Prompted by the pandemic, Africa’s leaders are on a path to ramp up capacity in vaccine manufacturing and boost the continent’s regulatory bodies for medicines. On 13 April, they pledged to increase the share of vaccines manufactured in Africa from 1% to 60% by 2040. This includes building factories and bolstering capacity in research and development.
The COVID-19 pandemic has left Africa woefully short of vaccines, according to John Nkengasong, director of the Africa Centres for Disease Control and Prevention (Africa CDC), based in Addis Ababa. The ambitious move represents an important step in boosting Africa’s capacity in public health, he added.
Nkengasong was speaking at a 2-day vaccines summit on 12 and 13 April, co-organized by Africa CDC and the African Union, and attended by 40,000 delegates. Also taking part were heads of state and leaders from research, business, civil society and finance.
“We have been humbled, all of us, by this pandemic,” said Abdoulaye Diouf Sarr, Senegal’s minister of health and welfare. The 1% figure “boggles the mind”, added virologist Salim Abdool Karim, formerly a science adviser to South Africa’s government.
Nature examines the opportunities and challenges that Africa’s plans present.
How can Africa manufacture more vaccines?
Africa, a continent of 54 countries and 1.2 billion people, produces only 1% of the vaccines it administers. The remaining 99% are imported. Most come from international procurement mechanisms, such as one organized through the United Nations children’s charity UNICEF. As high-income nations rush to vaccinate their populations against COVID-19, Africa has found itself at the back of the queue. According to Andrea Taylor, a researcher at Duke University in Durham, North Carolina, people in the poorest countries will need to wait until the end of 2022 before everyone is protected.
Kick-starting successful vaccine manufacturing needs at least four key ingredients: financing amounting to hundreds of millions of dollars; expanded research capacity; a commitment from governments to purchase vaccines; and regulatory bodies that meet international standards. Compared with other regions, African countries are lacking in all four.
The entire continent has around ten vaccine manufacturers (see 'Where are Africa's vaccine manufacturers?'). This is according to 'Vaccine manufacturing in Africa', a report on vaccine investment opportunities funded by the UK government. Four manufacturers — the Pasteur Institute of Dakar in Senegal, the Pasteur Institute of Tunis in Tunisia, Biovac in Cape Town, and the Pasteur Institute of Algeria in Algiers — have the capacity to manufacture the substance that a vaccine is made of. Two others — Ethiopia Public Health Institute in Addis Ababa and Biovaccines in Lagos, Nigeria — have announced plans to reach that point. Two manufacturers are or plan to be involved only in ‘fill and finish’ processes or packaging and labelling.
Historically, international donors have been significant funders of African vaccine capacity, including research and development, such as France’s Pasteur Institute, whose research institutes are in Algeria, Morocco, Tunisia and Senegal. Imported vaccines are also funded in large part through international aid. Gavi, a partnership representing international donors and pharmaceutical companies, buys vaccines at low prices from pharmaceutical companies, and UNICEF has established a vast network to distribute them across low- and middle-income countries.
Is manufacturing already ramping up?
Until the pandemic, progress was slow. There was not enough demand for vaccines made in Africa to make manufacturing profitable, according to the UK government’s analysis. Companies, moreover, say that selling vaccines across Africa is expensive. But the African Union's free-trade area, which began operating from January of this year, will benefit companies that sell to different countries as they will pay fewer additional costs in the form of taxes and tariffs.
International donors are also stepping up. The Africa CDC plans to establish five new vaccine-manufacturing centres across the continent. The ambition is for Africa to manufacture 60% of its required vaccines within 20 years, according to John Nkengasong, director of the Africa CDC.
The African Development Bank, moreover, says it aims to help finance at least two technology platforms for vaccine production, which will be capable of producing at least 300 million doses per year. These platforms will need investments of up to US$400 million.
What is the role of medicines regulation?
All vaccines need approval from their national regulatory authorities. But, across Africa, these authorities range in quality from “robust and functional” to offering regulation that is “virtually non-existent”, according to a study published last month1 by researchers at the School of Pharmacy at the University of the Western Cape in South Africa.
The pandemic has prompted calls to accelerate efforts to establish an African Medicines Agency (AMA) — similar to the European Medicines Agency (EMA) — which would provide national African regulators with regulatory guidance on new medicines as the EMA does in Europe. The project is being led by the African Union and the Africa CDC. The AMA will cost $100 million to establish.
As of February 2021, only eight countries had ratified an international treaty that would bring the AMA into existence1. Fifteen countries will need to ratify it to bring it into existence; Tedros Adhanom Ghebreyesus, director-general of the World Health Organization, urged countries to quickly relevant laws in their national parliaments.
Can Africa learn from other countries?
Companies in other low- and middle-income countries have become hubs for vaccine manufacturing. The roots of vaccine manufacturing in India, which supplies around 70% of Africa’s vaccines, lie in a desire among policymakers for national self-reliance in vaccines and therapeutics dating from the 1950s and 1960s — shortly after the country attained independence from the United Kingdom. Indian companies such as the Serum Institute in Pune and Bharat Biotech, which have risen to prominence during the pandemic, did not suddenly emerge overnight, Rajinder Sur, Bharat Biotech’s chief executive told the AU meeting.
The Serum Institute, now the world’s biggest vaccine manufacturer — producing more than 1.5 billion doses a year — was founded in 1966. Its owner, race-horse breeder Cyrus Poonawalla, began cultivating therapeutic anti-tetanus serum from the serum of retired horses, and, within two years, expanded into tetanus-vaccine manufacturing — and then gradually into production of multiple vaccines. A pivotal moment came in 1994 when the institute achieved accreditation from the WHO and began to export its vaccines and selling to agencies such as UNICEF.
Other lower-income countries now producing COVID-19 vaccines, including Thailand and Vietnam, can do so at least in part because they benefited from an influenza-technology transfer programme run by the WHO some 15 years ago, says Martin Friede, coordinator of the WHO’s Initiative for Vaccine Research in Geneva.
The WHO established a training centre for 11 participating manufacturers to learn how to make pandemic influenza vaccines. By 2009–10, six of the countries were producing vaccines against avian influenza H1N1. The WHO is now trying to replicate this facility with the COVID-19 Vaccines Global Access (COVAX) manufacturing task force. At the same time, some countries are actively looking to acquire technology for RNA-vaccine manufacturing. As Nature reported last month, this is partly because the technology is more straightforward to develop and less capital-intensive.
In the next pandemic, will Africa make its own vaccines?
The AU meeting ended on an upbeat note, with delegates talking of “tipping points”, “now-or-never moments” and “global goodwill” to enable Africa to finally create its own vaccines industry. Progress will need political commitment, long-term finance and regional cooperation, said Patrick Tippoo, executive director of the African Vaccine Manufacturers’ Initiative, a group of vaccine manufacturers and research institutes.
The foundational problem, Tippoo added, is that the continent’s leaders have lacked the vision to recognize the centrality of local vaccine manufacturing in health-care policy.
The lack of manufacturing and weak regulation will require long-term governmental support if they are to be overcome, said Solomon Quaynor, a vice-president at the African Development Bank Group. Without such support, he warned the meeting’s delegates, “there will be no vaccine manufacturing in Africa”.
But momentum is on the side of new beginnings. “In the final analysis, the onus is on us as Africa. I do know we can do the job,” said Ngozi Okonjo-Iweala, Nigeria's former finance minister and now director-general of the World Trade Organization.
Ncube, B. M. et al. J. Pharm. Policy Pract. 14, 29 (2021).