Accelerating Vaccine Manufacturing in Africa: Three Considerations for Gavi

One of the most salient lessons from the pandemic is the need to diversify manufacturing capabilities and bolster supply resilience to avoid a repeat of the slow and inequitable vaccine roll out in African countries. To turn this lesson into action, the Gavi Secretariat is rapidly advancing plans for a new financial mechanism in the form of an Advance Market Commitment (AMC) to ‘pull’ African-made vaccines to market.

Gavi’s ongoing efforts under this proposed mechanism and its broader African Vaccine Manufacturing Accelerator (AVMA) have generally been well received, including by the African Union (AU) and African manufacturing companies, as a step towards the AU’s goal to “manufacture 60 percent of Africa’s routine immunization needs on the continent by 2040.”

But before the proposal is slated for review by Gavi’s board at its upcoming meeting in early December, there are questions that still need to be addressed, including some that CGD discussed in a previous blog, about the type of manufacturing capacity the mechanism should support; the underlying market dynamics that should inform key design features; and the funding needed to set it up for success.

This blog dives deeper into some of these issues and calls on Gavi to consider three factors as it fine tunes plans to get this mechanism off the ground: trade-offs, scope, and timeframe. These reflections build on a private roundtable discussion with leading health and financing experts, convened by CGD in October 2023 and held under Chatham House rules. Our insights are based on publicly available documentation about AVMA’s proposed design. (Plans and design details reflected here may differ from current thinking in instances where updates have not been made public.)

1. Explicitly acknowledge—and accept—trade-offs between the proposed twin objectives

The Gavi Secretariat has proposed two objectives for the new mechanism, described in a September 2023 update as: A) sustainable African vaccine manufacturing base with global market health contributions; and B) improved pandemic response capacity, supply resilience, and security sovereignty.

Both are critical objectives. In practice, however, these goals are not fully synergistic, and it seems less obvious that a single mechanism could be designed to simultaneously incentivize progress on the capabilities needed to achieve both objectives. Supporting a healthier market for routine immunization requires an inherently different set of priorities than advancing supply resilience and response capacity for outbreaks and pandemics. (Publicly available materials stop short of exploring the trade-offs between the two objectives.)

For example, a sustainable vaccine manufacturing base optimized for routine vaccination, in line with objective A, may not be well suited for rapid repurposing of existing capacity to manufacture the vaccines needed in the event of a pandemic. Some antigens may be prime candidates to support a healthy, sustainable market for routine vaccines—but may not utilize the flexible platform technology that would enable a quick pivot to pandemic vaccines. In short, increasing sustainable vaccine manufacturing capacity does not necessarily equate to stronger capacity for pandemic preparedness and response. The latter also requires robust research and development and strong and flexible regulatory systems, among other capabilities.

As the Gavi Secretariat internalizes these trade-offs, it should align on a clear hierarchy of objectives. Greater clarity on the primary objective beforehand would provide an overarching framework to inform decision-making and will help to avoid making ad-hoc choices going forward. One option is to lean more into achieving a sustainable and diversified vaccine manufacturing base in Africa (objective A) as the primary goal of this mechanism. This could help ensure the incentive structure is realistic and definitions of success are appropriately tailored, rather than weighing the objectives equally and potentially falling short on multiple fronts.

2. Clearly define the enabling ecosystem for AVMA’s success

There will be a continued need for complementary interventions to create an effective enabling ecosystem for a viable African vaccine manufacturing industry, alongside the proposed mechanism’s demand-side focus. Many of these interventions are understandably beyond Gavi’s direct influence. Still, overall success will depend, in large part, on Gavi’s ability to work closely with other partners to create this enabling environment.

For example, existing shortcomings and inefficiencies in regulation will need to be addressed. Solely using the World Health Organization (WHO) prequalification process as a requirement to guarantee efficacy, safety, and quality poses significant bottlenecks for advancing a robust African vaccine manufacturing industry. Additionally, applying for WHO prequalification requires a functional National Regulatory Authority. Yet only two countries on the continent (Egypt and South Africa) have National Regulatory Authorities that have achieved the WHO’s maturity level 3 benchmark for current vaccine producers.

