 months ago
Following up on the Council conclusions of 11 December, the Commission has adopted a proposal for a Council recommendation on a common framework for the use, validation and mutual recognition of rapid antigen tests. Since the outbreak of the COVID-19 pandemic, diagnostic testing has been rapidly evolving, demonstrating its central role in outbreak control. The recommendations put forward by the Commission will ensure the uniform use, validation and recognition of rapid antigen tests in the EU.
The Commission has also today signed a framework contract with Abbott and Roche allowing the purchase of over 20 million rapid antigen tests for up to €100 million, financed by the Emergency Support Instrument (ESI). From early 2021, these tests will be made available to member states, as part of the EU strategy to COVID-19 testing.