WHO、マラリアワクチン使用を初めて推奨　

WHOは10月6日、英製薬大手 GlaxoSmithKlineが開発したマラリア予防のワクチンRTS,S/AS01の使用を初めて推奨すると発表した。これまでWHOの基準を満たすマラリアワクチンは存在していなかった。

2019年以降、ガーナ、ケニア、マラウイのアフリカ3カ国で試験的に80万人以上の子供に接種して効果を調べ、高い効果を確認できたことから、広く使用することを認めた。

参考

2019/3/5   マラリアワクチンの臨床試験 開始

日本人研究者が創業した米国メリーランド州の創薬ベンチャー VLP Therapeuticsは2月4日、独自技術 i-αVLP (inserted alpha VLP) Technology で開発したマラリアワクチン候補 VLPM01の新薬臨床試験開始届（IND）が米食品医薬品局（FDA）により認可され、フェーズ I/IIa の患者登録を開始したことを明らかにした。Walter Reed Army Institute of Research で臨床試験が実施される。
 同社初の臨床入り品目となる。

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2020/4/8   愛媛大学と大日本住友製薬、新規マラリア伝搬阻止ワクチン開発へ

愛媛大学プロテオサイエンスセンターと大日本住友製薬は4月3日、米国のNPO団体のPATH（Program for Appropriate Technology in Health）と3者共同で進めている「新規マラリア伝搬阻止ワクチンの前臨床開発プロジェクト」が、公益社団法人グローバルヘルス技術振興基金（GHIT Fund）の助成案件に選定されたと発表した。

5億円の助成金を受け、新規マラリア伝搬阻止ワクチン製剤の前臨床開発を行う。

マラリア防除用蚊帳
　2013/6/8　住友化学のOlyset Net 　
　2017/7/29　本の紹介　「日本人ビジネスマン、アフリカで蚊帳を売る: なぜ、日本企業の防虫蚊帳がケニアでトップシェアをとれたのか? 」　

　　2020年9月14日　NHK「逆転人生」で、住友化学のマラリア防除用「オリセット®ネット」の開発普及ドキュメンタリー「マラリアを予防せよ　命の蚊帳を世界に届ける」が紹介された。

　

WHO recommends groundbreaking malaria vaccine for children at risk

Historic RTS,S/AS01 recommendation can reinvigorate the fight against malaria

6 October 2021
The World Health Organization (WHO) is recommending widespread use of the RTS,S/AS01 (RTS,S) malaria vaccine among children in sub-Saharan Africa and in other regions with moderate to high P. falciparum malaria transmission. The recommendation is based on results from an ongoing pilot programme in Ghana, Kenya and Malawi that has reached more than 800 000 children since 2019.

“This is a historic moment. The long-awaited malaria vaccine for children is a breakthrough for science, child health and malaria control,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. “Using this vaccine on top of existing  tools to prevent malaria could save tens of thousands of young lives each year.”

Malaria remains a primary cause of childhood illness and death in sub-Saharan Africa. More than 260 000 African children under the age of five die from malaria annually.

In recent years, WHO and its partners have been reporting a stagnation in progress against the deadly disease.

"For centuries, malaria has stalked sub-Saharan Africa, causing immense personal suffering,” said Dr Matshidiso Moeti, WHO Regional Director for Africa. “We have long hoped for an effective malaria vaccine and now for the first time ever, we have such a vaccine recommended for widespread use. Today’s recommendation offers a glimmer of hope for the continent which shoulders the heaviest burden of the disease and we expect many more African children to be protected from malaria and grow into healthy adults.”
　

WHO recommendation for the RTS,S malaria vaccine

Based on the advice of two WHO global advisory bodies, one for immunization and the other for malaria, the Organization recommends that:

WHO recommends that in the context of comprehensive malaria control the RTS,S/AS01 malaria vaccine be used for the prevention of P. falciparum malaria in children living in regions with moderate to high transmission as defined by WHO.  RTS,S/AS01 malaria vaccine should be provided in a schedule of 4 doses in children from 5 months of age for the reduction of malaria disease and burden.

