On Jun. 22, 2021, Moderna announced that the European Commission (EC) had purchased an additional 150 million doses of Moderna’s COVID-19 vaccine, including the ability to purchase other COVID-19 vaccine candidates from Moderna’s pipeline. This purchase brought the EC’s confirmed order commitment to 460 million doses. Under the terms of the agreement, delivery of Moderna’s updated variant booster vaccine candidate will begin in 2022.

Moderna remains on track to meet its quarterly delivery commitments to the European Union in 2021, as the Company continues to build out its supply chain in Europe.

Initial data from Moderna’s Phase 2 study in the U.S. showed that a single 50 µg dose of mRNA-1273 or mRNA-1273.351 given as a booster to previously vaccinated individuals increased neutralizing antibody titer responses against SARS-CoV-2 and two variants of concern, B.1.351 (first identified in South Africa) and P.1 (first identified in Brazil). A booster dose of mRNA-1273.351, the Company’s strain-matched booster, achieved higher neutralizing antibody titers against the B.1.351 variant of concern than a booster dose of mRNA-1273. Safety and tolerability profiles following third dose booster injections of 50 µg of mRNA-1273 or mRNA-1273.351 were generally comparable to those observed after the second dose of mRNA-1273 in the previously reported Phase 2 and Phase 3 studies. A manuscript describing these preliminary results was submitted as a preprint to medRxiv and will be submitted for peer-reviewed publication upon completion of the multivalent mRNA-1273.211 booster arm.

The European Commission granted a conditional marketing authorization (CMA) for COVID-19 Vaccine Moderna, based upon the recommendation of the European Medicines Agency (EMA) for use of the COVID-19 Vaccine Moderna for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 18 years of age and older.

On December 18, 2020, the U.S. FDA authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18 years of age or older. Moderna has also received emergency (or other conditional, interim or provisional) authorization for use of its COVID-19 vaccine from health agencies in Canada, Israel, the European Union, the United Kingdom, Switzerland, Singapore, Qatar, Taiwan, the Philippines, Thailand, Brunei, Paraguay, Japan, South Korea and an Emergency Use Listing (EUL) from the World Health Organization (WHO). Moderna has filed for emergency (or other conditional, interim or provisional) authorization for use of its COVID-19 vaccine in adolescents with health agencies in the European Union, Canada, the U.S., Switzerland and Japan.