“We have to stop treating manufacturing as the final step in vaccine development. In my opinion, it’s actually the linchpin of the entire system.”
Anand Ekambaram, Principal, Global BioVax Solutions
In this episode of the PharmaSource podcast, Dora, PharmaSource’s Editor, brings together five leaders who collectively span R&D pipelines, capital markets, manufacturing operations, tech transfer, and on-the-ground work in low- and middle-income countries (LMICs). The panel includes Krish Ramanathan, Interim CEO of the Gates Medical Research Institute; Savant Ahmed, Chief Business Officer at Exela Pharma Sciences; Christopher Locher, CEO of Versatope Therapeutics; Kristopher Howard, Managing Director of NRL Enterprise Solutions; and Anand Ekambaram, Principal at Global BioVax Solutions and formerly Executive Director and Head of Manufacturing and Supply Chain at CEPI.
The Funding Landscape
Six years after COVID-19, the global vaccine ecosystem should be in better shape. The lessons were learned, blueprints were drafted, and for a moment, political will existed. Instead, the sector now finds itself navigating a funding environment that has deteriorated rapidly.
U.S. withdrawal from Gavi and other global immunization programs could see up to 75 million children miss routine vaccines. NIH grant-making has fallen from nearly 800 new funding notices per year to around 80. NIAID, the U.S.’s premier infectious disease institute, has been directed to deprioritize pandemic preparedness entirely, with staff instructed to remove terms like “biodefense” from public-facing channels. Against this backdrop, Executive Order 14292 ended federal funding for gain-of-function research in foreign countries, with institutions facing potential five-year bans for violations.
Christopher Locher’s company, Versatope Therapeutics, has felt this acutely. NIH cut the company’s funding following a 90-day freeze, and then the SBIR program was paused for a further six months. ‘The company’s been working at risk for quite a while,’ Christopher says. ‘It won’t be sustainable forever.’ He describes Kendall Square in Cambridge, historically one of the most densely concentrated biotech corridors in the world, as visibly hollowed out, with thousands of R&D jobs lost across both industry and academia.
Recently, Eli Lilly announced the acquisition of three vaccine developers (Curevo, LimmaTech Biologics, and Vaccine Company) in deals worth up to $3.8 billion combined, deploying revenues from its GLP-1 portfolio into infectious disease prevention. It is a significant counterpoint: large-cap pharma moving decisively into vaccines at the precise moment early-stage funding is retreating. Notably, all three targets sit outside the vaccine categories that have drawn political scrutiny, potentially signalling that private sector confidence has contracted selectively, not categorically.
What is clear, as Krish Ramanathan notes, is that the structural damage to the vaccine industry as a whole extends well beyond funding headlines.
“What we are worried about is the sustainability of the clinical research environment in Africa. These sites may not be sustainable in the long run if they can’t find creative ways of financing to keep their staff.”
Krishnan Ramanathan, Interim CEO, Gates Medical Research Institute
For Krish at the Gates Medical Research Institute, whose portfolio focuses on tuberculosis and malaria, with over 80% of studies conducted in Africa, the concern is less about the institute’s own continuity and more about the ecosystem it depends on. Clinical research sites that have historically relied on NIH and USAID funding are being forced to reduce staff. Logistics partners that move samples across borders are facing viability questions. The scaffolding that supports complex multi-country trials is under sustained financial pressure.
How Capital Markets Are Reading the Vaccine Sector
From an investor perspective, the signals are difficult to read as anything other than deeply cautionary. Savant Ahmed, whose business at Exela operates large-scale fill-finish manufacturing in North Carolina, has observed the shift. Roughly two years ago, around 20% of incoming inquiries at Exela related to vaccines. That figure has now dropped close to zero.
Vaccine hesitancy has been building for years; the current U.S. administration has accelerated it. A recent POLITICO poll found that nearly half of American adults now believe the science on vaccines remains open to debate. Among Republicans polled, six in ten favor administering fewer vaccines, compared to three in ten Democrats. That kind of demand uncertainty feeds into investor confidence.
“The clinical stage funding for vaccines is under pressure, even as the overall biotech picture has improved. XBI has almost doubled over the last year, and early-stage biotech funding — excluding vaccines — has been reasonably healthy. Vaccines are the outlier.”
