Phase 3 clinical trials of Sputnik V coronavirus vaccine to start today

Russian Health Minister Mikhail Murashko on September 8 announced the beginning of Phase 3 clinical trials of the Sputnik V coronavirus vaccine developed by the Gamaleya Institute, state-run media Interfax report confirmed. Phase 3 of the coronavirus vaccine's clinical trials will begin today, September 9, Murashko said at a live-streamed annual press conference, hosted by the Cardiology National Medical Research Center. Further, he added that the volunteers participating in the clinical trials will be monitored via a special application. Trials of Russia’s Sputnik V Coronavirus vaccine will begin in as many as 5 countries including India.

“I know it has proven efficient and forms a stable immunity,” Putin said. “We must be grateful to those who made that first step very important for our country and the entire world,"—Russia's President Vladimir Putin said in an AP report.

Russian Direct Investment Fund's (RDIF) head Kirill Dmitriev announced that the vaccine’s Phase III trial trials will begin in Saudi Arabia, United Arab Emirates (UAE), the Philippines, Brazil, and India. The results will be published in the month of October-November, 2020. Phase 3 of the clinical trials will have 40,000 subjects, some of whom will receive a placebo instead of the vaccine, the Interfax report confirmed. It added that Russia expedited the registration of the Sputnik V vaccine in August and phases I and II have already been completed pre-registration. Federal Service for Surveillance in Healthcare (Roszdravnadzor) approved the first batch of the vaccine for the civil circulation. The first batches of Russia’s COVID-19 vaccine against are being supplied already within the framework of Phase 3 clinical trials, Russian Healthcare Minister Mikhail Murashko reportedly said. 

“We are ready to assert that the protective effect of this vaccine will be detectable and remain at a proper level for 2 years, or maybe even more,” Director of the Moscow-based Gamaleya Institute that developed the vaccine said in an AP report, without providing any evidence to back up the claim.

“Fast-tracked approval will not make Russia the leader in the race, it will just expose consumers of the vaccine to unnecessary danger,” said Russia’s Association of Clinical Trials Organizations in a statement.

Read: US Election 2020: Biden Rejects Trump Aide's China Claim, Pitches Russia As Biggest Threat

Read: Moscow's COVID-19 Death Toll Soars To 4,891 As Russia Tests 'Sputnik V' Vaccine

Similar to CanSino and AstraZeneca

Russian Sputnik V preparation was developed by the Gamaleya National Research Institute of Epidemiology and Microbiology of the Russian Healthcare Ministry and has been produced jointly with the RDIF, as per the reports. Similar to Oxford’s AstraZeneca COVID-19 vaccine, the Sputnik-V vaccine uses adenovirus which is largely modified to carry genes for the “spike” protein that hampers coronavirus in the immune systems. Professor Alexander Gintsburg, director of the Moscow-based Gamaleya Institute said that the vaccine has shown “sufficient” immune response “to counteract any imaginable dose infecting (a person) with COVID-19.” While the international medical fraternity and experts remain cautious over the vaccine’s effectiveness and safety, Russian developers made claims about its efficacy was similar to the technology of the vaccines being developed by China’s CanSino Biologics and Britain’s Oxford University and AstraZeneca.

Read: Germany Ups Pressure On Russia In Navalny Poisoning Probe

Read: Raab: Russia Very Likely Behind Navalny Poisoning