Moderna is bringing local mRNA manufacturing to the UK through a large-scale facility, while BioNTech has broken ground on a modular scalable mRNA plant in Kigali, Rwanda. Is this the start of a localized production trend?

BioNTech this morning announced its efforts to bring localized vaccine manufacturing to Africa have reached a milestone with the commencement of construction of a manufacturing facility in Kigali, Rwanda expected to produce around 50 million doses of mRNA vaccine. The news comes eight months after BioNTech struck deals with the governments of Rwanda and Senegal.

The 30,000 square-meter facility will be initially equipped with two BioNTainers – modular cleanrooms built from ISO sized containers – for the manufacture of a range of mRNA-based vaccines targeted to the needs of the African Union member states, including the Pfizer-BioNTech COVID-19 vaccine.

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Commenting on the construction, Tedros Adhanom Ghebreyesus, WHO Director-General, said: “The COVID-19 pandemic has 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. I welcome BioNTech’s efforts to establish manufacturing sites in Rwanda, Senegal and South Africa, as well as its plans to commence clinical trials of its malaria vaccine candidates later this year.”

Meanwhile, Moderna has announced an agreement with the United Kingdom government to establish an mRNA vaccine manufacturing facility expected to provide access to rapid pandemic response capabilities and Moderna’s respiratory virus vaccine candidates. The facility will produce COVID-19, seasonal influenza, respiratory syncytial virus (RSV), and potential other vaccines for the UK market, with the capacity for up to 250 million vaccines a year once operational in 2025.

The location of the plant has not yet been disclosed, nor has the cost of the site or whether Moderna or the UK government will fund it. Reuters did report, however, that the deal includes a pledge by Moderna to make a minimum R&D investment of £1.1 billion ($1.35 billion) in the UK.

While the UK’s economy is on a downward spiral, it still differs significantly from African countries like Rwanda and Senegal, yet the need for in-country mRNA production is clearly a major driver with Prime Minister Boris Johnson stating the deal was important in “bringing supercharged, homegrown vaccines right to our shores.”

In other localized production news, Moderna recently announced plans to establish an mRNA plant in Kenya, while an mRNA tech-transfer hub in Cape Town, South Africa is being set-up by the WHO with support from Biovac. Training is also underway to localize mRNA in Latin America with support from the Bio-Manguinhos Institute of Technology on Immunobiologicals at the Oswaldo Cruz Foundation (FIOCRUZ) in Brazil, and Sinergium Biotech, a private sector biopharmaceutical company in Argentina.

Localized trend?

When the pandemic began in 2020, governments scrambled to ensure their citizens had access to therapies and potential vaccines. In the US, Operation Warp Speed locked up vaccine manufacturing capacity as part of an $18 billion spend, while EU countries similarly used their spending power to ensure access to billions of doses of products; particularly the new messenger RNA (mRNA) vaccines from Moderna and BioNTech/Pfizer.

Vaccine production has traditionally been geographically concentrated: Merck & Co., for example, produces its global supply of its HPV vaccines from two major sites in the US. However, demand for vaccines is global, and with increased supply chains pressures during the pandemic, talk of the need for in-region manufacturing arose. While pressures have somewhat abated, some governments have realised having production in their own countries will secure access to vaccines going forward and be a major advantage in the light of future endemics and pandemics.

Unlike egg-based or recombinant vaccine production, mRNA manufacturing can be done at large-scale in relatively small and flexible facilities. As such, this wealth of localized investments from governments and vaccine firms makes sense for this modality. But with only two mRNA products reaching global markets to date, time will only tell whether this is a global trend that is set to continue.