New Delhi: In a significant development related to the coronavirus vaccine, India is likely to resume phase 2 clinical trials of the Russian COVID-19 vaccine, Sputnik V, said sources. An expert panel at the Central Drugs Standard Control Organisation (CDSCO) on Friday recommended granting permission to Dr Reddy’s Laboratories for conducting phase 2 clinical trials of the vaccine.
Notably, the Hyderabad-based pharmaceutical firm had on October 13 reapplied to the Drugs Controller General of India (DCGI) seeking permission to conduct combined phase 2 and 3 human clinical trials of the vaccine in the country.
After suffering a setback on the earlier trial, the firm has now come up with a revised protocol that stated that the Phase II trial would include 100 subjects, while the Phase III trials would involve 1,400 volunteers, as reported by PTI.
“Following deliberation, the SEC has recommended the grant of permission for the phase 2 clinical trial of the potential vaccine first. After they submit the safety and immunogenicity data of the first phase, they then would be allowed to proceed for phase 3 of the trials,” said a source to PTI.
The subject expert committee (SEC) on Covid-19 deliberated on the application on Friday.
The Indian pharma giant has collaborated with The Russian Direct Investment Fund (RDIF) to conduct clinical trials of the Sputnik V vaccine as well as its distribution.
Meanwhile, Russia announced on Wednesday (October 14) that it has granted regulatory approval to another coronavirus COVID-19 vaccine. The vaccine named EpiVacCorona comes after Russia recently granted similar approval to its first COVID-19 vaccine named Sputnik V.
Notably, Sputnik V is also the first vaccine candidate in the world to attain regulatory approval.
Sputnik V, which was developed by Gamaleya Institute in Moscow, was licensed for use in Russia in August. Sputnik V was also registered before Phase III trials just like EpiVacCorona. A human trial of Sputnik V is currently underway in Moscow for it.
Source: Zee News