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Europe: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment
European Medicines Agency
News & Press Releases
News: EMA starts review of VIR-7831 for treating patients with COVID-19 (new)
CHMP, Last updated: 15/04/202
EMA is reviewing currently available data on the use of the monoclonal antibody VIR-7831 (also known as GSK4182136) in the treatment of patients with COVID-19. EMA is starting this review to support national authorities who may decide on the use of this medicine for COVID-19 prior to marketing authorisation…
News: COVID-19 Vaccine Janssen: assessment of very rare cases of unusual blood clots with low platelets continues (new)
PRAC, Last updated: 14/04/2021
Statement 14 April 2021
Statement by President von der Leyen on developments in the Vaccines Strategy
The COVID-19 pandemic remains a severe threat to people’s health and livelihoods. We are in a race against time. The faster we reach our target of having 70% of adults in the European Union vaccinated, the better chances we have of containing the virus.
And the good news is: Vaccination is picking up speed across Europe! Member States have received over 126 million doses of vaccines as of yesterday. And I am happy to say that today we have reached 100 million vaccinations in the EU. This is a milestone that we can be proud of. Of these 100 million vaccinations, more than a quarter are second doses – which means that we have now more than 27 million people fully vaccinated.
This is good news. But as we can see with the announcement by Johnson & Johnson yesterday, there are still many factors that can disrupt the planned delivery schedule of vaccines. It is therefore important to act swiftly, anticipate and adjust whenever possible. We are doing everything in our power to support Europe’s vaccination roll-out, also by increasing the supply of vaccines in the coming weeks and months.
This is why I am pleased to announce that we have reached an agreement with BioNTech-Pfizer to, once again, speed up the delivery of vaccines. 50 million additional doses of BioNTech-Pfizer vaccines will be delivered in quarter 2 of this year, starting in April. Those 50 million doses were initially foreseen for delivery in the fourth quarter of 2021. Now, they are available in quarter 2.
This will bring the total doses delivered by BioNTech-Pfizer to 250 million doses in the second quarter. These doses will be distributed pro-rata to the population, among all the Member States. This will substantially help consolidate the roll-out of our vaccination campaigns. I want to thank BioNTech-Pfizer. It has proven to be a reliable partner. It has delivered on its commitments, and it is responsive to our needs. This is to the immediate benefit of EU citizens.
But let me also focus on the medium term. To prepare for the future, we are drawing the lessons from the first phase of our answer to the pandemic. It is clear that to defeat the virus decisively, we will need to be prepared for the following: At a certain point in time, we might need booster jabs to reinforce and prolong immunity; and if escape-variants occur, we will need to develop vaccines that are adapted to new variants; and we will need them early and in sufficient quantities. Having this in mind we need to focus on technologies that have proven their worth. mRNA vaccines are a clear case in point.
Based on all this, we are now entering into a negotiation with BioNTech-Pfizer for a third contract. This contract will foresee the delivery of 1.8 billion doses of vaccine over the period of 2021 to 2023. And it will entail that not only the production of the vaccines, but also all essential components, will be based in the EU.
The negotiations we are launching today – and hope to conclude very rapidly – are a further important step in Europe’s response to the pandemic. Other contracts, with other companies, may follow. We are in this together. And we will win this fight against the pandemic together…Thank you.