Researchers underline that larger and longer trials – including a placebo comparison – would be needed to establish the long-term safety and effectiveness of the vaccine for preventing COVID-19 infection.
Patients involved in early tests of a Russian coronavirus vaccine developed antibodies with"no serious adverse events," according to research published inFriday, September 4, but experts said the trials were too small to prove safety and effectiveness.after the Soviet-era satellite that was the first launched into space in 1957, had already received approval.
The trials were open label and not randomized, meaning there was no placebo and the participants knew they were receiving the vaccine and were not randomly assigned to different treatment groups. "Showing safety will be crucial with COVID-19 vaccines, not only for vaccine acceptance but also for trust in vaccination broadly," he said in a commentary in the"Since vaccines are given to healthy people and, during the COVID-19 pandemic, potentially to everyone after approval following phase 3 trials, safety is paramount."
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