Questionnaire Regarding Vaccination Against COVID-19

CUJ has submitted the following questionnaire to the Minister of Health, Labour and Welfare, Mr. Katsunobu Kato.

On 31 July 2020, your ministry announced that it had reached a basic agreement with Pfizer Inc. of the United States to supply 60 million people with a new coronavirus vaccine by June of next year, if the vaccine is successful. Your ministry also announced on 7 August that it had reached an agreement in principle with AstraZeneca of the United Kingdom to receive 120 million doses of the vaccine, if successful, by early next year. Developed countries are working to secure the vaccine, and your ministry is actively working to secure it. This is a major agreement at a time when vaccines are not yet available and their effectiveness and safety are not even known.

Vaccines are causing health problems, especially among children, due to adverse reactions. Vaccines, unlike drugs, are administered to healthy people. We must be cautious as well as careful. In order to hasten the development of this new biotech vaccine, they are being developed in a different way than the traditional method of development, and the way the vaccine works is completely different. Moreover, large-scale vaccination is being considered. We can’t help but be very concerned about the damage caused by adverse reactions. For this reason, we would like to ask the following questions:

We would appreciate it if you could respond in writing to CUJ by 23 September. Please understand that we will share your answers with those inside and outside of our organization.

1. Your ministry is hurrying up the development of vaccines by shortening the screening process, which is normally required in vaccine development, and easing regulations. Therefore, your ministry is allowing basic research, animal experiments, and clinical research on humans to proceed in parallel. Concurrent research means inoculating humans and confirming the safety and efficacy of the vaccine before it is almost completely confirmed. Why did you condone this kind of disregard for safety?

2. This time the agreement with multinational pharmaceutical companies such as Pfizer and AstraZeneca is not the traditional live, inactivated, or VLP vaccine, but a new mRNA vaccine or viral vector vaccine. Such vaccines have no experience with human inoculation and are more akin to human experimentation. Based on the experience of Nazi Germany, can we say that they violate the 1964 Declaration of Helsinki by the World Medical Association, which banned human experimentation in advanced medicine? What are your thoughts on this?

3. In addition to the mRNA vaccine and the viral vector vaccine, which were agreed upon in principle to be purchased, there is a DNA vaccine. The basic idea behind all three types of vaccines is to create a protein that has the function of a vaccine when introduced into the human body, as opposed to the traditional live, inactivated, and VLP vaccines, which all make the vaccine itself and inoculate the human body. If a substance that works as a vaccine is produced in the human body, this is the concept of gene therapy, which can be called human genetic modification. Gene therapy should be defined in the guidelines for gene therapy clinical trials. Please give us your views on this.

4. Along with the viral vector vaccines agreed upon in the contracts, the venture company AnGes Inc. of Osaka University is developing a DNA vaccine. If this gets into the human genome, it can lead to genetic modification of humans. This is ethically unacceptable. What is your opinion on this point?

5. As the new biotech vaccines involve genetic modification of humans, it should be subject to the Cartagena Protocol, which covers all organisms that have been genetically modified. What are your thoughts on this point? Are you discussing it with the Ministry of the Environment?

6. The human immune system is a complex system consisting of a variety of immune-related cells that communicate and work together. There is a risk that new types of biotech vaccines, which work in an unprecedented way, may interfere with this complex system and cause allergies, hypersensitivity, autoimmune diseases, etc. What is being done about this? How are you trying to address that?

7. The government’s policy of exonerating companies from liability in the event of a major adverse reaction is contrary to the concept of product liability, which is aimed at protecting consumers. What are your thoughts on this issue? Also, if the government promotes the vaccination, it will be subject to state compensation. Consequently, we think that both companies and the government should be held responsible.

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For more details, please read:

Mad Rush to Develop Biovaccines for COVID-19 over at Bio Journal

Japan’s AnGes speeds toward 2021 rollout in coronavirus ‘vaccine war’ over at The Japan Times