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The European Commission (EC) expects pharmaceutical companies Pfizer-BionTech and Moderna to apply for the first marketing authorizations for vaccines in the European Union (EU) in the second half of December, the president of the European Union reported on Thursday. institution, Ursula von der Leyen. .
These laboratories have transferred to Brussels that if there are no shocks, the official request for validation of their vaccine “could come as quickly as the second half of December”, said Von der Leyen after a video summit of EU leaders devoted largely to the coronavirus.
The president of the community executive explained that it would only be a question of requesting the “conditional marketing authorization” from the European Medicines Agency (EMA), which works in close collaboration and in real time. with pharmaceutical companies and their counterpart in the United States. the FDA.
This is only “the first of the steps” for the full availability of the first vaccines once proven to be safe and effective, added Von der Leyen, an end for which he did not propose a timetable.
“At the beginning come small numbers (of doses). Large numbers come later”, added the president of the EC, a doctor by training.
The European Commission is negotiating the joint purchase of vaccines for the countries of the European Union and “all the countries have joined forces to buy all the vaccines” from the diverse portfolio that Brussels is building.
So far, the EC has signed five contracts with European and American pharmaceutical companies Sanofi-GSK, Curevac, AstraZeneca and the University of Oxford and Johnson & Johnson, in addition to negotiating with Moderna and in talks with Novavax.
These cutting-edge contracts “four different types of technologies to produce a vaccine, and some may work better in certain population groups than others,” said Von der Leyen.
Asked whether the virtual summit discussed Hungary’s acceptance of vaccines from Hungary, Von der Leyen said the leaders had not addressed the issue.
But he stressed that it is essential that vaccines generate “safety and confidence”, which is achieved “if there is transparency on vaccine development and clinical trials” by sharing this information with the EMA and asking for its approval, which Russia did not do. with his Sputnik V.
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