Pam Barker | Director of TLB Europe Reloaded Project
We published a Julian Rose article on this topic, of rushing risky GMO-based vaccines to market, back in July titled Towards a Totalitarian Regime? European Commission Adopts GMO Vaccine to Combat Non Existent Covid-19 Virus.
Here we’re reissuing the introduction to that piece as background to the current legal action to stop temporary relaxation of the safety protocols for the clinical trials and manufacture of a GMO-based covid vaccine, permitted under EU regulation 2020/1043. This regulation was adopted in emergency circumstances on July 15, 2020 without either parliamentary debate or scientific consultation:
In a panic to get a covid vaccine out, the European Commission is planning exemptions to established safety rules concerning genetically modified organisms (GMOs). This is the topic of Julian Rose’s article below. The vote in the European Parliament to permit this fast-tracking and exceptional status of vaccine trials and products containing GMOs occurred on July 7, 2020. Here is the press release issued on the same day: Parliament to allow COVID-19 vaccines to be developed more quickly.
We remind readers of the coalition of four EU countries formed – as the Inclusive Vaccines Alliance – to ensure it is European-made vaccines that are are delivered within the EU.
Addressing the issue, this report from Euractiv comes from June 18, 2020 (EU goes easy on GMOs in race for COVID-19 vaccine):
As part of its new vaccine strategy, the European Commission has proposed to temporarily relax the EU’s strict rules on genetically modified organisms (GMOs) in order to speed up the search for a COVID-19 vaccine and cure.
Brussels is ready to loosen its stance on GMOs in order to avoid bottlenecks in clinical trials for a coronavirus vaccine involving multiple countries.
Current GMO legislation does not foresee situations of urgency, resulting in very complex and time-consuming procedures, the Commission argues, saying “there is considerable variety across member states in the national requirements and procedures implementing the GMO directives.”
Potential vaccines currently under development by pharmaceutical companies such as Astra Zeneca and Johnson & Johnson contain or consist of GMOs.
The proposed derogation, which still needs to be voted by the European Parliament and the EU Council of Ministers, will last for as long as COVID-19 is regarded as a public health emergency, the Commission said.
The relaxed rules will apply not only for clinical trials on a COVID-19 vaccine but also for treatments, the Commission’s communication reads, although compliance with good manufacturing practices (GMPs) and an environmental risk assessment of the products will still be carried out before their marketing authorisation.
The Commission called on the EU’s co-legislators to adopt the proposal swiftly in order to enable clinical trials to take place in Europe as quickly as possible.
German MEP Peter Liese, European People’s Party (EPP) spokesperson for health, agreed with the Commission’s push on passing the derogation as soon as possible, saying that it needs to be done before the summer break. …
This report from Reuters of June 10, 2020 (Exclusive: Europe to accelerate trials of gene-engineered COVID-19 vaccines – sources) makes it clear that individual nations’ safety protocols concerning vaccines and other medicines are to be superseded:
… The reform is expected to reduce member states’ power to impose extra requirements on drug companies when they conduct clinical trials on medicines and vaccines containing genetically modified organisms (GMOs), according to the sources.
In some countries like Italy and France, for example, treatments must receive authorization from government environment or research departments, as well as from health and drug authorities, under rules that are up to 20 years old and also cover the more publicly sensitive area of GMO crops.
This has long caused bottlenecks in a pharmaceutical industry that increasingly relies on genetic engineering.
Such delays could be particularly problematic now that Europe may quickly need to accelerate trials, an EU Commission official said, warning that some of the most promising COVID-19 shots under development contain GMOs. …
It is also clear from the Reuters’ piece that it is simply corporations fearing loss of market share in Europe in relation to other big pharma competitors, public health be damned:
The European Commission is expected to put forward the plans as early as next week. They are part of a wider EU strategy aimed at securing enough doses of a possible vaccine for the bloc as it fears lagging behind the United States and China.
Finally, this article from early 2018 (Why Does Europe Lag Behind the US and China in the Gene Editing Race?) explains how European biotechs are at a regulatory disadvantage in terms of getting out gene-edited medical products.
Vaccines: action for annulment against European regulation 2020/1043
LE LIBRE PENSEUR
All the rules were relaxed to facilitate vaccine manufacture, while Professor Didier Raoult was required to conduct a billion tests for hydroxychloroquine. Isn’t that wonderful!
The applicants are:
La Coordination nationale médicale sante environnement (CNMSE), European Forum for Vaccine Vigilance (EFVV), Children’s Health Defense Europe, La Ligue Nationale Pour la Liberté des Vaccinations (LNPV), International Association for Independent and Benevolent Scientific Medicine, Terra SOS-Tenible.
This appeal follows the European regulation n°2020/1043 adopted urgently on July 15, 2020, which abolished all procedures for protection, risk analysis, control, monitoring, labeling and public information concerning the use, transport, release into the environment, injection into humans of genetically modified organisms and microorganisms whenever research or clinical trials on a vaccine or a drug against Covid-19 are involved.
Thus, specific measures to control the risk related to genetic modification of living organisms are no longer applied in this area.
The stated objective of this suppression is to gain a few weeks in the eventual development of a vaccine. Risk analyses and control measures are therefore being eliminated for the sole purpose of speeding up the process. Before submitting its project, the Commission did not carry out any scientific consultation to analyze the risk, particularly in relation to new genetic modification techniques.
