Sputnik V Vaccine Update in India

Sputnik V Vaccine Status 

Gam-COVID-Vac, trade-named Sputnik V, is a candidate vaccine for COVID-19 developed by the Gamaleya Epidemiology and Microbiology Research Institute and registered by the Russian Ministry of Health on 11 August 2020. Gam-COVID-Vac was approved for distribution in Russia, although it was only evaluated in a limited number of people in early-stage clinical trials lasting two months, usually a procedure involving one or more years of clinical review for evidence of vaccine safety and viral disease efficacy.

22 January 2021

CEO Kirill Dmitriev said the price of vaccine is same for all markets and announced it to be less than $10 per shot

25 January 2021 

Pakistan approves emergency use of Russia’s Sputnik V vaccine.


16 December 2020 

The Gamalaya centre and RDIF jointly announced the efficacy of vaccine to over 90 percent after phase 3 post registration clinical trials. 

11 January 2021 

The mid stage trials have been submitted by the company to India's drug regulator for review and seeks for approval for later stage trials.


Sputnik V: India To Make 300 Million Of Sputnik V Covid Vaccines

     Russia is already testing the first samples of Sputnik V that were produced in India, its embassy in New Delhi said on Twitter on Friday, sharing a news story in which their vaccine czar Kirill Dmitriev was quoted.

     "In India, we have agreements with four large manufacturers," Dmitriev, the head of the Russian Direct Investment Fund (RDIF) told Rossiya 24 TV, according to news agency TASS.

     Hetero Biopharma has already announced a deal with the RDIF to make more than 100 million doses of Sputnik V, whose efficacy has been found to be more than 91% in trials done outside India.

India is the world's biggest vaccine maker, and the pharmaceutical industry is freeing up capacity and accelerating investments ahead of the global rush for COVID-19 shots

Sputnik V: Sputnik V to offer 2 years protection, say developers

The developers of the Sputnik V vaccine, that is currently undergoing trials at a few locations around the world, have claimed that the vaccine may provide 2 years protection from COVID-19. 

According to a report by news agency IANS,  Alexander Gintsburg, the head of the vaccine's developer, Gamaleya National Research Center for Epidemiology and Microbiology has claimed that the vaccine will be effective against novel coronavirus for two years after being administered to a person. 

"Experimental data received at that point demonstrate that a similar vaccine would offer protection for two years, maybe more."


Latest Update (8th December): Clinical trial: 17 volunteers given Russia’s Sputnik V Covid-19 vaccine in Pune

"Seventeen healthy volunteers were administered Sputnik V vaccine in the last three days as part of human trials," Dr S K Raut, Head of Clinical Research Department of Noble Hospital here, said.

The inoculation process began on Thursday, he added. “All the volunteers, who were administered the vaccine, will be under observation for the next few days,” Dr Raut added.

The selection of the volunteers was done as per the laid-down norms as they need to be healthy, doctors said.

The third phase trials of the vaccine are planned to be held at the KEM Hospital Research Centre located near Pune, another doctor said.

According to the Clinical Trial Registry- India (CTRI), a total of 1,600 subjects are planned to be roped in for these trials (100 in phase-II and 1,500 in phase-III).

Besides Pune, trials for this vaccine are also planned to be held in Lucknow and Kanpur (Uttar Pradesh), Jaipur (Rajasthan), Vellore (Tamil Nadu), Mysore (Karnataka) and Puducherry.

Latest Update (1st December): British experts report Russian vaccine Sputnik V to be ‘reasonably effective’.

Russia’s highly touted Sputnik V vaccine is “reasonably effective” at preventing the coronavirus based on preliminary results from its mass trials but questions over its data still remain, British vaccine experts have said.

Sputnik V’s developers announced the vaccine’s 95% efficacy last week, citing data obtained 21 days after volunteers received the second of its two doses.

Much like previous Sputnik V results, the news was met with initial skepticism by Western scientists, who questioned the integrity of the data released under the Kremlin’s careful watch.


 Update (26th November): Russian vaccine claims 95% efficiency with the cost of the vaccine set to be less than 10 USD per shot.

Russia on Tuesday said that the efficacy of its Sputnik V COVID-19 vaccine is over 95 per cent and the cost of one dose of the shot for international markets will be less than USD 10 (around Rs 740). 

Preliminary data from volunteers obtained 42 days after the first dose (corresponds with 21 days after the second dose) indicates the efficacy of the vaccine above 95 per cent, the Gamelya National Centre and the Russian Direct Investment Fund (RDIF) said in a joint statement.


Company:  Gamaleya Scientific Research Institute of Epidemiology and Microbiology

Country of origin: Russia

Previous phase trial results: 

Researchers found that the vaccine produced antibodies in all 72 participants within 21 days and has a good safety profile.

https://www.boomlive.in/buzz/russian-sputnik-v-phase-1-and-2-trials-results-published-1961

Phase 3:

92% effective at protecting people from Covid-19,

Sputnik V vaccine’s efficacy gives way to mass vaccination in Russia against COVID-19 in the coming weeks,

Side effects

1 in 7 volunteers report side effects after taking Sputnik V

complaints of weakness

muscle pain for 24 hours 

an occasional increase in body temperature

The Gam-COVID-Vac phase III trial was reported on 28 August 2020, and its status was changed on 10 September to "recruiting"[11] The study is a randomized, double-blind, placebo-controlled, multi-center clinical trial involving 40,000 volunteers and is scheduled to run until May 2021. Balram Bhargava, director of the Indian Medical Research Council (ICMR), said that through its early stages, Russia has been able to quickly monitor a COVID-19 vaccine candidate. The developers say it to be the best vaccine against COVID-19 as of October 2020.

Read more - AstraZeneca Corona Vaccine live update

Ref:

https://sputnikvaccine.com/

https://www.boomlive.in/buzz/russian-sputnik-v-phase-1-and-2-trials-results-published-1961

https://www.timesnownews.com/health/article/1-in-7-volunteers-report-side-effects-after-taking-sputnik-v-latest-updates-on-russian-coronavirus-vaccine/653800

https://www.themoscowtimes.com/2020/11/30/russias-sputnik-v-coronavirus-vaccine-reasonably-effective-british-experts-a72182

https://indianexpress.com/article/india/clinical-trial-17-volunteers-given-russias-sputnik-v-covid-19-vaccine-in-pune-7094153/