Summary of key findings of the malaria vaccine pilots

Key findings of the pilots informed the recommendation based on data and insights generated from two years of vaccination in child health clinics in the three pilot countries, implemented under the leadership of the Ministries of Health of Ghana, Kenya and Malawi. Findings include:

  • Feasible to deliver: Vaccine introduction is feasible, improves health and saves lives, with good and equitable coverage of RTS,S seen through routine immunization systems. This occurred even in the context of the COVID-19 pandemic.
    　
  • Reaching the unreached: RTS,S increases equity in access to malaria prevention.
    • Data from the pilot programme showed that more than two-thirds of children in the 3 countries who are not sleeping under a bednet are benefitting from the RTS,S vaccine.
    • Layering the tools results in over 90% of children benefitting from at least one preventive intervention (insecticide treated bednets or the malaria vaccine).
      　
  • Strong safety profile: To date, more than 2.3 million doses of the vaccine have been administered in 3 African countries – the vaccine has a favorable safety profile. 
    　
  • No negative impact on uptake of bednets, other childhood vaccinations, or health seeking behavior for febrile illness. In areas where the vaccine has been introduced, there has been no decrease in the use of insecticide-treated nets, uptake of other childhood vaccinations or health seeking behavior for febrile illness.
    　
  • High impact in real-life childhood vaccination settings: Significant reduction (30%) in deadly severe malaria, even when introduced in areas where insecticide-treated nets are widely used and there is good access to diagnosis and treatment.
    　
  • Highly cost-effective: Modelling estimates that the vaccine is cost effective in areas of moderate to high malaria transmission.

Next steps for the WHO-recommended malaria vaccine will include funding decisions from the global health community for broader rollout, and country decision-making on whether to adopt the vaccine as part of national malaria control strategies.

Financial support

Financing for the pilot programme has been mobilized through an unprecedented collaboration among three key global health funding bodies: Gavi, the Vaccine Alliance; the Global Fund to Fight AIDS, Tuberculosis and Malaria; and Unitaid.
　

Note to editors:

  • The malaria vaccine, RTS,S, acts against P. falciparum, the most deadly malaria parasite globally, and the most prevalent in Africa.
  • The Malaria Vaccine Implementation Programme is generating evidence and experience on the feasibility, impact and safety of the RTS,S malaria vaccine in real-life, routine settings in selected areas of Ghana, Kenya and Malawi.
  • Pilot malaria vaccine introductions are led by the Ministries of Health of Ghana, Kenya and Malawi.
  • The pilot programme will continue in the 3 pilot countries to understand the added value of the 4th vaccine dose, and to measure longer-term impact on child deaths.
  • The Malaria Vaccine Implementation Programme is coordinated by WHO and supported by in-country and international partners, including PATH, UNICEF and GSK, which is donating up to 10 million doses of the vaccine for the pilot.
  • The RTS,S malaria vaccine is the result of 30 years of research and development by GSK and through a partnership with PATH, with support from a network of African research centres.
  • The Bill & Melinda Gates Foundation provided catalytic funding for late-stage development of RTS,S between 2001 and 2015.

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GSK welcomes WHO recommendation for broad roll-out of its RTS,S/AS01e (RTS,S) malaria vaccine        

2015発表

MosquirixTM（RTS,S）which was developed in partnership with the PATH Malaria Vaccine Initiative (MVI), is the first candidate vaccine for the prevention of malaria to reach this milestone. While other vaccines tackle viruses or bacteria, RTS,S has been designed to prevent malaria caused by the Plasmodium falciparum parasiteマラリア原虫, which is most prevalent in sub-Saharan Africa (SSA).

MVIは、米国のNPO団体PATH (Program for Appropriate Technology in Health)において、ビル＆メリンダ・ゲイツ財団の寄付を受けて1999年に始まったプログラムの名称で、「マラリア撲滅」を目指して国際的なマラリアワクチンの研究開発を強力に支援

