BioNTech and Moderna lobbyists calling for mRNA vaccines NOT to be classified as gene therapy

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On 17 January 2024, BioNTech and Moderna lobbyists hosted a lunch in the European Parliament with Members[1] to discuss the forthcoming revision of the pharmaceutical legislation.

Their main objective was to change the legislation’s definition of ‘gene therapy’. At present, mRNA vaccines (like the COVID-19 vaccine) are to be classified as gene therapy. However, they felt that only products that modified the genome should be classified as gene therapy.

1. Do EMA and the Commission classify Comirnaty and Spikevax mRNA vaccines as gene therapy? If so, what are the corresponding regulatory consequences?
2. Has EMA carried out DNA integration assessments[2]or is it going to request them from independent laboratories?
3. What is the Commission’s position on this opaque lobbying without debate?

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