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The European Medicines Agency (EMA) approved the BioNTech-Pfizer coronavirus mRNA vaccine on Monday. It means the mass vaccination of some 450 million people across the EU is one step closer. EMA's positive assessment of the vaccine was widely expected. EU countries are currently grappling with a fierce second wave of the virus. The Amsterdam-based drug regulator was under pressure from European countries, including Germany, to speed up its decision, which was originally scheduled for December 29. The recommendation applies to those of at least 16 years of age, EMA director Emer Cooke said. Aside from age, limitations also apply to pregnant women. As only limited data is available for that group, it should be assessed on a case-by-case basis whether it would be safe to give a jab, said Harald Enzmann, Chair of EMA Human Medicines Committee.
What are the next steps?
Having gained the green light from the European Medicines Agency (EMA), the final step is approval by the European Commission, which is expected later on Monday. Preparations for the vaccine rollout come as the identification of a highly infectious new strain of the coronavirus in Britain caused chaos across the region, with countries shutting off travel ties with the UK and disrupting trade ahead of the Christmas holiday. EMA officials told a news briefing that it was highly likely the vaccine would work against the new variant of the coronavirus. German officials have said the rollout could begin on December 27. The pharmaceutical companies will also need to submit follow-up data on their vaccine for the next year. EMA said it had worked around the clock but needed to make sure the vaccine was safe and effective before giving its approval.
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