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Russia became the first country to grant regulatory approval for a novel coronavirus vaccine when its health ministry registered Sputnik V on August 11. , Sputnik V is an adenovirus-based vaccine candidate against COVID-19 developed by the Gamaleya National Research Center in coordination with the Russian defence ministry. The Russian Direct Investment Fund (RDIF) has also submitted applications to the WHO for accelerated registration and prequalification of the Sputnik V, according to an official statement released by the Russian embassy in New Delhi on Wednesday. Meanwhile, reports have surfaced that some volunteers of Sputnik V trials have developed coronavirus infections.
A top official of the center has revealed that there have been instances of infection among volunteers of Sputnik V trials, Russian news agency TASS reported on Wednesday.
The developer of the vaccine is also considering disclosing the data on who among the volunteers were administered Sputnik V, before summing up the results of the study, the agency said.
As per the earlier plan, the trial participants were supposed to be told whether they received the vaccine or the placebo only after the end of tests.
"...Apparently, there are (coronavirus) infections (among the post-registration trials participants). At some point in mid-November the provisional results will be summed up, then we will find out the difference between the placebo and the test samples," the center's director Alexander Gintsburg was quoted as saying to TASS.
Gintsburg, however, suggested that coronavirus infections among the volunteers maybe those who received the placebo and not Sputnik V.
Phase 1 and 2 clinical trials of the Sputnik V vaccine were completed on August 1, 2020.
"All the volunteers are feeling well, no unforeseen or unwanted side effects were observed. The vaccine induced strong antibody and cellular immune response. Not a single participant of the current clinical trials got infected with COVID-19 after being administered with the vaccine," the developer wrote on a website, which was created to provide accurate and up-to-date information about Sputnik V.
But Russia approved the vaccine before conducting crucial phase-3 trials, drawing criticism from the scientific community, with some experts questioning its safety.
Post-registration trials of the vaccine started in Moscow on September 7, with the first volunteers receiving the vaccine on September 9.
In all, it will include 40,000 people participate in the program, out of which 10,000 will be given a placebo instead of the vaccine, TASS reported.
According to Gintsburg, the last group of volunteers may be inoculated by the end of January 2021.
A number of countries, including UAE, India, Venezuela, Egypt and Brazil have agreed to join the clinical trials of Sputnik V locally.
Dr Reddy`s Laboratories Ltd is conducting the clinical trials of the Sputnik-V vaccine in India. The Hyderabad-based drugmaker received renewed approval for late-stage trials of the vaccine earlier this month after initially signing a deal with the Russian Direct Investment Fund in September.
On Wednesday, the company rolled out a preliminary timeline for the India trials suggesting that the trails may be completed by as early as March 2021.
Enrolment of volunteers for the mid-stage trial of the Sputnik-V vaccine is expected to start in the next few weeks and the trial may end by December.
The company expects to enroll 100 participants for the mid-stage trial and 1,500 people for the late-stage.
With inputs from IANS
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