The German-based BioNTech, which co-developed with Pfizer an mRNA COVID vaccine, said on Wednesday that it will set up modular “turnkey” mRNA vaccine facilities to produce the vaccine in Rwanda and Senegal in 2022 – with a fill-and-finish collaboration in Ghana as well.  South Africa, which is the new hub for the WHO-supported mRNA vaccine R&D and manufacturing hub focusing on open-access products- may also join the initiative later, said the company in a press release.

Speaking at a press briefing Wednesday morning, which included the presidents of Rwanda, Ghana and Senegal, as well as WHO and Africa CDC, BioNTech CEO Ugur Sahin, described the new cutting-edge BioNTainer initiative for vaccine production as  – following “the most elementary principle of reducing complexity by copying the manufacturing units having modular action unit and by copying the process and transferring it to another place.

“But this is not about innovation alone, it it is about collaboration,” Sahin added, “for example, implementation of the manufacturing side, about regulation, about supply of vaccines… no one can do it alone, we have to do it together,” Sahin said.

He said that the first containers would be delivered to Africa in mid-2022 “and we want to start with the manufacturing of the first vaccine batches in the first months after we deliver the containers.” The new production facilities are designed to produce not only COVID-19 vaccines, but other “future vaccines” in the planning for malaria, tuberculosis and HIV:

“If these vaccines are successful and approved they will be produced in Africa, and these containers can be useful.”

Welcomed by African leaders

The initiative was roundly welcomed by the heads of Ghana, Senegal, Rwanda  – all of whom were present at the briefing – as well as the heads of WHO and Africa CDC.

“Today is a historic day. Today, we are putting an end to the vaccine injustice that has occurred during the pandemic, where Africa was left by the wayside,” said Senegal’s President Macky Sall, who opened Wednesday’s public briefing in Marburg, Germany, where the three African heads of state had been meeting with BioNTech officials over the past several days on the BioNtainer concept.

“Thanks to the innovation of BioNtech, with the BioNtainer, we are going to transfer the technology to Africa, to produce the API for the mRNA vaccines, along with the fill-and-finish.  And  we can thus be able to produce COVID-19 vaccines, as well as having the potential to produce vaccines for other diseases,” he said.

“We commend this cooperation between Europe and Africa, between BioNTech and African countries, as well as foundations and development banks that are providing the financial backing, so that we can very soon produce these vaccines on our continent.”

Meanwhile, Africa CDC head John Nkengasong praised BioNTech for “showing leadership” on the innovative ‘turn key’ production facilities, saying, “You are teaching us how to fish, and not giving us a fish….The African Union and Africa CDC will continue to work with you in this journey.”

And Ghana’s President Nana Akufo-Addo, said his country would be dedicating it’s National Vaccine Institute to support the initiative to develop “partnerships for vaccine deployment and manufacturing in areas of funding, clinical trials and fill-and-finish capacity.”

Ghana will set up a fill-and-finish facility soon, he said, in order to perform the last step of the BioNTech process – to be completed outside of the modular vaccine factory containers.

WHO affirms initiative has African “ownership”

Meanwhile, WHO’s Director General Dr Tedros Adhanom Ghebreyesus expressed support for the new project – despite the criticism that had been levelled at it in a recent BMJ investigation, which had portrayed it as a potential competition to the new WHO-supported mRNA vaccine manufacturing hub set up in South Africa, which aims to promote an open-license approach to vaccine manufacturing – in contrast to collaborations built around the bilateral licensing of patented products, such as Pfizer’s.

Tedros visited the South African mRNA hub, which has replicated a version of the Moderna mRNA vaccine, just last Friday.

“Many colleagues have been discouraged about the success of this project,” said Tedros, in an oblique reference to the earlier criticism levelled at the notion of shipping ready-made vaccine facilities in containers to Africa. He underlined that the endorsement by African national and African Union leaders shows that the BioNTech initiative is viable:

“Their presence shows political commitment, their presence shows ownership. And when projects are owned and political commitment is provided from the leaders, projects normally succeed…. failure is not an option for this project, from what I observed,” said Tedros.

.@DrTedros @WHO in oblique reference to prior @BMJ criticism of the initiative says "many colleagues have been discouraged about the success of this project….one thing that convinces me is that the presence of these leaders – their presence shows ownership." https://t.co/0GvaqaRSJ9 pic.twitter.com/lZFEBRQmiD

— Health Policy Watch – Global Health News Reporting (@HealthPolicyW) February 16, 2022

‘Miniaturized’ and standardized mRNA production

The new manufacturing systems effectively takes advantage of the comparatively small size of mRNA vaccines inputs, and their unique production technology, to “miniaturize” and standardise the vaccine production process, said BioNTech’s BioNTech Chief Operating Office (COO) Sierk Poetting at a press conference later Wednesday afternoon.

He said innovation had been developed at Pfizer’s Marburg, Germany facility, which is Pfizer’s largest manufacturing operation, and would also now serve as global quality control center for the plug-and-play systems sent to Africa.

The modular facilities would be built of ISO-standard 40 foot containers “We can put them on trucks, boats, or planes and ship those manufacturing BioNtainers to the world, to the target locations,” said Poetting.

“The power of the mRNA drug class is that it is versatile and can be prepared rapidly,” said Sahin, noting that the facilities would also serve the production of future mRNA vaccines under development by Pfizer for other diseases.

