The opening lines of a recent New York Times article were notable for what wasn’t there: the authors, in both the title and on first use, referred to the novel coronavirus as “the virus;” no corona-, no COVID-19, no SARS-CoV-2. It’s reflective of the degree to which COVID-19 has become all-consuming; in Summer 2020, coronavirus needs no introduction.
As the virus sits atop the collective consciousness, so too does its cure. The Times article describes a viral video that advocates (among other things) the use of hydroxychloroquine as a COVID-19 treatment, an improbably contentious, partisan issue in the United States. That its use is so fraught underscores how hopeful we are for a treatment or prevention. This desperation amplifies an already urgent medical need, putting biomedical research in the spotlight like no time in recent memory.
A recent version of a COVID-19 relief bill in Congress recognizes this fact: according to STAT, the funding package includes $20 billion in funding for the Biomedical Advanced Research and Development Authority (BARDA), an HHS agency primarily responsible for “transition of medical countermeasures such as vaccines, drugs, and diagnostics from research through advanced development.” That funding figure represents a 1150% increase over BARDA’s originally planned funding for 2020. The same bill also includes $15.5 billion for NIH biomedical research, in acknowledgment that “much [research] has been disrupted by the forced hiatus at many universities and research centers.”
Monday, July 27, saw the beginning of a 30,000-participant trial for a vaccine developed by NIH and the biotech company Moderna, injecting the phrase “phase 3 trial” into the broader lexicon. The study is sure to receive previously unthinkable scrutiny. (Predictably, the vaccine is the target of similarly intense financial speculation; popular stock-watching site the Motley Fool ran three stories about Moderna in 24 hours in the wake of the trial news.) All of Us, the sprawling, NIH-backed research study that hopes to eventually recruit a million participants, has used this moment to underscore the importance of scientific research and the value of human participation:
“I think it’s really good that research is becoming more emphasized. I want to make a difference.” Bella shares her top health concerns, family health history + reasons to #JoinAllofUs. You can sign up at https://t.co/7uNue4Gmhn. pic.twitter.com/G4oKV1bmAN— AllofUsResearch (@AllofUsResearch) July 14, 2020
In June, All of Us expanded their data collection program to include COVID-19 information, including “antibody testing, a survey on the pandemic’s impacts and collection of electronic health record information.” The data will ultimately be accessible for analysis in the Researcher Workbench data platform.
And though some animal testing was bypassed to speed up vaccine development (a decision not without critics), our colleagues at Speaking of Research illustrated in a recent blog post how critical animal research was in arriving at a phase 3 trial, particularly in building the fundamental knowledge that helped researchers arrive at their current understanding of the virus:
“We know from foundational studies in animal models, particularly mice, that the vaccine induces cells to make the spike protein, which then prompts the immune system to make antibodies that attach to the spike proteins. The working hypothesis is that these antibodies may prevent the virus from infecting healthy cells.”
Indeed, the day after the phase 3 trial of the Moderna vaccine got underway, the New England Journal of Medicine published results of a preclinical study on 24 rhesus macaques, showing promising results: “The vaccine did not completely prevent infection, but kept the virus from propagating greatly.… Lab tests also found that the vaccine stimulated strong immune responses, including high levels of antibodies capable of neutralizing the virus.” The Foundation for Biomedical Research points out in a recent YouTube video that five of the major vaccine contenders are leaning heavily on research with nonhuman primates:
As the world eagerly awaits a vaccine, the vital role of biomedical research has become increasingly visible. It is perhaps unsurprising, then, that medical testing on animals is seeing its highest approval rating in several years, according to a recent Gallup poll. But as researchers—whether they study humans or nonhuman animals—enjoy increased prominence and (in some corners) approval, the challenges of doing their work remain immense: despite promising reports from the spending bill mentioned above, many systems and institutions face significant budgetary concerns, and the logistical obstacles to conducting research amidst a pandemic can be overwhelming.
At a time like this, maintaining the highest ethical standards in research is more crucial than ever, and PRIM&R is eager to help. Since March we’ve maintained a resource list for those in research ethics oversight, and on August 18, PRIM&R will host Research Ethics and COVID-19: Lessons Learned and Future Considerations, a virtual, one-day conference addressing how those working in research ethics can evaluate and adapt to the current moment, and best support the research field going forward.
Tim Badmington is the Policy and Engagement Manager at PRIM&R.