The move was seen as a formality after the European Medicines Agency (EMA) delivered a positive scientific opinion on the vaccine at lunchtime today [January 6].
“I want to thank the European Commission for its engagement and endorsement and the EMA for its recommendation, which is another significant moment in our company’s history,” said Stéphane Bancel, CEO, Moderna, reacting to the authorization today. “The EMA and the Committee for Medicinal Products for Human Use reviewers, working over the holidays, provided a thorough review and comprehensive guidance as we worked together to achieve this authorization. I am proud of the role Moderna has been able to play globally in helping to address this pandemic."
Vaccine delivery timeline
Moderna will deliver the total amount of 160 million doses that the EU has ordered between the first and the third quarters of 2021, reported the Commission.
And the US biotech confirmed today that the first deliveries of the vaccine to countries in Europe are expected to begin next week. Lonza, the US biotech’s partner, has been preparing its plant in Visp, in south west Switzerland, to ramp up to large-scale production of the vaccine.
The EU is the fourth jurisdiction to authorize Moderna’s COVID-19 vaccine, following the US on December 18, Canada on December 23, 2020 and Israel on January 4, 2021. Additional authorizations are currently under review in Singapore, Switzerland and the UK.
The Moderna vaccine supply will add to the 300 million doses of the vaccine distributed by BioNTech and Pfizer in the EU, the first vaccine to have been authorized in the EU on December 21, 2020.
Portfolio of COVID-19 vaccines secured for EU
The EU Commission outlined how it has secured agreements with six COVID-19 vaccine developers so far.
Contracts have been concluded with AstraZeneca (400 million doses), Sanofi-GSK (300 million doses), Johnson and Johnson (400 million doses), CureVac (405 million doses) as well as Moderna (160 million doses) and BioNTech-Pfizer (300 million doses). The Commission said it has also concluded exploratory talks with Novavax with a view to purchasing up to 200 million doses.
“This means that the Commission has secured a portfolio of more than 2 billion doses. For the Commission, it was important from the beginning to build a diversified portfolio of vaccines based on different technologies, to increase the chances that one or more of the vaccine candidates are approved by the EMA. Should all vaccines candidates turn out to be safe and effective, Member States have the possibility to donate part of their doses to lower-and-middle income countries.”
EU ‘slow’ rollout, and vaccine approval system under fire
Some EU member states have been coming under fire for the slow roll-out of the Pfizer-BioNTech vaccine, which was approved in the EU on December 21.
The EU's vaccine approval system has also been disparaged for being overly sluggish.
BioNtech CEO, Uğur Şahin, recently criticized the EU’s failure to order more doses of its vaccine, telling Der Spiegel that it and partner Pfizer are now looking to rapidly boost production as concerns grow of a European ‘gap’ left by the lack of other approved vaccines.
He said BioNTech was also aiming to get a new production facility online in Marburg, Germany, in February “far earlier than planned”. It should be able to produce 250 million doses in the first half of 2021.
