Dr. Wolfgang Wodarg, pulmonologist and former head of a public health department, and Dr. Michael Yeadon, ex-Pfizer research director for respiratory diseases, petitioned the EMA, the European Medicines Agency, on December 1, 2020, to immediately stop clinical trials of the Corona vaccines. The petition has been supported by at least 80,000 people and can be further supported. The flood of emails from concerned supporters was so high so that during the peaks the EMA’s server was temporarily unavailable. Nevertheless, as of December 11, 2020, there has been no response, no comment from the EMA on the petitioners’ submission.
As 2020News has learned, on December 10, 2020, at least one of the petitioners requested to Harald Enzmann (harald.enzmann@bfarm.de), Chair of EMA’s Committee for Medicinal Products for Human Use (CHMP), that the agenda for the live EMA hearing on Corona vaccines scheduled today, December 11, 2020, from 1 – 4 p.m. (2020News will report) be changed to include discussion of the fact and content of Dr. Wodarg’s and Dr. Yedaon’s request. In response to the petitioner’s email, only Ms. Irene Bachmann (p2@bfarm.de), acting as Mr. Enzmann’s absentee deputy, responded, stating in substance that it was assumed that the EMA would get back to the petitioners in this matter. 2020News would like to encourage its readers to ask the persons involved at EMA to what extent the aspects discussed in the petition have found their way into the public and internal discussion of the vaccine issue at the EMA.
As 2020News has learned, the petition has not yet been brought to the attention of the relevant staff of the entities responsible for deciding on vaccine approval at the national level – in Germany, for example, the Paul Ehrlich Institute. It is unclear why the EMA has not sought dialogue regarding the concerns raised with the institutes of the EU member states.
Dr. Wordarg and Dr. Yeadon see major vaccine threats to the population. They point to the extremely short period of clinical trials: vaccines are supposed to be emergency licensed after a few months of human clinical trials, whereas in the normal course it takes five to ten years for a vaccine to undergo all safety testing. There are significant concerns about the possible occurrence of an exuberant immune response, which, for example, had led to the death of all cats in a Corona vaccine under development for cats. In addition, there are fears that the vaccine could render women infertile because it can trigger antibodies that can then attack not only the Corona viruses but also special proteins that are structurally very similar to the viruses and essential for the formation of a placenta. These dangers cannot be ruled out due to the extremely shortened observation period, which, the petitioners told 2020News, is not compatible with the European precautionary principle.
In the EU, the precautionary principle applies, among other things, to drug approval. A product is only approved in the EU if its harmlessness is essentially proven. This corresponds to the comparatively low level of compensation for physical damage suffered. If you can no longer use your arm because you suffer paralysis from a heart medication, you will receive a maximum of about €100,000 in compensation for the loss of enjoyment of life from the pharmaceutical company that caused the damage, if you win your lawsuit. In addition, the injuring party must pay for material resources and costs for caregivers who have become necessary due to the injurious event.
In the USA, the precautionary principle does not apply. Here, the regulations regarding potentially hazardous products are much more manufacturer-friendly. Market approval is only denied to products for which the potential for harm has already been proven. However, injured persons in the USA receive incomparably higher compensation payments. In the case of a paralyzed arm, compensation payments of several million US dollars may be due in the USA. The fear of high compensation claims is a similarly effective deterrent in the USA as the precautionary principle is in Europe.
The TTIP, CETA, etc. trade agreements were intended to override the precautionary principle for Europe in favor of companies, but without changing the compensation rules. They would have given companies the most advantageous of both worlds: low barriers to market entry with little risk of being obliged to pay damaged from harmful products. TTIP did not come about, but CETA entered into force, at least provisionally, under pressure from lobbyists. The similarly structured free trade agreement with Japan (JEFTA) has been concluded. It remains to be seen to what extent these agreements will play a role in the Corona and lockdown events.
However, vaccinations are already a very low-risk proposition in both the U.S. and the European region. Liability for vaccine damage is shifted to the state in both legal systems. Accordingly, from an economic point of view, vaccine manufacturers have little reason to invest particularly heavily in studies or to refrain from marketing a potentially toxic vaccine. It is the responsibility of the government authorities to prevent damage to the population by careful examination and the prevention of undesirable influence on the authorities called upon to make decisions.
In the USA, the Emergency Preparedness and Response Act (PREP) applies in the event of damage caused by the use of drugs, medical devices and vaccines that, like the Corona vaccines, are marketed under emergency use authorizations. This could result in a complete exemption from liability for the manufacturing companies.
