In September 2023, France launched a national in-school vaccination campaign aimed at students in secondary schools. The vaccine used is the Gardasil 9, an HPV vaccine said to prevent cervical, vaginal, vulvar and anal cancer, as well as genital warts. However, there is much controversy surrounding this product both when it comes to its efficiency and safety profile. In France, several patient organizations have raised concerns.
E3M, an organization which helps patients suffering from macrophagic myofasciitis syndrome, was established in February 2001 to represent people affected by this disease caused by aluminum-based adjuvants present in most vaccines currently used. Without being in any way opposed to vaccination, the association advocates for the return of vaccines without aluminum and the development of alternative adjuvants recognized as non-toxic to health.
Macrophagic myofasciitis is described in the following way on the organization’s website and can be very disabling. With unspecific symptoms, (partially) shared with other pathologies, it is often labeled as fibromyalgia or as chronic fatigue syndrome even related to psychosomatic or outright psychiatric pathologies, before the diagnosis of Macrophagic Myofasciitis is established:
Macrophagic myofasciitis is a neurological disease induced by aluminum hydroxide used as an adjuvant in many vaccines.
It is a complex disease whose clinical picture is dominated by:
– Chronic fatigue;
– Chronic muscle and joint pain (lasting more than 6 months) often aggravated by effort, with debilitating muscular fatigue;
– Neurocognitive difficulties (impairment of visual memory, working memory and dichotic hearing);
– Genetic predisposition is suspected, it is being explored currently.
On April 25, 2023, in a letter concerning the Gardasil vaccination campaign in French secondary schools, E3M called upon the Minister of Health and Prevention. The organisation asked the minister:
– to implement a moratorium on this vaccination,
– to order the implementation of independent expert studies on the toxicity of the aluminum adjuvant used in the Gardasil vaccine.
– as well as ordering the lifting of the industrial secret on the exact composition of Gardasil 9 and in particular on the pharmacokinetics and pharmacodynamics of its adjuvant, AAHS (the amorphous aluminium hydroxyphosphate sulphate).
Receiving no reply to their letter, E3M then decided to bring the matter to the Conseil d’Etat (the French State Council) on 11 July 2023, demanding an emergency moratorium on the deployment of the HPV vaccination campaign in secondary schools. The basis of their appeal is as follows:
we are indeed in the presence of an (i) recently developed aluminium adjuvant, with unknown pharmacokinetics and pharmacodynamics (still covered by trade secret) (ii) likely, like conventional aluminium adjuvants, to migrate to the brain (iii) With an additional risk associated because of the presence of DNA fragments of papillomavirus in the vaccine – this latest alert, although raised by Dr Lee in the US as well as Professor Belec in France, have not been the subject of any serious discussion.
A hearing was held on 20 December 2023 in the presence of 9 judges, 6 representatives from the Ministries of Health and Education, the lawyer of E3M as well as three of its members, its President, Didier Lambert, a scientist and a lawyer. After a session of almost two hours, the organization patiently awaited the conclusions of the State Council.
On 9 February 2024, the State Council rejected E3M’s request for a moratorium without properly addressing their concerns.
In its judgement, the State Council refuses to consider the Gardasil 9 aluminum adjuvant as “new” because it has been used in other vaccines for the last 20 years. E3M maintains that it is still recent and under patent, depriving independent researchers of any possibility of analysis as to its pharmacokinetics and safety.
The State Council also maintains that “no safety signal has been detected” since the marketing authorization of Gardasil 9 by the EMA (European Medicine Agency) in June 2015. In response to this argument, E3M simply points out that a marketing authorization is not synonymous with safety, especially since the manufacturer did not use a placebo (inert substance) to conduct its clinical trials on Gardasil 9. The manufacturer used Gardasil 4 as a comparator, and to evaluate Gardasil 4 the manufacturer used not a placebo but an aluminum adjuvant. This implies that both Gardasil 4 and Gardasil 9 have escaped the “gold standard” acclaimed in scientific circles – the double-blind placebo-controlled clinical trials – where the placebo is actually inert (saline water).
