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Russia’s COVID-19 vaccine phase 3 trials: India denies Moscow’s claim

Russia has said that it sees strong global interest in its first coronavirus vaccine dubbed ‘Sputnik V’ being registered for use on Tuesday, adding that the country plans to conduct phase 3 trials in different countries, including India. However, officials at the Union Health Ministry have reportedly denied Moscow’s claim saying no such talk on collaboration had been held.

On Tuesday, August 11, the vaccine developed by the Gamaleya Research Institute and the Russian Defence Ministry was registered by the health ministry for use amid widespread safety concerns raised by various experts from across the world. President Putin announced the approval of the Sputnik V vaccine, claiming it as the world’s first vaccine against the SARS-CoV-2, the virus that causes COVID-19.

A report from the first information website on Sputnik V stated that Russia plans to conduct phase 3 clinical trials in different countries, including Saudi Arabia, UAE, Brazil, India and the Philippines. The Russian Direct Investment Fund (RDIF), which finances the production of the Sputnik V in Russia, also claimed that it plans to start mass production in other countries in partnership with local sovereign wealth funds, including India, South Korea and Brazil, as well as, in Saudi Arabia, Turkey and Cuba.

But, a senior official in the Indian Council of Medical Research (ICMR) had denied any information on the matter, reported The New Indian Express.

“As far as our information is concerned, there is no movement on that front yet. Besides, there is also no data from phase 1 and 2 trial of the Russian vaccine yet,” a senior official was quoted as saying by the report.

The report, citing sources, added that Bharat Biotech has been approached by Russia for the production of the Sputnik V vaccine. However, the Hyderabad-based vaccine manufacturer is yet to confirm the claim.

Which countries have shown interest in the Sputnik V vaccine?

Russia claimed that at least 20 countries, including UAE, Saudi Arabia, Indonesia, Philippines, Brazil, Mexico and India had expressed interest in obtaining the Sputnik V. Moscow said it plans to start mass production of the vaccine in September and ramp up the production to 200 million doses by the end of 2020, including 30 million doses in Russia.

Despite the scepticism, the Philippines said it has accepted Russia’s offer to participate in clinical trials, vaccine supply and production of the Sputnik V. The Philippines is expected to begin large-scale human trials of Russia’s coronavirus vaccine in October. However, Rodrigo Duterte’s spokesman said that the President will not receive the jab until regulators guarantee its safety, AFP reported. Earlier, Duterte had offered himself up as a guinea pig for the first shot. A report from the Manila Bulletin, quoting an official from the Department of Science and Technology (DOST), said that Sputnik V will be registered in the Philippines by conducting a local phase 3 clinical trial, possibly simultaneous with the phase 3 clinical trial in Russia, an official from the Department of Science and Technology (DOST) said.

Similarly, the Brazilian state of Parana had signed a deal to test and produce the Russian COVID-19 vaccine, although officials stressed that they would have to be sure of the vaccine’s safety and effectiveness first. The RDIF is inviting partners to cooperate on international production and clinical trials of the vaccine.

Why is the Sputnik V vaccine under questions?

While the phase 1 clinical trials of the Russian vaccine were registered in June 2020, no results have been published in the scientific literature. The vaccine underwent two phases of trials in June and July – with the first phase involving 38 civilians and 38 military volunteers. The second phase included about 100 people, The Moscow Times reported.

Moreover, the candidate is yet to undergo the final stage of testing which requires large numbers of volunteers to assess the safety and efficacy of the vaccine. Registration of volunteers for the phase 3 trials began Tuesday and the studies will also be conducted in other countries, including Saudi Arabia, the United Arab Emirates and the Philippines, according to RDIF head Kirill Dmitriyev.

When will the Sputnik V vaccine be available to the public?

Russian Health Minister Mikhail Murashko had said the first batch of the coronavirus vaccine is likely to be released within two weeks, adding that vaccination will be voluntary. Tatyana Golikova, a deputy prime minister in charge of health issues, had said officials hoped that vaccinations of medical workers could start by late August or early September. While mass production of the vaccine is expected to begin in September, Moscow plans to begin a mass vaccination campaign in October. – Times Now News

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