Статья старая, но оставлю здесь
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The world has bet the farm on vaccines as the solution to the pandemic, but the trials are not focused on answering the questions many might assume they are. Peter Doshi reports As phase III trials of covid-19 vaccines reach their target enrolments, officials have been trying to project calm. The US coronavirus czar Anthony Fauci and the Food and Drug Administration leadership have offered public assurances that established procedures will be followed.1234 Only a “safe and effective” vaccine will be approved, they say, and nine vaccine manufacturers issued a rare joint statement pledging not to prematurely seek regulatory review.5 But what will it mean exactly when a vaccine is declared “effective”? To the public this seems fairly obvious. “The primary goal of a covid-19 vaccine is to keep people from getting very sick and dying,” a National Public Radio broadcast said bluntly.6 Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston, said, “Ideally, you want an antiviral vaccine to do two things . . . first, reduce the likelihood you will get severely ill and go to the hospital, and two, prevent infection and therefore interrupt disease transmission.”7 Yet the current phase III trials are not actually set up to prove either (table 1). None of the trials currently under way are designed to detect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus. View this table: Table 1 Characteristics of ongoing phase III covid-19 vaccine trials In a September interview Medscape editor in chief Eric Topol pondered what counts as a recorded “event” in the vaccine trials. “We’re not talking about just a PCR [polymerase …
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But what will it mean exactly when a vaccine is declared “effective”? To the public this seems fairly obvious. “The primary goal of a covid-19 vaccine is to keep people from getting very sick and dying,” a National Public Radio broadcast said bluntly.6
Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston, said, “Ideally, you want an antiviral vaccine to do two things . . . first, reduce the likelihood you will get severely ill and go to the hospital, and two, prevent infection and therefore interrupt disease transmission.”
Yet the current phase III trials are not actually set up to prove either (table 1). None of the trials currently under way are designed to detect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus.
Но что в действительности означает, когда вакцину называют "эффективной" ? Для обывателя ответ представляется очевидным. "Изначальная цель вакцин против ковид-19 состоит в том, чтобы защитить людей от тяжелой болезни и смерти" - прямо заявляют национальные СМИ.
Питер Хотес, декан национальной школы тропической медицины в колледже медицны Бейлора в Хьюстоне сказал: "В идеале вы хотите чтобы антивирусная вакцина делала две вещи... во-1 сокращала вероятность того, что вы заболеете тяжело и будете госпитализированы и во-2 предотвращала инфицирование и тем самым прерывала распространение инфекции.
Тем не менее, текущая фаза III испытаний вовсе не предназначена для того чтобы доказать эти обе вещи.
Ни одно из испытаний которые сейчас идут, не сконструированы таким образом, чтобы обнаружить сокращение тяжелых случаев, требующих госпитализации, использовании интенсивной терапии или смерти. Ни одна из вакцин, которые сейчас разрабатываются, не исследуется на предмет предотвращения распространения инфекции
Ну собственно случай в клинике в Израиле, описанный в научной статье, это наглядно и показал...