Russia in Talks with India to Ease Production of Sputnik-V Coronavirus Vaccine and Phase-3 Clinical Trials

The Russian government is in talks with India for the production of the Covid-19 vaccine candidate Sputnik V and permissions to carry out Phase 3 clinical trials in the country. The Indian government on Tuesday confirmed Russia’s statement, adding that talks are under active consideration.

On the issue of vaccine production, India has reached out to domestic vaccine manufacturers known in the field for quality and high production capacities. Authorities also said India will partner with Russia for clinical trials if needed.

“The Russians have developed a vaccine using the adenovirus vaccine platform. The government of Russia approached Indian government through appropriate channels and sought help on two counts; one was to consider the manufacture of their vaccine through our network of companies and second, to explore the possibility of carrying out Phase-3 clinical trials after following our regulatory processes,” said Dr VK Paul, member (health) of Niti Aayog and head of the national task force on Covid-19 management.

The Russian government had granted emergency approval for the Sputnik-V vaccine early last month and were going to carry out Phase-3 trials subsequently. Moscow has faced flak and warned against the vaccine’s use due to its approval based on early trials. But Russia has dismissed such criticism as an information war.

However, according to preliminary findings published in The Lancet journal, results from early-phase non-randomised vaccine trials showed that two formulations of the vaccine have a good safety profile detected over 42 days, and induced antibody responses in all 76 participants within 21 days.

“There has been significant movement, outreach has been extended to several companies in India. Two-three have come forward and are also in touch with the Russian government and the vaccine team. On the regulatory front, Indian scientists have looked at the data. There would be Phase-3 trials in the normal course of things and if required. We are paving way for the trials as per requirements of science and regulations,” Dr Paul added.

He said India has attached great importance to the request and partnership offer of Russians as they are a ‘special friend’ to India and he also called the collaboration a win-win for both countries as well as the world.