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India will extend all help to Russia in manufacturing and conducting advanced clinical trials of its Sputnik V vaccine in the country.
The Russian government has approached the Indian government and sought help on two counts, said VK Paul, Member (Health), NITI Aayog, addressing the media as part of the Health Ministry’s briefing in Delhi.
Two counts
Paul said the two counts are: First, to consider manufacturing of vaccines through our network of companies that are known for better quality vaccine manufacturing and, second, to carry out “phase 3 clinical studies or any bridging studies” in India.
This confirmed what Russian officials had earlier said. Kirill Dmitriev, Russian Direct Investment Fund (RDIF) Chief Executive Officer, in an article in Sputnik News, had said that India is one of five countries that is expected to start trials on the Russian vaccine this month.
‘Results in October’
“The post-registration studies involving more than 40,000 people started in Russia on August 26, before AstraZeneca started its Phase 3 trials in the US with 30,000 participants. Clinical trials in Saudi Arabia, the UAE, the Philippines, India and Brazil will begin this month. The preliminary results of the Phase 3 trials will be published in October-November 2020,” he said.
The announcement of Sputnik V vaccine, developed by Moscow’s Gamaleya Institute, sent the Western scientific community into a tizzy.
A research paper published in The Lancet last week said the Russian vaccine candidate had no serious adverse effects. Results from two early-phase Russian non-randomised vaccine trials (Sputnik V) in a total of 76 people showed that two formulations of a two-part vaccine have a good safety profile with no serious adverse effects over 42 days, and induce antibody responses in all participants within 21 days, the journal said.
“Secondary outcomes from the trial also suggest the vaccines also produce a T-cell response within 28 days,” it added.
The Russian proposal comes even as India recorded a rise of 75,809 Covid-19 cases on Tuesday with the total tally crossing 42 lakh; 8,83,697 cases are still active, 33,23,950 have recovered and 72,775 have died.
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