2024-07-10 15:39:45
The continent relies heavily on foreign countries for vaccines. Only 1% of the vaccines administered are produced locally, with the rest imported mainly from Asia.. As the Covid-19 pandemic has painfully revealed, this dependence on outsiders creates risks for supply chains and for access to vaccines.
The ethical and moral questions surrounding this vaccine inequity have awakened the conscience of Africa and the international community and reignited the debate on establishing local vaccine manufacturing. Today, many public and private stakeholders are involved in the development of such production systems. But there are still some obstacles. explain.
Very poor production capacity
During the Covid-19 pandemic, despite the implementation of international solidarity mechanisms such as COVAX equipment). The continent cannot rely on local vaccine production due to its reliance on imports.
This situation is not surprising: in 2020, Only 10 vaccine manufacturers operate in 5 countriesThis reveals the lack of political and financial support for the development of the pharmaceutical industry on African soil over decades. International partners and local governments have long favored importing vaccines and redirecting their efforts to other sectors seen as higher priorities.
However, following the outbreak, strong African and international mobilization contributed to the revitalization of vaccine production programs. Today we count Approximately 30 projects in 14 countries.
Many actors participated
Many stakeholders have been involved or are involved in accelerating the development of production in Africa, either through technical and financial support or by leveraging resources or expertise: actors and donors committed to global health (Organization World Health Organization, Gavi, the Vaccine Alliance, path…), Pan-African Development and Health Entity (Africa Centers for Disease Control and Preventionin particular), or even local or international vaccine manufacturers (Pfizer, Moderna, etc.).
Building on this mobilization, the African Union announced in 2021 that its ambition is to have an African vaccine manufacturing industry capable of developing, producing and supplying 60% of the doses required by the continent by 2040.established Partnership for African Vaccine Manufacturing (PAVM).
However, to develop a regional vaccine industry, it is not enough to just build factories and production lines. We must be able to create a profitable ecosystem to fund the creation of a sustainable vaccine industry: train adequate qualified human resources, strengthen regulatory frameworks, encourage technology transfer and research and development, improve intra-continental transport infrastructure, and Public utility services (water, electricity, sanitation).
PAVM’s estimated $30 billion in funding will cover its 20-year action plan to strengthen the ecosystem and help achieve its ambitions.. The mobilization of capital, as well as the mobilization of financiers, is crucial.
Who is involved in financing?
Financial commitments have been gradually announced since 2021. International Finance Corporation, the private sector arm of the World Bank Group, pledges $600 million in support, Bill & Melinda Gates Foundation donates $40 millioneven Coalition for Epidemic Preparedness Innovations provides $50 million. The grants are intended to directly support “long-established” African manufacturers, Biovac and Aspen Pharmacare Holdings Limited in South Africa or the Institut Pasteur Dakar (IPD) in Senegal.
The budget is also planned to strengthen the ecosystem required for the emergence and sustainable development of the vaccine industry. For example, this is the case for this project MAV+ (Manufacturing and Access to Vaccines, Medicines and Health Technology Products in Africa) The European Commission announced an allocation of €1 billion.
But for manufacturers to establish themselves and grow, they must be able to sell their vaccines. Prequalification is required for vaccines purchased and distributed by international donors such as Gavi-UNICEF.
Obtaining prequalification is a top priority for manufacturers
Pre-qualification process The goal of the United Nations, led by WHO, is to ensure that vaccines, medicines, diagnostics and vector control meet international standards of quality, safety and effectiveness.
The granting of prequalification is based not only on a review of documents but also on a physical inspection of the production site and quality control activities. Any manufacturer, regardless of country, can request prequalification of their products.
Obtaining prequalification from African vaccine manufacturers is a key point. In fact, UNICEF’s strict procurement procedures require Prequalification as a criterion for vaccine selection. Seeing its vaccine added to the list of prequalified products means an opportunity for manufacturers to participate in tenders Gavi, the Vaccine Alliance/UNICEF.
Remember that the public-private partnership Global Alliance for Vaccines and Immunization (Gavi) has been a major donor of vaccines to the continent since 2000: two-thirds of vaccines distributed to Africa It was purchased through UNICEF using funds from the Global Alliance for Vaccines and Immunization, with the remainder purchased directly by African countries.
Another benefit of being prequalified: In late 2023, Gavi announced the creation of a financial instrument to support the sustainable production of vaccines on the African continent, called AVMA (African Vaccine Manufacturing Accelerator). Incentives paid to manufacturers upon obtaining WHO prequalification are intended to compensate for necessary investments and encourage manufacturers to produce in Africa.
Getting Pre-Qualified: Obstacle Course?
Getting prequalified can be a long and complicated process. If, according to the World Health Organization, it is necessary to calculate It will take at least 3 months to complete the processin practice from the establishment of production capacity, At least 10 years (average regarding 20 years) It may be necessary to obtain prequalification from the World Health Organization for the first vaccine.
In addition to the time factor and investment involved in prequalification, there is another challenge: the need for a so-called “functional” regulatory body in the producing country. In fact, an application for prequalification of a vaccine can only be submitted if the national regulatory authority in the country where the manufacturer is located meets a certain level of quality assessed by the World Health Organization.
To date, only two African countries, viz. egypt and south africa, this purpose has been achieved. In other words, 12 of the 14 countries with production projects are currently unable to see vaccines produced on their soil prequalified…
The paradox of international aid
Here we see the limits of international support and the emergence of a paradox. International investment is working to expand the scale of vaccine manufacturing by strengthening production capabilities and industrial ecosystems.
However, the vaccines produced by these new manufacturers will not be eligible for tenders launched by GAVI-UNICEF until they are prequalified, thus posing risks to their economic viability, the development of production capabilities and their sustainability . As a reminder, GAVI-UNICEF funds two-thirds of the continent’s vaccine needs. Therefore, without adequate market access, no matter how much money is invested in supporting vaccine production in Africa, the industry cannot rise.
Of the 30 vaccine production projects announced today, how many can pass prequalification? Who will purchase the vaccine doses before the prequalification process is finalized?
These issues must be addressed now if investment is to be best directed and new manufacturers brought to market.
Solutions exist. This might involve, for example, implementing national or regional policies that prioritize African manufacturers in subsistence countries (while awaiting pre-qualification). Or strengthen technical assistance to speed up prequalification.
Whatever solutions are envisioned, donors, African authorities and local manufacturers must develop a common strategy. This is particularly important because, in addition to its direct impact on health, the deployment of this industry might bring many benefits to the continent by constituting a lever for economic development or increasing autonomy and national sovereignty. It might also play a key role in strengthening global health security if another pandemic occurs…
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