From Bio Journal - September 2020

Mad rush to develop biovaccines for COVID-19

On 31 July 2020, MHLW reached a basic agreement to be supplied with COVID-19 vaccine sufficient for 60 million vaccinations from the US Pfizer Inc. by June 2021 provided that development of the vaccine is successful. Additionally, on August 7, MHLW also reached basic agreement with the UK AstraZeneca to be supplied with sufficient vaccine for 120 million vaccinations from the beginning of 2021, again provided that the development of the vaccine is successful. The Japanese government is thus moving positively to secure supplies of the vaccine, as are the governments of other developed countries. However, since the vaccine has not yet been developed, these large-scale agreements come at a time when the efficacy and safety of the vaccines are unknown.

In the past, the development of vaccines involved live vaccines in which the toxicity of the virus was weakened, but as the toxicity of the viruses was known to revive to a certain extent, causing side effects, inactivated vaccines, in which the virus made to be inactive became the mainstream. In the case of inactivated vaccines, since the effect was weak, inoculations had to be carried out two or more times and it was necessary to add an adjuvant to increase immune strength, placing addition burden on the body.

Replacing these conventional methods, there is currently an ongoing shift towards development of vaccines applying biotechnology such as genetic modification. The Human papillomavirus (HPV – which causes cervical cancer) vaccine was developed by the application of genetic modification utilizing a moth cell and is now known as the pioneer of VLP (virus-like particles) vaccine. While it is said that development lead times are shortened compared with the ten or more years needed to develop a live vaccine or inactivated vaccine, as development lead times for vaccines developed in this way are at least four to five years, development methods are also sharply changing toward biotech vaccines that use DNA or mRNA, or involve the use of virus vectors, in order to further reduce lead times. For the COVID-19 virus, a venture company started up at Osaka University, Anges, Inc., is progressing with the development of a DNA vaccine, an inactivated vaccine and a VLP vaccine.

Governments of many countries, such as the US government, are rushing to develop vaccines by allocating large budgets and relaxing restrictions, for example by shortening screening usually necessary for the development of vaccines. The Japanese government is also approving parallel progress in basic research, animal experiments and clinical trials on humans, pushing forward development with the allocation of huge budgets. This simultaneous parallel development signifies that humans will be inoculated at a stage before the safety and efficacy of the vaccines are confirmed. With safety disregarded from the outset, these are nothing less than human experiments and are therefore acts that violate the World Medical Association's Declaration of Helsinki (1964) that banned human experimentation in advanced medical treatment based on the experience of Nazi Germany.

The developing companies are also changing. Up until about February or March this year the main developers were US and Chinese vaccine makers and biotech ventures. That has now switched to massive funds being poured into development by multinational pharmaceutical corporations, such as US Pfizer and the UK AstraZeneca that the Japanese government has come to vaccine supply agreements with. These two companies are using a new development method that will reduce the development lead time to about one year. It seems the companies are eyeing the huge profits to be made by the company that can develop a vaccine just a little faster than its rivals.

The biotech vaccines that are now the mainstream of vaccine development are DNA vaccines, mRNA vaccines, and virus vector vaccines. The basic thinking now is that, in contrast to conventional live vaccines, inactivated vaccines and VLP vaccines, where humans were inoculated with the vaccine itself, the protein that has the vaccine function is produced when the new biovaccine is introduced into the body. That is, the substance that works as a vaccine is produced inside the human body. This is the general idea of gene therapy.

To sum up the problematical points of the above, the first issue is that priority has been given to development while disregarding safety. Just as gene therapy floundered due to the frequent occurrence of leukemia, the kinds of new health effects that might occur are totally unpredictable. Secondly, there are doubts about efficacy. Even now, it has proven impossible to get a true picture of the COVID-19 virus and the phenomenon of a sharp drop in immune reaction has been observed in infected patients. Even if the vaccine should display effectiveness, it is thought that it will quickly lose efficacy just at a time when enormous amounts of money are being poured into continued purchases of the vaccines. Thirdly, genes will be made to function inside the body, but if this extends to reproductive cells this may possibly lead to a reconstruction of human genes. This should normally be governed by guidelines relevant to clinical trials for gene therapy, but nothing of this nature has been indicated. Fourthly, this being a genetic modification of human beings, it should be subject to the Cartagena laws of the Convention on Biological Diversity, to which all genetically modified organisms are subject, but there has been no indication regarding this either. Fifthly, above all, the human immune system is able to function due to various kinds of immune-related cells communicating with each other. Intervening in this complex mechanism carries with it the danger of bringing about allergies, hypersensitivities and autoimmune diseases.

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