Indian officials said on Monday that the country was considering Russia’s request to conduct Phase-3 clinical trials of the coronavirus vaccine Sputnik-V and manufacture it, PTI reported.
NITI Aayog member VK Paul said that the government attaches “great importance to this offer of partnership from a very special friend to this nation”. He added that there has been “significant movement” on both trials and manufacture of the vaccine.
“Some companies have come forward to work with the Russian government, others are in discussion with Russian counterparts,” Paul said, according to India Today. “It will be good for both countries.”
Paul said Indian scientists have looked at the data from the vaccine trials so far. He said Sputnik-V will go through rigorous trial protocols before being administered to Indian volunteers. “For manufacture, trials, and regulatory facilitation, we are working in the spirit of science and friendship,” he added.
Paul said it was premature to comment on whether India, like the United Kingdom and China, will allow emergency use authorisation of the vaccine. If such an authorisation is given, a country can bypass Phase-3 trials or expedite them so that the vaccine would be available for administration to the people soon.
The NITI Aayog member said three vaccines being manufactured in India at present are in different trial stages, PTI reported. A vaccine by Bharat Biotech in collaboration with the Indian Council of Medical Research and another by Zydus Cadila Limited have completed Phase-1 trials and have moved on to Phase-2, he said. On the other hand, the Pune-based Serum Institute of India has also started the process of conducting Phase-2 and Phase-3 human clinical trials of a vaccine.
Results published in medical journal The Lancet on September 5 showed that Russia’s coronavirus vaccine produced an antibody response in all participants in early-stage trials. The dose also did not cause any adverse effects on the participants. The medical journal, however, said that long-term trials were needed to determine the efficiency of the vaccine.
Russia, which on August 11 announced that it has developed the world’s first coronavirus vaccine, has faced criticism from scientists and experts for not conducting Phase-3 trials to determine its safety.
India and Russia are currently the world’s second and fourth-most affected countries, with over 42 lakh cases in India and 10 lakh in Russia, according to India’s Ministry of Health and Family Welfare and the Johns Hopkins University.