Russian Covid-19 vaccine, Sputnik-V, has received green light for post-registration trials and vaccination trials may begin in mid-September, even as reports said Russian authorities are in talks with the Indian government for vaccine coproduction.
The government also on Tuesday said India and Russia were in communication on the Sputnik-V Covid vaccine developed by Gamaleya Research Institute of Epidemiology and Microbiology and the Russian Direct Investment Fund.
Health Secretary Rajesh Bhushan, co-chair of the national Covid-19 vaccine administration task force, confirmed the dialogue on a day when Russia is learnt to have formally approached India for collaboration to produce Sputnik-V and for approval to conduct phase-3 human trials in India.
“The two countries are in communication. Initial information has been shared. Some details are awaited,” said Bhushan, indicating India had asked Russia for additional safety data.
Russia tested and registered Sputnik-V in record time, raising safety concerns with phase-3 trials that are yet to be concluded. Russian President Vladimir Putin announced the registration on the new Covid-19 vaccine on 11 August. There were also reports that one of Putin’s daughters had been administered the dose and the vaccine provided “stable immunity and was effective”.
However, the WHO on Monday said the real test would be in phase-3 trials during which 30 per cent protection at population level needed to be established.
Russian authorities claimed that the jab had undergone all the necessary checks and had proven to be ‘safe and effective’. Kirill Dmitriev, CEO of the RDIF, claimed that his own parents had been vaccinated with the vaccine and had not shown any side effects.
“We get a lot of questions about the vaccine, including the platform on which it was developed. RDIF and the Gamaleya Institute strive for maximum transparency about the details of the vaccine’s development, which is why we post all information about adenovirus vaccines at sputnikvaccine.com. We would like to thank everyone for their interest in “Sputnik V” both in Russia and abroad - the vaccine website has already been visited by representatives of more than 200 countries. We plan to add new content to the site with new details on the vaccine in the future,” RDIF's official website cited Dmitriev as saying.
The Indian drug regulator has, so far, approved only one foreign vaccine candidate for phase-2 and 3 human trials in India. This is the Oxford University and Serum Institute of India collaborative candidate being administered to 1,700 Indians.
Government sources said Russian Ambassador Nikolay Kudashev had contacted Principal Scientific Adviser K Vijay Raghavan for vaccine-making partnership and the matter was before the national vaccine task force.
Bhushan today said 172 UN member nations had joined COVAX, the multi-lateral vaccine procurement system developed by the WHO jointly with the Coalition for Epidemic Preparedness Initiative and global vaccine giant GAVI.