Only radical transparency can ensure trust in covid-19 vaccines, says Els Torreele
With at least eight candidates in phase 3 clinical trials, and billions of dollars invested in accelerating vaccine development, the race for a covid-19 vaccine is about to go into overdrive. But who will protect public health if political leaders are ready to hijack established safeguards and oversight of pharmaceutical companies for their own political survival and geopolitical dominance? Only radical transparency of clinical trial data and independent assessment by the scientific and public health community can break this dangerous gridlock and ensure the adequate protection of our health and wellbeing while restoring trust in covid-19 vaccines.
Vaccines are a public health intervention which, more than any other, require people’s collective buy-in. Trust in the system that generates and evaluates vaccine efficacy and safety is paramount. While commercial conflicts of interests preclude self-regulation by pharmaceutical corporations, we would normally rely on public pharmaceutical regulatory bodies like the US Food and Drug administration (FDA) or European Medicines Agency (EMA). However, the very institutions mandated with the protection of our health and wellbeing against commercial and political interests are themselves under huge pressures to hasten approvals.
Late June, barely six months after the identification of the new SARS-CoV-2 virus, China announced its approval for military use of Cansino’s Ad5-nCoV vaccine. Mid-august, Vladimir Putin surprised the world as Russia approved their Sputnik V vaccine amid concerns this was premature. Donald Trump is pushing hard to get a vaccine approved in the USA before the November presidential election, while the UK government is creating a legal framework to approve a vaccine before the end of the year.
In recent weeks, concerns among scientists and experts are growing over the political pressure the US administration is putting on the FDA, which has long served as a global reference for regulatory standards. Last week’s announcement that the FDA would consider emergency authorization for covid-19 vaccines before phase 3 trials are complete, has caused particular concern. European countries will be hard pressed to not follow suit and are already exploring legal loopholes to allow early distribution of unlicensed vaccines. Yet, as vaccine and public health experts keep emphasizing, robust phase 3 efficacy trials are the only way to establish whether a vaccine is effective in protecting against infections and disease, and safe to administer to large groups. Given the high stakes involved, only robust and independent review of the results will suffice in order to validate the study conclusions and fully understand the performance, and limitations, of each vaccine.
Additionally, it is important to clarify in advance what we expect from covid-19 vaccines. Efficacy and safety of a vaccine are not binary, but fall along a gradient and may evolve over time as more evidence is accrued, or the pandemic evolves. While there exists no absolute threshold for efficacy, a target of minimum 50% has been suggested for a covid-19 vaccine to be useful, while 70-80% efficacy in preventing infection would likely be needed to effectively curb the pandemic. There are also different types of efficacy to consider as one assesses the potential benefits and risks of a given vaccine candidate: does the vaccine protect against infection, or primarily reduce disease severity and mortality? Unfortunately, these nuances are largely lost in the bidding war for approving the first vaccines, touted as magic bullets that will promptly bring our lives back to normal.
The speed at which scientists and vaccine developers have been able to move multiple vaccine candidates into clinical trials is truly impressive. Yet, we still need robust scientific processes and oversight, with all the normal public health safeguards in place including transparency when it comes to deciding what is considered a “safe and effective vaccine.” Decisions to approve a vaccine should not be taken behind closed doors or be driven by political instead of health purposes.
Seeking to reassure the public, nine pharmaceutical corporations recently made the remarkable pledge that they will not apply for marketing authorization for their covid-19 vaccines before having established safety and efficacy through a phase 3 trial, stating they “make the safety and wellbeing of vaccinated individuals our top priority.” While this is a welcome commitment, self-regulation by the pharmaceutical industry cannot be the solution, as evident from decades of regulatory practice to weigh benefits against harm for the public as a counterforce to commercial objectives.
If vaccine nationalism and other pressures undermine the ability of regulators to do their job of safeguarding the quality, safety and efficacy of pharmaceutical products and protecting public health, the only way to ensure an independent assessment, and gain people’s trust in the process, is radical transparency. Making it mandatory for the study designs and results of all clinical trials to be made available in a timely manner would allow independent review by the scientific and global health community, which has already shown its capacity to publicly peer-review and pinpoint biased, flawed or ill-founded conclusions during this pandemic. An open and collective review process would reclaim the status of covid-19 vaccines as global commons, and represent a building block towards the collective governance of covid-19 vaccines and related knowledge as true People’s Vaccines.
An often heard argument against full transparency of clinical trial data is that these would comprise proprietary or commercially-sensitive information, and therefore not to be shared publicly. However, this argument is difficult to maintain in a public health crisis like this one, when a wide range of public and private partners are mobilizing and collaborating to develop vaccines, not in the least the many thousands of volunteers willing to take the risk to receive experimental vaccines, and the massive sums of public funding that are being invested in covid-19 vaccine development.
A protective vaccine will be an important addition to public health measures to curb the covid-19 pandemic and restore our livelihoods and social lives. However a poorly effective or unsafe vaccine will do more harm than good. While established mechanisms to regulate pharmaceutical companies and protect public health seem compromised, the global scientific and public health community must step up and take responsibility for upholding the legitimacy of medical research and development in the public interest.
Full transparency and collective independent review of clinical findings are the only way forward. It will be in everybody’s interest to have a truly effective and trusted vaccine: politicians, companies, scientists, regulators and indeed all of us – the people.
Els Torreele, Researcher and advocate on medical innovation for access (former director of the MSF Access Campaign)
Competing interests: no competing interests