“If you take away funding from research and development, especially for diseases with pandemic potential, these programs are going to get delayed. We are going to lose time, and some of that time you just can’t make up later with more funding.”
Anand Ekambaram, former Executive Director and Head of Manufacturing and Supply Chain Division at CEPI, brings over 30 years of expertise in vaccine and biologics manufacturing. His career spans leadership roles at Merck, managing vaccines and sterile fill-finish operations, Vice President of Global Clinical Supply Chain at Bristol Myers Squibb, and developing manufacturing partnerships across Africa, Asia, and South America. Today, through Global BioVax Solutions, he advises NGOs and private equity on vaccine manufacturing and technology transfer.
In the latest PharmaSource podcast episode, Anand explores how three US policy shifts are creating compounding disruption across the global vaccine ecosystem. Plus, he explains what COVID taught us about the structural inequity in vaccine access, and provides his framework for building resilient regional manufacturing capacity that can withstand future crises.
How US Policy Changes Are Disrupting Global Vaccine Manufacturing
Three policy shifts from the current US administration are creating compounding effects across the vaccine ecosystem: withdrawal of funding for global health programs, aggressive reshoring incentives coupled with new tariffs, and changing FDA perspectives on vaccine safety.
Immediate Funding Gaps in Global Immunization
The US government’s withdrawal of funding for global health agencies has created immediate pressure on immunization programs in low-income countries. Gavi, the Vaccine Alliance, which has delivered excellent results in bringing vaccines to underserved populations, relied on the US for approximately 15% of its total funding.
“About 15% of Gavi’s funding was coming from the US government, and that money is no longer there for vaccines and immunization,” Anand explains. “To the best of my knowledge, they’ll have to figure out other ways to do it. This could lead to significant cutbacks in immunization programs.”
The impact extends beyond Gavi to multiple global health agencies that previously received US support.
The 4-5 Year Manufacturing Capacity Gap
The pharmaceutical industry has announced up to $300 billion in reshoring investments, driven by both new administration incentives and lessons learned from COVID about supply chain fragility. However, manufacturing veterans warn of a critical timeline problem.
“All this manufacturing capacity that has been announced is not going to be online for at least four to five years,” Anand explains. “That’s how long it takes to build, to qualify, to validate, and get licensure for a new manufacturing facility, especially for vaccines and biologics.”
This timeline creates a peculiar market dynamic. While there’s aggressive political pressure for domestic manufacturing, the physical reality of building and validating pharmaceutical facilities means any announced capacity today won’t produce vaccines until 2029-2030 at the earliest.
The reshoring trend actually started earlier than the current administration, driven by geopolitical tensions and COVID, exposing supply chain vulnerabilities. However, the current policy environment has accelerated announcements without accelerating the fundamental constraints of pharmaceutical facility construction.
Innovation Freeze in Vaccine Development
Perhaps the most immediate impact has been on innovation funding.
“Innovation has had a chilling effect, even while the overall biopharma sentiment index published by EndPoints has shown an uptake,” Anand notes. “It’s the vaccine sector that has been very badly affected by policy changes because investors simply don’t want to take a risk on vaccines until they get clarity on policy.”
Changing attitudes toward vaccines reflected in policy changes at the FDA level have created uncertainty that’s proving disruptive to early-stage funding. Anand knows of at least two or three startup companies with “very promising data that would’ve normally been funded” that have either lost funding or are unable to secure investment.
“The vaccine sector has been very badly affected by the policy changes,” he emphasizes. “Investors simply don’t want to take a risk on vaccines till they get clarity on policy.”
How CDMOs Will Weather the Storm
Despite the reshoring announcements, Anand believes the CDMO industry as a whole will remain resilient, though individual European operations may see volume pulled to US-based manufacturing.
“The CDMO and CMO industry as a whole, I think, will do fine,” he predicts, offering three reasons for his optimism.
First, the timeline factor means current CDMO relationships remain critical for at least four to five years while new capacity is being built.
