JRL NEWSWATCH: “Tricky data; ‘Sputnik V’ developers respond to Western critics, but the debate might overlook the vaccine’s biggest problem” – Meduza

File Photo of Blue-Gloved Hand Holding Syringe and Injecting Arm, adapted from image at nih.gov

“… [In response to concerns about their Lancet-published data, Russian vaccine] developers say … the methods … give only rough values …. [a] problem [that] would not have arisen … if their sample size had been larger. … [But they] do not explain … why they limited their trials to so few people. … [S]pecialists say … Gamaleya Center[] research data show signs of manipulation, deliberate or not. … highlight[ing] the unlikely ‘coincidence of data points’ showing antibody levels and shares of activated lymphocytes on particular days … among volunteers from different groups. … [Meanwhile, an] epidemiologist … stressed …. ‘All the talk about falsified data distracts from this study’s real problems. I think few people doubt that the vaccine is immunogenic, but such a small sample … means there’s a chance … they missed side effects. … Covid-19 Coronavirus file photo, adapted from image at cdc.gov[In addition,] the result … isn’t evidence of effectiveness but merely a pass to the final phase … that still needs to be carried out. … [I]t will be difficult to operate with a small sample when other manufacturers are planning [to test with] tens of thousands …. Publishing phase I/II data in The Lancet … doesn’t make the vaccine effective … [E]veryone … understands this. … ‘[Russian] clinical science … really … has no reputation at all. … [S]ome biologists and bioinformaticians … publish here and there, but it’s been failure in clinical and population studies … I can only welcome at least one of our few publications.'”

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