AFRICA – BioNTech has initiated an early-stage study to evaluate its experimental malaria vaccine, BNT165b1, in humans.

The effort is one of several focused on addressing the mosquito-borne disease that kills over 600,000 each year, most of them children in Africa. The complicated structure and lifecycle of the malaria parasite has long stymied efforts to develop vaccines.

The Phase 1 trial is expected to enrol 60 volunteers in the United States with no history of malaria to assess the vaccine candidate at three-dose levels.

This is the first vaccine candidate from BioNTech’s malaria project and is set to also establish a vaccine production site in Africa.

BioNTech’s malaria vaccine effort is based on its mRNA technology, which was employed during the pandemic to quickly develop Covid-19 vaccines, by prompting the human body to make a protein that is part of the pathogen, triggering an immune response.

Other malaria vaccine prospects

After decades of work, the only approved malaria vaccine, Mosquirix, made by British drugmaker GSK, was this year endorsed by the World Health Organization (WHO), but a lack of funding and commercial potential has thwarted GSK’s capacity to produce as many doses as needed.

Another keenly-watched effort is a malaria vaccine from Oxford University. Mid-stage trial data was published in September.

No direct comparisons have been made, but some scientists suggest the Oxford shot is a step forward from Mosquirix and provides longer immunity.

Investing in Africa

In June 2022, The German pharmaceutical company BioNTech broken ground for the production site of its COVID-19 vaccine in Rwanda’s capital, Kigali.

According to BioNTech, the facility, dubbed the African modular mRNA manufacturing facility, has a target for the first set of manufacturing tools to be delivered to the site by the end of this year.

Across the continent, only 17% of Africa’s 1.3 billion people are fully vaccinated against COVID-19, compared with over 70% of the population in the European Union.

When the Rwanda facility is up and running, it will be the first mRNA vaccine plant in Africa. The BioNTech-Pfizer COVID-19 vaccine is based on relatively new technology using messenger ribonucleic acid (mRNA).

Initially, the 30,000-square-meter (323,000-square-foot) plant in Kigali will contain two modular vaccine production containers and have an estimated annual capacity of about 50 million vaccine doses, according to a BioNTech press release.

Basing the plant on the modular containers will enable the company to scale production as needed, according to BioNTech.

It’s expected that the first set of containers will arrive in Rwanda in late 2022, with vaccine production starting 12 to 18 months after that.

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