BioNTech and Moderna are frantically lobbying the European Parliament to stop a reclassification of mRNA injections as “gene therapy” in the upcoming revision to the European Union’s (“EU’s”) pharmaceutical legislation.
Moderna is also lobbying the European Medicines Agency (“EMA”), the UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”) and the Swiss Agency for Therapeutic Products (“Swissmedic”) to urgently “rethink their gene therapy definition.”
According to an article published last year in the International Journal of Molecular Sciences, the mode of action of covid-19 mRNA injections should classify them as gene therapy products but they have been excluded by regulatory agencies. The wide and persistent biodistribution of mRNAs and their protein products, incompletely studied due to their classification as vaccines, raises safety issues.
Moderna and BioNTech expected to have their products regulated as gene therapies. Moderna, Inc. acknowledged in its Q2 2020 Securities and Exchange Commission (SEC) filing that “currently, mRNA is considered a gene therapy product by the FDA.” Furthermore, BioNTech founder, Ugur Sahin, in a 2014 article, stated “One would expect the classification of an mRNA drug to be a biologic, gene therapy, or somatic cell therapy.”
mRNA: Vaccine or Gene Therapy? The Safety Regulatory Issues, International Journal of Molecular Sciences, 22 June 2023
That Big Pharma is now lobbying the European Parliament to not classify mRNA as gene therapy was raised by a Member of the European Parliament (“MEP”), Virginie Joron, who submitted a written question to the European Commission on 2 February:
On 17 January 2024, BioNTech and Moderna lobbyists hosted a lunch in the European Parliament with Members 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. [Emphasis added]
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 or is it going to request them from independent laboratories?
3. What is the Commission’s position on this opaque lobbying without debate?
Lobbies calling for mRNA vaccines not to be classified as gene therapy, Question for written answer, European Parliament, 2 February 2024
The lunch hosted by BioNTech and Moderna on 17 January was held under the auspices of the “Kangaroo Group,” a MEP-industry group providing extracurricular contact between corporate industry lobbyists and MEPs.