Report: Russia says its Covid-19 vaccine ready for market despite no Phase III data

Report: Russia says its Covid-19 vaccine ready for market despite no Phase III data

In what looks like a cautionary tale about politics interfering with science, the Russian government has said a vaccine against Covid-19 developed in one of its academic institutions is ready for use despite not having undergone Phase III clinical trials.
The Associated Press reported Tuesday that Russian President Vladimir Putin had said that the vaccine, Gam-COVID-Vac Lyo, developed by the Gamaleya Research Institute of Epidemiology and Microbiology in Moscow, had undergone necessary testing and proven “efficient,” providing a stable immunity for participants.
The move makes Russia the first country to clear a vaccine for use by the public, and Putin emphasized that one of his two daughters had herself been inoculated, responding with a fever that soon went away and showing a high number of antibodies. However, the announcement has raised alarm bells given that the vaccine has not undergone Phase III testing, which an official from the institute was quoted as saying it will.
The U.S. National Institutes of Health-run ClinicalTrials.gov database lists two Phase I/II studies of the vaccine, with 38 participants each, while the World Health Organization’s list of vaccines in development – current as of July 31 – states that it is in Phase I development.
That would place it far behind those vaccines being developed by Western and Chinese companies and institutions, many of which are running Phase III trials that plan to enroll as many as 30,000 participants. For example, British drugmaker AstraZeneca and the University of Oxford are running a Phase III study of their vaccine, AZD-1222, or ChAdOx1-S. U.S.-based Pfizer and its German partner, BioNTech, are likewise running a Phase III study of their vaccine, as is U.S. biotech company Moderna. Meanwhile, several Chinese firms have also begun Phase III development, including Sinovac and Sinopharm.
But Russia said last week that it planned to launch a nationwide vaccination campaign in October, focusing on teachers and healthcare workers, in what appears to be an effort to gin up national pride. Yet, a report issued last month by cybersecurity agencies in the U.K. and Canada and endorsed by their counterparts in the U.S. stated that Russian hacker group Cozy Bear had been targeting institutions involved with Covid-19 vaccine development efforts.
Photo: yulenochekk, Getty Images

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