2024-08-23 04:30:00
«Mpox is not coronavirus», confirmed Hans Kluge, World Health Organization (WHO) Regional Director for Europe on August 20, 2024. It was enough to alleviate concerns raised by the World Health Organization’s declaration on August 14 that it constituted a public health emergency of international concern after a resurgence of monkeypox outbreaks in the Democratic Republic of the Congo (DRC) since 2023. The emergence of the new virus strain 1b has raised concerns about its potential danger and its spread to neighboring countries (Burundi, Kenya, Uganda, Rwanda). All this is in addition to the confirmed cases in Sweden last July.
In its current recommendations, the World Health Organization reports that there are three vaccines available in the world to prevent acne: MVA-BN from Denmark’s Bavarian Nordic Company, LC16 from Japanese laboratory KM Biologics, and LC16 from Japanese laboratory KM Biologics. The second case obtained is the Acam2000 vaccine, which comes from the American company Emergent Biosolutions, which until 2017 was owned by the French laboratory Sanofi.
The Danish-Bavarian Nordic vaccine is the only authorized vaccine in Europe against smallpox and pox
The vaccine from the Nordic Laboratory in Bavaria, Denmark, is at the forefront of the global fight against MPOX. In the first international MPO crisis in 2022, he was even the only one. Between 2022 and 2023, this third-generation smallpox vaccine uses a modified virus that can be injected in two doses 28 days apart, with 15 million doses sold in 76 countries around the world. It is currently the only vaccine with rights against smallpox in the EU and emergency authorization for MPOX. MVA-BN is sold in the Member States, the European Economic Area and the UK under the brand Imvanex, in Canada under the Imvamune brand and in the US and Switzerland under the Jynneos brand, and is produced entirely by Bavarian Nordic in Kvitsgaard, north of Copenhagen, Denmark. The group has another oral vaccine plant in Bern (Switzerland) (not MVA-BN), as well as a filling and packaging plant in the United States.
Available production capacity of 10 million doses by the end of 2025
Currently, Bavarian Nordic does not detail its production capabilities. The Danish laboratory has a total global installation capacity of 30 million doses per year, but its portfolio also includes vaccines beyond smallpox. Rolf Sass Sørensen, the group’s vice president of investor relations, pointed out to L’Usine Nouvelle: “We have spare capacity of 10 million doses by the end of 2025“Except for dosage”Already signed with the United States, Canada and other countries or ordered by Hera», the European Agency for Health Emergency Preparedness and Response, created by the European Union in 2021.
On August 17, 2024, Bavarian Nordic Company publicly stated that its available production capacity was 10 million doses, of which 2 million doses could be provided before the end of the year. In recent days, the African order has not yet been formalized, although discussions are ongoing. Instead, 440,000 doses of vaccine were ordered directly from a European country on August 21, but the specific identity has not been disclosed. In addition, the Danish group is studying the possibility of finding partners in Africa to directly produce the vaccine on the continent. No timetable available, Rolf Sass Sørensen said “The project is only in the discussion stage”. At the same time, Bavarian Nordic announced on August 16 that it would donate 40,000 doses of vaccine to be delivered to Hera. This will also add 175,420 doses, for a total of more than 215,000 emergency doses, to be provided to the Africa Centers for Disease Control and Prevention.
Currently, the vaccine is only authorized for emergency use to prevent MPOX in subjects aged 18 years or older in the EU. On August 17, Bavarian Nordic initiated a request to the European Medicines Agency (EMA) to extend this authorization to the 12-17 age group. He hopes to achieve this goal by the fourth quarter of this year. Finally, the laboratory also recently announced that it is preparing clinical trials of the vaccine, which will be conducted in Africa, more precisely in the Democratic Republic of Congo and Uganda, for pediatric use in the age group of 2 to 12 years.
Japanese vaccine recommended by WHO but rarely approved
The World Health Organization recommends another vaccine, LC16, produced by Japan’s KM Biologics laboratory on behalf of the Japanese government. According to the World Health Organization report, the vaccine was approved for use in preventing smallpox in Japan in 1975 and has received an extension for use in preventing smallpox in Japan from 2022. Japan holds a “significant” stockpile of LC16 doses, according to an Aug. 20 press release from the United Nations, which did not provide further details. However, the vaccine has rarely been approved or sold outside of Japan. It has been licensed for smallpox vaccination in the United States since 2014 and is the only smallpox vaccine approved for pediatric use, according to the National Institutes of Health. However, U.S. authorities have not approved its use against MPOX. The EU has not yet issued authorization for LC16.
If a vaccine is not available in Denmark and Japan, the World Health Organization recommends using Acam2000 from US laboratory Emergent Biosolutions. Sanofi Pasteur’s smallpox vaccine has received temporary emergency authorization for use against smallpox in countries including the United States and Canada, but has not yet been approved in Europe. On August 19, Emergent Biosolutions announced that it would donate 50,000 doses of Acam2000 to the African NGO Direct Relief for emergency needs in Central Africa. The laboratory mentioned in a press release that the contract to produce this vaccine is part of the strategic stockpile to fight smallpox, especially against bioterrorism in countries such as the United States.”allied governments”. Joe Papa, president and CEO of Emergent Biosolutions, said in this release that inventories are adequate and capacity is “possible.About 40 million more doses could be available if needed».
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