Finally, the State Council refers to a 2023-report from the ANSM (The National Agency for drug safety) which states that while using Gardasil 9 in recent years, no new safety signals has appeared in pharmacovigilance data. It is important to note, that in this report it is stated that Gardasil 9 has the same safety profile as Gardasil 4. This only shows that there was no “new safety signal” for Gardasil 9 compared to the Gardasil 4.
Since the ANSM persists in comparing these two vaccines, it is of great importance to know that there were indeed “safety signals” on Gardasil 4. Multiple adverse effects were reported between 2006 – 2020. There were 846 serious adverse reactions, including 115 demyelinating cases (MS, Guillain Barre, etc.).
As regards the presence of DNA fragments from the papillomavirus in the vaccine, raised by Dr Lee in the United States and Professor Belec in France, this issue was not touched upon by the State Council in their refusal to E3M.
In this context, E3M decided to pursue their legal action before the Administrative Court of Paris in a longer procedure which again ultimately ended with the State Council.
On 25 July 2024, several months later, the final decision was reached; the State Council rejected (last resort, without possibility of appeal) E3M’s request. It was this refusal that prompted the organization to file an international petition with the European Court of Human Rights this month, invoking article 6 of its Convention – the right to a fair, public and reasonable trial. E3M sees the State Council’s decision as:
– a refusal to consider the application of the precautionary principle in health matters,
– a refusal to examine essential elements submitted by the applicant in support of a negative benefit-risk balance
in direct violation of European Union law.
The arguments and numerous scientific documents submitted by E3M to the French court cast doubt on the safety of Gardasil and justified, according to E3M, in the name of the precautionary principle, a moratorium on the deployment of the vaccination campaign in secondary schools in France. According to E3M, the State Council in its decision did not fully consider the disputed elements and did not deploy any diligence despite the seriousness of the alerts. On the contrary, they hid behind the so-called “good safety profile” of the vaccine which they claim is based on a marketing authorization and a pharmacovigilance system. They were not interested in the warning issued by Professor Belec regarding the risks associated with the presence of DNA fragments in Gardasil vials. Professor Belec is a French professor, head of the virology laboratory at the European Georges Pompidou Hospital and one would have hoped that the State Council would conduct his hearing for example. The E3M association considers that this refusal to consider the elements attached to its application (scientific studies in particular) constitutes a violation of its right to a fair trial.
It may seem surprising, in view of the history of the Gardasil vaccine, that the warnings of E3M is not taken more seriously in France. The subject of several criminal complaints, scientific warnings and followed by worrying pharmacovigilance figures, Gardasil remains a controversial vaccine to this day. In 2015, Denmark asked the European Commission to determine whether various symptoms reported as possible side effects of the HPV vaccination were actually related to this injection. In 2016, the Danish centre of Cochrane filed a complaint with the European Medicines Agency (EMA) denouncing scientific error regarding most trials of anti-HPV vaccines, insofar as the “placebo” used contains an aluminium adjuvant, suspected of being neurotoxic. It is therefore difficult to find a difference between the potential harms of the vaccine and those of the “placebo”. In August 2022, a US judge ordered the opening of a multidistrict lawsuit against its manufacturer, Merck, that began in 2023. The numerous plaintiffs accuse Merck of concealing the serious side effects of Gardasil by overstating the benefits, misleading parents and thus extorting their uninformed consent.
Very soon after the HPV vaccination campaign in secondary schools in France began in September 2023, a cry of alarm was raised when a young boy died after his school vaccination. Elouan, 12 years old, experienced a malaise immediately after his injection, he fell down and died in the hospital a few days later. A patient welfare organization and several parents from various cities in France then requested the urgent suspension of the HPV vaccination campaign in schools invoking safety concerns, incomplete information and inadequate framework for medical procedures within schools. These appeals were rejected by the courts.
The Gardasil saga continues in European countries and around the world, and we are following with interest the legal actions of organizations such as E3M as well as many parents in litigation against Merck in the United States.
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