European Commission Orders 80M More Doses of Moderna’s COVID-19 Vaccine

The European Commission (EC) has exercised its option to purchase an additional 80 million doses of mRNA-1273, Moderna’s COVID-19 vaccine candidate, the company said Friday.

The additional doses bring the EC’s confirmed order commitment to 160 million doses, which will commence from the company’s dedicated European supply chain, according to Moderna.¹

The mRNA-1273 vaccine has not been approved by the FDA and is not available in the United States. However, mRNA-1273 has been recommended for emergency use authorization (EUA) by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC).²

In a statement issued Thursday night, FDA Commissioner Stephen M. Hahn, MD, and Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research, said that the FDA will rapidly work toward finalization and issuance of an EUA for mRNA-1273.

FDA officials have also notified the CDC and Operation Warp Speed of their work on an EUA for mRNA-1273, for which they can execute plans for vaccine distribution, according to Hahn and Marks.³

If granted an EUA by the FDA, mRNA-1273 would become the second COVID-19 vaccine to receive the designation. The FDA approved an EUA application for vaccine BNT162b2 on December 11, 2020 for the first COVID-19 vaccine, jointly developed by Pfizer and BioNTech. Administration of BNT162b2 began on Monday with the initial wave of recipients.⁴

In Europe, the first deliveries of mRNA-1273 are expected to commence early in 2021 following regulatory approval by the European Medicines Agency (EMA). These deliveries are subject to receipt of the positive opinion from the EMA’s scientific committee for human medicines (CHMP) and the European Commission’s Decision regarding the conditional marketing authorisation (CMA) for the vaccine.¹

“We appreciate the confidence in Moderna and mRNA-1273, our COVID-19 vaccine candidate, demonstrated by today’s increased supply agreement with the European Commission” Stéphane Banel, chief executive officer of Moderna, said in a statement. “As we shift our focus now to prepare for the delivery of our vaccine candidate, pending a positive opinion from the EMA and other regulators, we remain committed to working with governments and partners globally to address this pandemic.”¹

According to Moderna, the company has supply agreements of committed orders of more than 470 million doses worldwide.

Those orders include:

• United States: 200 million doses, with an option for an additional 300 million doses
• European Union: 160 million doses
• Japan: 50 million doses
• Canada: 40 million doses, with an option for an additional 16 million doses
• Switzerland: 7.5 million doses
• United Kingdom: 7 million doses
• Israel: 6 million doses

Other countries, including Qatar and Singapore, have also placed orders with Modena. The number of doses as well as names of some countries are have not been disclosed.

References

• European Commission exercises option for additional 80 million doses of Moderna’s COVID-19 vaccine candidate [news release]. Cambridge, MA; December 18, 2020: Moderna. Accessed December 18, 2020. https://investors.modernatx.com/news-releases/news-release-details/european-commission-exercises-option-additional-80-million-doses
• Moderna receives FDA advisory committee vote supporting emergency use for Moderna’s vaccine against COVID-19 in the United States [news release]. Cambridge, MA; December 17, 2020: Moderna. Accessed December 17, 2020. https://investors.modernatx.com/news-releases/news-release-details/moderna-receives-fda-advisory-committee-vote-supporting
• FDA statement on vaccines and related biological products advisory committee meeting [news release]. Silver Spring, MD; December 17, 2020: FDA. Accessed December 17, 2020. https://www.fda.gov/news-events/press-announcements/fda-statement-vaccines-and-related-biological-products-advisory-committee-meeting-0
• Coppock K. FDA Committee Recommends Emergency Use Authorization for Moderna’s COVID-19 Vaccine. Pharmacy Times^®. Published December 17, 2020. Accessed December 18, 2020. https://www.pharmacytimes.com/news/fda-committee-recommends-emergency-use-authorization-for-modernas-covid-19-vaccine