  • Mosquirix is the brand name given to this malaria candidate vaccine. Its scientific name, RTS,S, reflects the composition. RTS,S also contains the AS01 adjuvant system.[i]
  • RTS,S aims to trigger the body’s immune system to defend against the Plasmodium falciparum malaria parasite when it first enters the human host’s bloodstream and/or when the parasite infects liver cells. It is designed to prevent the parasite from infecting, maturing and multiplying in the liver, after which time the parasite would re-enter the bloodstream and infect red blood cells, leading to disease symptoms.
  • The safety and efficacy of RTS,S has been evaluated in a large-scale phase III trial, in which it was administered in three doses, one month apart, with an additional fourth dose given 18 months later. Results from this trial have consistently demonstrated that RTS,S can help to protect children against malaria in endemic countries, when used in addition to other malaria control measures such as bed nets.
  • RTS,S is the most advanced malaria vaccine candidate in development globally. It was created in 1987 by scientists working at GSK laboratories. Early clinical development was done in collaboration with the Walter Reed Army Institute for Research. In January 2001, GSK and PATH, with grant monies from the Bill & Melinda Gates Foundation to PATH, entered into a public-private partnership to develop an RTS,S-based vaccine for infants and young children living in malaria-endemic regions in sub-Saharan Africa.
  • GSK has invested more than $365 million to date and expects to invest a further $200 to $250 million until development is completed. Between 2001 and the end of 2014, the MVI, supported by grants from Bill & Melinda Gates Foundation, invested more than $200 million to advance the RTS,S project.
  • The EMA’s CHMP opinion is a final stage in the Article 58 procedure initiated in July 2014, by which the CHMP gives a scientific opinion, in co-operation with the World Health Organization (WHO), on a medicinal product for human use that is intended exclusively for markets outside of the European Union (EU). This assessment requires medicinal products to meet the same standards as those intended for use in the EU.

　

GlaxoSmithKline (GSK) plc welcomes and applauds the WHO recommendation for the broader deployment of GSK’s RTS,S malaria vaccine to reduce childhood illness and deaths from malaria in children living in sub-Saharan Africa and other regions with moderate to high transmission as defined by WHO. RTS,S is the first and only malaria vaccine to have been shown in pivotal long-term clinical trials to significantly reduce malaria in children. The vaccine is the result of over 30 years of research led by GSK, with PATH and other partners.  

Thomas Breuer, Chief Global Health Officer, GSK, said: “GSK is proud that RTS,S, our ground-breaking malaria vaccine, developed over decades by our teams and partners, can now be made available to children in sub-Saharan Africa and other regions with moderate to high malaria transmission. This long-awaited landmark decision can reinvigorate the fight against malaria in the region at a time when progress on malaria control has stalled. Both real world evidence and clinical trial data show that RTS,S, alongside other malaria prevention measures, has the potential to save hundreds of thousands of lives.”

In anticipation of the decision and wider roll-out beyond the pilot programmes in Malawi, Kenya and Ghana, GSK is working with partners to develop solutions to ensure equitable and long-term access to the RTS,S vaccine for the people who need it.  GSK has committed to donate up to 10 million RTS,S doses for use in the pilots, and to supply up to 15 million doses annually, following a recommendation and funding for wider use.  A Product Transfer, including technology transfer for long-term antigen production, is also underway with Bharat Biotech of India. GSK will now work closely with partners, funders and governments to support additional supply of the vaccine, and has committed to make the 15 million annual doses available at no more than 5% above cost of production.

This recommendation from WHO, informed by data generated from the pilot programme, is a second key milestone for the RTS,S malaria vaccine in recent weeks. In August, data from a study of 6,000 children by the London School Hygiene and Tropical Medicine, published in the New England Journal of Medicine, showed that after three years the combination of seasonal administration of antimalarials (known as Seasonal Malaria Chemoprevention/SMC) and RTS,S vaccination lowered clinical episodes of malaria, hospital admissions with WHO-defined severe malaria, and deaths from malaria by about 70% compared to SMC alone.[1]These data indicate that the impact of RTS,S vaccination can be increased to further reduce mortality, especially when combined with other recommended malaria control interventions in a seasonal setting.

Since the launch of the malaria vaccine pilots in 2019, 3 countries (Ghana, Kenya and Malawi) have led the introduction of the vaccine in selected areas of moderate to high malaria transmission, reaching more than 800,000 children with at least 1 dose of the vaccine. More than 2.3 million vaccine doses have been administered to date. Community demand for the vaccine is strong and evidence shows it can effectively be delivered through the routine child immunization platform.

GSK believes that beating malaria is a shared responsibility and demands a range of tools – from accessible testing and treatment to preventative measures like a vaccine, complemented by bed nets as well as trained health workers to support prevention and treatment in the community.

GSK continues active research in malaria as part of its extensive Global Health research and development programme, and also works with partners such as Comic Relief and AMREF Health Africa to increase public health awareness, train health workers in underserved communities to better diagnose and treat malaria, and increase access to testing and medications.