BioNTech and Moderna lobby the EU, Swiss and UK regulatory agencies to stop mRNA injections being classified as gene therapy
Moderna is also lobbying the European Medicines Agency (“EMA”), the UK’s Medicines and Healthcare products Regulatory Agency
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.
The invitation to BioNTech-Moderna’s Kangaroo Group lunch stated:
BioNTech and Moderna are leading pharmaceutical and biotechnology companies in mRNA Platform Technology. Both companies recognise the importance of the overall objectives of the European Commission’s proposal for a reform of the EU General Pharmaceutical Legislation (GPL), creating an innovative and competitive EU healthcare ecosystem at a global level, investing in R&D, increasing equal access to and availability of innovative medicines to patients across the EU.
As demonstrated during the covid-19 pandemic, mRNA is an agile and flexible platform technology, enabling faster provision of vaccines and treatments to patients. mRNA-based products for disease prevention or treatment are under development for cancer, rare diseases, HIV, malaria, mpox and priority pathogens as well as other life threating [sic] conditions.
In this context, it is important that the GPL provides a clear and broad scope for the definition of Platform Technologies, as well as a clear demarcation between Gene Therapies Medicinal Products that alter human genomes, and those that do not (e.g. mRNA).
The establishment of a legal basis for a “Platform Technology Master File” and the development of accompanying scientific guidance by the European Medicines Agency is needed to ensure global regulatory alignment, enable and strengthen the development of platform technologies in Europe and to realise their public health potential. [Emphasis added]
1st Strasbourg Lunch Debate 2024, Wednesday, 17 January 2024 at 13.00 hrs, Kangaroo Group
It’s not the first time that more than one Big Pharma company has joined forces to lobby European officials. In 2021, the research and campaign group Corporate Europe Observatory highlighted a worrying “high level of unity among Big Pharma.” The subject of the article was lobbyists defending Big Pharma’s monopoly on intellectual property (patent) rights on vaccines.
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