Second, the structure of pharmaceutical innovation protects CDMO demand. “The CDMO industry gets about 50% of its business from small and medium-sized biotech companies, which don’t have their own manufacturing capacity,” Anand explains. “They’re not the ones announcing these huge investments. It’s Big Pharma.”
Small and mid-sized biotechs still need somewhere to manufacture clinical supplies, and that ecosystem remains vibrant regardless of Big Pharma’s reshoring plans.
Third, 50% of new clinical trial starts come from companies without internal manufacturing. “They still need a place to make their clinical supplies, so that ecosystem is still vibrant,” he notes.
The Compounding Effect on Pandemic Preparedness
The policy shifts create a compounding problem for future pandemic preparedness. Reduced funding for global immunization weakens the continuous manufacturing operations that would provide surge capacity during a crisis. The innovation freeze delays development of next-generation vaccine platforms.
“If you take away funding from research and development, especially for those diseases that have pandemic potential, these programs are going to get delayed,” Anand warns. “We are going to lose time, and some of that time you just can’t make up later with more funding.”
The concern is particularly acute for diseases on the WHO Blueprint pathogen priorities list.
“I can’t see how other sources could make up for the withdrawal of U.S. funding, given that the U.S. was the largest backer of research and development for these products,” he states.
What COVID Taught Us About Vaccine Manufacturing Inequality
These current policy disruptions are particularly concerning because COVID already exposed the fundamental structural problems in global vaccine access. The pandemic served as a real-world test of vaccine manufacturing capacity and revealed that geography determined who received protection rather than public health.
Manufacturing Capacity Determined Who Got Vaccines
“COVID exposed in a very stark manner that vaccine access followed manufacturing capability far more than public health need,” Anand explains. “Countries that had capacity immunized their people. Countries that didn’t simply had to wait in line.”
Early in the pandemic, when supply was extremely constrained, governments prioritized their own populations, showing up in advanced purchase agreements, export controls, and informal prioritization of domestic and regional markets.
Even when global mechanisms like COVAX were created to ensure equitable access, they competed for supply in a market where early production had already been allocated through advanced purchase agreements and export controls.
“Even when global mechanisms like COVAX were created, they were competing for supply in a market where early production had already been spoken for,” Anand explains. “None of that was surprising, but it had major consequences.”
The crisis wasn’t primarily about funding or political intent. It reflected decades of concentrated vaccine manufacturing in a small number of countries, with most capacity located in North America, Western Europe, India, and China.
“The inequity we saw was structural,” Anand emphasizes. “It reflected decades of concentration of vaccine manufacturing in a small number of countries. COVID didn’t create that imbalance; it revealed it.”
Technology Transfer Takes Time
Countries without existing fill-finish or drug substance capability couldn’t simply step in and produce vaccines, even when intellectual property or know-how was being shared.
“Technology transfer takes time, trained people, regulatory readiness, and a mature supply chain,” Anand notes. “In a crisis measured in months, not years, these gaps mattered enormously.”
This reality drove his work at CEPI, where the organization evolved from funding early-stage vaccine development to building the broader ecosystem needed to deliver vaccines in low and middle-income countries.
How to Build Resilient Vaccine Manufacturing Capacity
Given the funding gaps created by US policy changes and the structural inequities exposed by COVID, what’s the path forward? Anand shares his framework for building sustainable vaccine manufacturing capacity in regions that have historically depended on imports. The goal isn’t complete self-sufficiency for every country, but creating resilient regional networks with meaningful participation and surge capacity for future crises.
The Strategic Case for Domestic Manufacturing
Domestic vaccine manufacturing delivers benefits that extend far beyond crisis response. It improves supply reliability, strengthens routine immunization programs, builds skilled workforces, and provides countries with agency over how products are designed, priced, and supplied.
“Countries that have their own supply have better immunization programs,” Anand explains. “It builds a skilled workforce and industrial capability that can spill over to other sectors. It gives countries more agency in how products are designed, priced, and supplied.”
Manufacturing capability can also serve as a stepping stone to more complex parts of the value chain, including product development.
Economic Reality Requires Routine Production
From a purely economic standpoint, local manufacturing makes sense when demand is large, sustainable, and predictable, and when the cost of disruption becomes unacceptable.
