Russia Approves COVID-19 Vaccine Before Phase 3 Evaluation, Raising Concerns

Russia has approved the world’s first coronavirus vaccine, President Vladimir Putin announced Tuesday, prompting widespread concerns about the vaccine’s safety as it is only entering a late-stage clinical trial this week.

The adenoviral vector vaccine, dubbed Sputnik V, was developed by Moscow’s Gamaleya Institute. The conditional approval was based on results on early-phase trials that wrapped up Aug. 1. It will be available to the public starting Jan. 1, with mass manufacturing set to commence in September, Putin said.

Former FDA Commissioner Scott Gottlieb stressed that the vaccine — which he said he would not take outside of a clinical trial — needs to be properly evaluated in a large-scale study and he downplayed the significance of Russia’s approval, calling it an authorization essentially based on inconclusive phase 1 data.

“They’re certainly not ahead of us, and we certainly wouldn’t allow a vaccine to be used for mass distribution at this point based on the data that we have in hand,” Gottlieb said.

Putin defended the approval, saying “It works fairly effectively. It forms stable immunity and … has gone through all the necessary checks. It forms stable antibody and cell-mediated immune response.”

However, Florian Krammer, a professor at Icahn School of Medicine at Mount Sinai’s department of microbiology, also expressed strong doubts about the vaccine.

“I certainly would not take a vaccine that hasn't been tested in phase 3. Nobody knows if it’s safe or if it works,” he said. “They are putting healthcare workers and their population at risk.”

The Gamaleya Institute claimed that a phase 3 trial for the Gamaleya vaccine would begin today (Wednesday) and will involve “more than 2,000 people” in Russia, the Middle East and Latin America.

By comparison, several other promising vaccine candidates have already entered critical phase 3 trials in tens of thousands of patients, including candidates from AstraZeneca, BioNTech and Moderna in the U.S. and several other countries. — James Miessler