Medical experts are insisting that transparency becomes an absolute priority in the race for a Covid-19 vaccine, in what may be the quickest such development in history.
The political pressure to produce a successful vaccine swiftly for a disease that has already caused nearly a million deaths globally has raised public concerns, even as regulators and health officials around the world have repeatedly issued assurances that safety will not be compromised.
Boosting public trust in vaccines requires transparency, scientists and medical experts argue, urging pharmaceutical companies to release more information about their clinical trials and to avoid cutting corners in the traditional regulatory process.
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“Transparency in clinical trials, price negotiations and research and development investments is of paramount importance for ensuring equitable and fair access to vaccines,” The Lancet Covid-19 Commission, an advisory group backed by the British medical journal, wrote last week.
On Thursday, two American vaccine developers, Pfizer and Moderna, appeared to respond to such calls and released the details of clinical trial protocols they will use to evaluate their candidates – information typically kept confidential during trials. The British pharmaceutical company AstraZeneca has since followed suit.
“It’s definitely an unprecedented step,” John Donnelly, principal at US-based Vaccinology Consulting, said of the disclosures. “In normal circumstances, if you had companies competing to produce a vaccine for the same indication, there’s no way they would do this,” he said, noting the immense scrutiny the companies faced.
The releases have sparked a wave of analysis and critique of the methodology, including of the interim stages at which the results will be accessed before the end of the full clinical study. Experts say these points could be when companies seek authorisation for their vaccines, if they meet the proscribed efficacy criteria.
Such information is of critical importance in the United States, where the White House has said a vaccine may be approved as early as October, before the November presidential elections, raising concerns about political interference in the regulatory process.
Having the protocols open for review by the scientific community will help ensure that companies uphold the standards they lay out, biostatistician Thomas Lumley said.
“If we can trust them, it’s important that we know we can, and if we can’t, it’s important that we know we can’t,” said Lumley, professor of biostatistics at the University of Auckland in New Zealand.
Similar sentiment built around a lack of information surrounding a pause of the global trials for AstraZeneca’s vaccine candidate earlier this month, which was triggered by a safety review following the unexplained illness of a participant in Britain.
The trials have since resumed in Britain, Brazil, India and South Africa, but were still under review, as of Monday, in the US. However, no further information was provided after an independent committee in Britain told regulators there it was safe to resume the study.
“This will not do,” Ashish Jha, dean of the school of public health at Brown University in Providence, Rhode Island, wrote in an editorial in Time magazine on Friday. “We need a lot more transparency in this process to ensure that only a vaccine proven by data to be safe and effective will be approved.”
The push by scientists and health professionals for transparency comes as nine vaccines have made it into Phase 3 trials, with several already being used outside these clinical studies.
These include candidates in China, where vaccines developed by domestic companies have already been granted emergency use approval for certain high-risk populations, such as frontline health care workers.
Chinese-developed experimental vaccines last week received similar emergency authorisation in the United Arab Emirates, which is running Phase 3 trials.
Russia’s Sputnik V vaccine, which shocked the international community after being approved following early clinical tests on just 76 people, has been subject to calls for more data transparency.
A group of European, American and Japanese researchers on Friday expressed their concerns about what they say is missing from the published results from the early clinical trials of the Russian vaccine. They called for “a detailed answer and rendering the actual data available”. Both the clinical study and the researchers’ letter were published in The Lancet.
Such calls for transparency from the scientific community have become a clear component of the development of a Covid-19 vaccine, according to immunologist Kylie Quinn, a research fellow at RMIT University in Melbourne, Australia.
While transparency was a “fundamental principle of vaccine development”, she acknowledged that different regions and jurisdictions were likely to use a variety of approaches.
But the step from Pfizer, Moderna and AstraZeneca to release their protocols could set the right precedent for further sharing from other companies – not just of protocols, but also of the data that eventually emerges from the Phase 3 trials, Quinn said, adding this could help build confidence.
“You have to have a safe vaccine, and you have to have an efficacious vaccine and you have to have the public trust,” she said. “The key ingredient is trust.”
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This article Coronavirus: as the pursuit for a vaccine accelerates, calls grow for transparency in clinical trials first appeared on South China Morning Post