* India's help sought for Phase-3 trial
MOSCOW/NEW DELHI: In some good news for millions living in hope for a COVID-19 vaccine shot, theRussian Health Ministry said on Tuesday that the first batch of Sputnik V vaccine has been produced for civilian circulation.
The supplies of the medication to the Russian regions are expected soon, the Health Ministry told reporters, reports Tass news agency.
"The first batch of the vaccine for preventing the novel coronavirus infection, Gam-COVID-Vac (Sputnik V) developed by the Gamaleya Research Institute of Epidemiology and Microbiology of the Russian Health Ministry passed the required quality tests and was produced for civilian circulation.
"In the near future, the supplies of the first batches of the vaccine to the regions are expected," the ministry said.
Russian Health Minister Mikhail Murashko earlier explained that civilian production at this stage meant vaccination of citizens from the risk groups, mainly teachers and doctors.
Earlier this month, a study published in the peer-reviewed journal 'The Lancet' said a Russian COVID-19 vaccine has shown no serious side effects and elicited an immune response in early human trials.
Russia last month registered the "Sputnik V", becoming the first country to approve a Covid-19 vaccine. Sputnik V, an adenovirus vector-based vaccine, was developed by the Gamaleya Scientific Research Institute of Epidemiology and Microbiology along with Russian Direct Investment Fund.
On August 15, the Russian Health Ministry announced the launch of the vaccine production.
The Lancet study's authors also held that large, long-term trials, including a placebo comparison, and further monitoring are needed to establish the long-term safety and effectiveness of the vaccine for preventing COVID-19 infection.
Russia seeks India's help for Sputnik vaccine Phase-3 trial, production: The Russian government has sought India's help in manufacturing the Sputnik V vaccine and also to conduct Phase-3 trials or bridging studies in the country, a top official said on Tuesday.
"The Russian government approached the Indian government through appropriate channels and sought help on two counts - to consider its manufacturing through our network of companies that are well-known for vaccine manufacturing of high quality. The second request was, if need be, Phase-3 or any bridging studies be conducted in India," said NITI Aayog member, Dr VK Paul.
The Indian government attaches great importance to this offer of partnership from a very special friend of this nation, and on both the tracks there has been significant movement, he added.
Calling it a "win-win" situation for India, Paul said: "India can manufacture that vaccine in large and significant quantities, which is good for Russia and India and the specific part of that quantity can also be provided to the world."
The NITI Aayog member said that Indian scientists have looked at the data of their vaccine and there would be a need for a Phase-3 trial. "We are working in partnership with this vaccine candidate for manufacturing, trial, and regulatory facilitation in the spirit of partnership, science, and humanity."
Outreach has been extended to several companies in India and four of them have already come forward, Paul said, adding that others are in discussion with their Russian counterpart and the government is facilitating the process of how that connection can be made.
Meanwhile, in India, three vaccines are in advanced stages. There are two indigenous vaccines being developed by Zydus Cadila and Bharat Biotech in collaboration with the Indian Council of Medical Research. The Serum Institute of India has also partnered with AstraZeneca for manufacturing the COVID-19 vaccine candidate developed by the University of Oxford.
"Bharat Biotech-ICMR's Phase-1 is completed and enrollment for Phase-2 has started today. Zydus Cadila's Phase-2 is progressing nicely. Manufacturing capacity of Serum Institute is unimaginable - 75 to 100 million doses per month. The Phase-3 trials in 17 sites on 1,600 people will start soon," Paul added.
Earlier, the CEO of the Russian Direct Investment Fund, Kirill Dmitriev, had said that Russia was looking for a partnership with India to produce the COVID-19 vaccine. (IANS)