The international group of scientists who wrote to The Lancet requesting more detailed information on the results of clinical trials of the Russian vaccine “Sputnik V” were dissatisfied with the developers’ response. The authors of the open letter said they would continue to seek publication of the missing data. The developers of the vaccine from the Russian Gamaleya Research Institute of Epidemiology and Microbiology insist on the accuracy of the results published in the Lancet. Suspicious coincidences pointed out by critics of the article were explained by the Russians as a small sample size and the peculiarity of the testing process. However, they refused to continue the public discussion of the research. The Lancet, which recently experienced a scandal involving the retraction of a published article and had to change its editorial policy as a result, clearly has no desire to engage in the ensuing scientific debate and risk its reputation again. By publishing the correspondence between the authors and the critics of the study, the journal provides only very general comments on the matter. A representative of the Lancet declined to answer the BBC’s follow-up questions.
On August 1, the country’s Health Minister Mikhail Murashko announced that the coronavirus vaccine developed by Russian scientists had completed clinical trials. 10 days later, President Vladimir Putin announced the registration of the drug, assuring that the vaccine “works sufficiently effectively,” “has passed all necessary checks,” and creates stable immunity. Abroad, these statements were met with skepticism: clinical trials for any drug take at least a year, and the most stringent requirements apply to testing the efficacy and safety of vaccines.
However, on September 4, the prestigious medical journal Lancet published an article on the successful trials of the Russian vaccine (both variants). The study, whose lead author is Denis Logunov, deputy director of the Gamaleya Center, claims that tests of the vaccine have shown that it is well tolerated and “induces a strong humoral and cellular immune response in 100% of healthy participants”.
Foreign scientists had several questions about the article. Some noted the remarkable and unlikely coincidence of indicators between different test groups. Others were surprised by the speed of publication and the confusion about the dates. The trials were completed only on August 10, and to prepare and print such a study in three weeks is almost unbelievable (even forgetting that Murashko announced the completion of the trials even earlier).
Scientists expressed their concerns in an open letter to the Lancet, demanding that the full clinical protocol for the “Sputnik” trials be made public. However, Russia’s response, published nearby, not only failed to satisfy critics, but also heightened their wariness of the research. “[The authors of the Russian article] never provided any data,” said one of the authors of the open letter, Enrico Bucci, a biology professor at Temple University and a well-known crusader against pseudoscience. “They haven’t even given us access to the original research data. In other words, they reserve the right to deny access to the data – this is totally unacceptable!”
“The response to our questions was formal, we never saw the actual data,” agrees Konstantin Andreev, a graduate student at Northwestern University in the US, who also signed the appeal to the Lancet. According to him, as a biologist he noticed many peculiarities in the article of Russian scientists even before he read about the suspicious coincidence of research data on the Internet. Then he contacted Professor Bucchi and became a co-author of a collective letter, but he was also dissatisfied with the answer of the developers of “Sputnik”. “We intend to contact the editors of the Lancet and request the publication of this clinical protocol so that an independent group of scientists can analyze the full data and at least ensure that they have not been falsified,” explains the expert.
The developers of “Sputnik” are confident about the effectiveness of the Russian vaccine, but they don’t want to talk about it. The only statement on the matter was made on September 10 on behalf of the Logunov Russian Direct Investment Fund, which is funding the development of the vaccine along with the Russian Ministry of Health. “The published data are reliable and accurate and have been peer-reviewed by five Lancet reviewers,” the statement said. “The full clinical protocol has been submitted to the journal’s editorial office.” Arseny Palagin, press secretary of the Russian Direct Investment Fund (RDIF), when asked what exactly the clinical protocol sent to the editors of The Lancet represented: “A full report on the research conducted, 300 pages.”
The number of offerings should remain the same: The Lancet is one of the most authoritative medical journals in the world. Judging by the fact that the latest data in the Russian scientists’ article is dated August 10, and it was published on September 4, the entire lengthy process of preparing the publication, which is described in detail on the journal’s website, took about three weeks. This is surprisingly short, considering that even the Lancet’s fastest publication method (known as Swift+) takes 20 working days, or four weeks.
However, it was not possible to clarify the chronology in the journal. The Lancet refused to disclose details of the Russian scientists’ preparation of the article for publication. In response to the BBC’s request for exact dates – when the paper was submitted to the editorial office, when it underwent internal review, when the article was sent to reviewers, how many days it took to write the reviews, when the editing was completed, when the research was accepted for publication, etc. (separate time is allocated for the graphic design of the paper and illustrations) – the magazine’s press service refused to answer. Other clarifying questions were left unanswered: how many reviews did the article receive, where were the reviewers from, how much time did they have to read and evaluate the research, and did they have any questions about the data presented by the authors.
“The study has been independently reviewed by international experts in Covid-19 and vaccines. The editors of The Lancet communicate confidentially with the authors, and the details of the review, including the dates and comments of the reviewers, are not made public,” said the journal’s official representative. The question of under what circumstances the editor of The Lancet can consider retracting a publication – as happened in May with another article, forcing changes to the journal’s editorial policy – also remained unanswered.
“To whiten oneself, one must blacken another,” commented Elena Smolyarchuk, head of the Center for Clinical Drug Research at Sechenov University and head of the first phase of the “Sputnik” vaccine research, on foreign scientists’ claims against the Russian vaccine, according to the BBC. “Let’s face it – there is currently a kind of competition for leadership in vaccine development and production,” she continues. “I can say that The Lancet is a journal with a high scientific reputation. And before publishing an article, the journal’s experts naturally asked for primary data, which formed the basis for the statistical analysis and materials of the article.”
The three-week preparation period for the article is explained by the fact that the scientists collected and processed interim data on the results of the first, second, third, and fourth weeks after the vaccination. At the end of the study – on the 42nd day – there was not much work left to do. “The Lancet would not allow publication of unverified data,” she says confidently. “If someone does not know or understand something, that does not mean it cannot exist.”
As for the authors’ reluctance to provide access to their research data, Smoliarchuk does not see anything surprising either. According to her, they plan to make it available only to interested vaccine partners who intend to produce it or to countries that intend to buy it. “But for simple enthusiasts trying to find compromising material that does not exist, on what basis should a developer provide anything?” she wonders.
Smolyarchuk says she and her family have already had COVID-19 – but if that hadn’t happened, she would have willingly received the “Sputnik” vaccine and vaccinated her relatives without hesitation. Foreign scientists are not very reassured by these statements. They say that it is not so much the test results of the vaccine that concern them, but rather the secrecy of its developers. “We don’t know if it’s good or bad, if it protects against the coronavirus or not. In general, we know very little about it,” says Konstantin Andreev. “Strictly speaking, it’s not even a vaccine, it’s just a vaccine candidate.”
“However, we are not satisfied with a cavalier approach to such research (given its enormous importance) and the possibility of setting a dangerous precedent by making clinical trials virtually unnecessary to bring a product to the pharmaceutical market”. “The lack of transparency in the results of preclinical or clinical trials, not to mention the transparency of the process itself, continues to raise concerns,” agrees Thomas Cueney of the International Federation of Pharmaceutical Manufacturers and Associations. Even in the current extraordinary situation, vaccine manufacturers must adhere to the highest standards of quality, safety and efficacy, he said.
But it seems that not many people want to wait. In China, where the coronavirus vaccine was approved with little fanfare in June (almost two months earlier than in Moscow), more than 350,000 people have already received the vaccine, according to the latest data. No vaccine in the world has completed trials.