Savant Ahmed, Chief Business Officer, Exela Pharma Sciences
Savant also points to the specific product categories that have been most targeted by policy changes: the childhood vaccine schedule, COVID mRNA vaccines, HPV, and RSV. Seasonal flu and pneumococcal vaccines appear relatively less affected — for now. But the chilling effect on the investment environment is broad. Changes to BARDA and federal immunization funding have compressed the addressable market that vaccine developers can credibly model.
Some short-term legal relief has materialized, with a federal judge placing a temporary hold on several administrative changes. There are also reports that the White House views some of its vaccine policy positions as a political liability ahead of the midterms. But the underlying hesitancy trend, Savant argues, will require more than a change in tone to reverse.
Is the Damage Reversible? Path Dependency and the Long View
Kristopher Howard, who works with governments, investors, and donors to establish sustainable vaccine manufacturing in LMICs, introduces a concept that reframes the question of reversibility: path dependency. The industry will not return to the same configuration it was in before the funding disruption, even if the money returns.
The Gavi 6.0 replenishment cycle is a case in point. Instead of the nearly $12 billion anticipated, the fund came in at $9 billion. Undersubscribed by close to $3 billion over a five-year period. This represents manufacturers who cannot hit economies of scale, revenue streams that are interrupted, and suppliers who are in a structurally different position when the next cycle begins.
“It’s a path-dependent variable. The fact that we actually had this drop-off for a few years is going to impact the way that everybody is positioned in a few years’ time.”
Kristopher Howard, Managing Director, NRL Enterprise Solutions
The pullback has not been exclusively American. European ODA budgets have also tightened, compounding the pressure on an ecosystem that was already navigating post-COVID demand contraction for COVID-specific vaccines.
Anand Ekambaram discusses geopolitical instability. Wars and oil price increases siphon fiscal capacity from governments that might otherwise invest in immunization programs. The infrastructure for moving vaccines, samples, and materials across borders requires a degree of baseline stability that cannot be assumed.
Building a New Funding Architecture Beyond Single-Donor Dependency
The broader structural question is whether the model that positioned the U.S. as the anchor funder for global pandemic preparedness was ever sustainable, and what can replace it. Krish is clear that the answer cannot be a single actor, however sophisticated.
What emerges instead is a “shared value ecosystem” requiring both supply-side and demand-side financing. On the supply side, manufacturers need CapEx backing for capacity that will lie idle in non-pandemic periods — capacity that has no commercial logic without some form of public or institutional backstop. On the demand side, many LMICs lack the mechanisms to rapidly commit to procurement volumes in ways that give manufacturers the forward visibility they need.
Both problems are structural, and both need multi-actor solutions. The Gates Foundation has maintained investment through this period. Wellcome Trust remains active. But none of these organizations, individually or collectively, replicates the scale and coordination capacity that U.S. government agencies historically provided.
Manufacturing Geography: Access Still Follows Production Location
Six years on from COVID-19, the central structural lesson, that access to vaccines followed manufacturing geography rather than public health need, has not been systematically addressed. Anand describes significant positive momentum in the mindset shift toward regionalized manufacturing, but persistent structural barriers that prevent translation into operational reality.
On the positive side, the African Vaccine Manufacturing Accelerator (AVMA) has committed over a billion dollars to expand regional production capacity. The EU Commission has invested comparably. BioNTech’s move to install a manufacturing facility in Kenya represents a notable private-sector signal. Regional manufacturing hubs are now embedded in the mainstream policy discourse in ways they were not before 2020.
“Nobody anywhere in this community with any degree of credibility is going to argue for preserving a centralized manufacturing and procurement system on the basis of lowest unit cost. The mindset has changed. Decentralized regional vaccine manufacturing is now seen as the key to resilience, equity, and empowerment.”
Anand Ekambaram, Principal, Global BioVax Solutions
But the structural barriers remain. Much of the capacity built to manufacture COVID vaccines is now idle because COVID-specific demand has largely vanished. The commercial procurement and reimbursement models that would make regional manufacturing economically viable have not yet materialized. It is a classic chicken-and-egg: facility developers wait for commercial signals, and procurers wait for tangible infrastructure progress.
