Helene Banoun
Independent Researcher, 13001 Marseille, France; helene.banoun@laposte.net; Tel.: +33-6-32-46-78-33
Received: 9 June 2023
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Revised: 19 June 2023
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Accepted: 21 June 2023
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Published: 22 June 2023
Abstract: COVID-19 vaccines were developed and approved rapidly in response to the urgency
created by the pandemic. No specific regulations existed at the time they were marketed. The regulatory agencies therefore adapted them as a matter of urgency. Now that the pandemic emergency has passed, it is time to consider the safety issues associated with this rapid approval. The mode of action of COVID-19 mRNA vaccines should classify them as gene therapy products (GTPs), but they have been excluded by regulatory agencies. Some of the tests they have undergone as vaccines have produced non-compliant results in terms of purity, quality and batch homogeneity. The wide and persistent biodistribution of mRNAs and their protein products, incompletely studied due to their classification as vaccines, raises safety issues. Post-marketing studies have shown that mRNA
passes into breast milk and could have adverse effects on breast-fed babies. Long-term expression, integration into the genome, transmission to the germline, passage into sperm, embryo/fetal and perinatal toxicity, genotoxicity and tumorigenicity should be studied in light of the adverse events reported in pharmacovigilance databases. The potential horizontal transmission (i.e., shedding) should also have been assessed. In-depth vaccinovigilance should be carried out. We would expect these controls to be required for future mRNA vaccines developed outside the context of a pandemic.
Keywords: mRNA vaccines; COVID-19; drug regulation; gene therapy; vaccinovigilance; pharmacokinetics
EL MODO DE ACCIÓN DE LAS #VACUNAS #COVID-19 DE mRNA DEBERÍA CALIFICARLAS COMO #PRODUTOSDETERAPIAGENÉTICA, PERO HAN SIDO EXCLUIDAS DE TAL CONSIDERACIÓN POR LAS AGENCIAS REGULATORIAS#HELENEBANOUNhttps://t.co/QtyVZuFjsZ https://t.co/XNhQWi16vB
— Guillermo Ruiz Zapatero (@ruiz_zapatero) June 27, 2023
EN ESPAÑA DEBE TENERSE EN CUENTA EL ART 13 DEL CONVENIO DE OVIEDO
— Guillermo Ruiz Zapatero (@ruiz_zapatero) June 27, 2023
Únicamente podrá efectuarse una intervención que tenga por objeto modificar el genoma humano por razones preventivas, diagnósticas o terapéuticas y sólo cuando no tenga por finalidad una modificación en el genoma https://t.co/vf7De5tLvu
New data for the week ending 6.16.23 now available on OpenVAERS. https://t.co/jYe2hwM0Hd #VAERS https://t.co/hud3fzZfNh
— Guillermo Ruiz Zapatero (@ruiz_zapatero) June 27, 2023
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