JOIN US1 out of 7 Russian vaccine volunteers complained of side effects: Report
As Dr Reddy's Laboratories readies to receive 10 crore doses of Russia's coronavirus vaccine, Sputnik V, nearly one in seven volunteers to whom the vaccine was given have reported side effects, Russian news agency TASS cited the country's health minister saying.
"Approximately 14% have small complaints of weakness, muscle pain for 24 hours and an occasional increase in body temperature," Russian health minister Mikhail Murashko reportedly said.
He added that the complaints were predictable and described in the instructions given. The symptoms "level-off" in a day and a half, the minister said.
While Russia dubbed these side effects as 'small complaints' and 'predictable,' over 30 scientists have expressed serious concerns about the vaccine in an open letter to the Lancet.
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Russia has billed Sputnik-V as the first vaccine against coronavirus to be registered in the world. Large-scale trials, known as Phase III, involving at least 40,000 people, were launched in Russia on Aug. 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 showed no serious adverse effect and has triggered immune response on the 76 volunteers.
The report said the data showed that the vaccine was "safe, well tolerated, and does not cause serious adverse events in healthy adult volunteers".
A group of scientists, over 35, had sent a formal letter to the Lancet September 14 outlining doubts about the accuracy of early 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 before completing full human trials.
They said they found patterns in the Phase I/II data, which was peer-reviewed in the journal, that looked "highly unlikely", with multiple participants reporting identical antibody levels.
Russia denounced criticism as an attempt to undermine Moscow's research and a Russian investor claimed vindication when Britain's prestigious Lancet published research that showed patients in early tests developed antibodies with "no serious adverse events."
The trials were open label and not randomised, meaning there was no placebo and the participants knew they were receiving the vaccine and were not randomly assigned to different treatment groups.
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 Lancet 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".
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 the clinical trials and distribution of Sputnik V vaccine in India.