On October 4, 2023, a group of eight Members of the European Parliament took a significant step by addressing a comprehensive 15-page letter to the European Medicines Agency (EMA), urging prompt and resolute action concerning the marketing authorizations of COVID-19 vaccines.
The letter, composed in precise legal and technical language, underscores several key arguments advocating for the immediate withdrawal of these products, as outlined below:
1. Misleading Marketing: The vaccines, originally designed for personal protection, have been erroneously promoted by various entities including companies, politicians, and healthcare professionals for transmission control purposes.
2. Absence of Public Health Emergency: At present, there is no prevailing international public health emergency of significant concern (PHEIC), and clinical trials for these vaccines targeting the latest variant (XBB.15) have only recently commenced, with projected completion set for 2024.
3. Genetic Modification Concerns: These vaccines qualify as genetically modified organisms (GMOs), yet the proper legal procedures for their authorization were not followed, as they were mistakenly categorized as “vaccines.”
4. Failure to Meet Quality Standards: The products fall short of meeting the required quality standards. They pose potential harm, exhibit a lack of efficacy, and carry an unacceptable risk of side effects. Furthermore, they lack the declared qualitative and quantitative properties, including the ability to confer immunity.
5. Documentation and Trial Irregularities: The authorization process was marred by the submission of inaccurate documentation, and numerous irregularities in the clinical trial data have been reported.
6. Inadequate Information for Informed Consent: The product inserts, extensive documents spanning hundreds of pages, do not fulfill the necessary information requirements for obtaining informed consent.
7. Breaches in Good Manufacturing Practices: There have been instances of non-compliance with good manufacturing practices, which raises concerns about the integrity of the production process.
In their concluding remarks, the MEPs emphasized the essential role of the medicines agency in upholding the principles of good administration and medical practice. They underscored that failing to suspend the contested marketing authorizations would not only contradict these principles but could also implicate human rights considerations. The gravity of the issues at hand encompasses not only the well-being of citizens but also the allocation of taxpayers’ funds, making this a matter of utmost importance.