Twenty-six scientists question early-stage trial results of Russia's Sputnik-V vaccine
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Raising concerns
Twenty-six scientists, most of them working at universities in Italy, have signed an open letter questioning the reliability of the data presented in the early-stage trial results of the Russian COVID-19 vaccine, named "Sputnik-V".
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Unlikely data
Addressing the editor of The Lancet, the international peer-reviewed medical journal in which Moscow's Gamaleya Institute published its early-stage trial results, the scientists said they saw patterns in the data that looked "highly unlikely". The letter, published on the personal blog page of one of the signatories, said the Phase I/II trial results data showed multiple participants reporting identical antibody levels.
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Critique rejected
However, the scientists said they were basing their conclusions on summaries of the Russian trial result data, published in the journal, rather than the original data itself. "In lack of the original numerical data, no conclusions can be definitively drawn on the reliability of the data presented, especially regarding the apparent duplications detected," the letter said. The Gamaleya Institute, which developed the vaccine, rejected the critique.
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Positive results
Russia published results on Friday of its Phase I/II trial, which included 76 participants and was conducted in June-July this year. Participants developed a positive immune response and no serious side effects, the study's authors said.
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A sizeable number
A Phase III trial, involving 40,000 participants, was launched on Aug. 26. Around 31,000 people have already subscribed to take part, Health Minister Mikhail Murashko said.