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Regulatory Focus™ > News Articles > 2021 > 3 > COVID innovation lessons could be applied elsewhere

COVID innovation lessons could be applied elsewhere

Posted 22 March 2021 | By Jeff Craven 

COVID innovation lessons could be applied elsewhere

The global urgency of the COVID-19 pandemic spurred the development of new models of vaccine and drug development. Could these innovations help with researching non-pandemic vaccines or drugs, and potentially serve as a template in other areas of medicine?
 
Two papers recently published in Health Affairs suggest that, yes, these innovations could be applied elsewhere if deemed successful—but it’s also important to note the shortcomings of these new models as well.
 
Unprecedented speed and scale
No matter how you measure the COVID-19 vaccine effort, the acceleration of development and potential access to COVID-19 vaccines is “entirely without precedent,” David E. Bloom, PhD, professor in the Department of Global Health and Population at the Harvard T. H. Chan School of Public Health in Boston, and colleagues wrote in a recent analysis. The previous record-holder was the mumps vaccine, where a 4-year gap separated the isolation of the mumps virus and the licensure of the vaccine.
 
The speed of COVID-19 vaccine development and manufacturing, Bloom and colleagues noted, can be attributed to the “massive financial and human resources” dedicated to the effort on a global scale. For example, $13 billion has been attributed to Operation Warp Speed program in the United States, which includes at least $2.5 billion earmarked for vaccine development and the rest to advance purchase agreements. In the United Kingdom, $4 billion has been committed to vaccine financing and purchase agreements, while the European Union has allocated a similar amount. “Collectively, wealthy countries accounting for just 13 percent of global population now have rights to more than half of all committed vaccine doses,” Bloom and colleagues wrote.
 
International private-private and public-private collaborations have also been unprecedented during the pandemic. In a separate analysis, Bhaven N. Sampat, PhD, associate professor in the Department of Health Policy and Management at Columbia University in New York, and coauthor Kenneth C. Shadlen, PhD, a professor of development studies at the London School of Economics, explained that innovation in biomedical policy historically consisted of “push funding”—directly funding research and development—and “pull funding,” or rewarding successful products.
 
While the landscape of innovative policy under COVID-19 has changed, the focus during the pandemic has mostly been on “public-sector support for downstream research, development, and production,” even if it hasn’t always been clear who the funders are and the types of activities they’re supporting, Sampat and Shadlen wrote. Efforts by the National Institutes of Health (NIH) to develop the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership also included involvement from Biomedical Advanced Research and Development Authority (BARDA), Centers for Disease Control and Prevention, U.S. Food and Drug Administration, Department of Defense, and Department of Veterans Affairs, they noted.
 
Global “push” and “pull” funding efforts
Globally, there has been less funding for “push” efforts, but they share “similar characteristics with the US approach, including an emphasis on vaccines and a focus on downstream development and manufacturing.” International “push” efforts also include initiatives identifying COVID-19 therapeutics like the RECOVERY trial in the United Kingdom and the World Health Organization (WHO) Solidarity trial. Philanthropy has also proven to be an important aspect of innovation during COVID-19, with initiatives like COVID-19 Therapeutics Accelerator—founded by the Gates Foundation, the Wellcome Trust and Mastercard—working to issue grants to identify existing drugs and develop new therapeutics that work against COVID-19.
 
Admittedly, the bulk of the global efforts in COVID-19 are focused on developing effective vaccines, Sampat and Shadlen said. “Even before the pandemic, downstream vaccine research featured substantial public support, and that is reflected in the COVID-19 approach,” they noted. “But the degree of shift—including billions in funding for late-stage trials, building manufacturing capacity, and manufacturing at risk—is remarkable.”
 
So-called “pull” efforts can also be seen in COVID-19 innovation models and take the form of advanced vaccine purchase agreements made by entities like BARDA and governments in the United Kingdom, Australia, Canada, Israel, Japan, and in the European Union. The COVAX initiative—led by Gavi, the Vaccine Alliance, Coalition for Epidemic Preparedness Innovations (CEPI), and WHO—is an example of a global “pull” effort to procure vaccine doses with the aim of vaccinating 20% of the population in low- and middle-income countries. “Collectively, the contracts with individual countries and global purchasers may have incentivized and accelerated development among participating firms,” Sampat and Shadlen explained. “Another way to think about advance procurement agreements is not as innovation incentives but as mechanisms for countries to secure priority access to vaccines.”
 
While much of the innovation discussed was positive, the potential downsides of process innovation also need to be considered. Conducting parallel clinical trials, for example, can save on the time spent between trial phases analyzing data, publishing results, and seeking funding for the next trial phase. However, “it could also prove disastrous if it were to come at the cost of compromised safety,” gaps in trial design, underrepresenting certain demographic groups, or failure to track key trial endpoints, Bloom and colleagues wrote. “If an approved vaccine turns out to cause significant and widespread side effects in the general population, it could reinforce existing and foster new vaccine hesitancy with respect to COVID-19 vaccines, and potentially non-COVID-19 vaccines as well.”
 
Sampat and Shadlen acknowledged that, even as the amount of resources funding pandemic initiatives, “the COVID-19 innovation system is structurally different from the biomedical innovation system before it, which by and large followed a model of innovation in which the public sector supported fundamental research, and firms (incentivized by the prospect of patent-protected profits) did most of the applied research, trials, and development.”
 
Applying COVID lessons to future development
Applying the “push” side of COVID-19 innovations would look like “more public funding for late-stage research, clinical trials, development, and manufacturing,” which could come at the expense of basic science funding,” Sampat and Shadlen said. As “pull” side COVID-19 innovations have been rooted in advanced purchase agreements, it is unclear whether this approach would be useful outside of a pandemic response. “[T]here are questions of whether firms avoided certain types of research that would have been useful, because of the lack of patent or other incentives,” they said. “Concerns about constrained manufacturing capacity for vaccines suggest that larger purchase commitments could have been useful, too.”
 
A lack of global coordination has been present, despite efforts to the contrary, which “may have had consequences for the speed of innovation and the types of vaccines and therapeutics we invested in, and it may also affect access to them throughout the world,” the authors said, noting that storage and distribution needs of certain vaccines could have an effect on health outcomes. “The COVID-19 pandemic has demonstrated that effective biomedical research policy does not end with drug and vaccine development alone.”
 
Lessons will undoubtedly be learned from the pandemic if widespread COVID-19 vaccination is achieved over the next few months and years, according to Bloom and colleagues, and “will offer lessons for how to optimize the development and accessibility of vaccines against other pathogens, under both outbreak and other scenarios.” The knowledge gained from COVID-19 cooperation and financing could, for example, be applied in efforts against antimicrobial resistance, they pointed out.
 
“Efforts undertaken to speedily bring the world safe and effective COVID-19 vaccines hold great promise for protecting human health and economic and social wellbeing. But whether that promise is realized depends in part on the risks of acceleration and their management,” Bloom and colleagues concluded. “If these can be managed successfully, the global community will owe great thanks to those who have been willing to break the mold when it comes to vaccine development, manufacturing, and delivery.”
 
Health Affairs Bloom et al.
 
Health Affairs Sampat and Shadlen
 

 

© 2021 Regulatory Affairs Professionals Society.

Tags: BARDA, CDC, coronavirus, EMA, EU, FDA, US

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