Scientists around the world are scrambling to develop a covid-19 vaccine. A newly proposed strategy could dramatically improve this currently disjointed process, allowing for the accelerated development of multiple vaccines at once.
“To return to a semblance of previous normality, the development of SARS-CoV-2 vaccines is an absolute necessity,” declare the authors of a Science Perspective published today. “To achieve this goal, all the resources in the public, private, and philanthropic sectors need to participate in a strategic manner.”
Notice they say “vaccines,” plural. That’s intentional and a key component of their proposed coordinated approach to covid-19 vaccine research and development.
“We want to see multiple successful vaccines and vaccine platforms meet the global need of immunizing billions of adults [and] children and restoring economic and health to the world,” said Larry Corey, a co-author of the new paper and a member of the Fred Hutchinson Cancer Research Center, in a press release.
Corey’s collaborators include Francis Collins of the National Institutes of Health and Anthony Fauci and John Mascola, both of the National Institute of Allergy and Infectious Diseases.
Over 120 vaccine candidates are currently being developed around the world, according to the World Health Organization. This effort requires lots of people, time, and money. Sadly, these efforts may also involve lots of redundancy and wasted efforts, poor research methods, and unsanctioned or unproven testing practices.
The new guidelines are meant to help in this regard. They describe a multifaceted, highly coordinated, and rational approach to covid-19 vaccine development. The plan is meant to help partners in government, academia, and the private sector manage the plethora of new findings, including multiple development paths running in parallel. This will involve a harmonized and collaborative approach to vaccine development, trials, and ultimately manufacturing and distribution, according to the authors.
“The research and development of COVID-19 vaccines will require creativity, cooperation and commitment to save as many lives as possible as soon as we can,” said Corey. “Besides scientists and health experts, we need the help of industry and affected communities throughout the country to participate in large-scale trials of potential COVID vaccines.”
That multiple vaccines might be needed to protect people from SARS-CoV-2, the virus that causes covid-19, is a sobering revelation. It’s still early days, but scientists don’t yet have a firm handle on what constitutes an effective and robust immune response against covid-19 or how to go about vaccine trials in a manner that’s safe, effective, and efficient.
Writing in the Perspective article, the authors say trials for multiple candidate vaccines can happen in parallel and produce critically important data regarding safety and efficacy. This will in turn—hopefully—lead to rapid turnaround times for the licensing and distribution of selected vaccines. Safety is obviously key, as vaccines can trigger dangerous allergic reactions or even make future infections more severe. Experiments on nonhuman animals could help in this regard, according to the authors.
To harmonize multiple lines of vaccine development, the authors say research teams should share data, achieve consensus on what constitutes an effective vaccine, employ standardized lab equipment, adopt common design architectures for clinical trials, and all work with the NIH’s Data Safety and Monitoring Board for oversight.
To help coordinate all this, the authors point to a newly launched program called Accelerating COVID-19 Therapeutic Interventions and Vaccines, or ACTIV, which was spearheaded by the NIH. This collaborative program will work with government institutions, academia, industry, and philanthropic individuals and organizations, helping to make sure they’re on the same page about trial designs, data sharing, and so on. ACTIV has already partnered with the U.S. Food and Drug Administration, Centers for Disease Control and Prevention, the World Health Organization, and Biomedical Advanced Research and Development Authority, among many other public and private organizations.
Importantly, the new Perspective addresses the possibility of deploying challenge trials, in which young, healthy volunteers are administered promising vaccines and then intentionally exposed to SARS-CoV-2. A Policy Forum article published last week in Science gave tentative approval for such trials, with some reservations and conditions. Likewise, the authors of the new Perspective consider this possibility, but they’re also hesitant, as they explain:
...this approach has shortcomings with respect to pathophysiology and safety. Although the risk of severe disease or death in young healthy individuals from COVID-19 is quite low, it is not zero, and we do not yet have proven effective therapies for COVID-19 to rescue volunteers with complications from such a challenge. It is likely that a SARS-CoV-2 challenge strain will, by design, cause mild illness in most volunteers and thus may not [replicate] the pulmonary pathophysiology seen in some patients. Moreover, partial efficacy in young healthy adults does not predict similar effectiveness among older adults with major cofactors associated with COVID-19 disease, nor would it prove reduction of transmissibility to major susceptibility groups. Whether such experiments may be worthy of pursuit or would have a beneficial impact on timelines for vaccine development needs careful consideration evaluation by an independent panel of ethicists, clinical trialists, and experts on vaccine development.
Clearly, using intentional infections to test vaccines is something that needs to be figured out, but it won’t be easy, given the differing opinions on the matter.
Lastly, but very importantly, there’s the manufacturing side of the vaccine equation to consider. Inventing and testing multiple covid-19 vaccines is obviously a huge hurdle, but mass production and distribution introduces another set of challenges altogether.
Vaccines are not equal when it comes to development, requiring variable levels of cost, equipment, resources, and time to produce. Scientists don’t yet know the nature of a prospective covid-19 vaccine, but the authors say it’s still important to plan. To that end, they’re calling on the relevant stakeholders (both public and private) to fund the required biomanufacturing infrastructure and proactively identify hurdles to distribution, such as costs, supply chains, and logistics.
The sooner we get a vaccine or a suite of vaccines, the better, but it’s clearly going to take time. Hopefully those with the power to do so will take heed of this coordinated strategy and reach the finish line sooner rather than later.