As Dr Reddy’s Laboratories prepares to receive 10 crore doses of Russia’s coronavirus vaccine, Sputnik V, nearly one in seven volunteers given the vaccine have reported side effects. TASS the country’s health minister quoted as saying.
“About 14% have small complaints of weakness, muscle pain for 24 hours and an occasional increase in body temperature,” said Russian health minister Mikhail Murashko.
He added that the complaints were predictable and described in the instructions given. Symptoms “stabilize” in a day and a half, the minister said.
While Russia called these side effects ‘small complaints’ and ‘predictable’, more than 30 scientists have expressed serious concerns about the vaccine in an open letter to the Lancet.
Read also: Data on Russian Covid-19 vaccine trial are ‘puzzling’, say 16 scientists
Russia has announced Sputnik-V as the world’s first registered coronavirus vaccine. The large-scale trials, known as Phase III, involving at least 40,000 people, were launched in Russia on August 26, but have yet to be completed.
The results of the trial, published in the Lancet Journal on September 4 stated that the two-part vaccine did not show any serious adverse effects and has triggered an immune response in all 76 volunteers.
The report said the data showed the vaccine to be “safe, well tolerated and does not cause serious adverse events in healthy adult volunteers.”
A group of scientists, over the age of 35, had sent a formal letter to the Lancet On September 14, he highlighted doubts about the accuracy of the first data on Russia’s Covid-19 vaccine, highlighting growing concern among scientists about the safety and efficacy of the Sputnik-V vaccine, which the government approved for use earlier. to complete full human trials.
They said they found patterns in the Phase I / II data, which were peer-reviewed in the journal, that seemed “very unlikely,” and that several participants reported identical levels of antibodies.
Russia denounced the criticism as an attempt to undermine the Moscow investigation and a Russian investor claimed his claim when the prestigious British Lancet Published research that showed that patients in early tests developed antibodies without “serious adverse events.”
Also read: Russia completes the recruitment of volunteers for the Covid-19 vaccine trial
The trials were open-label and non-randomized, meaning there was no placebo and the participants knew they were receiving the vaccine and were not randomized to different treatment groups.
The researchers stressed that larger and longer trials, including a comparison with placebo, would be needed to establish the long-term safety and efficacy of the vaccine in preventing Covid-19 infection.
the Lancet The report said the 76 participants in these trials would be monitored for up to 180 days, adding that a more rigorous phase 3 clinical trial involving 40,000 volunteers “of different ages and risk groups” is planned.
About 300 of the 40,000 Russian volunteers have been vaccinated so far.
On September 16, the Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, and Hyderabad-based Dr Reddy’s Labs announced a collaboration on clinical trials and distribution of the Sputnik V vaccine in India.
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