The application for the emergency use of the Covid-19 vaccine is addressed to the European Drug Administration.
REPUBLIKA.CO.ID, FRANKFURT – Company Pfizer and BioNTech apply for an emergency use permit the Covid-19 vaccine made to European drug regulators, following similar moves in the United States and the UK, the company said on Tuesday. The submissions to the European Drug Administration (EMA) come after the two companies filed for approval in the US on November 20, taking a step closer to launching their production vaccine.
In applying for permits in Europe, which is likely this year, the two partners are in close competition with Moderna, which on Monday (30/11) said it would ask European regulars to recommend conditional approval for its Covid-19 vaccine.
US drugmaker Pfizer and Germany’s BioNTech reported results of a final stage clinical trial on November 18, which showed that their vaccine was 95 percent effective at preventing Covud-19, without significant safety concerns. That raises hopes that the US and Europe will give their blessing in early December.
The European submission completes the so-called rolling review process, which was started by the EMA on 6 October.
The UK government said last week that its US-German partners reported their final clinical trial data to the UK’s Medical and Health Regulatory Agency (MHRA).
source: Antara / Reuters
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