NewsWorldEuropean medicines regulator approves Pfizer-BioNTech COVID-19 vaccine

European medicines regulator approves Pfizer-BioNTech COVID-19 vaccine

Europe’s medicines regulator on Monday (December 21) approved the use of the COVID-19 vaccine jointly developed by U.S. company Pfizer and its German partner BioNTech , putting Europe on course to start inoculations within a week.

European Union countries including Germany, France, Austria and Italy have said they plan to start vaccinations from Dec. 27 as Europe tries to catch up with the United States and Britain, where inoculations began earlier this month.

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.

The EMA had started a rolling review of preliminary data from Pfizer trials on Oct. 6 in an effort to speed an approval process that usually takes at least seven months.

The EMA clearance, initially granted as conditional marketing approval (CMA), is valid for one year and can be renewed annually. It can be converted into a standard marketing authorisation after further data checks. This would be valid for five years but can be renewed for unlimited validity.

The process took longer than the ultra-fast emergency authorisation given by Britain, the first western country to endorse a COVID-19 shot.

(Reuters)

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