With promising results from three major COVID-19 vaccine trials and potentially more to come, it’s becoming clear that access to coronavirus vaccines will soon become reality. But despite unprecedented global pushes to ensure access for low- and middle-income countries, the majority of available vaccine doses have been earmarked for wealthy countries that have the political and financial capital to make direct agreements with pharmaceutical companies.
Currently, vaccines for approximately 250 million people have been secured through COVAX, an unprecedented effort to make access more equitable for all countries. However, several high-income countries are making arrangements outside of the COVAX Facility, which will mean that COVAX is likely to fall well short of the required doses to vaccinate high-risk populations in Africa, let alone achieve herd immunity among the continent’s population of 1.3 billion.
Unfortunately, we’ve seen this scenario play out before. When new antiretrovirals were developed to treat the HIV epidemic, it took seven years before they were widely available throughout the African continent. Delays of 10-20 years were also seen with the rollout of hepatitis B, rotavirus, and other vaccines, in part due to weak and fragmented regulatory systems that caused delays in approvals and increased the cost of scaling up new health technologies.
A similar delay in access to COVID-19 vaccines would not only jeopardize health in African nations and other LMICs but would also hamstring the global response elsewhere.
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To be sure, COVAX and other initiatives will play a critical role in expediting the arrival of COVID-19 vaccines in Africa, at least initially. However, the mechanism is not meant to be a long-term solution to solve the access gap for LMICs. What’s more, current COVAX commitments — as well as overall global manufacturing capacity for COVID-19 vaccines — are well short of meeting the vaccination needs across the African continent.
It’s long past time that we act collectively to close the access gap for African countries, as well as other LMICs. And with greater collaboration, scale-up of innovations, and continued progress on more sustainable solutions, we have the tools to do it.
Cross-continental regulatory collaboration
There are practical and proactive steps that governments and their medicines regulatory authorities can take now to pave the way for expedited approvals and registration of COVID-19 vaccines. This will only be achieved with more effective collaboration across regulatory authorities with other in-country national counterparts and immunization programs.
Given that most regulatory authorities in Africa lack the technical know-how to fully evaluate or approve vaccine products, the current pandemic should act as a catalyst for enhanced regulatory reliance and mutual recognition so that product application information and inspection findings can be shared readily and easily across regulators simultaneously. Requiring manufacturers to approach and file applications with separate authorities has been a major cause of delays in the rollouts of past innovations.
Regulators can also ensure processes for emergency use authorization are up to date, clear, and ready to initiate quickly for COVID-19 vaccines, and they can understand what steps need to be taken if the World Health Organization issues an emergency use listing. This would include collaborating with the national immunization programs, the national pandemic response teams, and public and private health system stakeholders in their countries to introduce vaccines, facilitate access, and foster trust in their communities.
Regulatory authorities can collaborate and share information more effectively through active and engaged participation in regional and continental harmonization initiatives such as the African Vaccine Regulatory Forum, which established a joint review procedure in 2017 to address similar regulatory challenges during an Ebola outbreak.
When individual regulators participate in and accept the results of joint product application reviews, it helps build the capacity of participating regulators while also consolidating the review and approval process, both of which pay dividends in faster approval times and thereby faster access to emergency, lifesaving products. Donors and implementing partners can support this effort by sharing up-to-date information and training opportunities on good manufacturing practices and other topics that help sharpen the skills of participating regulators.
Actions that African governments take today will not only enable a sustainable and quality-assured supply of efficacious vaccines to fight the pandemic but will also help maintain public trust.—
Fostering public trust
Lessons from polio and Ebola containment efforts have taught us that accelerated access to new technologies must also be accompanied by efforts to ensure that these products are made available in ways that foster and maintain public trust. Clear and transparent regulatory processes — along with effective and deliberate communication about approvals, availability, and even potential risks and early engagement of local community leaders — are critical ways for governments to achieve this.
Additionally, with access to new technologies comes the ethical and public health imperative to ensure they continue to work as intended in real-world settings by assessing quality and safety through post-marketing surveillance and pharmacovigilance programs, respectively. Here, again, regional collaboration and harmonization are helping to scale these critical programs on the continent.
For example, with support from the U.S. Agency for International Development and technical assistance from USP, the East African community completed — and publicly released the results of — a first-of-its-kind regional post-marketing surveillance survey, paving the way for similar efforts in the future.
Similarly, the African Medicines Quality Forum, a technical working group of the African Union Development Agency, is a continental collaborative that helps national quality control laboratories strengthen their capacity for medicines quality testing and helps prevent falsified and substandard medicines from reaching consumers.
Continuing to strengthen these locally led efforts is critical as part of the rollout of COVID-19 vaccines since fraudulent vaccines have already been found in several countries.
Looking at long-term solutions
With support from global partners, many African nations are strengthening collaboration and systems that allow for greater bargaining power through pooled procurement and advanced purchasing commitments. The United Nations Economic Commission for Africa — with support from USP — is working with the African small island states to pioneer a joint framework for pooled procurement that incentivizes procurement from quality-assured local manufacturers.
As pooled procurement arrangements and expanded local vaccine manufacturing become central strategies for ensuring sustainable access for Africa, medicines regulatory authorities must proactively put in place policies, regulations, and enforcement measures to help ensure the quality of locally produced products and ensure that poor-quality alternatives are not undercutting the potential market for these products locally, regionally, and internationally.
In both the short term and long term, actions that African governments take today will not only enable a sustainable and quality-assured supply of efficacious vaccines to fight the pandemic but will also help maintain public trust. Past pandemics have shown that these actions, collaborations, and investments pay off. It’s time for Africa-led collaboratives to be at the heart of not only the current pandemic response but future ones as well.