By Tony Winterburn • 01 December 2020 • 12:19
Pfizer and BioNtech Application For Approval in Europe Could See Vaccine Rolled Out In Days.
VACCINE manufacturers Pfizer and BioNtech say they have applied to the European Medicines Agency for conditional marketing authorisation of their covid-19 vaccine. If the authorization is granted, it could potentially enable the use of Pfizer and BioNTech’s vaccine in Europe before the end of 2020, BioNTech said in a press release. Such authorization, known as a CMA, is granted to medicines or vaccines “that address unmet medical needs of patients on the basis of less comprehensive data than normally required,” the EMA says on its website.
This comes just as new figures from the ONS today, December 1, revealed more than 74,500 deaths involving Covid-19 have now occurred in the UK. A total of 71,719 deaths have so far been registered in the UK where Covid-19 was mentioned on the death certificate, according to the latest reports from the UK’s statistics agencies. This includes 65,006 deaths in England and Wales up to November 20 and registered up to November 28.
Pfizer and BioNtech’s available data must indicate that the medicine’s benefits outweigh its risks and the applicant should be in a position to provide the comprehensive clinical data in the future.
“Today’s announcement marks another key milestone in our efforts to fulfil our promise to do everything we can to address this dire crisis given the critical public health need,” Dr Albert Bourla, Pfizer chairman and CEO said in the press release. We have known since the beginning of this journey that patients are waiting, and we stand ready to ship Covid-19 vaccine doses as soon as potential authorizations will allow us.”
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