EU’s Covid-19 vaccinations to begin from December 27, confirms European Commission president
European Medicines Agency (EMA) has said in a press release that its human medicines body, the Committee for Medicinal Products for Human Use (CHMP), is evaluating data available from Pfizer and BioNTech to provide Conditional Marketing Authorization (CMA).
“It’s Europe’s moment,” Ursula Von der Leyen, president of the European Commission, tweeted on Thursday confirming that Covid-19 vaccination will start across the European Union on December 27, 28 and 29, two days after Christmas.
With the Pfizer/BioNTech Covid-19 vaccine already being administered in the US and the UK, the announcement has come later than anticipated in the EU. However, the European Medicines Agency (EMA) has said in a press release that its human medicines body, the Committee for Medicinal Products for Human Use (CHMP), is evaluating data available from Pfizer and BioNTech to provide Conditional Marketing Authorization (CMA).
Also, a CHMP meeting to discuss the same which was initially scheduled for December 29, 2020, has been advanced to December 21, 2020, to conclude the assessment, the statement said.
Given that the Covid-19 vaccine developed by Pfizer and BioNTech was pioneered in Germany, it became difficult for the European leaders to explain to their citizens how the US and the UK approved the vaccine before the EU. The EMA has explained that the agency is looking for providing a conditional marketing authorization to the vaccine unlike the emergency approval that was given in the UK and the US.
The EMA says conditional marketing authorization requires less comprehensive data than normal and the data should establish that the medicine’s benefits outweigh the risks posed. The manufacturer should also furnish complete clinical data in the future.
Once CHMP gives its nod for the vaccine based on the assessment on December 21, 2020, EMA is expected to authorize the vaccine for usage in all EU and European Economic Area (EEA) countries, the statement said. This was confirmed by health-policy spokesman Stefan de Keersmaecker of the European Commission, who said, “As soon as EMA has adopted a positive recommendation, the commission will take a decision authorizing the vaccine on the market within two days.”
EU has already placed orders for 300 million vaccine doses for its member states. It has also signed deals with Moderna, whose vaccine is currently under review by the US authorities and another deal for 200 billion doses of Novavax’s experimental Covid-19 vaccine.
(With agency inputs)