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Moderna and the European Commission (EC) Amend Covid-19 Vaccine Agreement to Supply Omicron-containing Bivalent Candidates; EC Purchases Additional 15 Million Doses

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Moderna and the European Commission (EC) Amend Covid-19 Vaccine Agreement to Supply Omicron-containing Bivalent Candidates; EC Purchases Additional 15 Million Doses | Pharmtech Focus

Moderna, Inc.(NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced 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. In addition, the EC has agreed to purchase an additional 15 million doses of Omicron-containing vaccine booster candidates from Moderna.

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

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

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 positive 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.

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