Company’s malaria vaccine candidates to enter first in-human trial later in 2022
KIGALI, Rwanda
BioNTech kicked off construction Thursday of the first manufacturing site for mRNA-based vaccines in Africa in Rwanda’s capital of Kigali, which could ensure equal distribution of vaccines.
The leading biotechnology company signed deals last year with Rwanda and the Senegalese Institut Pasteur de Dakar to set up manufacturing sites.
The company expects to set up additional factories in Senegal and South Africa in close coordination with partners.
Ugur Sahin, the chief executive and co-founder of BioNTech, said the first African mRNA manufacturing facility will be based on the BioNTainer concept — exact replications of the BioNTech factory in Germany.
BioNTech indicated it will work with staff from sites in Germany to accelerate the training of 100 colleagues who will run the production and all associated laboratory and quality assurance tasks at the Africa site.
The BioNTainers will be equipped to manufacture a range of mRNA-based vaccines targeting the needs of African Union member states.
They could conceivably include the Pfizer-BioNTech coronavirus vaccine and BioNTech’s investigational malaria and tuberculosis vaccines if they are successfully developed, approved, or authorized by regulatory authorities.
Sahin described the groundbreaking ceremony in Rwanda’s Special Economic Zone as a milestone in the establishment of scalable mRNA vaccine production in Africa.
“We have reached the next milestone with the construction of the first African mRNA manufacturing facility based on our BioNTainers — just four months after we introduced the BioNTainer concept in February,” he said. “This factory will be the first in an African network to provide sustainable production capacity for mRNA pharmaceuticals. Further manufacturing facilities in Africa and on other continents are planned to follow. The goal we pursue together with governments and regulatory authorities is to produce vaccines for Africa here with highly skilled professionals from Africa.”
The estimated initial annual capacity of the Pfizer-BioNTech COVID-19 vaccine will be 50 million doses, the company said. Manufacturing in the BioNTainers in Rwanda is expected to commence approximately 12 to 18 months after installation.
The company’s program is aimed to develop a highly effective malaria vaccine based on BioNTech’s mRNA platform with vaccine candidates expected to enter first-in-human trials later in 2022, said Sahin.
World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus welcomed BioNTech’s efforts to establish manufacturing sites on the continent as well as its plans to commence clinical trials of malaria vaccine candidates later this year.
“The COVID-19 pandemic exposed the need for significantly greater local production of vaccines and other essential products in all regions of the world, especially in Africa which relies heavily on imported products and was left behind in the global rush for COVID-19 vaccines,” he said.
Rwandan President Paul Kagame said working with other partners, the country intends to build on the investment to attract a vibrant biopharmaceutical research and manufacturing sector.
