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Law360 (January 6, 2021, 7:13 PM EST) -- The vaccine developed by Moderna to battle the COVID-19 virus has been given regulatory approval in the European Union, with deliveries expected to start as early as next week.
Moderna said Wednesday that the European Commission — the executive body of the EU — gave conditional marketing approval for the vaccine to be put on the market in the EU's 27 different member states. First deliveries are expected next week, Moderna said, adding that 160 million doses have been acquired for the EU.
Approval came after the European Medicines Agency recommended the green light, according to the company.
"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," Moderna CEO Stéphane Bancel said in a statement. "I am proud of the role Moderna has been able to play globally in helping to address this pandemic."
Ursula von der Leyen, the European Commission president, noted in a statement that Moderna's vaccine is the second vaccine to be approved in the EU. Last month, the vaccine developed by Pfizer and BioNTech was approved by the EU.
Moderna asked for approval in the EU in late November, but the EMA had been conducting a "rolling review" of the vaccine, according to the European Commission. Rolling reviews involve evaluating nonclinical data about the vaccine as it becomes available.
The United Kingdom, a former member of the EU, gave Pfizer and BioNTech approval for the vaccine on Dec. 2. Swiss health regulator Swissmedic also has announced that it approved the Pfizer and BioNTech vaccine.
"And more vaccines will come," von der Leyen said in a statement Wednesday. "Europe has secured up to 2 billion doses of potential COVID-19 vaccines. We'll have more than enough safe and effective vaccines for protecting all Europeans."
The U.S. Food and Drug Administration signed off on Moderna's request for emergency use authorization of its COVID-19 vaccine last month as well. Moderna's treatment has also been approved in Canada and Israel, according to the company.
Other vaccine candidates, such as those being developed by Johnson & Johnson and AstraZeneca, have yet to formally apply for marketing authorization from the EMA, but the agency has said it has already begun conducting rolling reviews of those prospective vaccines.
--Additional reporting by Andrew Karpan and Britain Eakin. Editing by Stephen Berg.
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