Sputnik V is a human adenoviral vector vaccine against COVID, Russian researchers said (Representation)
Moscow:
Russia’s Sputnik V vaccine against COVID-19 will be tested in India on 100 volunteers, the Comptroller General of Medicines at the Central Indian Medicines Control Organization (DCGI) told Russia’s Sputnik news agency on Thursday.
DCGI authorized pharmaceutical giant Dr Reddy’s Laboratories to perform the tests. However, the date and time of the test will be determined by the company.
Sputnik news agency quoted the organization as saying the vaccine will be tested in the second phase of its clinical trials before moving on to phase 3.
Last week, the DCGI expert committee recommended granting permission to Dr Reddy’s Laboratories to conduct phase 2 clinical trials on the Russian COVID-19 vaccine candidate, Sputnik V, in India.
According to a government official, Dr Reddy’s Lab said that in the Phase 2 clinical trial – “would include 100 subjects and for Phase 3 it would take 1,400 subjects.”
“Once the pharmaceutical company submitted the phase 2 safety and immunogenicity data, it would be analyzed by the expert panel and then they could proceed to the phase 3 trial,” added the official.
On October 13, the ANI news agency reported that Dr Reddy’s labs had reapplied a new protocol to DCGI to seek approval for the conduct of phase 2 and 3 clinical trials of the Russian COVID-19 vaccine.
It should be noted that on October 5, the Subject Matter Expert Committee (SEC) had conducted a thorough assessment of the previous application submitted by Dr Reddy’s Lab. The SEC subsequently ordered the drug company to apply with a revised protocol and more information.
The Indian drug maker has partnered with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of the Sputnik V vaccine as well as its distribution.
According to RDIF, it will supply 100 million doses of its potential COVID-19 vaccine to Indian pharmaceutical company Dr Reddy’s Lab.
Last month, RDIF CEO Kirill Dmitriev informed that Russia was in close dialogue with the Indian government and Indian drugmakers regarding the location of production of its Sputnik V vaccine in India.
In addition, a prestigious medical journal The Lancet had published the results of phase I-II clinical trials of the Russian vaccine demonstrating its safety and effectiveness.
On August 11, the Sputnik V vaccine candidate, jointly developed by RDIF and the Gamaleya National Research Center in Epidemiology and Microbiology, was registered by the Russian Ministry of Health and became the world‘s first registered vaccine against COVID -19.
According to Russian researchers, Sputnik V is a human adenoviral vector vaccine that fights against coronavirus disease.
(Except for the title, this story was not edited by GalacticGaming staff and is posted from a syndicated feed.)