Kris Howard, drawing on landscape assessments of vaccine manufacturing in Africa conducted in 2023, 2024, and 2026, identifies a recurring pattern of misaligned expectations. Countries sponsoring manufacturing projects frequently underestimate timelines; not recognizing that securing WHO prequalification is only the beginning, and that marketing authorization must then be obtained country by country in each target export market. Cost projections also routinely prove optimistic. Initial $150 million estimates could potentially become $300 million realities mid-project. And demand from a single country is almost never sufficient to make a commercial vaccine manufacturing facility viable.
What Does Pandemic-Ready Manufacturing Actually Look Like?
Anand offers the clearest articulation of what “pandemic-ready” manufacturing capacity genuinely requires, and it is not a mothballed facility waiting to be switched on. Biologics manufacturing is a living operational ecosystem. Skilled operators, quality control and quality assurance teams, active regulatory compliance, functioning supply chains, customs infrastructure: none of these can be assembled in weeks once a pandemic begins. They take years to mature.
The realistic model is a “warm” facility. One that is continuously operational on routine immunization products, with staff who are continuously trained and a supply chain that is continuously active. The same technology platforms used for pandemic vaccines (cell culture systems, purification systems) are largely shared with routine vaccine production. With modest operational adjustments, including strategic stockpiling of around six months of routine immunization inventory, such a facility can be redirected to pandemic production relatively quickly.
“An idle facility is neither commercially sustainable nor technically and operationally a feasible way to respond to pandemics. The routine immunization demand is the foundation that keeps regional manufacturers viable — and pandemic-ready.”
Anand Ekambaram, Principal, Global BioVax Solutions
Savant’s experience at Exela during COVID illustrates this model. The company was one of the only U.S. fill-finish manufacturers outside Pfizer’s internal network to produce the Pfizer/BioNTech vaccine for the U.S. market. The reason Exela could respond was precisely because it maintained lower-than-industry-average utilization rates as a deliberate strategic choice, preserving surge capacity that was immediately available when needed. The same excess capacity was subsequently deployed during the GLP-1 injectable surge. But Savant acknowledges that this philosophy is unusual within the sector. Private equity pressure typically drives facilities toward maximum utilization, which eliminates the swing capacity that the pandemic response depends on.
Early-Stage Development Choices That Determine Manufacturability
One theme that runs through the conversation is the relationship between choices made early in product development and the manufacturability of a vaccine years later. Anand explains that manufacturability and tech transfer need to be built into the product from the start, not treated as a logistical exercise at the end of development.
Many vaccine candidates are simply not transferable across manufacturing geographies because early development decisions on formulation, container format, process design, and platform technology were made without regard for where, and by whom, the product would ultimately be manufactured at scale. Correcting those choices later is expensive, slow, and sometimes impossible.
The implication is that regional manufacturing resilience is not only a procurement or infrastructure problem. It is partly a product design problem, and one that requires manufacturers and developers to engage much earlier in the process than has historically been the norm.
Christopher draws on Versatope’s own experience to illustrate what resilient process design looks like in practice. His team has invested heavily in yield optimization, using extended batch manufacturing, inline culture monitoring, and tailored feed strategies, precisely because those choices determine how transferable a process will be. Having backup manufacturing options built into the strategy from the outset, he argues, is core product strategy.
Allocation, Equity, and the Politics of Pandemic Response
Even in a world of more distributed manufacturing capacity, the question of allocation during a pandemic remains fraught. Anand notes that governments will prioritize their own populations when supply is constrained. Designing around that reality is more productive than treating it as a failure of goodwill.
Regional manufacturing facilitates equity because it embeds vaccine supply within existing webs of economic interdependency. Countries that share borders and trade relationships have stronger incentives to maintain equitable allocation than a distant manufacturer with whom the relationship is purely transactional. Even so, some degree of inequity should be planned for.
Building “bridges in peacetime” by negotiating allocation agreements before the next pandemic and creating economic leverage that makes equitable distribution a rational self-interest calculation for all parties is the approach Anand advocates. The WHO Pandemic Agreement offers a framework for institutionalizing these norms, though its stress test will come only when the next pandemic arrives.
