Russian researchers say 2 small COVID-19 vaccine trials produced antibodies and had no serious side effects

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A group of Russian scientists said that two trials of the country’s COVID-19 vaccine found it produced antibodies and had no serious side-effects, according to research published in medical journal “The Lancet” on Friday. But the trials were small, each involving just 38 patients, and they were open and non-randomized, meaning there was no placebo and the patients involved were aware they were being given the vaccine. The participants were aged 18 to 60 and were given an initial dose, followed by a booster 21 days later. “The most common adverse events were pain at injection site (44 [58%]), hyperthermia (38 [50%]), headache (32 [42%]), asthenia (21 [28%]), and muscle and joint pain (18 [24%],),” said the report. “Most adverse events were mild and no serious adverse events were detected. ” The researchers acknowledged that more clinical trials are required and noted that the two small trials mostly involved men and younger, healthy volunteers. A Phase 3 trial involving 40,000 volunteers from different age and risk groups is planned, they said. Russia became the first country to register a COVID-19 vaccine in August, before it had completed Phase 3 trials, dismaying experts who fear it may come with safety issues that could stoke antivaccination and anti-science sentiment. The World Health Organization said at the time that Phase 3 trials are crucial for evaluating the safety of a vaccine.
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