The Drug Controller General of India on October 17 allowed Dr. Reddy’s laboratories to perform a late stage clinical trial of Russia’s COVID-19 Sputnik V vaccine in the country. . The Hyderabad-based company called the Drugs Controller General of India (DCGI) on 13 October after submitting a re-application with more details about the Phase 2 and 3 trials. Sputnik v SARS-CoV-2 virus, developed by Moscow’s Gamaleya Institute, the Russian Ministry of Defense and the Russian Direct Investment Fund (RIDF). Modified as a vector carrying protein is based on human adenovirus.
Dr. Reddy’s trial will include a randomized controlled study, safety and immunization study at multi centers at 1,500 volunteers. On the same day, it was reported that Delhi-based Mankind Pharma had signed an agreement with the Russian Direct Investment Fund (RIDF) for the distribution and sale of Sputnik V in India. The companies are yet to officially confirm the development, which will provide 300 million doses of Sputnik V for distribution in India. Sputnik is named after the world’s first satellite launched by the then Soviet Union, along with the Astrogenica-Serum Institute of India (Bharat Biotech) and Zydus Cadila Is a top vaccine contender undergoing clinical trials.
In September, both Dr. Reddy’s and RDIF, which are marketing the vaccine abroad, have partnered with Trial for Sputnik V and its distribution in India. After regulatory approval, RDIF will supply 100 million doses to Dr. Reddy in India. In addition to the Indian clinical trial data, the Russians will provide phase 3 clinical trials as well as safety and immunity studies. Sputnik V is undergoing trials in Moscow with 40,000 participants. Last week, Phase 3 trial also started in UAE. The trial will take six months to complete.
Media reports state that the two-dose vaccine is available to the public in Russia, but may not be available in other countries until at least the first half of 2021. On 16 September, RDIF entered into an agreement with Dr. Reddy to conduct clinical trials and distribute 100 million doses of the vaccine in India. The results of Sputnik’s Phase 1 and 2 trials were published in The Lancet in early September and it was shown that the vaccine triggered a strong immune response.
News agency Reuters showed 100 percent of participants who developed antibodies to the new coronovirus, including two trials conducted in June-July and 76 participants, according to the Lancet. Russia became the first country to approve the vaccine but was criticized for moving ahead with Sputnik V without extensive testing.