“For small or intermittent volumes, finished product from established hubs is almost always cheaper,” Anand states. “The tipping point comes with sustained routine immunization volumes, and when logistics, cold chain risk, lead times, or waste start to add real cost.”
“COVID showed that delays aren’t just inconvenient. They’re economically and socially expensive and disastrous,” Anand notes. “That’s why regional fill-finish anchored in routine demand but able to surge in a crisis often ends up being the most rational economic choice.”
The CEPI strategy focused on supporting manufacturing capability for routine vaccines while ensuring equipment, supply chains, and processes could be rapidly repurposed for pandemic response.
Regional Solutions Over National Self-Sufficiency
Not every country should pursue end-to-end manufacturing capability. Regional or specialized approaches make more economic sense.
“It’s not feasible for every small or medium-sized country to have its own self-sufficient manufacturing industry because it’s a capital-intensive process,” Anand notes. “I estimate somewhere between half a billion to three-quarters of a billion population is needed before such investments become feasible.”
For countries below this threshold, regional consortiums offer the solution, though Anand acknowledges these are “easier said than done.”
The Sandbox Strategy
CEPI developed and funded a sandbox concept to improve technology transfer outcomes. This smaller-scale operation allows teams to practice processes and build competency before scaling up.
“A sandbox is simply a smaller scale operation where you run the process and use that for the learn-by-doing element,” Anand explains. “You practice at small scale and use that as a way to build competency for large scale.”
This approach provides local staff with hands-on experience that translates to successful large-scale operations.
“Equipment is easy,” Anand summarizes. “The real challenge is building robust quality systems, contamination control discipline, and aseptic culture that can sustain performance long after the tech transfer team has left.”
Product Development Choices Create Long-Term Consequences
Supply chain resilience must be designed during product development, not after facilities are built and operational.
“Supply chain resilience works best when it’s designed in from the very beginning, in the overall product development process,” Anand emphasizes. “It starts with product and process design, not after a facility is built and operational.”
Choices around equipment platforms, reagents, consumables, and drug product containers all carry long-term supply chain implications. Specialized bespoke equipment may deliver short-term efficiency but creates long-term fragility.
“If you select specialized bespoke equipment, you’re setting the stage for later problems,” Anand warns. “You may get efficiency in the short term, but you’ll get fragility in the long term.”
The Ideal Global Vaccine Network
Anand describes his ‘perfect’ global vaccine network. This wouldn’t be one massive centralized system, which failed during COVID. Neither would it be every country attempting everything independently.
“It would be a federated network built around regional hubs with some degree of specialization and strong interoperability,” Anand envisions.
This network would include a small number of global centers with advanced research and development, and platform development. Regional manufacturing hubs would use standardized platforms, especially for sterile fill-finish, supporting routine immunization while maintaining surge capacity for pandemic products.
“This requires advanced thought to make sure you develop these products on a common technical platform,” Anand explains.
Geographic Distribution and Regulatory Harmonization
Hubs would be distributed geographically to reduce concentration risk and align with regional disease burdens. The entire network would be designed for interoperability, with product and process choices favoring platforms, containers, and consumables transferable across sites.
“Supply chains should be built for resilience, particularly for vaccines, not just for cost,” Anand emphasizes. “Cost is important, but you can’t be solely focused on cost.”
Regulatory approaches would be harmonized so that manufacturing and technology transfer doesn’t restart from zero each time.
Allocation Rules and Continuous Operation
The system requires clear, enforceable rules for vaccine allocation during crises based on public health need rather than manufacturing location or purchasing power.
“Vaccines can’t simply flow to the highest bidder or only to countries that manufacture,” Anand states. “It has to be based on public health needs and agreed principles. Otherwise, even the best-designed network will fail.”
Critically, facilities must remain continuously warm, producing routine vaccines daily and building workforce skills and quality culture.
“You can’t have a facility built for surge that hasn’t been operational for years and expect to start it and start supplying product when there’s a surge need,” Anand emphasizes. “When a pandemic hits, you’re scaling up, not starting over.”
