From Bio Journal - November 2020

A rapid succession of COVID-19 vaccine clinical trial suspensions

In contrast to previous vaccines, the COVID-19 vaccines now being developed insert genes into the human body (see BJ Sptember 2020), causing antigens to be formed inside the body, inducing antibodies. This is none other than the "genetic engineering of human beings." Driven forward by rapid developments in biotechnology and governments that wish to see hurried development, almost all multinational pharmaceutical corporations are engaging in the development race using this method. These pharmaceutical corporations are, in almost all cases, working jointly with bio-venture companies.

In addition to this being a type of vaccine that has never been experienced before, severe problems have arisen due to the extremely rushed development, and because of this a rapid succession of suspensions and interruptions are occurring. Firstly, problems have arisen with the virus vector vaccine being jointly developed by the UK AstraZeneca and Oxford University. The UK Prime Minister Boris Johnson, having completely failed with the COVID-19 countermeasures, is attempting a last-ditch comeback by allowing clinical trials with almost no screening. The characteristic of this vaccine is that it uses a chimpanzee adenovirus as the gene carrier vector. The reason why the trial was forced into suspension was that one of the volunteers contracted transverse myelitis, in which pain and numbness are experienced. Where it would normally be necessary to sufficiently confirm the safety of the vaccine, after a suspension of the trial in the UK for one week the trial was resumed with the causality between the transverse myelitis and the vaccine remaining unclear, following which trials also restarted in Japan and the USA.

The virus vector vaccine being jointly developed by the US Johnson & Johnson and the Belgian Jansen Pharmaceutical has also run into abnormalities during clinical trials, causing the trials to be suspended, including those taking place in Japan. The adenovirus type 26 is being used as the virus. The companies have not given a detailed explanation of the problem, saying that it is "an abnormality that cannot be explained." The DNA vaccine being developed by the US Inovio Pharmaceuticals has also been forced to suspend trials after the US Food and Drug Agency (FDA) pointed out several problem areas.

In Russia, following the "Sputnik V" virus vector vaccine developed by the Gamaleya National Center of Epidemiology and Microbiology, the "EpiVacCorona" peptide vaccine developed by the State Research Center of Virology and Biotechnology Research Center has been approved. Sputnik V is a double inoculation vaccine where inoculation with the adenovirus type 26 is first carried out, followed by inoculation with the adenovirus type 5. Neither of these have passed through the large-scale clinical trials that are necessary for final vaccine approval and some specialists are casting doubt on the safety and efficacy of the vaccines.

In China, SARS vaccines have been under development for more than ten years, but this eventually ended in failure. This is because antibody-dependent enhancement of infection (ADE), where infection by and multiplication of the virus grows stronger, has occurred with inoculation by the vaccine. This is a phenomenon where the antibodies that are supposed to protect the body from the virus do the reverse and promote infection and cause the infected immune cells to run out of control, resulting in aggravated symptoms. This is a serious phenomenon, and with COVID-19 this also has the danger of bringing about large-scale side effects. The theory that the Chinese SARS vaccine development is responsible for COVID-19 is still influential, and rushing vaccine development and inoculation due to political demands may not only bring about frequent occurrences of ADE but could potentially invite the appearance of a totally new virus. If COVID-19 countermeasures are sought from applications of biotechnology, it is possible that there will be a further increase in suffering.

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(English Index)