ER Editor: 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.
Towards a Totalitarian Regime? European Commission Adopts GMO Vaccine to Combat Non Existent Covid-19 Virus
In a decision that will shock many, the European Commission has taken a big step towards its ambition to subject its citizens to a totalitarian regime in which DNA-altering technology forms the centre piece of mass control and unapologetic rule by despotism.
Under the chairmanship of the German Minister of Health, Jens Spahn, The Commission has adopted a new ruling which calls for ‘the swift development of a GMO vaccine against Covid-19’.
Overturning its own earlier regulatory position, the Commission issued a press release on 14 July 2020, stating that this new act provides a ‘temporary derogation’ of clinical trials for a vaccine under what it cites as ‘the contained use of genetically modified organisms.’
The press release goes on to say
“The regulation will apply only as long as Covid-19 is regarded as a pandemic by the World Health Organisation, or as long as an implementing act by which the Commission recognises a situation of public health emergency due to Covid-19 applies.”
The text goes on to state
“The derogation provides that most operations related to the conduct of clinical trials will not require a prior environmental risk assessment or consent.”
Jens Spahn is quoted as saying
“A vaccine against Covid-19 is urgently needed. This regulation will ensure that clinical trials in the EU can start without delay and that no precious time is lost. The act adopted today shows that the EU is ready to take the lead in the global effort to secure the development of a safe and efficient vaccine.”
The European Commission, in need of a further ‘fear factor’ to exacerbate worry about a ‘second wave’, has clearly adopted the deeply flawed and widely disproven WHO position, that Covid-19 is a ‘public health emergency’. More than this, it has decided that only a GMO Vaccine can eradicate that which is supposedly the cause of this emergency.
One could hardly ask for a more blatant example of the New World Order centralised control system – being pressed into service at the hands of unelected technocrats, Big Pharma and vaccination moguls whose names we are already all too familiar with.
This calls for a large scale act of international resistance and a reversal of the deeply arrogant rule by despotism which is attempting to wrest control of the planet.
The URL for the Commission’s Press Release and details of the regulation here.
Full text below
Today, the Council adopted a regulation which aims to speed up the development and the deployment of a vaccine against COVID-19 in the EU. The act provides for a temporary derogation for clinical trials with such vaccines from the prior environmental risk assessment required in the EU legislation on the deliberate release in the environment and the contained use of genetically modified organisms (GMOs). In addition, it clarifies that this temporary derogation also applies when member states allow medicinal products containing or consisting of GMOs intended to treat or prevent COVID-19 to be used in certain exceptional and urgent situations defined in the pharmaceuticals legislation. The environmental impact of medicinal products (including vaccines) containing or consisting of GMOs intended to treat or prevent COVID-19 will remain part of the marketing authorisation process, respecting the environmental safety requirements set out in the GMO legislation.
The regulation will apply only as long as COVID-19 is regarded as a pandemic by the World Health Organisation (WHO) or as long as an implementing act by which the Commission recognises a situation of public health emergency due to COVID-19 applies.
A vaccine against COVID-19 is urgently needed. This regulation will ensure that clinical trials in the EU can start without delay and that no precious time is lost. The act adopted today shows that the EU is ready to take the lead in the global effort to secure the development of a safe and efficient vaccine.
JENS SPAHN, FEDERAL MINISTER OF HEALTH OF GERMANY
The regulation provides for a derogation from certain provisions of Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms and Directive 2009/41/EC on the contained use of genetically modified micro-organisms. The derogation provides that most operations related to the conduct of clinical trials will not require a prior environmental risk assessment or consent. These operations include packaging and labelling, storage, transport, destruction, disposal, distribution, supply, administration or use of investigational medicinal products for human use containing or consisting of GMOs intended to treat or prevent COVID-19. The manufacturing of such products will however still be subject to all provisions in those directives.
The regulation also clarifies that certain provisions of Directives 2001/18/EC and 2009/41/EC are not applicable when member states grant access to medicinal products containing or consisting of GMOs in certain exceptional and urgent situations. These cases are defined in Directive 2001/83/EC on the Community code relating to medicinal products for human use and Regulation (EC) No 726/2004 laying down Union procedures for the authorisation and supervision of medicinal products for human and veterinary use.
The regulation was adopted by written procedure.
Background and next steps
The Commission adopted its proposal on 17 June 2020. The European Parliament voted in favor of the proposed regulation on 10 July 2020. The regulation will be published in the Official Journal of the European Union on 17 July and enter into force on the following day.
Julian Rose is an early pioneer of UK organic farming, writer, international activist, entrepreneur and teacher. His latest book ‘Overcoming the Robotic Mind – Why Humanity Must Come Through’ is particularly prescient reading for this time: see www.julianrose.info. He is a frequent contributor to Global Research.