Initiation of the tender procedure for mRNA COVID-19 vaccines by the Health Emergency Preparedness and Response Authority (HERA) of the European Commission (EC)

Initiation of the tender procedure for mRNA COVID-19 vaccines by the Health Emergency Preparedness and Response Authority (HERA) of the European Commission (EC)



Moderna welcomes the initiation of a tendering procedure for mRNA COVID-19 vaccines by the Health Emergency Preparedness and Response Authority (HERA) of the European Commission (EC) and intends to participate in this process. HERA was set up as a service of the EC to strengthen Europe's ability to prevent, detect, and rapidly respond to cross-border health emergencies.

As one of two mRNA COVID-19 vaccines approved for use in Europe alongside BioNTech-Pfizer’s vaccine, which has an agreement with the European Commission for the provision of COVID-19 vaccines until 2026, the initiated tendering procedure will allow Member States to secure access to a diversified portfolio of mRNA-based COVID-19 vaccines in 2024 and beyond.

A diversified supply of mRNA COVID-19 vaccines is vital for Europe and public health worldwide. mRNA technology has shown itself to be a proven platform for COVID-19 vaccine development through the pandemic. It has the necessary flexibility to mitigate the risk posed by future variants of concern and to facilitate respective vaccine updates.

Moderna has consistently shown its ability to develop, manufacture, and supply COVID-19 vaccines against circulating variants. Moderna’s updated COVID-19 vaccine for the 2023 vaccination season continues to provide an immune response against currently circulating strains of COVID-19, including JN.1.

It is vital that healthcare professionals and the general public have a choice in addressing their vaccination needs in line with the latest scientific and real-world evidence. This is vital for vulnerable populations, such as the elderly and immunocompromised, and to help bolster the readiness of healthcare systems across the European Union.

Key stakeholders in Europe, such as the European Medicines Agency, have expressed the need for a diversified portfolio of COVID-19 vaccines. As we look towards the 2024 vaccination season and associated preparation, it will be important to allow adequate time to prepare the capacity required for manufacturers to manufacture and supply COVID-19 vaccines for this year’s season, taking into account expected recommendations from global public health authorities and regulators on the potential need for variant updated vaccines.

Forward-Looking Statement Disclaimer

This statement contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: the potential tender process for COVID-19 vaccines by the HERA, the terms of the potential tender; the benefits of a diversified supply of mRNA COVID-19 vaccines for Europe; the strengths of Moderna’s platform; and the potential for Moderna to secure additional sales of COVID-19 vaccines to Member States. The forward-looking statements here are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond the Company’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those other risks and uncertainties described under the heading “Risk Factors” in the Company’s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (“SEC”) and in subsequent filings made by the Company with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, the Company disclaims any intention or responsibility for updating or revising any forward-looking statements contained here in the event of new information, future developments or otherwise. These forward-looking statements are based on the Company’s current expectations and speak only as of the date hereof.

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