The Drugs Controller General of India has pulled the plugs on the proposal of pharma company Dr. Reddy’s laboratories to conduct the third phase trial of Russia’s Sputnik V vaccine. So far, early trials on the Russian vaccine have been conducted on a small group of overseas population.
Russia became the first country that announced an effective COVID-19 vaccine, and immediately, Dr. Reddy’s Lab joined hands with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of the Sputnik V vaccine as well as its distribution in India.
However, global experts raised concerns over the safety and efficacy of the vaccine because it is impossible to develop any vaccine in such a short time. Union health minister Harsh Vardhan recently hinted that India has not given its green signal to Dr. Reddy’s to go ahead with the trial of the vaccine among the Indian population yet.
Since September 1, the phase-3 trial of Sputnik V is underway in Russia on around 40,000 subjects.
“After detailed deliberation, the committee recommended that the firm should follow the regulatory requirements and conduct phase 2/3 trial in the country with proper monitoring for humoral and cell-mediated immune response,” the committee that looked into Dr. Reddy’s proposal said.
Currently, three vaccine candidates are under trial in India. The Pune-based Serum Institute of India has collaborated with AstraZeneca for manufacturing the Oxford Covid-19 vaccine candidate. They are conducting phase 2 and 3 human clinical trials of the vaccine.
Another vaccine developed by Bharat Biotech in collaboration with ICMR and the other developed by Zydus Cadila Ltd. is in the second phase of human trials.