BioNTech, flush with $145M from CEPI, looks to expand mRNA vaccine production in Africa – FiercePharma

As various efforts to produce next-generation vaccines in Africa are being carried forward by the likes of the World Health Organization (WHO) and the Bill & Melinda Gates Foundation, BioNTech is angling to turn its Kigali, Rwanda, facilitywhich opened in Decemberinto the continents first commercial-scale mRNA plant.

The Coalition for Epidemic Preparedness Innovations (CEPI) is committing up to $145 million to bolster BioNTechs efforts to establish mRNA vaccine R&D, plus clinical and commercial manufacturing, at the German companys facility in Kigali. The goal is to establish an end-to-end vaccine ecosystem on the continent, which would help Africa better prepare for potential future epidemics and pandemics, BioNTech and CEPI said in a joint release.

BioNTech first unveiled plans for the Kigali plant in 2021 and inaugurated the facility late last year. The site leverages BioNTechs modular manufacturing units called BioNTainers, which are designed to produce a range of mRNA-based vaccines.

With the added help from CEPI, BioNTech figures its Kigali plant could become the first commercial mRNA facility in Africa, which would support the African Union and Africa CDCs goal to produce 60% of all locally required vaccine doses on the continent by 2040.

BioNTech aims to crank out shots for diseases such as malaria, mpox and tuberculosis at the plant. The company says its committed to providing affordable access to its shots, with plans to target low- and middle-income countries and give priority supply to African countries.

Further, BioNTech and CEPI plan to work together to rapidly respond to outbreaks in Africa caused by known viral threats or as-yet-unknown pathogens with epidemic or pandemic potential.

The majority of the $145 million offered up by CEPI is earmarked to help BioNTech establish clinical-scale manufacturing for mRNA-based shots in Kigali. As it stands, BioNTechis running clinical trials for tuberculosis, malaria and mpox vaccineprogramsin Europe, the U.S. and South Africa. The company plans to launch studies in Africa for its candidates against malaria, HIV and mpox.

In addition, BioNTech will leverage CEPIs investment to help provide manufacturing capacity for third-party projects, including those by African-based researchers, academic groups, local businesses, public-private partnerships and non-profit organizations.

Africa still has to import 99 percent of all the vaccines it needs to protect its people from potentially deadly diseases, meaning many are left waiting far too long to get the life-saving doses they need, Richard Hatchett, M.D., CEO of CEPI, said in a statement. This must change if the world is going to avoid the terrible inequity of vaccine distribution that so clearly exacerbated the effects of the COVID-19 pandemic.

While Western drugmakers were able to rapidly develop and distribute vaccines during the COVID-19 pandemic, equitable access to those shots around the world became a big point of contention. In turn, many drugmakers, including BioNTech and its mRNA rival Moderna, launched efforts to expand in Africa.

Still, not all of those plans have come to fruition.

Earlier this year, Moderna said it was reevaluating its decision to build a $500 million manufacturing facility in Kenya, noting that it hadnt received any vaccine orders from the African continent since 2022. The Africa CDC was not pleased, arguing that Modernas effort to shift the blame onto the continent served to perpetuate the inequity that characterized the response to the COVID-19 pandemic.

Elsewhere, major health and philanthropic organizations have attempted to step up to the plate.

In October, for instance, the Gates Foundation said it would spread $40 million between a handful of companiesincluding Belgiums Quantoom, Senegals IPD and South Africas Biovacto develop and crank out mRNA vaccines for Africa and beyond.

And last April, WHO officially opened an mRNA vaccine hub in Cape Town, South Africa. The organization tapped South African biotech Afrigen Biologics for the sites pilot project, which revolves around leveraging the publicly available sequence of Modernas COVID shot to produce a local version of the prophylacticdubbed AfriVac 2121at lab scale.

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BioNTech, flush with $145M from CEPI, looks to expand mRNA vaccine production in Africa - FiercePharma