Russia has teased a COVID-19 (coronavirus) vaccine that has not gone through Phase III trials.This isn’t the first time Russia has rushed a vaccine without safe tests. It could turn out to be fine.Russia has named the vaccine Sputnik-V, and explicitly likened it to that iconic show of force.
President Vladimir Putin said this week that Russia’s secret COVID-19 vaccine, named Sputnik-V, is being administered to some members of the public now. By alluding to Russia’s groundbreaking (and Cold War-furthering) low orbit satellite in the name of its vaccine, the Russian government is suggesting an enmity that’s not appropriate for vaccine development under normal circumstances.
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“The Russian vaccine was developed by the Gamaleya National Research Center for Epidemiology and Microbiology in Moscow,” MIT’s Technology Review reports. “Although it has been tested on some volunteers, Russia has not finished the larger type of study needed to prove it is safe or protects recipients against infection by the coronavirus.” The vaccine is made from virus parts carried in a safer virus as an envelope.
Developing vaccines is slow, difficult work that’s even more difficult and risky when outside pressures are forcing scientists to rush. Even if the initial idea and experiment is successful and produces a viable, testable vaccine, there are subsequent levels of testing to ensure the vaccine is safe and effective. Putin announced that the vaccine has “gone through all the necessary tests,” and that his daughter is among the recipients.
But the Russian scientists confirmed they haven’t done what are called Phase III trials, when the vaccine is administered to human subjects in a scientifically supported experimental context. China also began experimentally administering a vaccine to human subjects in June. Right now, there’s no demonstrable science that either vaccine is effective according to internationally accepted medical guidelines.
The situation is playing up a classic dynamic faced by scientists who must communicate to the public: Scientific rigor exists for a reason, and drawing meaningful conclusions take time, but politicians or financially interested parties can start publicly railing on whatever they want at any time. They can make outlandish claims while scientists are ethically and morally obligated to only say what they can verify.
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And now, in the time when Phase III trials should be happening, pushing ahead without them means no large group understanding of side effects or broader efficacy before it’s potentially too late for a particular vaccine to ever work. We’ll be back where we started, with scientists who are observing the fastest possible rigorous protocol.
Forbes contributor Steven Salzberg, himself a biostatistician and Johns Hopkins University professor, wrote an opinion piece on August 2 where he claimed the U.S., too, should skip Phase III trials. “The careful, step-by-step vaccine approval regimen wasn’t designed for a global emergency, in which every day of delay means that thousands of people die,” he suggested in that piece. Salzberg has since followed up and clarified why his original piece was, at best, extremely misguided.
Salzberg’s claim is a blatant falsehood—as though tens of thousands of children didn’t die each year of polio, let alone the series of childhood diseases that we’ve developed vaccines for since. People who developed and then tested vaccines on their own families, for example, were doing that out of desperation, not out of a pointed disregard for scientific rigor.
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