Driven by the pandemic, African leaders are on track to increase their vaccine manufacturing capacities and strengthen the continent’s drug regulatory bodies. On April 13, they pledged to increase the share of vaccines made in Africa from 1% to 60% by 2040. This includes building factories and building research and development capacity.
The COVID-19 pandemic has left Africa woefully short of vaccines, according to John Nkengasong, director of the African Centers for Disease Control and Prevention (Africa CDC), based in Addis Ababa. This ambitious initiative represents an important step in strengthening Africa’s public health capacities, he added.
Nkengasong spoke at a 2-day vaccine summit on April 12-13, co-hosted by Africa CDC and the African Union, and attended by 40,000 delegates. Also in attendance were heads of state and leaders from research, business, civil society and finance.
“We have all been affected by this pandemic,” said Abdoulaye Diouf Sarr, Senegalese Minister of Health and Welfare. The 1% figure “is staggering,” added virologist Salim Abdool Karim, a former science adviser to the South African government.
Nature examines the opportunities and challenges presented by Africa’s plans.
How can Africa make 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 purchasing mechanisms, such as the one organized by UNICEF, a United Nations children’s charity. As high-income countries rush to vaccinate their populations against COVID-19, Africa finds 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 have to wait until the end of 2022 for everyone to be protected.
To successfully launch vaccine manufacturing, you need at least four key ingredients: funding in the hundreds of millions of dollars; expanded research capacity; a commitment from governments to purchase vaccines; and regulatory bodies that meet international standards. Compared to other regions, African countries are lacking in all four.
The whole continent has about ten vaccine manufacturers (see “Where are the vaccine manufacturers in Africa?”). This is according to ‘Manufacture of vaccines in Africa’, a report on vaccine investment opportunities funded by the UK government. Four manufacturers – the Institut Pasteur in Dakar in Senegal, the Institut Pasteur in Tunis in Tunisia, Biovac in Cape Town and the Institut Pasteur d’Algérie in Algiers – have the capacity to manufacture the substance from which a vaccine is made. Two others – the Ethiopian Institute of Public Health in Addis Ababa and Biovaccines in Lagos, Nigeria – have announced plans to reach this stage. Two manufacturers are or plan to be involved only in the “fill and finish” processes or in the packaging and labeling.
Historically, international donors have been major funders of African immunization capacity, including research and development, such as the French Pasteur Institute, whose research institutes are located in Algeria, Morocco, Tunisia and in Senegal. Imported vaccines are also financed largely by international aid. Gavi, a partnership representing international donors and pharmaceutical companies, purchases vaccines at low prices from pharmaceutical companies, and UNICEF has established a large network to distribute them in low- and middle-income countries.
Is manufacturing already accelerating?
Until the pandemic, progress was slow. According to the UK government’s analysis, the demand for vaccines made in Africa was not sufficient to make manufacturing profitable. What’s more, companies say selling vaccines across Africa is expensive. But the African Union free trade area, which started operating from January this year, will benefit companies that sell to different countries as they will pay less additional costs in the form of taxes and tariffs. .
International donors are also mobilizing. The African CDC plans to establish five new vaccine manufacturing centers across the continent. The ambition is for Africa to manufacture 60% of its necessary vaccines within 20 years, according to John Nkengasong, director of the Africa CDC.
The African Development Bank, on the other hand, 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 require investments of up to US $ 400 million.
What is the role of drug regulation?
All vaccines must be approved by their national regulatory authorities. But, across Africa, these authorities range from being “robust and functional” to offering regulation “virtually non-existent,” according to a study released last month.1 by researchers at the School of Pharmacy at the University of the Western Cape in South Africa.
The pandemic prompted calls to accelerate efforts to create an African Medicines Agency (AMA) – similar to the European Medicines Agency (EMA) – which would provide African national regulators with regulatory guidance on new medicines, such as the does EMA in Europe. The project is led by the African Union and the African CDC. The creation of the AMA will cost $ 100 million.
As of February 2021, only eight countries had ratified an international treaty that would give birth to WADA1. Fifteen countries will have to ratify it to make it exist; Tedros Adhanom Ghebreyesus, Director General of the World Health Organization, urged countries to quickly pass relevant laws in their national parliaments.
Can Africa learn from other countries?
Businesses in other low- and middle-income countries have become hubs for vaccine manufacturing. The roots of vaccine manufacturing in India, which supplies approximately 70% of African vaccines, lie in the desire of policy makers for national self-sufficiency in vaccines and therapeutics dating back to the 1950s and 1960s – shortly after that the country gained independence from the United Kingdom. Indian companies such as the Serum Institute in Pune and Bharat Biotech, which rose to prominence during the pandemic, did not suddenly appear overnight, Rajinder Sur, chief executive of Bharat Biotech, said at the meeting. of the AU.
The Serum Institute, now the world’s largest vaccine manufacturer – producing over 1.5 billion doses per year – was founded in 1966. Its owner, racehorse breeder Cyrus Poonawalla, began to cultivate anti-tetanus therapy serum from the serum of retired horses, and, within two years, expanded to manufacture tetanus vaccines – then gradually to the production of multiple vaccines. A pivotal moment came in 1994 when the institute gained accreditation from the WHO and began exporting its vaccines and selling them to agencies such as UNICEF.
Other low-income countries that are now producing COVID-19 vaccines, including Thailand and Vietnam, may do so at least in part because they have benefited from an influenza technology transfer program run by the ‘WHO about 15 years ago, says Martin Friede, coordinator of the WHO Vaccine Research Initiative in Geneva.
WHO has established a training center for 11 participating manufacturers to learn how to make pandemic influenza vaccines. In 2009-2010, six of the countries were producing H1N1 avian influenza vaccines. WHO is now attempting to replicate this facility with the COVID-19 Vaccines Global Access (COVAX) manufacturing working group. At the same time, some countries are actively seeking to acquire technology for the manufacture of RNA vaccines. As Nature reported last month, this is in part because the technology is easier to develop and less capital intensive.
In the next pandemic, will Africa make its own vaccines?
The AU meeting ended on an optimistic note, with delegates speaking of “tipping points”, “now or never times” and “global goodwill” to enable Africa to finally create its own. vaccine industry. Progress will require political commitment, long-term funding and regional cooperation, said Patrick Tippoo, executive director of the African Vaccine Manufacturers Initiative, a group of vaccine manufacturers and research institutes.
The fundamental problem, Tippoo added, is that the continent’s leaders lack the vision to recognize the central role of local vaccine manufacturing in health policy.
Lack of manufacturing and weak regulation will require long-term government support to be overcome, said Solomon Quaynor, vice president of the African Development Bank Group. Without such support, he warned meeting delegates, “there will be no vaccine manufacturing in Africa.”
But the momentum is on the side of new beginnings. “In the final analysis, the responsibility lies with us as Africa. I know we can do the job, ”said Ngozi Okonjo-Iweala, former Nigerian finance minister and now director general of the World Trade Organization.