evidence: 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] https://www.floridahealth.gov/_documents/newsroom/press-releases/2024/01/20240103-halt-use-covid19-mrna-vaccines.pr.pdf, 3 January 2024: ‘The FDA’s response does not provide data or evidence that the DNA integration assessments they recommended themselves have been performed.’ ‘DNA integration could theoretically [...] transform a healthy cell into a cancerous cell.’DNA fragments detected in monovalent and bivalent Pfizer/BioNTech and Moderna modRNA COVID-19 vaccines from Ontario, Canada:Exploratory dose response relationship with serious adverse events,David J. Speicher, Jessica Rose, L. Maria Gutschi, David Wiseman, Kevin McKernan, http://tinyurl.com/2s3npu8m: ‘All products tested exceeded the guidelines for residual DNA set by the FDA and WHO of 10 ng/dose by 188 –509-fold.’