Two-dozen experimental COVID-19 vaccines are now in human clinical trials, according to the World Health Organisation. It usually takes more than a decade to develop a new vaccine — but just because we’re expediting research to curb the new coronavirus doesn’t mean we can leave communities behind.
The race is on. Across the world, teams of scientists are rushing to develop effective treatments and preventive vaccines for the new coronavirus, SARS-CoV-2.
Typically, it can take at least a decade to develop a new vaccine, with the shortest timeline in history being four years to develop one for mumps. As part of this process, potential vaccines go through stages of research, from preclinical work in animals to phase one clinical trials that test the safety of potential vaccines in healthy volunteers. From there, vaccine candidates move onto larger phase two and three studies that see if the vaccines are effective at preventing a given disease.
Potential vaccines can spend up to six years in early testing before they ever find their way into human studies, the International Federation of Pharmaceutical Manufacturers & Associations points out.
Today, however, experimental vaccines to protect against SARS-CoV-2 and the disease it causes — COVID-19 — have reached more advanced human trials in less than six months. The scientific community has been able to do this, in part, by adopting strategies to speed up research — including how vaccines are tested, and how those results are communicated and acted upon. Innovative vaccine designs being tested may also speed manufacturing timelines.
Phases of clinical research that would have usually happened one after another are now running concurrently. With the emergence of pre-print websites, research findings including those of COVID-19 studies, are frequently made available before they have undergone peer review, a process which can take months. Some findings have also been reported first in press releases — something that was seriously frowned upon before. It is important to highlight that any results reported before peer-review are preliminary, and have not yet been vetted for validity and quality.
The perils and promise of research on overdrive
Expedited timelines bring the promise of lives saved, but adapting the standard research process also presents challenges and trade-offs.
Concurrently run clinical trial phases may lead to the public misperception that standard ethical and regulatory requirements have been compromised. Disseminating results by press release — instead of via peer-reviewed publication — can be misused to manipulate public reaction, generate funding or hide critical information.
Lastly, historically-disenfranchised communities may have different, and more complex concerns around research, given a history that includes exploitation within research and ongoing issues with discrimination and equity in health systems. As such, expedited timelines may heighten suspicions around profit motives, while delayed research may be seen as the de-prioritisation of a disease that disproportionately affects Black communities in South Africa.
All of these concerns can influence the public’s faith in the vaccine development process and decrease their willingness to receive a future vaccine.
Throughout these complex challenges and trade-offs, community engagement is key to ensuring the demand for an expedited research process is fairly balanced against the need to involve communities affected by COVID-19 in studies meaningfully.
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Recent concerns about COVID-19 vaccine studies raised by advocacy groups in South Africa, further underscore the essential nature of innovative community engagement in the rapidly evolving COVID-19 research landscape. Critical points about prevention measures for COVID-19 trial participants are also being raised. While these standards will vary across different settings and may change as the pandemic progresses, it highlights the need for inclusive and transparent decision-making, particularly on issues of protection of study participants.
It also underscores why community engagement plans are so crucial for the success — and community buy-in — of trials.
These strategies, pioneered in HIV research, can balance the power inequalities between researchers and communities and can also ensure studies respect participants’ values and cultural differences. They build strong partnerships in which information flows not only from scientists to communities but also from communities to researchers to facilitate innovation. While this may sound like a “nice-to-have”, history has shown that it is a critical safeguard to trial conduct, and, if done well, can speed not only the research process but also translation of research results into real-world practice.
You can speed some things, but not everything
More than a decade ago, UNAids, together with the HIV prevention advocacy organisation, Avac, published the first international guidelines on Good Participatory Practices (GPP) for HIV prevention trials. Today, the latest version of this document premises community engagement in clinical trials on principles such as respect, transparency and accountability. Used by organisations such as the South African Medical Research Council and HIV Vaccine Trials Network (HVTN), the guidelines also recommend that community engagement happens throughout the research process — from work done before studies begin to what happens after they conclude.
In April, the World Health Organisation released similar guidelines for COVID-19 research community engagement that advocate for widespread consultation and the use of community advisory boards (CABs). CABs are composed of community members, local leaders and civil society organisations. These bodies — already common in HIV and TB studies — help guarantee communities’ interests are safeguarded during clinical trials.
Globally, health advocates are now establishing a COVID-19 Advocates Advisory Board (CAAB) to ensure the ethical, efficient, and accelerated advancement of COVID-19 research. AVAC, which has worked for years on HIV vaccine advocacy, is leading this group on issues around COVID-19 vaccine research. We believe that informed, research-literate global health advocates have an important perspective to add regarding potential benefits or drawbacks of strategies to fast-track COVID-19 research as well as community-related concerns.
The WHO’s ACT-Accelerator (ACT-A), as well as the United States government’s Operation Warp Speed programmes aim to pool funding and expertise across organisations and agencies to produce COVID-19 tests, vaccines and treatments more quickly. The CAAB will be working to make sure that these programmes deliver on commitments to include civil society in research planning, development and implementation as well as the dissemination of results.
Now, as potential coronavirus vaccines enter large-scale human studies, scientists and researchers must work with communities from the outset. African scientists and researchers need to drive research conducted on the continent, working closely with civil society, advocates, and communities most affected by the pandemic. Above all, the safety and well-being of the communities most impacted by COVID-19, must always drive scientific and policy decision-making.
Building research literacy and ways to engage with people will be critical to ensuring communities participate and support COVID-19 research. Such a broadly representative effort will help guarantee products that are ultimately shown to be effective will be trusted and accepted by those who need them most.
The building of that trust must begin today, with a commitment to community engagement in research that is as broad and deep as the research effort itself. Doing this — and supporting smart strategies to pursue scientific innovation at a “pandemic speed” without compromising safety may help end COVID-19. It may also usher in a new era of expedited, inclusive research to address HIV and future pandemics to come.
Nandisile Luthuli is the regional stakeholder engagement advisor for Avac, a United States-based organisation that advocates for the creation and use of new HIV prevention options around the world. Simba Takuva is the sub-Saharan African regional medical liaison and programme lead for the HIV Vaccine Trials Network. The opinions expressed in this article are those of the authors.
Nandisile Luthuli is the regional stakeholder engagement advisor for Avac, a United States-based organisation that advocates for the creation and use of new HIV prevention options around the world.