Africa is Making Progress on Vaccine Development – But Big Pharma Warns That Process is Costly and Slow Drug & Diagnostics Development 06/12/2021 • Kerry Cullinan Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to print (Opens in new window) Pharma Panel: Moderator Glaudina Loots (South African government), Sai Prasad (Bharat), Holm Keller (BioNTech), Patrock van der Loo (Pfizer), Adrian Thomas (J&J), John Lepore (Moderna) and Charles Wolf (Sanofi) The African Union has made steady progress to manufacture vaccines on the continent, but this is a complicated, expensive endeavour that required long-term commitment, Big Pharma companies warned. Welcoming delegates to the Partnership for African Vaccine Manufacturing (PAVM) reportback six months after it was set up, Rwandan President Paul Kagame said building pharmaceutical manufacturing on the continent had become a matter of life-and-death. “Africa’s challenges during the COVID pandemic in securing timely access to tests, therapeutics and vaccines have served as a constant reminder that we need to be doing things for ourselves,” said Kagame. “That does not mean acting alone. Vaccine research and production is fundamentally a global enterprise. We therefore have to work in partnership with each other as Africa and also with key partners around the world,” said Kagame. He said that the recent ratification of the African Medicines Agency treaty was an important development. “It is essential to maintain the momentum and fully establish this agency without which Africa cannot independently authorise and register medicines and vaccines,” said Kagame. He also hailed agreements reached between Rwanda and Senegal and the German company, BioNtech, to start the production of mRNA vaccines as early as next year, as well as the mRNA tech transfer hub set up in South Africa by the World Health Organisation (WHO), which “is working with South African companies to build valuable knowledge best for our continent”. “These initiatives underway in various countries are evidence of a strong momentum which must be supported and sustained. Because of this terrible pandemic, an opportunity has been created to fundamentally change the pharmaceutical production landscape on our continent,” he concluded. Africa CDC’s John Nkengasong Dr John Nkengasong, executive director of the Africa Centres for Disease Control and Prevention (CDC), stressed that partnerships were central to the continental goal of producing 60% of vaccines it needed by 2040. Currently, this figure is 1%. Nkengasong said one of the meeting’s aims was to get agreement on “an AU-endorsed approach for facilitating regulatory approval processes, which will be packed with what we call potential pathways that we can use because of the speed at which the continent is moving in producing vaccines”. Options for vaccine authorisation, as presented by Dr Nkengasong. Complexity of vaccine development Later in the day, a panel addressed by key Pharma companies stressed the complexity and expense of vaccine development. Sanofi’s Charles Wolf said that “very long term agreements, and stable negotiations, are vital, vital for vaccine stability”. Pfizer representative responsive for Africa, Patrick van der Loo, said that for most of his company’s vaccines, tech transfers for formulation and fill finish took around three years. In July, Pfizer signed a letter of intent with the Biovac Institute in South Africa to manufacture the Pfizer-BioNTech COVID-19 vaccine for distribution within the African Union. “To facilitate Biovac’s involvement in the process, the tech transfer, the onsite development, the equipment installation activities, have begun basically immediately,” said Van der Loo. “We expect that the Cape Town facility will be incorporated into our supply chain by the end of this year,” he added, saying that the company would get the drug substance from facilities in Europe soon and manufacturing of finished doses will commence early in 2022. “At full operational capacity, the annual production there will exceed 100 million finished doses and all these doses will exclusively be distributed within the 55 member states that make up the African Union,” he added. However, he warned that challenges experienced in South Africa included unstable power supply and water shortages. Step-by-step approach Adrian Thomas of Johnson and Johnson (J&J), which has a partnership with the South African pharmaceutical company, Aspen, said that this relationship was being built in a “thoughtful way, step-by-step building on strength and experience”. “The overarching message that we have for Africa is that we support, and want to be part of, the long-term strategy for manufacturing internally and across the industry. But it’s it is going to be critical to look at multiple platforms and make sure that we distribute the risk across platforms across diseases and have stepwise progress. It has to be sustainable for the long term,” he stressed. Moderna’s John Lepore said it was exciting that Africa had a continental strategy for vaccine manufacture – the only region in the world to do so. “We have committed to spend up to $500 million to produce a factory that can make up to 500 million doses. And it’s really the [PAVM] strategy that gives us the confidence to make that investment,” said Lepore. “We’re currently doing our own due diligence to make the final site selection, and when we look at the key criteria we need to be successful, they match very well with the strategy that already been developed by the African Union, and the African CDC.” Production of Sinopharm’s inactivated COVID-19 vaccine candidate. Not just fill-finish Unlike the other companies that were mostly involved in fill-finish arrangements with African companies, BioNtech’s Holm Keller said that it wanted its malaria and TB vaccines be manufactured in Africa “end-to-end for drug substance and drug product” “We have started working on a factory set up that would produce formulated drug bulk,” said Keller. “BioNtech’s focus will be on drug substance and not on fill-finish.” He added that his company intended to start building the first factory in a few months in 2022, although he did not disclose where this would be other than to mention meetings in Ghana and South Africa. Sai Prasad, CEO of Indian manufacturer Bharat, stressed that the “complexity of vaccine development and manufacturing cannot be overstated”. “It takes sometimes decades to develop vaccines. It takes a big amount of investment – usually more than $100 or $200 million, irrespective of whether it is fill-finish or drug substance. “And when you make those investments, there has to have stability over a 20 or 30 year period for a vaccine manufacturing company or a product development company to take root and take shape.” The PAVP meeting continues on Tuesday. Image Credits: Sinopharm. Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to print (Opens in new window) Combat the infodemic in health information and support health policy reporting from the global South. Our growing network of journalists in Africa, Asia, Geneva and New York connect the dots between regional realities and the big global debates, with evidence-based, open access news and analysis. To make a personal or organisational contribution click here on PayPal.