One in seven volunteers for Sputnik V report side effects
What's the story
Sputnik V, the COVID-19 vaccine developed and approved by Russia, has shown side effects in some trial volunteers. The reactions, according to state-run news agency TASS, have been reported in about one in seven people who have been inoculated by the shot as part of a massive Phase-3 study. Here is all you need to know about it.
Study report
14% subjects displayed reactions
In a recent conversation with TASS, Russian Health Minister Mikhail Murashko provided an update on the progress of the late-stage trial of Sputnik V. He said that the vaccine doses have been given to more than 300 of the planned 40,000 volunteers and about 14% of them have reported mild problems like weakness, muscle pain, and an increase in body temperature.
Serious effect
No serious effects seen so far
The minister emphasized that none of the volunteers have reported any serious side effects so far. Even for the 14% who witnessed the mild symptoms, the reactions last for 24 hours and level off by the next day. "The complications are described in the instructions (of the vaccine trial) and are predictable," he added while speaking to TASS.
Regimen
Sputnik V involves a two-dose regimen
Notably, the Sputnik V vaccine is given in two doses at a gap of 21 days. Each dose uses a different adenovirus and the spike protein from the coronavirus to induce an antibody-based immune response against COVID-19. Last month, Russian President Vladimir Putin claimed that the shot forms a 'stable immunity,' and one of his daughters has already been inoculated.
Approval
Approval with pending trials, raised questions
Even though the late-stage human trials of Sputnik V were not completed, Russia granted approval to the shot earlier last month, clearing it for public use. The move drew major flak from the scientific community, with many experts claiming that premature approval, and the lack of full safety and efficacy data, could put people at risk.
Distribution
Still, Russia has been moving ahead with production, distribution
Despite the alarms, Russia has been moving ahead with the production and distribution of the vaccine (for those at high-risk) while carrying out the late-stage trials at the same time. The country started mass-manufacturing last month and has already released the first batch of the shot in civil circulation, following necessary quality tests in the laboratories of Roszdravnadzor [Russia's medical device regulator].
Information
Mass-vaccination drives likely to begin in October or November
Further, Russia is expected to begin mass-inoculation drives for Sputnik V in October or November, which is when the initial data from the Phase-3 trial is likely to be revealed.
Deal
100 million doses to be supplied to India
The Russian Direct Investment Fund, the sovereign wealth fund that backed the Sputnik V project, has inked a deal with Hyderabad-based Dr. Reddy's Laboratories to conduct a clinical trial of the vaccine on the Indian population and supply 100 million doses. However, the progress of the trial and the supply of the doses would depend on approvals from India's Central Drugs Standard Control Organization.