The EU will approve the Pfizer Covid-19 vaccine before Christmas

BERLIN / BRUSSELS: The European Union is due to approve its first Covid-19 vaccine before Christmas, after its regulator set a deadline for review following the start of immunization campaigns in the United States and the United Kingdom.
The European Medicines Agency (EMA) said a group of experts would meet on Monday (December 21st) to consider for a possible approval the vaccine made by the American company Pfizer and the German partner BioNTech. Earlier, he said the meeting could be delayed until December 29.
Rising infection rates and stricter blockade measures in many European nations have added to the pressure on the EMA to act as soon as possible.
While the EMA’s mandate is to issue recommendations on new medical treatments, the European Commission has the final say on approval and usually follows EMA’s advice. EU politicians have said this will happen soon.
German Health Minister Jens Spahn told a news conference that he hopes EU approval will be in place before Christmas, paving the way for the first vaccinations by the end of the year.
European Commission President Ursula von der Leyen echoed those sentiments on Twitter: “(It is) The first Europeans are likely to be vaccinated before the end of 2020”.
The EMA said its meeting of experts had been postponed after companies provided more data, as requested, and the EU Commission would quickly follow its procedures to rule on the approval “in a few days”.
He added that any approval would come with a safety monitoring plan, manufacturing controls, an investigation plan for use in children and mandatory obligations for manufacturers to provide more data on efficacy and safety.
The UK was the first to approve the emergency shooting on December 3, followed by Canada on December 9 and the US Food and Drug Administration (FDA) on December 11.
The EMA stated in early December that it intends to issue its views on the BioNTech / Pfizer vaccine by 29 December and another candidate developed by Moderna by 12 January.
Both the American biotechnology company Moderna and Pfizer-BioNTech reported the vaccine’s effectiveness in studies well over 90% – an unexpectedly high rate. Any side effects improved quickly and were not serious, they said.
BioNTech reiterated that it was on track to deliver 50 million doses globally this year for 25 million courses with two doses needed for immunization.