What LMIC Governments Are Actually Asking For
Krish and Kris both work directly with LMIC governments and ministers of health. Governments in these countries need solutions that deliver tangible impact within a four-to-five year electoral cycle. Vaccine manufacturing does not. Even a clinically advanced product must clear SRA approval, WHO prequalification, and country-level procurement authorization before it reaches a population; a timeline that routinely stretches well beyond any single administration’s window. Bridging that gap requires regulatory innovation and better infrastructure for data sharing, supplier-buyer matching, and local market authorization.
A further problem Kris identifies is category confusion. Countries frequently approach vaccine manufacturing as they would general pharmaceutical or industrial manufacturing, without recognizing it as a distinct and technically demanding category with its own cost structure, regulatory requirements, and timeline realities. Single-country demand is almost never sufficient to make a facility commercially viable. And securing WHO prequalification, often treated as the finish line, is in practice just the starting point for gaining market access country by country across target export markets.
Reasons for Cautious Optimism
Despite the weight of the challenges discussed, the panel closes on notes of genuine (if carefully qualified) optimism. Several themes emerge:
Muscle memory. The institutional capacity built during COVID, the manufacturing relationships, the regulatory fast-track mechanisms, and the supply chain coordination has not entirely dissipated. Savant’s concern about talent loss is legitimate and urgent, but the broader institutional memory of what rapid vaccine scale-up requires still exists, and will make a future response faster than it would otherwise be.
Shifting mindsets. Anand observes that the conversation itself has changed. No credible voice in the ecosystem now argues for maintaining highly centralized manufacturing on pure cost grounds. Decentralized regional manufacturing has achieved consensus as the right direction, even if the path to getting there remains contested.
New talent and collaboration. Krish points to a younger generation of professionals in both government and industry who are more digitally fluent, more globally networked, and less anchored to models that were built in a different geopolitical era. He also observes growing ministerial-level collaboration across Southeast Asia, Africa, and Latin America. A form of South-South coordination that could provide institutional momentum independent of Western funding cycles.
International coordination. Christopher sees the proliferation of national biomanufacturing strategies across Japan, South Korea, Australia, India, the EU, and the U.S., as an underutilized source of collective strength. Right now, those efforts run largely in parallel, and in competition. Bringing them into closer alignment on capital and financing, he argues, would accelerate the buildout of a genuinely distributed global supply network far more effectively than any single national program could achieve alone.
Distributed innovation. Savant notes that China has emerged as the second major biopharma innovation hub globally, and a more distributed innovation ecosystem less dependent on U.S. funding and U.S. political cycles may, in the long run, prove more resilient than the one it replaces.
“I look at India’s vaccine manufacturing capacity. It was built over 50 years, incrementally. Local innovation, reverse engineering, starting small, and building. Now India is a global powerhouse. There is something to be said for that steadfastness — and not losing the sense of mission.”
Anand Ekambaram, Principal, Global BioVax Solutions
A Real-Time Case Study
Since the podcast was recorded, the Ebola Bundibugyo outbreak in the Democratic Republic of the Congo and Uganda has exposed many of the vulnerabilities discussed in the conversation: fragile regional response capabilities, declining investment in medical countermeasures, shortages of protective equipment and diagnostics, and weakened public health infrastructure. The themes discussed were framed as a broader warning about the erosion of global health preparedness, which now reads as a real-time case study in the consequences of treating global health security as an optional budget item rather than a strategic necessity.
Public health experts have linked delayed detection, reduced field surveillance, weakened local response capacity, and shortages of trained personnel to the sharp reduction in United States global health engagement, including cuts to USAID-supported preparedness programs and the withdrawal of support from key multilateral health mechanisms. Several recent reports have highlighted these concerns, including news articles from CFR, Physicians for Human Rights, and CNN.
The podcast argues that resilience cannot be built during an emergency; it must already exist through sustained investment in first-response capabilities, regional partnerships, manufacturing ecosystems, and trusted public health infrastructure. Without durable and long-term investment, outbreaks can quickly escalate from containable public health events into geopolitical and humanitarian crises.
Perhaps the clearest lesson emerging from the current outbreak is that vaccine readiness and outbreak preparedness are not acts of charity or development aid. They are essential components of international security infrastructure.
