Inevitable vaccine lost battle - 30 years of inaction, remove people’s ladder (2 of 2)

Recently Nihon Keizai Shimbun Electronic Edition reported the following:

必然だったワクチン敗戦　不作為30年、民のはしご外す (2 of 2)

2021年5月9日 5:30 [有料会員限定]

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新技術でインフルエンザワクチンに挑んだバイオ企業、UMNファーマの挫折は語り草だ。工場建設に100億円超を投じたが、認可申請は17年、既存ワクチンに比べて「臨床的意義に乏しい」との理由で退けられた。

UMNは債務超過に陥り、曲折の末に塩野義製薬の傘下に入っている。米国で認可済みのワクチンだっただけに、医薬品業界は「単に新しいワクチンを導入したくないだけではないか」（国内製薬会社）と不信を募らせた。

研究者と技術は海外に流出している。あるウイルス学者は「日本は規制が多い一方、支援体制が貧弱だ」と指摘する。危険なウイルスを扱える実験施設は国内に2カ所しかなく、ひとつは周辺住民の反対で最近まで稼働しなかった。

厚労省、農水省、文科省をまたぐ規制は複雑で、遺伝子組み換え実験は生態系への影響を防ぐ「カルタヘナ法」に縛られる。欧州は医薬品を同法の適用除外とし、米国は批准もしていない。

製薬会社は日本市場を迂回する。武田薬品工業が開発中のデング熱ワクチン、田辺三菱製薬のタバコ葉の植物由来ワクチンも国内承認への計画は未定のままだ。

政府は新型コロナで急きょワクチン担当大臣を置いたが、アンジェス、塩野義などが開発中の国産ワクチンは承認されるとしても22年以降の見通しだ。国家の危機管理という原点を見失って漂流した30年の代償は大きい。

問われる科学的理解

ワクチンはラテン語の「牛」が語源で、牛痘から死亡率がはるかに高い天然痘のワクチンが開発されたことに由来する。日本のワクチン開発の停滞は官だけの責任ではない。副作用のリスクを踏まえても予防接種のメリットが大きいという公衆衛生に対する理解がわたしたち国民を含めて社会全体で足りなかった。

2013年に定期接種になった子宮頸（けい）がんワクチンは接種率が1%未満にとどまる。投与後に慢性の痛みや運動機能の障害などが出るとして一部メディアで「薬害」と騒がれ、接種勧奨が中止されたためだ。

大規模調査でワクチンと痛みなどに因果関係は証明されなかったが、その後も接種率は改善していない。科学的根拠のない不確かな情報であっても「なんとなく打ちたくない」というムードが広がると挽回が難しい。がん患者を減らす効果が証明され、接種率90%を目指している世界のワクチン先進国とは対照的だ。

日本は予防接種法を改正し、義務接種を取りやめた。かつてのような学校での集団接種も見られなくなった。ワクチン接種は個人の判断に委ねられている。

厚労省は新型コロナワクチンの副作用の疑いを公表している。「科学とは信じることではなく理解すること」。18世紀末に天然痘ワクチンを開発したエドワード・ジェンナーの理念をかみしめ、国民一人ひとりが危機と向き合わなければならない。

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The frustration of UMN Pharma, a biotech company that attempted to tackle the flu vaccine with a new technology, was a legend. Although it invested more than 10 billion yen in the construction of the factory, the application for approval was rejected in 2017 because it was "of little clinical significance" than the existing vaccines.

UMN fell into insolvency and become a subsidiary of Shionogi after some twists and turns. Because it was a vaccine only approved in the United States, the pharmaceutical industry would " just don't want to introduce a new vaccine anymore" (domestic pharmaceutical company) as distrust grew stronger.

Researchers and technology drifted overseas. One virologist said, "while Japan has a lot of regulations, the support system is poor”. There were only two experimental facilities in the country that could handle dangerous viruses, and one of them did not operate until recently due to oppositions from the local residents.

Regulations across the Ministry of Health, Labor and Welfare, the Ministry of Agriculture, Forestry and Fisheries, and the Ministry of Education were complicated, and genetic recombination experiments were bound by the "Cartagena Law" that prevented impacts on the ecosystem. Europe had exempted drugs from this law, and the United States also did not ratify the law.

Pharmaceutical companies bypassed the Japanese market. A plan for domestic approval of the dengue vaccine under development by Takeda Pharmaceutical Company, and also the plant-derived vaccine from tobacco leaves owned by Mitsubishi Tanabe Pharma remained undecided.

The government had hurriedly appointed a minister to take charge of vaccines for the new Corona, but even if the domestic vaccine being developed by AnGes, Shionogi and others were approved, it was something expected to be beyond 2022. The price for losing sight of the origin of national crisis management and the 30-year drifting was great.

Questioning scientific understanding

“Vaccine” was a word derived from the Latin word "cow", vaccine was derived from the development of a smallpox which had a much higher mortality rate. The stagnation of vaccine development in Japan was not the sole responsibility of the government. On public health issue regarding the fact that the benefits of vaccination were great then the risk, the understanding by people of the whole society including us was not enough.

The cervical cancer vaccine, which was routinely inoculated in 2013, had an inoculation rate of less than 1%. This was because some media complained that chronic pain and impaired movement function would occur after administration, and the promotion on vaccination was subsequently discontinued.

A large-scale survey had not proved a causal relationship between the vaccine and pain, but the vaccination rate did not improve since then. There was also incorrect information that had no scientific basis, and as the mood of "I don't want to be jabbed somehow" spread, it would be difficult to turn the tide. This was in contrast to the world's advanced vaccine countries, which have proven effective in reducing cancer patients and were aiming for a 90% inoculation rate.

Japan amended the Immunization Law and canceled compulsory vaccination. Mass inoculations at schools like those used to be were no longer seen. Vaccination was left to the desire of an individual.

The Ministry of Health, Labor and Welfare had announced suspicions of side effects of the new corona vaccine. "Science is not about believing but understanding." Each and every citizen had to face the crisis with the thinking of Edward Jenner, who developed the smallpox vaccine at the end of the 18th century.

              So, Japan has its own historical problems in dealing with public vaccination. In dealing with the Covid-19, its vaccination rate is far behind many advanced countries. One reason for that is the slow vaccine supply from overseas. Investigation into the scenes behind this "vaccine lost battle" reveals a blank 30-year of inaction by the Japanese government. I am wondering if Japan will review its vaccine policy in view of the current pandemic.