EU set to approve Pfizer COVID-19 vaccine before Christmas

BERLIN/BRUSSELS (Reuters) – The European Union is on course to approve its first COVID-19 vaccine before Christmas after its drug regulator brought forward a deadline for review following the start of immunisation campaigns in the United States and Britain.

The European Medicines Agency (EMA) said an expert panel would now convene on Monday Dec. 21 to consider for possible approval the vaccine made by U.S. company Pfizer and German partner BioNTech. It had previously said the meeting could be as late as Dec 29.

Rising infection rates and tighter lockdown measures in many European nations have added to the pressure on the EMA to act as quickly as possible.

While EMA’s mandate is to issue recommendations on new medical treatments, the European Commission has the final say on approval and typically follows EMA’s advice. EU politicians said that would happen swiftly.

German Health Minister Jens Spahn told a news conference that he hoped EU approval would be in place before Christmas, clearing a path for the first inoculations by the end of the year.

EU Commission President Ursula von der Leyen echoed those sentiments by saying on Twitter “(It is) Likely that the first Europeans will be vaccinated before end 2020.”

EMA said its expert meeting was brought forward after the companies had provided more data, as requested, and the EU Commission would fast-track its procedures to rule on approval “within days”.

FILE PHOTO: The headquarters of the European Medicines Agency (EMA), is seen in London, Britain, April 25, 2017. REUTERS/Hannah McKay

It added any approval would come with a safety monitoring plan, manufacturing controls, an investigation plan for use in children and binding obligations by the manufacturers to provide more efficacy and safety data.

Britain was the first to approve the shot for emergency use on Dec. 3, followed by Canada on Dec. 9 and the U.S. Food and Drug Administration (FDA) on Dec. 11.

EMA said in early December it planned to issue its view on the BioNTech/Pfizer vaccine by Dec 29, and on another candidate developed by Moderna by Jan. 12.

Both U.S. biotech firm Moderna and Pfizer-BioNTech have reported vaccine effectiveness in trials of well above 90% – an unexpectedly high rate. Any side effects have eased quickly and had not been serious, they said.

BioNTech reiterated it was on track deliver 50 million doses globally this year, for 25 million two-dose courses needed for immunization.


Additional reporting by Thomas Seythal, Ludwig Burger, Patricia Weiss, Kirsti Knolle and Francesco Guarascio; editing by Thomas Escritt and Keith Weir


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