MIL-OSI Europe: Answer to a written question – New EU bulk order for 146 million doses of Moderna COVID-19 vaccine – E-000608/2025(ASW)

1. The list of participating countries is available in the contract award notice that was published on 24 January 2025[1]. The framework contract was signed by the Commission on behalf of the participating countries.

2. As the Commission pointed out in its reply to Written Question P-000356/2024[2], the framework contract signed with Moderna in January 2025 is fully flexible and does not bind the contracting authorities to make any purchase. Indeed, the volume of 146 million doses is the maximum ceiling that contracting authorities could purchase if they would have a need during the whole duration of the framework contract. In order to establish the ceiling, the Commission has consulted the contracting authorities prior to launching the call for tender and asked them about their estimated possible needs in case of crisis.

3. The Spikevax (Moderna COVID-19 vaccine) received a marketing authorisation based on a thorough review by the European Medicine Agency (EMA), of clinical evidence confirming a favourable benefit-risk profile[3]. The vaccine was initially assessed in around 30 000 adults and over 3 000 children[4]. Adapted versions targeting emerging variants, like JN.1, are also approved based on data showing their ability to induce an immune response that can predict clinical efficacy and safety[5]. EMA monitors EudraVigilance data[6] from millions of vaccinated people, reviewing safety information from clinical studies, medical literature and periodic safety update reports to identify and investigate safety signals.

• [1] https://ted.europa.eu/en/notice/-/detail/51540-2025
• [2] https://www.europarl.europa.eu/doceo/document/P-9-2024-000356-ASW_EN.html
• [3] https://www.ema.europa.eu/en/documents/assessment-report/spikevax-previously-covid-19-vaccine-moderna-epar-public-assessment-report_en.pdf
• [4] https://www.ema.europa.eu/en/medicines/human/EPAR/spikevax
• [5] https://pubmed.ncbi.nlm.nih.gov/39591137/
• [6] https://www.ema.europa.eu/en/human-regulatory/research-development/pharmacovigilance/eudravigilance