New DelhiIn 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, sources said. A panel of experts from the Central Standard Drug Control Organization (CDSCO) recommended on Friday granting permission to Dr. Reddy Labs to conduct phase 2 clinical trials of the vaccine.
Notably, the Hyderabad-based pharmaceutical company had reapplied on October 13 to the Comptroller General of Drugs of India (DCGI) requesting permission to conduct combined phase 2 and 3 human clinical trials of the vaccine in the country.
After suffering a setback in the previous trial, the company has submitted a revised protocol stating that the phase II trial would include 100 subjects, while the phase III trials would involve 1,400 volunteers, PTI reported.
“Following deliberation, the SEC recommended granting permission for the phase 2 clinical trial of the potential vaccine first. After submitting the safety and immunogenicity data from the first phase, they would be allowed to proceed to phase 3 of trials. “a source told PTI.
On live Tv
The subject matter expert committee (SEC) on Covid-19 deliberated on the app on Friday.
The Indian pharmaceutical 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 vaccine against the COVID-19 coronavirus. The vaccine called EpiVacCorona is produced after Russia recently granted similar approval to its first COVID-19 vaccine called Sputnik V.
Notably, Sputnik V is also the first vaccine candidate in the world to achieve regulatory approval.
Sputnik V, which was developed by the Gamaleya Institute in Moscow, was licensed for use in Russia in August. Sputnik V was also registered prior to Phase III testing as was EpiVacCorona. A human trial of Sputnik V is currently underway in Moscow.
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