Parliament voted without debate, without discussion, without questions and without tabling amendments.
However, it is clearly established that genetic modification of living organisms, in particular microorganisms artificially modified to be injected into humans, presents numerous risks, in particular the risk of recombination of potentially more virulent viruses, or the risk of interactions with human DNA causing random and unknown diseases.
This elimination of all risk assessment measures and all biosafety control measures for the environment and for health is contrary to the precautionary principle, a fundamental principle of the European Union’s operating treaty and a constitutional principle of French law. This abolition of the guards is also contrary to the interest and health of citizens. Obtaining a useful and safe vaccine that is not dangerous is incompatible with the urgency and suppression of risk control measures.
The applicants intend to see the precautionary principle respected and denounce an unacceptable regression in terms of public health and the environment.
The associations denounce this arbitrary suppression of risk control measures that constitute an indispensable protection of health and the environment. Public policies cannot be guided by fear, by immediate events of false urgency, but must respect the health of the citizen and provide all guarantees.
The applicant associations have therefore filed an action for annulment with the Court of Justice of the European Union (CJEU) in order to obtain the annulment of this European regulation.
This confirms the statements made by Michèle Rivasil in her interview on September 7, where she explained that this decision was taken in secret in the European Parliament.
It is not up to the public under these conditions to become guinea pigs for experimental vaccines and drugs that are presented as “safe” but whose manufacturers do not want to assume the consequences.
The press release is reproduced below:
Six associations call for the cancellation of the EU regulation on GMO covid vaccines 19
On October 10, six associations in Europe filed an action for annulment before the European Court of Justice against a regulation abolishing the risk assessment of GMOs for vaccines against Covid 19.
Regulation 2020/1043, adopted this summer by the Union, allows producers of vaccines and anti-Covid19 treatments containing GMOs to dispense with the need to produce an environmental impact and biosafety study before the start of clinical trials. Published on July 17, the text was adopted by the European Parliament under an emergency procedure, without amendments or debate. This exception to the GMO legislation is contrary to the precautionary principle provided for in the Treaty on the Functioning of the European Union.
These GMO vaccines against Covid 19, for which clinical trials have begun, present very real risks. The report by molecular geneticist Cristian Velot du Criigen, reminds us that they could lead to viral recombinations potentially more serious than the viruses that we are trying to fight with the vaccine, impacting animal life and human health. The risks of interaction with human DNA or the introduction of new genetic technologies may have unknown, potentially serious and irreversible consequences. In other words, no specific measures will be applied to control the risk of genetic modification of living beings.
The six requesting associations – CNMSE, Terra SOS Tenible, LNPLV, EFVV, AIMSIB, Children’s Health Defense Europe – denounce this dangerous experimentation, both for the participants in clinical trials and for the human population and the environment, and demand the immediate application of the precautionary principle, in compliance with the rules of law.
“Having had the chance to organize, under the aegis of the Ile-de-France Regional Council, an innovative experiment on personalized vaccination, I discovered highly toxic molecules and pesticides in the composition of vaccines. It therefore seems essential to me that the implementation of any new vaccine against Covid be exemplary and that all the essential steps be particularly respected” explains Dr Dominique Eraud, President of the National Medical Coordination Health Environment (CNMSE).
“The implementation of this regulation must be stopped immediately. EU Regulation 2020/1043 is fundamentally a regulation against life, reason, law, justice and science, since even the Commission, after bypassing all democratic controls, did not have the moral decency to ask for a scientific opinion,” says Josefina Fraile, President of Terra SoS Tenible.
“By publishing this regulation, the European institutions are giving the European Union member states the right to put in place dangerous, even biocidal, legislative measures that should be denounced,” emphasizes Jean-Pierre Eudier, President of the National League for Vaccination Freedom (LNPLV).
For Dr. Kris Gaublomme, President of the European Forum for Vaccine Vigilance (EFFV):
“We denounce the drift of European States towards authoritarianism, control and restriction of fundamental rights, through systematic derogations to the rules of law under the pretext of the Covid-19 epidemic, which we see particularly with the EU2020/1043 regulation. Our recourse to the Court of Justice of the European Union aims at enforcing the rules of law.”
“The European authority is offering a blank cheque to the pharmaceutical industry to bring to market new GM drug and vaccine technologies for which not all the studies demonstrating safety have been carried out. It is the patients in these conditions who serve as guinea pigs and we, as doctors, refuse this state of affairs” insists Philippe Harvault, President of the International Association for Independent and Caring Scientific Medicine (AIMSIB).
Finally, according to attorney Robert F. Kennedy Jr., President of Children’s Health Defense Europe,
“The need to consider different types of risks before starting clinical trials of vaccines that will be accelerated and widely distributed cannot be underestimated. Vaccines using genetically modified organisms can have an impact on the environment. Other vaccines being considered for Covid 19, such as mRNA vaccines, use nanoparticles to introduce genetic material into our cells and program their response. Unlike the vaccines we know about, this mechanism is a form of “hacking” into our genetic functioning. It is an entirely new experimental technology about which we know very little. Many people have already experienced serious side effects in clinical trials with Covid vaccines under development. To allow and continue such experiments without any evaluation and without debate about the long-term risk they pose to our health or their ethical aspects is irresponsible and reckless. Urgency should not lead to blind decisions. Our political leaders have a duty to ensure that the precautionary principle is respected, otherwise we will all be in danger.”