Gavi is considering ways to address these challenges, such as by identifying manufacturers and, therefore, National Regulatory Authorities that might require support through the milestone payment process.

It could also work with regional partners, most notably the African Union and Regional Economic Communities (RECs) such as the East African Community (EAC) and the Southern African Development Community (SADC), and global partners, including donors, to implement innovative regulatory approaches, such as pairing mature National Regulatory Authorities from donor countries with selected African National Regulatory Authorities and/or directly supporting selected African National Regulatory Authorities. Still, efforts by other partners to build on existing initiatives, provide adequate financial and technical assistance, and harmonize regulatory processes are—and will continue to be—essential to strengthen regulatory systems for vaccines and, ultimately, enable AVMA’s success.

Greater clarity on the connections to the myriad efforts to advance vaccine manufacturing across 14 countries in Africa, ranging from workforce capacity to input materials and working capital, will also help drive alignment across investments.

And finally, Gavi must ensure the proposed mechanism is flexible and able to adapt to—and even nudge—shifts in the overarching landscape after it launches. For example, Gavi must build on the initial openness to adjust the financing instrument if recent proposals advance to establish an AU pooled procurement mechanism.

Ultimately, the broader ecosystem in which the proposed mechanism—and AVMA—will operate will be a key determinant of overall success—and Gavi should be a key player, alongside other partners, in collectively addressing bottlenecks and shaping the enabling environment going forward.

3. Right-size the timeframe in view of longer-term sustainability

As the Gavi Secretariat hones in on final details for this time-limited mechanism, it must confront the potentially different time horizons for achieving the two objectives. There is also some risk of a mismatch between the proposed ten-year window and the time required to make realistic progress on these goals. For example, given manufacturing complexities and the existing gap in antigen manufacturing capabilities on the continent, technology transfer can take a long time to materialize, with some previous efforts taking up to ten years. The proposed mechanism must take these timelines into account and align expectations, incentives, and intended outcomes accordingly.

There are several other outstanding considerations regarding the timeframe and longer-term sustainability, some of which are currently being worked out in real time. First, would it be strategic, from a sustainability standpoint, to design the mechanism for wider applicability, beyond vaccines procured via UNICEF? Such an approach would no doubt increase the mechanism’s operational and administrative complexity. But it could take a more incremental expansion pathway. (Importantly, there are already plans to include Gavi-supported vaccines procured through UNICEF, including Gavi and non-Gavi volumes.)

Second, how would the mechanism work in tandem with Gavi’s approach to eligibility, transition, and co-financing? Gavi’s leadership should build in arrangements for transitioning countries and previously eligible Gavi countries to finance some of the demand for these African manufactured products with domestic financing.

Third, how will the set of “priority antigens” eligible under this mechanism be revised to remain relevant as the range of vaccine preventable diseases expands? Again, Gavi’s leadership must ensure the mechanism is able to adapt to shifts in disease burdens and new technologies to ensure the mechanism remains fit-for-purpose throughout its operational window.

Finally, if the funding allocated to AVMA is underutilized within the mechanism’s proposed timeframe, what alternative use(s) would be beneficial and still aligned with AVMA’s objectives? Although it may be premature to fully hammer out specifics given future uncertainties, Gavi’s leadership and board should think through various contingency options as the mechanism gets underway to ensure the investment, even if partially repurposed, can still help advance the initiative’s ultimate objectives.

Conclusion

The proposed mechanism to accelerate vaccine manufacturing in Africa will be up for decision at Gavi’s board meeting in just a few weeks. The proposal, which is being fine-tuned further through ongoing consultations, is gaining momentum, including among African stakeholders, donors, and other partners who are keen to see this effort set up for success.

But this is far from a straightforward endeavor—the technical aspects are complex, and the underlying political economy dynamics are complicated to say the least. As these efforts progress, Gavi should be clear-eyed about what is feasible within the realities of trade-offs, scope, and timeline. Good intentions alone will not be sufficient to maximize the impact of Gavi’s investments.

Thanks to Gavi colleagues for feedback and corrections on an earlier draft.