WASHINGTON (CN) — Russia announced Tuesday that the vaccine candidate it hurtled through normal testing procedures has proven 95% efficacy at preventing the novel coronavirus.
Named after the Soviet-era satellite, the vaccine known as Sputnik V had only been tested on 76 volunteers, some of whom were recruited from the military, when Russia approved it in August as safe and effective.
Now that they have finished advanced trials involving 40,000 volunteers, however, authorities at Russia’s Gamaleya National Research Center said Tuesday in a news release that the vaccine showed no unexpected adverse effects.
As part of the Sputnik V trials, more than 18,000 patients received either two doses of the vaccine or a placebo.
A month after receiving the first dose, 39 of the 18,794 subjects tested positive for the virus. Of these, 31 were in the placebo group. The developers say this shows that Sputnik V is 91.4% effective after the first dose and over 95% effective after the second dose.
How coronavirus was diagnosed among the trial participants is unclear, however, as is whether volunteers were tested for the virus regardless of their symptoms.
“We expect the efficacy rate to be even higher based on the data three weeks after the second immunization when the body’s strongest and most stable response is achieved,” the Gamaleya Center’s Director Alexander Gintsburg said in a statement Tuesday. “We plan to conduct the third interim data analysis after 78 confirmed coronavirus cases among volunteers and we have every reason to believe that the results will exceed our initial expectations.”
Dr. Howard Forman, a practicing diagnostic radiologist who is also faculty director of finance at Yale University, said in an email Tuesday there were tradeoffs in prioritizing speed or scientific vigilance when creating a vaccine.
Many drugs that were found to be safe if approved earlier would have benefitted some patients, Forman noted — but medical professionals don’t know about that safety until after the fact.
“So, too, with vaccines,” Forman told Courthouse News. “In our country, hesitancy would suffer considerably if we took their more lackadaisical approach. Our citizenry demand transparent information about safety and efficacy as promised by the FDA and its underlying regulatory authority.”
Earlier this month, Moderna and Pfizer announced data showing their vaccine candidates could qualify for emergency use authorization from the U.S. Food and Drug Administration because they are 95% effective. AstraZeneca announced Monday that its vaccine is 90% effective, but the drug is promised to be cheaper and easier to distribute because it doesn’t have to be kept at an ultra-cold temperature.
Compared to $20 for Pfizer’s vaccine and $15 to $25 for Moderna’s, AstraZeneca said its treatment will only cost about $2.50.
Russia’s vaccine will cost about $10 a dose, though free for Russians, according to the Russian Direct Investment Fund, which bankrolled the development.
Asked whether the country’s leader has been vaccinated, Kremlin spokesman Dmitry Peskov said Tuesday that Preisdent Vladimir Putin “can’t use an uncertified vaccine.” Peskov pointed out that “widespread vaccination hasn’t started yet, and the head of state can’t take part in the vaccination as a volunteer.”
Deputy Prime Minister Tatyana Golikova estimated Tuesday that mass vaccination will start in 2021, with more than 2 million doses of Sputnik V produced in Russia this year.
The United States continues to break seven-day records of daily Covid-19 infections, most recently with more than 170,500 falling ill on Sunday. Nearly 258,000 people have died from Covid-19 in the U.S. and more than 12 million have been infected.