Inevitable vaccine lost battle - 30 years of inaction, remove people’s ladder (1 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 (1 of 2)

2021年5月9日 5:30 [有料会員限定]

新型コロナウイルスのワクチン開発で日本は米英中ロばかりか、ベトナムやインドにさえ後れを取っている。菅義偉首相が4月、米製薬大手ファイザーのトップに直々に掛け合って必要なワクチンを確保したほどだ。「ワクチン敗戦」の舞台裏をさぐると、副作用問題をめぐる国民の不信をぬぐえず、官の不作為に閉ざされた空白の30年が浮かび上がる。

世界がワクチンの奪い合いの様相を強める中で、国産ワクチンはひとつも承認されていない。ところが、厚生労働省で医薬品業務にかかわる担当者は「米国や欧州ほどの感染爆発は起きていない。何がいけないのか」と開き直る。「海外である程度使われてから日本に導入したほうが安全性と有効性を見極められる」

1980年代まで水痘、日本脳炎、百日ぜきといった日本のワクチン技術は高く、米国などに技術供与していた。新しいワクチンや技術の開発がほぼ途絶えるまで衰退したのは、予防接種の副作用訴訟で92年、東京高裁が国に賠償を命じる判決を出してからだ。

このとき「被害者救済に広く道を開いた画期的な判決」との世論が広がり、国は上告を断念した。94年に予防接種法が改正されて接種は「努力義務」となり、副作用を恐れる保護者の判断などで接種率はみるみる下がっていった。

さらに薬害エイズ事件が影を落とす。ワクチンと同じ「生物製剤」である血液製剤をめぐり事件当時の厚生省生物製剤課長が96年に逮捕され、業務上過失致死罪で有罪判決を受けた。責任追及は当然だったが、同省内部では「何かあったら我々が詰め腹を切らされ、政治家は責任を取らない」（元職員）と不作為の口実にされた。

いまや欧米で開発されたワクチンを数年から10年以上も遅れて国内承認する「ワクチン・ギャップ」が常態となった。国内で高齢者への接種が始まったファイザーのワクチンは厚労相が「特例承認」したものだが、これは海外ワクチンにだけ適用される手続きだ。

日本ワクチンが歩みを止めている間、米国は01年の炭疽（たんそ）菌事件を契機に公衆衛生危機への対応を進化させている。有事には保健福祉省（HHS）が中核となって関係省庁が一枚岩となり、製薬会社や研究機関と連携。ワクチン開発資金の支援や臨床試験（治験）、緊急使用許可といった政策の歯車が勢いよく回る。

世界のワクチン市場の成長率は年7%近い。致死率の高い中東呼吸器症候群（MERS）、エボラ出血熱などに襲われるたびに新しいワクチンが編み出された。新型コロナで脚光を浴びた「メッセンジャーRNA（mRNA）」の遺伝子技術もワクチンへの応用研究は20年越しで進められていた。

ワクチンは感染が広がらなければ需要がなく、民間企業だけでは手がけにくい。しかし日本では開発支援や買い取り、備蓄の機運は乏しい。北里大学の中山哲夫特任教授は「ワクチン・ギャップが生じるのはポリシー・ギャップがあるからだ」と政策の停滞を嘆く。

(to be continued)

Translation

Japan lagged behind not only the United States, Britain, China and Russia, but also Vietnam and India in developing a vaccine for the new coronavirus. In April, Prime Minister Yoshihide Suga directly contacted the top people of Pfizer, a major US pharmaceutical company, to secure the necessary vaccines. When investigating the scenes behind the "vaccine lost battle", it revealed the inability to remove the public's distrust over the side effect problem, and a blank 30-year shutting up due to the inaction of the government.

As the world intensified the competition for vaccines, no Japanese vaccine had been approved yet. However, a person in charge of pharmaceuticals at the Ministry of Health, Labor and Welfare became defiant, saying that "the infection explosion has not occurred as serious as in the United States and Europe. What’s wrong?" " To introduce it to Japan after it has been used to some extent overseas could determine its safety and effectiveness."

Until the 1980s, Japanese vaccine technology level in areas such as chickenpox, Japanese encephalitis, and whooping cough was high, and technologies were provided to the United States and other countries. The development of new vaccines and technologies declined to the point of almost zero after the Tokyo High Court issued a ruling in 1992 in which the government was ordered to compensate for the side effects of vaccination.

At this time, public opinion spread that it was an epoch-making decision that paved the way for victim relief. The country abandoned an appeal. The vaccination law was amended in 1994, and vaccination became an "obligation effort", and the vaccination rate dropped sharply due to the judgment of parents who feared of side effects.

Furthermore, the HIV-tainted blood scandal case also had casted a shadow. It was an incident over blood product, which was the same "biological product" as vaccine. The chief of the biologics section of the Ministry of Health and Welfare at that time was arrested in 1996, and was convicted of negligent fatalities in business. It was natural to take responsibility, but inside the ministry, it was used as an excuse (by former employees) for doing nothing, saying that "if something happened, we were relentlessly forced to bear responsibility and resign from our position while politicians did not take any responsibility" .

Right now, the "vaccine gap" in that vaccines developed in Europe and the United States were being approved in Japan with a delay from several years to over 10 years had become the norm. Pfizer's vaccine, which had begun to be given to the elderly in Japan, was "specially approved" by the Minister of Health, Labor and Welfare, but this was a procedure that applicable only to overseas vaccines.

While the Japanese vaccine progress had stopped, the United States evolved its response to the public health crisis in the wake of the 2001 anthrax incident. In an emergency, its Ministry of Health and Human Services (HHS) would play a central role, and related ministries and agencies would share one spirit in collaborating with pharmaceutical companies and research institutes. Policy gears were spinning around such as funding support to vaccine development, clinical studies (clinical trials), and emergency use authorization.

The growth rate of the global vaccine market was near 7% per year. A new vaccine would be developed every time when we were struck by cases that had high fatality rate such as the Middle East Respiratory Syndrome (MERS) and Ebola. The genetic technology of "messenger RNA (mRNA)", which was now in the limelight with the new corona virus, had its application research in vaccine being carried out for more than 20 years.

Vaccine would not be in demand unless the infection spread, and it would be difficult for private companies to handle it alone. Yet, in Japan, there was little momentum for vaccine developmental support, purchase, and stockpiling. Tetsuo Nakayama (中山哲夫), a specially appointed professor at Kitasato University (北里大学) lamented the stagnation of policy, saying that "the vaccine gap occurs because of a policy gap."

(to be continued)