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Russia skips COVID-19 vaccine trial, says millions to be vaccinated this month

No.672614 ViewReplyOriginalReport
https://arstechnica.com/science/2020/08/russia-rushes-to-distribute-its-untested-covid-19-vaccine-sputnik-v/

Russian President Vladimir Putin announced Tuesday that Russia is the first country in the world to grant regulatory approval for a COVID-19 vaccine—dubbed “Sputnik V.”

Putin claimed that one of his own daughters has already received a dose of the vaccine, according to reports from Moscow—though he didn’t note which daughter. Russian officials pledged to vaccinate millions within the month, starting with healthcare workers and teachers.

Little is known about Sputnik V, which was developed by researchers at the Gamaleya Institute in Moscow. There is no public data on the vaccine, let alone any published, peer-reviewed scientific studies. Public registration of two small clinical trials notes that Sputnik V uses a viral-vector-based design, but they suggest that it has only been tested in a small number of people. The trials, which began less than two months ago, each enrolled 38 healthy volunteers and have an estimated study completion date of August 15.

The World Health Organization, which tracks international COVID-19 vaccine development efforts, lists Sputnik V as being only in the first of three main clinical trial phases. Generally, Phase I clinical trials for vaccines are small—typically only involving dozens of people—and only assess the safety of the candidate. Phase II trials may involve hundreds of people and look further at safety, dosing, and the immune responses that the vaccine triggers, which may hint at the vaccine’s possible efficacy. Then there is the Phase III trial, which often involves tens of thousands of people and looks at whether the vaccine protects against infection and disease.

It appears that Russia has skipped Phase III—and possibly has not finished Phase II yet.