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Ученые опубликовали письмо с выражением беспокойства о результатах испытаний вакцины «Спутник-V»

Международная группа исследователей предположила, что отчеты об испытаниях российской вакцины «Спутник-V» могут оказаться неточными. Ученых взволновало, что в некоторых графиках встречаются повторы, а данных для проверки результатов недостаточно.

Открытое письмо уже подписали специалисты из Германии, Италии, США, Таиланда, Швейцарии и Японии. Его адресовали авторам российского исследования об испытаниях вакцины «Спутник-V» и редактору журнала The Lancet Ричарду Хортону. В нем ученые проанализировали опубликованные в статье графики и нашли похожие фрагменты.

Например, на рисунке номер два, где показан титр IgG-антител и нейтрализующих антител в разные моменты времени для всех групп пациентов, они нашли повторяющиеся точки данных. У девяти добровольцев, получивших rAd26-S (выделено красным), по-видимому, были одинаковые титры антител на 21-й и 28-й день, как и у семи из девяти добровольцев, получивших rAd5-S (выделено желтым). Кроме того, эксперты заметили, что в голубых и зеленых областях данные сходятся в совершенно не связанных между собой экспериментах. «Нам кажется, что наблюдение такого количества совпадений в разных тестах маловероятно», — заявили авторы письма.

Анализ второго графика / © Энрико Буччи

На третьем рисунке, показывающем результаты клеточного ответа на различные соединения, которые проверяли на добровольцах, специалисты также нашли схожие данные. Однако в этом случае исследуемая переменная (уровень клеточной пролиферации) постоянна, поэтому вероятность таких совпадений еще ниже. В четвертом графике, который показывает образование нейтрализующих антител к вирусным векторам, использованным в вакцине, они выявили те же проблемы, что и во втором.

Анализ третьего графика / © Энрико Буччи

Частые совпадения показались ученым подозрительными и заставили сомневаться в надежности исследования. Кроме того, авторов письма обеспокоило, что российские коллеги не предоставили исходные числовые данные, с помощью которых можно было бы проверить точность графиков (особенно в повторяющихся сегментах). Они отметили, что российские исследователи опубликовали недостаточно информации о выздоровевших пациентах, которые выступали контрольной группой, и не сравнили ее с результатами, полученными от разных групп добровольцев. Также специалистам важно было бы увидеть данные о каждом испытуемом и узнать, когда собирали плазму добровольцев, сколько дней прошло с появления первых симптомов и получения отрицательных результатов анализов на коронавирус.

Анализ четвертого графика / © Энрико Буччи

Статья российских ученых была опубликована в журнале The Lancet в начале сентября. В ней представлены результаты первой и второй фаз испытаний вакцины «Спутник-V». Авторы работы заявили, что препарат помог выработать иммунитет к Covid-19 у всех здоровых участников исследования и не вызвал серьезных побочных эффектов.

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