One in seven volunteers have complained of side effects, including weakness, muscle pain and rise in body temperature, after being injected with Sputnik V -- Russia’s vaccine against COVID-19 -- according to the country’s health minister.
Mikhail Murashko, the Russian health minister, said more than 300 out of the announced 40,000 volunteers have been vaccinated with Sputnik V so far, reported state-run TASS news agency.
Of these, approximately 14 percent volunteers have small complaints of weakness, muscle pain for 24 hours and an occasional increase in body temperature, Murashko was quoted as saying.
However, the symptoms “level off” by the next day of administering the anti-coronavirus vaccine, the minister reportedly said.
“The complications are described in the instructions and are predictable,” he said, according to TASS.
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On August 11, the Sputnik V vaccine, developed by the Gamaleya Research Institute of Epidemiology and Microbiology along with Russian Direct Investment Fund (RDIF), was registered by the Ministry of Health of Russia and became the world’s first registered vaccine against COVID-19 based on the human adenoviral vectors platform
The vaccine has not completed phase 3 or larger clinical trials. There has been scepticism in some quarters about limited data related to the efficacy of the vaccine.
Final clinical trials of the Sputnik V vaccine began in Moscow earlier this month. Volunteers are expected to receive a second shot of the adenovirus-based viral vector vaccine within 21 days of the first.
The report comes at a time when the RDIF, Russia’s sovereign wealth fund, and Dr Reddy’s Laboratories Ltd. have agreed to cooperate on clinical trials and distribution of the Sputnik V vaccine in India.
Upon regulatory approval in India, RDIF shall supply to Dr Reddy’s 100 million doses of the vaccine, Dr Reddy’s said in a release on September 16. The Sputnik V vaccine, which is based on a well-studied human adenoviral vector platform with proven safety, is undergoing clinical trials for the coronavirus pandemic, it said.
Deliveries could potentially begin in late 2020, subject to completion of successful trials and registration of the vaccine by regulatory authorities in India, the release said.
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