US-China: vaccine development offensive and defense, concern over mass production issue, scramble for it

Recently the Nihon Keizai Shimbun Electronic Edition reported the following:

ワクチン開発で米中攻防　量産課題、奪い合い懸念

新型コロナ ヘルスケア 国際

2020/5/19 23:00 (2020/5/20 5:07更新) 日本経済新聞　電子版

 新型コロナウイルスの予防ワクチンの実用化をにらんだ米中の攻防が激しくなってきた。米バイオ企業のモデルナは初期の臨床試験（治験）で抗体が確認できたとして、7月から大規模な治験を始める。中国でも、複数企業が今秋の実用化を目指し治験を急いでいる。開発が進むなか、さらなる焦点は量産体制の確立だ。米国が量産設備を持つ仏企業を取り込む動きが出るなど、政府主導の争奪戦が起こる懸念もある。

  18日、モデルナは3月から進める第1段階の治験での初期データを公表した。最初にワクチンを投与した8人で、コロナに感染し回復した人と同じレベルの抗体を確認できたという。同社は有効性を調べる第2段階の治験を飛び越え、製品化前の最終治験を7月に始める。通常なら1～2年かかる手続きを大幅に短縮する。

 150万人もの感染者を出した米国は国が前面に出てワクチン開発を急ぐ。米生物医学先端研究開発局（BARDA）は4月、モデルナへの4億8300万ドル（約519億円）の支援を決めている。

 それでも先を行くのは中国だ。世界保健機関（WHO）によると、コロナワクチンの開発は5月15日時点で世界で8種類が治験まで進んでおり、うち4種類を中国勢が占める。中国のバイオ企業、科興控股生物技術（シノバック・バイオテック）は4月に始めた第2段階の治験を7月に終える予定だ。

 ただ、どの企業でも新技術のワクチンを製造できるわけではない。モデルナが開発中のワクチンは核酸を化学合成し、それをワクチンに精製するなどのノウハウが必要だ。生産施設も不足している。新ワクチンを大量につくるにはウイルス培養の装置や空調など、複雑な設備が欠かせない。英アストラゼネカや米ジョンソン・エンド・ジョンソン（J&J）など製薬世界大手にしか対応可能な施設はない。

 「量産」を巡る攻防は始まっている。

 「米国が当社のワクチンを最も多く事前発注する権利がある」。仏製薬大手サノフィのポール・ハドソン最高経営責任者（CEO）は13日、米メディアにこう語った。米BARDAは国籍にこだわらずワクチン量産ができる企業に資金を出しており、サノフィも支援先の一つ。知財と比べて生産分野を軽視しがちな欧州のワクチン政策へのけん制だったと業界関係者は見る。

 欧州連合（EU）も巻き返しに出始めた。欧州委員会は有事に備えて用意している約24億ユーロ（2820億円）の緊急基金をワクチン確保に使うもようだ。域内での生産支援も検討している。（先端医療エディター　高田倫志）

Translation

Attacks and defenses between the United States and China with the aim of commercializing a new type coronavirus preventive vaccine had become fierce. Moderna, a US biotechnology company, would start a large-scale clinical trial in July, assuming that the antibody could be confirmed in an early clinical trial. For China, several companies were rushing to conduct clinical trials aiming for commercialization this fall. As development progresses, a further focus was on establishing a mass production system. There was a concern that a government-led competition might occur, for example, as the US moved to incorporate French companies that had mass production facilities.

 On the 18th, Moderna published initial data from the first phase of the clinical trial that started in March. The first eight people who received the vaccine were able to confirm the same level of antibodies as those who recovered from corona infection. The company would skip the second stage clinical trials that investigate the efficacy, and start the final clinical trial in July before commercialization. Significantly it shortened the procedure that would normally take 1-2 years.

 In the US, which ha1.5 million people infected, the nation had taken the lead in rushing vaccine development. In April, the US Biomedical Advanced Research and Development Agency (BARDA) decided to support Moderna with $ 438 million (about 51.9 billion yen).

 Still, China was ahead. According to the World Health Organization (WHO), as of May 15, corona vaccine development had progressed in 8 clinical trials in the world, of which 4 were in China. China's biotech company, Kaoxing Biotech, planned to finish the second phase clinical trial in July which was started in April.

However, not all companies could manufacture vaccines that need new technology. The vaccine being developed by Moderna required know-how such as chemically synthesizing nucleic acid and refining it into a vaccine. There were also shortages of production facilities. In order to produce a large amount of new vaccine, complicated equipment such as virus culture equipment and air conditioning were indispensable. Such facilities were available only in the world's largest pharmaceutical companies such as AstraZeneca in the UK and Johnson & Johnson (J & J) in the US.

 The offensive and defense war over "mass production" had begun.

"The United States has the most right to pre-order our vaccines." French pharmaceutical giant Sanofi's CEO Paul Hudson told US media on the 13^th. US BARDA had funded a company that could mass-produce vaccines regardless of nationality, and Sanofi was one of the supported recipients. People related to the industry believed that it was an alert on the European vaccine policy, which tended to neglect the production sector compared to intellectual property.

The European Union (EU) had begun to rollback. It seemed that the European Commission would, in order to prepare of an emergency, use about 2.4 billion euros (282.0 billion yen) of its emergency fund to secure vaccine. They were also considering supporting local production within their region.

Comments

              In this world, there are rich and poor countries. Sometimes it is due to its good or bad geographical location, and sometimes it is due to the wisdom of their political leaders in setting up good political and social system. Some countries have good way to attract foreign investment (and therefore making money). All countries have to decide their own budget in how to make money and how to spend money. Whether it will spend more for education, military and defense, medical facilities, and infra-structure building etc. depends on the judgement and foresight of political leaders. It is an art in ruling a country. In this way, policy decision will impact the development of a country: whether it could become richer or weaker. In history, globally strong countries come and go in, from the Roman Empire 2,000 years ago to the present-day USA. So, competition among the counties for influence and leadership is a normal phenomenon. I think for a country, the ability to secure vaccines to protect its citizens during an emergency is a sign of a good government.