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The European Medicines Agency (EMA) announced on Tuesday that it will hold an extraordinary meeting on December 29 to give or not the green light for the commercialization of the anti-Covid vaccine developed by the German company BioNTech and the American company Pfizer, reports Agerpres. citing AFP.
“If the information presented is robust enough to draw conclusions about the quality, safety and efficacy of the vaccine, the EMA will finalize its evaluation at a special meeting scheduled for December 29 at the latest,” it said in a statement. reported to the European agency, according to the cited source.
Apart from Pfizer / BioNTech, only the American company Moderna has so far applied for authorization of its anti-Covid vaccine for commercialization in the EU market. The latter is awaiting a decision from the EMA no later than January 12, 2021, reports dpa and Reuters.
Vaccination is postponed in the EU
The Financial Times notes that the European regulator has promoted the formal evaluation of the Pfizer / BioNTech and Moderna vaccines by the end of the year, or by the first half of January, postponing their distribution in EU countries until next year.
Member states would approve the vaccines individually, three to four days after the EMA’s decision, the source said.
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In the initial scenario, both vaccines should have been evaluated by December 22 at the latest, FT writes.
Pfizer and BioNTech completed submission of documents to the EMA on Monday, but on Sunday, representatives of the German company said they could deliver the vaccine after mid-December.
On the other hand, the vaccine produced by AstraZeneca, in collaboration with the University of Oxford, will not be examined until January, the cited source also states.
UK and US have a different approach
Recently, Member State officials have been lobbying the EMA to align itself with the UK and US regulators.
While in the UK the Pfizer / BioNTech vaccine could be approved this week, the US authorities are expected to make a decision in mid-December.
Medical authorities in the two states have announced that immunizations will begin a few days after the vaccines are authorized.
Instead, the EMA claims it will grant conditional authorization if it concludes that “the benefits of the vaccine outweigh its risks in protecting against Covid,” the source said.
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