The global race for covid-19 vaccines seems well underway to break all speed records. But this focus on rapid vaccine development, fuelled by unprecedented political, financial, and populist pressures, risks missing the target of global access to effective vaccines that can curb the pandemic, while irreparably damaging the public confidence of people desperate to return to their lives.
Vaccines are critical public health interventions because they prevent disease at population level, both protecting vaccinated individuals and curbing community transmission. That important aim, however, occurs only if the approved vaccines work well—an outcome now being chipped away at in the race for first marketing approval. Whether in Russia, where authorities announced approval of a vaccine without accompanying data, or in the United States with “Operation Warp Speed,” vaccine developers and (health) authorities are now favouring speed over robust evidence of effectiveness and public health impact, constructing a narrative that anything is better than nothing and lowering the bar on what constitutes a safe, effective, and useful vaccine.
The World Health Organization (WHO) published a Target Product Profile for covid-19 vaccines specifying minimal vaccine characteristics to guide developers—including 50 percent efficacy. However, these are only aspirational, and companies nor regulators are bound to follow them. Both FDA and EMA officials, for example, have already signalled that they would consider approving vaccines that only diminished severity of illness, rather than protected against infection.
Meanwhile, companies started floating acceptable efficacy goals of much lower than 50 percent, and forewarn that protection may be relatively short-lived. Key vaccine characteristics that are well-known to be critical for successful roll-out globally, such as immunization schedule (ideally a single dose), temperature stability (ideally no refrigeration), possibility for rapid scale up of manufacturing and low cost of goods, are currently not even being considered in the competition towards marketing approval. WHO has proposed a trial protocol that aims to test and compare different vaccine candidates in a standardized way, which would allow the best ones to be prioritised. But companies are not obligated to have their vaccine tested this way and for obvious reasons prefer setting up their own trials compared to placebo, with self-defined success criteria that may be less stringent than the WHO-recommended ones.
Proponents of the vaccine race advance narratives that first generation vaccines “may not be as good as we would like to” and that R&D towards better vaccines will be needed over the next years. Sensible as that may sound, a substandard first effort may not only harm people if corners are cut on safety, but also squander the opportunity to effectively channel the massive mobilisation of resources to curb the global pandemic and save millions of lives in a timely and equitable way, leaving crucial scientific questions unanswered and permanently altering the ability to develop and test better products.
One particular challenge is inclusion in clinical trials of the more vulnerable, and ensuring the vaccine also works for them. It is common for initial vaccine trials to enrol healthy volunteers with homogeneous characteristics in terms of health, age, ethnicity etc. Older adults with fragile health status, pregnant women, children, or those with comorbidities such as diabetes or tuberculosis are typically excluded in early trials, as are otherwise vulnerable populations with little access to health care such as poor communities everywhere, or migrants, and refugees. Approving covid-19 vaccines untested among those groups, however, could yield vaccines that work best in those needing them least.
It is highly unlikely that one single vaccine will be equally effective and useful in all populations. Instead, we may need different types of vaccines inducing different kinds of immunity to effectively establish protection globally. For that to happen, a needs-driven portfolio approach to vaccine development is needed, in which the scientific community collectively works towards advancing different vaccine profiles that can be assessed for their capacity to complement each other, rather than competing for the same niche.
Hopes for better vaccines tomorrow depend on what we do today. The widespread use of a first generation vaccine with only 30 percent efficacy—or durability of only months— will cripple establishing the efficacy of potentially better vaccine candidates. In addition to scientific and methodological complexities having to compare with suboptimal vaccines, people’s willingness to participate may have waned, especially in countries where populations already distrust government motives. Importantly, financial resources and political will may not last to move 2nd or 3rd generation vaccines forward if the initial—and unprecedented—investments fail to achieve significant health impact.
Voices from the vaccine establishment are raising concerns. Phil Krause, deputy director for vaccines at the FDA and member of the WHO working group for covid-19 vaccines warned during a recent conference that “A weakly effective vaccine can do more harm than good.” The CEO of Merck Ken Frazer, has noted that “potential vaccines may not have the qualities needed to be rapidly deployed in large numbers” and that raising hopes for a vaccine before year-end are doing “a grave disservice to the public.” These cautions, however, have been little heeded, drowned out by media hype and political demands such as Trump’s urging for a vaccine in 2020.
Another risk of speed over quality in the rush for a vaccine is further erosion of trust in science by communities at risk. Covid-19 has already exposed the vast gap between science and practice, and the importance of working with communities to educate them about covid-19 risk, prevention, and treatments. Suboptimal experimental design or ethics practice lays the ground for suboptimal rollout hampered by distrust, vaccine refusal, and misinformation.
By setting the performance bar far lower in covid-19 vaccine development than what would otherwise be acceptable for a new vaccine, we are also unwittingly redefining the very concept of a vaccine—from a long-term effective preventive public health tool to what could amount to a population-wide suboptimal chronic treatment. This might be good for business, but could prove fatal to global public health.
Els Torreele, Researcher and advocate on medical innovation for access (former director of the MSF Access Campaign)
Twitter: @ElsTorreele
Competing interests: no competing interests