Europe to Purchase Millions of Omicron-Containing Bivalent COVID-19 Vaccines

Massachusetts-based Moderna, Inc. announced yesterday an amendment to its agreement with the European Commission (EC) to convert contractually agreed doses of Moderna's COVID-19 vaccine (Spikevax, mRNA-1273) to the Company's Omicron-containing bivalent vaccines for supply in 2022, pending regulatory approval by the European Medicines Agency (EMA).

Under the amendment, contractually scheduled doses in July and August of Moderna's COVID-19 vaccine will be deferred to later in 2022, with all remaining contractually agreed doses of mRNA-1273 converted to Omicron-containing bivalent vaccines, pending EMA approval.

In addition, the EC has agreed to purchase an additional 15 million doses of Omicron-containing vaccine booster candidates from Moderna.

Moderna is advancing two bivalent candidates for utilization in global vaccination efforts.

The mRNA-1273.214 bivalent booster candidate is based on the Omicron subvariant BA.1 and has demonstrated favorable clinical data against variants of concern, including Omicron.

The second bivalent booster candidate, mRNA 1273.222, is based on the BA.4/5 strain.

Both bivalent candidates contain 25 µg of the currently authorized booster (mRNA-1273) and 25 µg of an Omicron-specific subvariant.

"The European Commission and Moderna have been steadfast partners in the fight against the COVID-19 pandemic. This agreement highlights the EC's trust in our mRNA platform and next-generation bivalent COVID-19 vaccines," said Stéphane Bancel, Moderna's CEO, in a press release issued on August 9, 2022.

"Participating member states will now have access to Omicron-containing vaccine booster candidates and protection against COVID-19, heading into the winter season."

The U.S. NIH Opendata portal displays interim variant activity data as of August 4, 2022.

On August 3, 2022, Moderna announced $10.8 billion in revenue for the first half of 2022.

"We continue to have advance purchase agreements for expected delivery in 2022 of around $21 billion of sales," added Bancel.

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