MOSCOW: Twenty-six scientists, most of them working in universities in Italy, signed an open letter questioning the reliability of the data presented in the results of the early-phase trial of the Russian Covid-19 vaccine, called “Sputnik-V”.
Addressing the editor of The Lancet, the international peer-reviewed medical journal in which the Gamaleya Institute in Moscow published the results of its early-stage trials, the scientists said they saw patterns in the data that seemed “very unlikely.” The letter, posted on the personal blog page of one of the signers, said that data from the results of the phase I / II trial showed that several participants reported identical levels of antibodies.
“Based on simple probabilistic evaluations, looking at so many conserved data points between different experiments is highly unlikely,” the open letter said. However, the scientists said they were basing their conclusions on summaries of the Russian trial’s results data, published in the journal, rather than the original data itself. “In the absence of the original numerical data, no definitive conclusions can be drawn about the reliability of the data presented, especially with regard to the apparent duplications detected,” the letter said.
The Gamaleya Institute, which developed the vaccine, rejected the criticism.
“The published results are authentic and accurate and were reviewed by five reviewers for The Lancet,” Denis Logunov, deputy director of the institute, said in a statement. He said his institute sent the entire raw data set on the trial results to The Lancet. “We specifically present the data that was produced (by the trial), not the data that is supposed to please the Italian experts,” Logunov said.
Naor Bar-Zeev, deputy director of the John Hopkins Bloomberg School of Public Health, who reviewed the Russian data, defended his analysis of the research. Science must balance disbelief, skepticism, and trust. That confidence is confirmed by plausibility, repeatability, and falsifiability. ”
“The results are plausible and not much different from those seen with other AdV vector products,” he said.
The researchers had provided more detail than was necessary for the review and answered their questions “intelligently, practically and safely but discreetly.” “In summary, I saw no reason to doubt the legitimacy of these results over others that I have read and reviewed. But of course you can never know, ”he said in an email.
A spokeswoman for The Lancet said the journal had invited the study authors to respond to questions posed in the open letter. She was following the situation closely, she said.
Russia on Friday published the results of its Phase I / II trial, which included 76 participants and was carried out in June-July this year. Participants developed a positive immune response and had no serious side effects, the study authors said. A phase III trial was launched on August 26, involving 40,000 participants. About 31,000 people have already signed up to participate, Health Minister Mikhail Murashko said.
Addressing the editor of The Lancet, the international peer-reviewed medical journal in which the Gamaleya Institute in Moscow published the results of its early-stage trials, the scientists said they saw patterns in the data that seemed “very unlikely.” The letter, posted on the personal blog page of one of the signers, said that data from the results of the phase I / II trial showed that several participants reported identical levels of antibodies.
“Based on simple probabilistic evaluations, looking at so many conserved data points between different experiments is highly unlikely,” the open letter said. However, the scientists said they were basing their conclusions on summaries of the Russian trial’s results data, published in the journal, rather than the original data itself. “In the absence of the original numerical data, no definitive conclusions can be drawn about the reliability of the data presented, especially with regard to the apparent duplications detected,” the letter said.
The Gamaleya Institute, which developed the vaccine, rejected the criticism.
“The published results are authentic and accurate and were reviewed by five reviewers for The Lancet,” Denis Logunov, deputy director of the institute, said in a statement. He said his institute sent the entire raw data set on the trial results to The Lancet. “We specifically present the data that was produced (by the trial), not the data that is supposed to please the Italian experts,” Logunov said.
Naor Bar-Zeev, deputy director of the John Hopkins Bloomberg School of Public Health, who reviewed the Russian data, defended his analysis of the research. Science must balance disbelief, skepticism, and trust. That confidence is confirmed by plausibility, repeatability, and falsifiability. ”
“The results are plausible and not much different from those seen with other AdV vector products,” he said.
The researchers had provided more detail than was necessary for the review and answered their questions “intelligently, practically and safely but discreetly.” “In summary, I saw no reason to doubt the legitimacy of these results over others that I have read and reviewed. But of course you can never know, ”he said in an email.
A spokeswoman for The Lancet said the journal had invited the study authors to respond to questions posed in the open letter. She was following the situation closely, she said.
Russia on Friday published the results of its Phase I / II trial, which included 76 participants and was carried out in June-July this year. Participants developed a positive immune response and had no serious side effects, the study authors said. A phase III trial was launched on August 26, involving 40,000 participants. About 31,000 people have already signed up to participate, Health Minister Mikhail Murashko said.
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