LONDON: Patients involved in early tests of the Russian COVID vaccine developed antibodies with no serious side effects, according to research published in the Lancet Friday. However, experts said that the trials were too small to prove safety and effectiveness. Russia announced in August that it had developed a vaccine for the novel coronavirus named ‘Sputnik V’ and that the vaccine had already received approval. Scientists from around the world were concerned about the trial data linked to the vaccine as moving too quickly in this case could have catastrophic consequences.
In the Lancet study, Russian researchers reported on two small trials, each involving 38 healthy adults aged between 18 and 60, who were given a two-part immunisation. Each participant was given a dose of the first part of the vaccine and then given a booster with the second part 21 days later. They were monitored over 42 days and all developed antibodies within the first three weeks. The report said the data showed that the vaccine was “safe, well tolerated, and does not cause serious adverse events in healthy adult volunteers”.
Since the trials were open label and not randomized, meaning that the participants knew they were receiving the vaccine and that there was no placebo, experts raised concerns on the reliability of the trials. Researchers underlined 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. The report said the 76 participants of these trials would be monitored up to 180 days, adding that a more rigorous phase 3 clinical trial was planned with the involvement of 40,000 volunteers “from different age and risk groups”.