Turnkey facilities will be pre-approved as GMP complaint in Germany

Sahin said that the modular facilities could be pre-approved as GMP compliant at Pfizer’s Marburg, Germany plant where the turnkey solution was developed – and which will supervise the initiative:

“The turnkey package includes the modular production unit, GMP compliance set up, and personnel training to ensure that we can transfer the technology,” he explained.

“The elements of the container-based, plug-and-play approach was modular design.. by having this standardized design, we can ensure that the facility, once approved somewhere, can be transferred to another place, and with a little additional work, the process can be GMP [compliant].

That means that the facility would be built and pre-approved to meet European manufacturing requirements, and once transferred to Africa, could be quickly approved by national regulatory processes as well, ensuring a quick start to manufacturing, said Sahin.

There would be six containers  – six for producing the active pharmaceutical ingredient and six more for producing the final drug product. They would be set up in an air-conditioned factory hall, equipped with refrigeration and other basic infrastructure, Poetting explained.  ‘Fill and finish’ would take place at other sites in collaboration with national and local African partners.

Sahin said that the first facility would be set up in mid-2022, with the aim of being fully operational by the end of the year.  The facilities could produce up to 50 million doses a year – although actual production would vary by demand. Products would be sold at cost in African Union countries.

“The goal of the BioNtainer is to reduce the cost and the speed of the development of manufacturing facilities, and provide a solution which is suitable for the needs of people living in this region,” said Sahin.

Did BioNTech’s kENUP consultants try to undermine South Africa’s mRNA vaccine hub?

Asked why BioNTech had decided not to share Pfizer’s vaccine technology with the new WHO-supported mRNA vaccine tech transfer hub in South Africa, Poetting said that the company would collaborate by taking staff that are trained there to help manage the new BioNTech manufacturing facilities – which would initially be staffed by Pfizer’s European teams.

“We will onboard the local teams and do the knowledge transfer and the production together,” Poetting said, adding, “we are actually collaborating with the transfer hubs. We will work together with the transfer hubs on staffing the units, on training the units, and for distribution of the units” he said. But for actual production processes, the BioNTainer facilities could be set up and become operational sooner, he asserted.

Meanwhile, Sahin refused to comment on the recent allegations, published in The BMJ that the  kENUP Foundation, a BioNTech consultancy that helped develop the BioNTainer initiative, had actually sought to undermine the South African tech transfer hub – which along with training African scientists and technicians also aims to develop open-access versions of mRNA vaccines.

According to The BMJ, kENUP had sent a mission report to the South African government after a visit last August, saying that the hub’s project “of copying the manufacturing process of Moderna’s COVID-19 vaccine should be terminated immediately. This is to prevent damage to Afrigen, BioVac, and Moderna . . .

“Provided that the release from patent cover will be granted by Moderna only during the pandemic, the sustainability outlook for this project of the WHO Vaccine Technology Transfer Hub is not favourable,” stated the report, obtained by The BMJ.  Scientists at Afrigen have since said that they managed to replicate the Moderna mRNA vaccine – without assistance from the US-based pharma firm, which has nonetheless promised not to enforce its patents on its COVID-19 vaccine during the pandemic.

“We can’t comment on behalf of kENUP, and also not on behalf of WHO,” Sahin said.  “We can just state that at the moment several projects with the same goal are underway, and we welcome any projects with the same goals.  What is important at the beginning, of course, to understand the overall framework, and what are the specific aspects of the individual partners, and identify ways to collaborate.”

New projects on African continent – a turning point…

In fact, the silver lining in the vaccine inequalities in Africa, sharply highlighted by the COVID pandemic, is the surge of new vaccine manufacturing initiatives, said Greg Perry, Assistant Director of the International Federation of Pharmaceutical Manufacturers and Associations, in a comment to Health Policy Watch.

“What is significant is how much is happening on the African continent, and much from private sector, from J&J ‘s agreement with Aspen Pharmacare, to the BioNTech- Biovac partnership on manufacturing and distribution activities, to the various BioNTech actions announced today,” he said.

He made his comment shortly after the new head of Tanzania, formerly one of the continent’s most COVID vaccine-hestitant countries, said that it, too, would like to set up a vaccine manufacturing plant to tackle COVD and other diseases.  New President, Samia Suluhu Hassan described her plans at a meeting with European Union President Charles Michel in Brussels, BBC reported.  Meanwhile, in Nigeria, a vigorous debate over the creation of a national vaccine manufacturing initiative is also underway.

“We should be open to all these initiatives,” Perry said. “But what is key is that are long term, sustainable, and based on voluntary  partnership.  Moreover  they will all face the same challenges,  needs for skills and regulatory support; long- term financing and demand stability. It’s these real challenges and solutions we are talking about in Brussels this week at the European-African Business Forum,” he said, referring to a pharma meeting ongoing this week ahead of European Union-African Union summit.

Ont the other side of the fence, pharma critics that have looked at the South African mRNA hub, as the seedling from which new patent-free modes of vaccines manufacture might take root and flourish on the continent, were not so enthusiastic about the new BioNTech initiative.

“When local production in Africa is done under monopoly control of Pfizer/BioNtec, how does that increase technological autonomy and resilience?” asked Els Torreele, a visiting fellow at the Institute for Innovation and Public Purpose at University College London, in a tweet.

https://twitter.com/ElsTorreele/status/1493974017967067142

Image Credits: BioNTech, BioNTech , @StellenboschUni, BioNTech Press conference .