By Eric Sagonowsky
As global vaccine players rush to deliver COVID-19 vaccines, Russia shocked the world Tuesday with news that it had approved a locally developed inoculation. But that approval was based on skimpy data, and experts characterized the move as a risky political stunt.
Indeed, the vaccine’s name—Sputnik V, after the Russian satellite that beat the US into orbit during the space-race era—seemed designed to provoke a response from international rivals.
Russia apprved the shot based on the “equivalent of phase 1 data,” former FDA commissioner Scott Gottlieb tweeted in response to the development. Scientists in Russia have tested the vaccine for two months, and haven’t yet run late-stage trials, Reuters reports.
Dismissing critics, Russian president Vladimir Putin said on state TV the vaccine “works quite effectively, forms strong immunity, and I repeat, it has passed all the needed checks,” as quoted by Reuters. Putin said one of his daughters has received the vaccine.
Developed by the state-backed Gamalaya Research Institute, the shot has been tested in phase 1 studies, according to the World Health Organization’s COVID-19 vaccine tracker. Vaccine expert Florian Krammer tweeted that he “certainly would not take a vaccine that hasn’t been tested in Phase 3,” adding that Russia is putting healthcare workers and others at risk.
Adding to the concern, Gottlieb speculated that the move could be “another effort to stoke doubts or goad [the] US into forcing early action on our vaccine.” Russia was reportedly behind “disinformation campaigns” about US COVID-19 shots, he said.
Fears of a vaccine rushed to the US market for political purposes have circulated widely in recent weeks. Seeking to allay those concerns, FDA commissioner Stephen Hahn pledged in a recent Washington Post op-ed that “no matter what,” he’ll make sure any approved vaccines have adequate data. Operation Warp Speed head Moncef Slaoui recently said on an American Enterprise Institute podcast he’d “resign instantly” if “forced to do something that I thought would be inappropriate.”
Be transparent about clinical data, experts say In a letter to Hahn, hundreds of scientists urged the FDA commissioner to take a careful look at vaccine candidates. Widespread uptake will only come after a thorough assessment and transparent review process, they said.
But comments from President Donald Trump brought the topic back to the fore last week. During an interview with Geraldo Rivera, Trump has said he’s “rushing” a COVID-19 vaccine, though not for the election. “I want to save a lot of lives,” the president told Rivera.
“I’m pushing it very hard and I want to push it very hard,” he said.
Leading COVID-19 vaccine makers have said a vaccine could be available by the end of the year, but some experts have said early 2021 is more realistic. The CEO of BioNTech, which is partnered with Pfizer and is among the vaccine frontrunners, said the company could seek approval “as early as October.”