Even seasoned biotech and pharma observers were impressed by the efficiency of the COVID-19 vaccine development process. “Within 63 days of the identification of the [virus genome] sequence, the first patient was dosed in a clinical trial,” says Andrew Lo, an economist at the MIT Sloan School of Management. Today more than 20 COVID-19 vaccines have been developed, with more in the pipeline.
But while vaccine R&D proceeded far more swiftly than most observers anticipated, the pandemic response hit a wall when it came to vaccine distribution, particularly in low- and middle-income countries. The result has been preventable cases and preventable deaths.
To protect the world from future pandemics, the entire vaccine life cycle—from basic research to clinical trials, manufacturing and vaccine distribution—needs to be reimagined, reinforced and coordinated globally, especially in the Global South, says Stacey Knobler, vice president of vaccine innovation and global immunization at the Sabin Vaccine Institute. But if we can learn from COVID-19, she says, then future pandemic threats—including the ever-present risk of a global influenza pandemic—could be nipped in the bud.
Planning for the worst
A global plan needs to be mapped out in ‘normal’ times to produce and distribute vaccines, according to a recent paper by Gerald Keusch, a Boston University infectious disease researcher, and Nicole Lurie, a strategic advisor to the Coalition for Epidemic Preparedness Innovations (CEPI), an international coalition that aims to develop vaccines to prevent pandemics.
This strategy should also reform incentives to encourage teamwork and data sharing during early-stage R&D, the two wrote. COVID-19 vaccine R&D moved quickly because researchers from government, academia and industry shared data as never before, bridging the gaps and gulches that typically separate disciplines and institutions, Keusch and Lurie argue. Future pandemic prevention efforts should include targeted funding that fosters such teamwork. To prevent influenza pandemics, for example, the Bill and Melinda Gates Foundation’s Global Grand Challenge for Universal Influenza Vaccine Development funds efforts built around “cross-fertilization of ideas from outside the traditional influenza research community.”
When promising vaccine candidates advance to clinical trials, drugmakers must be able to pivot quickly to manufacturing billions of doses. They're mostly not prepared to do it fast enough, Keusch says. “There's some reserve manufacturing capacity available, but not at the scale and the flexibility that's really necessary,” he says. “Better planning for flexible surge capacity … needs to be systematically thought about.”
The planning that did happen during COVID-19 directed vaccine doses to rich nations who had made deals with manufacturers, while less well-off nations had to sit and wait for donations. This left much of the world unvaccinated, month after month, which enabled the virus to spread, mutate and generate dangerous variants.
It’s not clear yet who would coordinate global pandemic prevention planning, but Keusch and Lurie point to the World Health Organization as “one of the few global entities that can advocate for the health of the world’s have-nots” and “convince and organize nations to promote equitable access.”
Finding funds
Most funding for COVID-19 vaccine development came from government agencies, including the NIH and the Biomedical Advanced Research and Development Authority (BARDA) in the United States and the European Commission. This funding subsidized corporate vaccine R&D, reducing the risk companies had to take to test and produce a new vaccine at scale — all while letting governments oversee aspects of vaccine development. The same model would help the world respond to future pandemics, says Marie-Paule Kieny, research director at INSERM in France and former assistant director at the World Health Organization (WHO). “It’s in the industry’s interest to ‘play again’ and engage in preparedness, knowing that the public sector will have to pay the lion’s share of the preparedness effort,” she says.
But pandemic preparedness also requires additional sources of capital, says Lo. He has proposed a ‘subscription-based’ preparedness plan under which nations would subscribe by contributing funds according to their population and the size of their economy, and the pooled funds would pay to develop and distribute vaccines when and where they’re needed. “It’s a kind of pandemic insurance,” Lo says. The plan is both equitable and feasible because algorithms exist to help fairly distribute public goods and services, he adds. The idea has generated intense interest and was discussed this fall at meetings of the United Nations General Assembly and the G20.
Toward vaccine equity
As the spread of COVID-19 variants has shown, in a pandemic no one is safe until everyone is safe. “Vaccine equity is the challenge of our time,” WHO Director-General Tedros Adhanom Ghebreyesus told the UN’s Economic and Social Council in April 2021, “and we are failing.” In most African countries, for example, only about 3% of the population had received even a single dose as of October 2021, and lower-income nations as a whole have received only 20% of the vaccine doses produced to date. Wealthy nations have simply not delivered the vaccines that lower-income nations need, says Patrick Tippoo, executive director of the African Vaccine Manufacturing Initiative. “We [must] never find ourselves in this situation again, where there is absolute dependence on external supply.”
Instead, low- and middle-income countries should build out their own R&D infrastructure to deliver the vaccines their people need and generate revenue in the process, Tippoo says. Africa has made modest progress toward this goal. BioVac, a South Africa-based pharma company where Tippoo is head of science and innovation, houses clinical-grade facilities for vaccine development and manufacturing and is currently producing a variety of childhood vaccines. Similar facilities are active in Egypt, Morocco, Tunisia and Senegal. Partnerships among nations can fill regional vaccine shortfalls, Tippoo says. “Given the right linkages with partners, we could possibly be producing a COVID-19 vaccine within a year,” he says.
To build this capacity, the Africa Centers for Disease Control recently partnered with CEPI to build biotech R&D expertise and manufacturing capacity on the African continent. This will pay off in lives saved, Tippoo says. “It is expensive, time-consuming, and will take a lot of effort, but not doing it is going to cost multiples of that economically and in terms of lives lost as well.”
Explore the quest to develop a universal influenza vaccine at this dedicated resource from the Sabin Vaccine Institute’s Influenzer Initiative.
The nonprofit Sabin Vaccine Institute is committed to extending the full benefits of vaccines to all people by advancing vaccine access, uptake and innovative R&D. Sabin does not develop or manufacture influenza vaccines.
