One in seven volunteers complained of side effects after being injected with Sputnik V, Russia’s experimental vaccine against the coronavirus disease (Covid-19), the country’s health minister said.
Mikhail Murashko, the Russian health minister, said that more than 300 of the 40,000 announced volunteers have been vaccinated with Sputnik V so far, according to the state news agency TASS.
“About 14% have small complaints of weakness, muscle pain for 24 hours, and an occasional rise in body temperature,” TASS quoted Murashko as saying on Wednesday, according to the Moscow Times.
The minister said that the symptoms after being injected with the coronavirus vaccine “stabilize” the next day. “Complications are outlined in the instructions and are predictable,” he said, according to TASS.
Volunteers are expected to receive a second injection of the adenovirus-based viral vector vaccine within 21 days of the first.
Sputnik V has yet to complete large-scale clinical trials, but it was approved by the Russian government last month, making it the first Covid-19 vaccine licensed for human use anywhere in the world.
Final clinical trials of the Sputnik V vaccine began in Moscow earlier this month.
However, scientists have cautioned against using any injection that has not passed all safety and efficacy checks.
The Russian health minister’s comments came after the country’s sovereign wealth fund said it had reached an agreement with major pharmaceutical companies Dr Reddy’s Laboratories for clinical trials and distribution of Sputnik V in India, a process that has yet to be approved by the Comptroller General of Drugs of India. (DCGI).
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The Russian Direct Investment Fund (RDIF) has said it is supplying 100 million doses of the vaccine to Dr. Reddy after regulatory approval in India. Indian officials said approvals will be given only after a thorough review.
Sputnik V caused no side effects and elicited an adequate immune response in 76 volunteers according to data from the phase 1/2 trial published in The Lancet earlier this month. But the results have been questioned by some scientists, who have sought a review of the data, citing what they said were striking similarities between patients.
RDIF reiterated Wednesday that the vaccine is safe. “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. Deliveries could potentially begin in late 2020, subject to the completion of successful trials and registration of the vaccine by regulatory authorities in India, “said a statement.
Sputnik V is among several vaccine candidates that Indian authorities are considering for the country. Dr. Balram Bhargava, director general of the Indian Council for Medical Research (ICMR), previously said that a high-level government committee was investigating data coming from Russia on its Covid-19 vaccine.
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