Sputnik V, the Covid-19 developed by the Moscow-based Gamaleya Research Institute, was the early rising star of Covid-19 vaccines. Now it is mired in controversy arising from the institute’s failure to share data about the vaccine.
After being developed, authorized, and administered at breakneck speed, it is now being rolled out in 39 countries and due to be rolled out in 27 more — with a combined population of more than 3.2 billion people. These are mainly lower- and middle-income countries that lost out to countries in Western Europe and North America in the race to secure sufficient vaccine doses to protect their populations.
But inconsistences in the Sputnik V trial data have left scientists questioning whether the analyses of the clinical trial data are too good to be true. If the data have been manipulated, and the vaccine is not as effective as claimed, this would have potentially catastrophic implications for the global Covid-19 immunization drive.
Regardless of whether the Sputnik V data have been manipulated or falsified, the fact that there is no way to know for sure based on the data published so far speaks volumes about the regulations that are supposed to govern clinical trial transparency. Lack of a coherent global framework means that different levels of data sharing can be expected based on where a clinical trial was conducted or where a vaccine is rolled out.
Russia’s Federal Service for Surveillance in Healthcare (Roszdravnadzor) —the equivalent of the U.S. Food and Drug Administration — approved Sputnik V for use in August 2020 after it was tested on just 38 people and before a Phase 3 trial had been completed, which is typically the final stage before a new drug is rolled-out. An open letter signed by nearly 40 scientists was published a few weeks later and highlighted suspicious patterns in Sputnik V’s early clinical data.
The Gamaleya Research Institute subsequently reported an impressive efficacy rate of 92% based on early analyses of Phase 3 data, close to the 95% rate reported by Pfizer/BioNTech and the 94.5% rate reported by Moderna. The institute also published its data analysis in The Lancet, one of the world’s most respected medical journals, but failed to include the raw data underpinning this analysis.
In mid-May, the same group of international scientists again highlighted concerns about Sputnik V after spotting patterns in The Lancet data analysis which showed the hallmarks of data manipulation. Gamaleya researchers defended the institute’s analysis in an open letter to The Lancet. They pointed out that in many countries, regulators — who had access to more data than the public — approved Sputnik V and that the vaccine has been administered to nearly 4 million people in Russia alone, with no major reporting of worrisome side effects. They also asserted that the earlier Phase 1/2 and Phase 3 data analysis in question was published in The Lancet following peer review.
But the institute has so far failed to respond to requests to publish the raw data from the Phase 3 clinical trial. As the scientific community has seen in many cases, such as the highly touted swine flu treatment Tamiflu, just because a vaccine or drug has been given the green light by regulators does not mean that manipulated or hidden data did not slip through the cracks. Add in the immense pressure that developers have been under to roll out effective vaccines as fast as possible, and it becomes clear that these regulatory steps are far from foolproof.
The Sputnik V issue highlights why better clinical trial transparency is urgently needed, and not just for the Russian vaccine but for all Covid-19 vaccines. An analysis of the world’s 20 leading coronavirus vaccines conducted by Transparency International, the organization I work for, identified a total of 86 clinical trials on registry platforms as of March 2021. Results have been announced for fewer than half of these. Of the trials with announced results, 41% of the reports provided no data analysis and instead only provided headline information via carefully worded press release or press conferences.
It would be easy to blame the companies developing the vaccines for not sharing all of their clinical trial data, but this is not necessarily a case of vaccine developers not playing by the rules. Rather, this issue reflects the lack of any real guidance on how, what, or when clinical trial data should be shared during health emergencies. Even in “normal” times, there is no harmonized global policy on clinical trial transparency despite the best efforts of the World Health Organization and transparency advocates in promoting best practices.
That said, a lack of coherent guidance does not excuse drug or vaccine developers from behaving in the most transparent manner possible.
The current debate over the Sputnik V data is possible only because Gamaleya published its data analysis in The Lancet. But as the saying goes, you don’t know what you don’t know, and this will remain true for as long as the raw data for Sputnik V — and the numerous other Covid-19 vaccine clinical trials with no published data analysis — remain hidden.
The only way for concerns over Sputnik V and other vaccines to be quelled is for the developers to publish full clinical study reports along with the raw data. Not only will this build confidence in Covid-19 vaccine, but it will pave the way for other developers to follow suit.
Jonathan Cushing is head of global health programs at Transparency International.