Four vaccine experts discuss how sustained financing, local research leadership, and community trust can strengthen vaccine development in low- and middle-income countries (LMICs), drawing on practical insights from India and Bangladesh.
For low- and middle-income countries (LMICs), a vaccine trial can bring resources and expertise into a community. The larger question is what remains when that trial ends. Can experienced staff continue working? Will laboratories and research sites be ready for the next study or outbreak? And will the people who contributed to the research have access to the vaccines it produces?
In written responses for Infection Control Today® (ICT®’s) connected to World Vaccine Congress Europe, 4 experts addressed these questions from complementary perspectives. Their responses covered the financing needed to sustain research infrastructure, the authority local partners should hold, and the practical differences that shape vaccine trials in India and Bangladesh.
A consistent message emerged: lasting capacity requires commitments that extend past an individual study. Community trust also depends on what happens before enrollment and after results become available.
ICT: What needs to change in vaccine financing and clinical trial infrastructure for low- and middle-income countries to lead vaccine development, and how can investments support lasting local capacity after individual trials end?
Sushant Sahastrabuddhe, MD, MPH, MBA, associate director general of the International Vaccine Institute, argued that financing must support the conditions that enable research, rather than treating each trial as a separate undertaking.
“For LMICs to lead vaccine development, we have to stop funding trials as one-off projects and start funding the ecosystem enablers,” Sahastrabuddhe said. “Sites need predictable financing, trained manpower who stay, and a steady pipeline of studies so that capacity doesn’t go cold between outbreaks.”
He pointed to experience in West Africa and Nepal, where sites developed for preparedness subsequently secured other major trials. Continued work, he explained, helps maintain readiness.
“Sustainable capacity comes from linking sites to financing, to regulators and to manufacturers from the start,” he said.
Ali Alloueche, vice president of business development and alliance management at Hilleman Laboratories, similarly called for a shift from short-term, trial-by-trial funding toward long-term investment in locally led clinical, regulatory, and laboratory capacity. Those investments should support multiple vaccines and enable rapid infrastructure activation during future outbreaks.
His guiding principle was concise: “Build once, activate many times.” Each investment, he explained, should leave behind skilled people and functioning infrastructure that remain useful after the initial project ends.
Cornelius Schmaltz, strategic science advisor at the European Commission’s DG HERA, emphasized the role of LMIC governments in prioritizing vaccine financing and trial infrastructure. He identified South-South cooperation as one avenue, including transnational clinical trial networks, regional regulatory harmonization, and pooled procurement.
These efforts also require “smarter, mutually beneficial global partnerships,” Schmaltz said.
He cited the Global Health EDCTP3 Joint Undertaking, a partnership involving the European Commission, Sub-Saharan African countries, and European countries, with a budget of 1.8 billion EUR over 7 years. According to Schmaltz, its collaborative platforms and long-term partnerships help strengthen the clinical research ecosystem while advancing vaccine candidates of particular relevance to Sub-Saharan Africa.
He also highlighted MAV+, a Team Europe initiative under the EU Global Gateway Africa-Europe Investment Package, with more than EUR 2 billion allocated to advance regional vaccine and pharmaceutical manufacturing in Africa.
“The use of blended finance is central because it helps bridge public health priorities and commercial bankability, especially where capital needs are high, and market signals remain uncertain,” Schmaltz said.
ICT: How can partnerships give local scientists and regulators meaningful authority over research priorities and trial design, while ensuring that participating communities can access the vaccines they help develop?
For Sahastrabuddhe, meaningful participation requires decision-making power from the beginning.
“Authority has to be built into the structure of the partnership, not as an afterthought,” he said. “That means local scientists and regulators co-designing the research questions and trial protocols and holding real decision-making roles in governance.”
He added that access commitments should be established at the same early stage. Through initiatives such as ACHIEVE Africa and the BRIGHT Fund, he said, the International Vaccine Institute is working toward models that connect funding with open knowledge sharing and affordable access for LMICs.
“Communities that take part in the research should be first in line to benefit from it,” Sahastrabuddhe said.
Alloueche likewise called for LMIC scientists, regulators, and communities to have meaningful authority over research priorities and trial design, including governance and evidence generation. Partners should agree upfront on how successful vaccines could become affordable and equitably accessible to the communities and countries that helped develop them.
His response connected research leadership with the purpose of the work: addressing unmet medical needs in LMICs.
ICT: What are the most significant regulatory and operational differences between conducting vaccine trials in India and Bangladesh, and how should sponsors account for those differences when designing studies across both countries?
Arpit Agarwal, MD, director of medical affairs at VaxTRIALS, part of Emmes Group, described differences that sponsors need to consider before establishing study timelines.
According to Agarwal, ethics committee approval and review by India’s national regulator, the Central Drugs Standard Control Organisation (CDSCO), can proceed in parallel. He described rule-based review periods of 90 working days, or 30 for India-discovered products.
In Bangladesh, he explained, ethics review through BMRC/RRC, regulatory approval through the Directorate General of Drug Administration, and the import license proceed sequentially. Agarwal cited Asian Development Bank analysis placing approvals at up to about 5 months from ethics submission.
Participant protections also differ. Agarwal said India’s rules clearly address serious adverse event reporting and compensation, while compensation guidance in Bangladesh is limited. He noted that India’s 2017 Indian Council of Medical Research (ICMR) ethics guidelines allow audiovisual recording of consent where the regulator requires it for certain trials involving vulnerable populations.
The distribution of research sites creates additional operational considerations. India offers sites across numerous states, with site ethics committees registered with the CDSCO. In Bangladesh, Agarwal said, about three-quarters of trial sites are in Dhaka, and a large share of trials occur at the research institute
His recommendations reflected both shared requirements and local differences.
“Use one core protocol with country-specific annexes,” Agarwal advised. He also recommended applying a single participant-protection standard, including insurance and compensation, across both countries.
“Use India for breadth and event accrual, and Bangladesh for depth at research-mature sites,” he said.
ICT: How can vaccine trials in South Asia strengthen community trust and recruit participants who reflect the populations most affected by the diseases being studied, while maintaining scientific rigor and participant safety?
Agarwal emphasized that trust-building should begin before enrollment. Meetings with local government health officials and community groups can help establish understanding, while study field workers need training to explain the research clearly to prospective participants and parents.
Community acceptance, however, cannot substitute for an individual’s decision.
“Community engagement does not replace individual informed consent,” Agarwal said. He also cautioned that participant payments may reimburse costs or time but must not become an undue inducement.
Consent discussions should allow sufficient time for questions and conversations with family members, even when that slows enrollment. Practical support can also help sustain participation. Agarwal cited icddr,b’s rotavirus trials, in which mothers could telephone study doctors after hours and receive free standard care with hospital referral. Researchers credited those measures with sustained participation, he said.
Representative recruitment requires deliberate planning. Agarwal recommended establishing recruitment targets using local disease-burden data and tracking enrollment by age, sex, and geographic area. Population censuses may also inform that work.
Safety planning must precede harm. He called for insurance or compensation arrangements, prompt adverse event reporting, and independent safety monitoring. Vulnerable populations require additional safeguards, with ICMR requiring further justification and scrutiny for groups including children and pregnant women.
The obligation to participants continues after enrollment and follow-up end.
“Finally, publishing results whether positive or negative also helps communities see that participation counts,” Agarwal said.
Together, the responses connect vaccine innovation with the systems that support it. Sustained financing keeps research teams ready. Local decision-making gives partnerships substance. Transparent consent and access commitments help ensure that communities remain central to the research they make possible.
