A group of scientists is survey the only study available to date to support a controversial vaccine candidate for the coronavirus that causes Covid-19, which is developed by the Russian government. The group claims to have identified “potential data inconsistencies” that make it very unlikely that some of the results are real.
The Russian vaccine study was released in the Lancet last week. It was a phase I / II study that involved a total of 78 healthy volunteers One of two formulations of the experimental vaccine, code-named Sputnik V. There were no reports of serious adverse events among the volunteers – which met the main objective of these early clinical trials – and there was also evidence that volunteers developed an immune response to the SARS. CoV-2 coronavirus, which in theory should protect you from infections.
The results were initially largely welcomed by the scientific community as there was no published evidence for Sputnik V published by the Russian authorities already approved for use a month earlier, seemingly based on this data. It still is not clear whether that approval will actually result in the country’s residents having access to a Covid-19 vaccine earlier than people in other countries Countries. A phase III study with Sputnik V began in late August Typically, this is the final step in clinical research required before treatment can be undertaken Market.
In one (n open letter to the Lancet and the study authors, signed by over 35 scientists and released in this weekResearchers claim they are suspicious those in the Lancet paper. The letter is mostly signed by scientists who work in the fields of immunology, biology or drug development and includes those resident in Europe, North America, and Venezuela (the only scientist from Russia is a Max Tushin, Microbiologist and geneticist at Kazan University).
The letter, in so many words, highlights aspects of the data that they consider lazy. The volunteers were divided into several treatment groups, testing variations of the vaccine that were either frozen or freeze-dried or only received half of the vaccine’s two-dose strategy for safety testing. The letter points to numbers that show some of these different treatment groups with very similar or even identical antibody levels or other post-inoculation immune responses. In other cases, the level of antibodies in the same group did not appear to decrease at all over the duration of the study, which lasted over a month. They were also concerned about the lack of information available about a group of people with documented Covid-19 who were featured in the study and used to compare the immune responses of the vaccinated group.
In itself, either of these things can’t be a big deal. However, the experts do not go so far as to specifically accuse the study’s researchers of fraudThey conclude that “the observation of so many data points obtained in different experiments is highly unlikely”.
The letter calls for the Lancet to examine the study and publish the raw study data on an individual level to help clarify these issues. According to a statement published by the Lancet, the letter has been forwarded to the study’s authors and the publisher is now encouraging them to “join the scientific discussion”.
Denis Logunov, lead author of the Lancet study, has not yet responded to a request for comment on the letter.
This news follows recent difficulties with another Covid-19 vaccine currently under investigation, the AstraZeneca / Oxford University vaccine. In this case there is concern that a volunteer has been found developed serious neurological symptoms at some point amore often reception the vaccine. However, at this point it is not clear whether the woman’s symptoms are actually related about the vaccine.
Unfortunately, if this letter leads to the discovery of bogus data, it would not be the first time the Lancet has been involved in such a scandal during this pandemic. In June the Lancet retracted One study suggests that the drug hydroxychloroquine was both ineffective and possibly increased in patients with severe Covid-19 their risk of death after outside scientists determined that the hospital data used for research was likely fabricated (Other clinical trial data has since shown that hydroxychloroquine is not as effective as other therapies for covid-19, but not necessarily dangerous).