Most people are more interested in getting back to normal after the pandemic than thinking about the next one. But health organizations don’t have that luxury and are readying for the next outbreak.
The Coalition for Epidemic Preparedness Innovations (CEPI), a global partnership, is working on next-generation mRNA vaccines to create a library of prototype vaccines from common virus families that could allow them to get shots out within 100 days if a dangerous new virus emerges. The organization is also collaborating with IQVIA, an analytics, technology, and clinical research services provider, to lay the groundwork so clinical trials for vaccines or treatments can come online quickly at far-flung global sites.
An African Vaccine Manufacturing Accelerator aims to give African countries the tools they need to make needed vaccines to fight a future outbreak, and World Health Organization (WHO) member state delegations are hammering out an international agreement to shore up global pandemic prevention, preparedness and response. Through it all, WHO is keeping tabs on several viruses, such as MERS, Ebola and Lassa fever, that have pandemic potential. If a new pathogen emerges, the hope is that the world will be vigilant and ready, having learned from the response to COVID-19, which was a mixed bag of wins and missteps.
And when another pandemic strikes, health officials will lean heavily on the lessons learned during COVID-19 to respond more effectively.
Looking back to look ahead
The response to COVID was successful in many ways, said Vicky Leamy, vice president of therapeutic strategy at IQVIA.
“I think we achieved the mission in front of us, which was to get vaccines available to reduce the burden of COVID-19,” she said.
“The low-and-middle-income country participation in the manufacturing, the clinical trials, the broad ecosystem needs to improve for the next one."
Vicky Leamy
Vice president, therapeutic strategy, IQVIA
The industry slashed typical vaccine development time by 94% — from 13 years on average to less than one year.
“Most of us who participated in COVID-19 research are proud of what we were able to achieve,” Leamy said.
While there was still a scramble to respond to the new virus, the industry was well positioned because of existing baseline work on mRNA vaccine technology and the infrastructure that allowed for rapid rollout of decentralized clinical trials, she said.
“I think we were all struck by the fact that many of those solutions were already available. They were just used in a way that they hadn't been in the past,” Leamy said.
New efficiencies also accelerated vaccine development, such as speeding up data cleaning and database lock, which is when the trial database is finalized and ready for analysis.
“If you look at where we were able to save time, a large percentage was on the back-end side, and that was bolstered through the real-time data cleaning approach that was employed,” she said. “And if you look at the big vaccine trials, the majority of them were able to lock their databases within 24 hours. We were able to do that with the ones we ran at IQVIA.”
Companies are applying these practices and lessons learned to get other drugs to market more quickly.
Learning from COVID failures
But for all the successes seen, there were also blunders. One glaring challenge was unequal access to clinical trials, vaccines and treatments in countries around the world.
“The low-and-middle-income country participation in the manufacturing, the clinical trials, the broad ecosystem needs to improve for the next one,” Leamy said.
It’s a message that resonates in Africa, said Sue Bailey, a senior director at IQVIA overseeing clinical operations in the Middle East and Africa.
“As a preparedness initiative, there is a lot more investment and political will towards creating more self-sufficiency in some of our lower-middle-income countries,” she said.
"Building sustainable clinical research capacity during ‘peacetime’ will enable trial sites to respond and operate at pace when faced with an infectious disease emergency.”
Dr. Richard Hatchett
CEO, CEPI
This will be a focus of the IQVIA/CEPI partnership.
“Underpinning [CEPI’s] 100 Days Mission is the need to get high-quality clinical trials up and running as efficiently and swiftly as possible once an outbreak has been identified — wherever in the world that outbreak may be,” said Dr. Richard Hatchett, CEO of CEPI in a written release. “Preparedness is key to this approach: Building sustainable clinical research capacity during ‘peacetime’ will enable trial sites to respond and operate at pace when faced with an infectious disease emergency.”
IQVIA has already laid some groundwork to facilitate decentralized trials in underserved countries, with a particular focus on Sub-Saharan Africa. But more commitment is needed, Leamy said.
“That ethos underpins a lot of what we intend to do with that partnership (with CEPI), and that is making sure we're providing equitable and meaningful access to clinical trial approaches,” she said.
Technological investments are crucial to opening trials to more people.
“Decentralized approaches allow us to provide access to individuals who maybe otherwise wouldn't have it, those who live in rural areas, those who are housebound,” Leamy said. “These are sometimes your sickest and most vulnerable individuals who are able to participate because of these new and novel approaches.”
New technology may further broaden that access.
“We believe that there are other technological approaches that could be bolstered that would allow us to push the envelope further. The industry broadly is looking at technology as a way to make clinical trials more accessible,” Leamy said. “And that could be through the approaches that we used, decentralized through the pandemic, but also looking at things like connected devices.”
However, newer technologies also need to be tested and familiar to users ahead of time to ensure they can support trials, even in remote areas, she said.
Ensuring better information sharing between countries is another area flagged for improvement.
“I think that there's been a lot of enhancement through the pandemic in terms of information sharing,” said Bailey. “The vision of CEPI is that it needs to support more of a coordinated global response with enabling local ownership at the forefront.”
Is there enough momentum?
While interest in pandemic preparedness was high during COVID the question is: Will that attention be sustained in the future?
“There's always a worry that memories can be short, but I also think that the commitment, the infrastructure and the capacity that's been built at the global level is substantially greater than it was when I started my career,” Leamy said.
Investment in pandemic preparedness efforts has come down from its peak but remains high.
“There's always going to be a desire to move back to normal our day-in-day-out lives. But among all of the stakeholders that we've been discussing private-partner or private-public [deals] across the entire ecosystem … it's different than it was before,” Leamy said. “That gives me great hope that we will be vigilant and ready for the next pandemic, regardless of whether that's two or 10 years out.”
