MOSCOW (Reuters) – Twenty-six scientists, most of whom work at Italian universities, have signed an open letter questioning the reliability of data presented in the early stages of Russian vaccine test results COVID-19, named “Sputnik- V”.
FILE PHOTO: A woman holds a small bottle labeled “Vaccine COVID-19” and a medical syringe in this photo on April 10, 2020. REUTERS / Dado Ruvic / Illustration / File Photo
In response to the editor of The Lancet, the international peer-reviewed medical journal in which the Gamaleya Institute of Moscow published the early stage of test results, the scientists said they saw patterns in the data that looked ” unlikely “.
The letter, published on the personal blog page of one of the signatories, stated that Phase I / II test results data showed multiple participants reporting similar antibody levels.
“On the basis of simple probabilistic analyzes the reality of observing so many data points preserved in various experiments is unlikely,” the open letter said.
However, the scientists said they were basing their conclusions on the summary data of the test result in Russia, which was published in the journal, rather than the original data itself.
“In the absence of original data figures, no conclusions can be drawn drawn to the reliability of the presented data, especially regarding the apparent duplicates observed,” the letter said.
The Gamaleya Institute, which developed the vaccine, has rejected criticism.
“The published results were accurate and accurate and were reviewed by five reviewers at The Lancet,” Denis Logunov, a deputy director at the institute, said in a statement.
He said his institute submitted a whole body of raw data on test results to The Lancet.
“We specifically present the data produced (by the test), not the data that is assumed to be pleasing to Italian experts,” Logunov said.
Naor Bar-Zeev, deputy director at the Johns Hopkins Bloomberg School of Public Health, who analyzed Russian data, defended his research analysis.
“Science must maintain a balance between disbelief, skepticism and trust. That trust is gained through feasibility, repetition and erasure.”
“The results are reasonable, and not much different from those seen in other AdV vector products,” he said.
The researchers provided more detail than was necessary for the review and responded to his questions “smart and with something truthful and confident but with little technique”.
“Under the line, I see no reason to doubt the legitimacy of these results other than the others I have read and analyzed. But of course I will not really know,” he said in an email.
A spokesman for the Lancet said the journal invited study authors to respond to questions posed in the open letter. It follows the situation closely, he said.
Russia released the results of the Phase I / II test on Friday, which included 76 participants and was conducted 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, involving 40,000 participants, was launched on August 26. About 31,000 people have subscribed to participate, Health Minister Mikhail Murashko said.
Writing by Polina Ivanova; Edited by Angus MacSwan