Moderna and the European Commission Agree on Amendment to COVID-19 Vaccine Supply Agreement

Moderna, Inc. announced an agreement with the European Commission (EC) to amend their originally agreed contractual delivery schedules for the Moderna COVID-19 vaccine booster product (Spikevax, mRNA-1273) or updated booster vaccine candidate.

The amendment allows participating Member States to have Moderna COVID-19 vaccine booster doses scheduled for delivery in the second quarter of 2022 to be delivered later in calendar year 2022 or early calendar year 2023. Participating Member States will have the possibility to receive the expected updated bivalent booster candidate following approval by the European Medicines Agency.

Moderna’s bivalent prototype and Omicron booster vaccine candidate (mRNA-1273.214) is currently being evaluated in a Phase 2/3 study. The Company expects initial data on mRNA-1273.214 in June to inform selection of its candidate for the Northern Hemisphere fall 2022 booster.

Moderna continues to expect advanced purchase agreements of approximately $21 billion for 2022 and continues to believe that COVID market dynamics will result in sales slightly higher in the second half of 2022 than in the first half.

Authorized Use

SPIKEVAX (elasomeran mRNA vaccine) has been granted Conditional Marketing Authorization by the European Commission, based upon the recommendation of the European Medicines Agency, and is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in individuals six years of age and older. A booster dose may be given at least three months after the second dose for people aged 18 years and older.