Scientist Behind Russian COVID-19 Vaccine Defends Fast-Tracked Pace
More than one month after the government of Russia announced it approved the world’s first vaccine for COVID-19, it announced it will share preliminary data from the first six weeks of the ongoing Phase III study.
Alexander Gintsburg, head of the Gamaleya Institute that produced the vaccine known as Sputnik V, told Reuters the breakneck pace of the vaccine development was necessary as he equated the pandemic to “wartime” conditions. However, Gintsburg assured the news agency that Russia’s scientific community was not cutting any corners related to safety.
“People are dying just like during a war,” Gintsburg told Reuters. “But this fast-tracked pace is not synonymous, as some media have suggested, with corners being cut. No way.”
Russia’s vaccine is an adenoviral vector vaccine developed by Moscow’s Gamaleya Institute. The vaccine has been genetically modified to infect cells than make those cells manufacture spike proteins of SARS-CoV-2, the novel virus that causes COVID-19. After the government of Russia announced the vaccine approval well-ahead of Phase III studies, the Russia Direct Investment Fund launched a website to provide greater and more transparent information about the vaccine.
“The vaccine induced strong antibody and cellular immune response. Not a single participant of the current clinical trials got infected with COVID-19 after being administered with the vaccine,” according to the Russian website.
Gintsburg told Reuters the study hoped to show at least a 75% efficacy from Sputnik V, which is higher than the 50% efficacy threshold set by the U.S. Food and Drug Administration for vaccine approval in the United States. Gintsburg also noted that no serious side-effects from the vaccine have yet been reported. Some minor side-effects have been reported in about 15% of the test population, he added.
Although little data was publicly shared when the vaccine was given the green light by Russian regulators, Gintsburg said the approval was ethical due to the concerns of the pandemic.
“The choice was between giving people the opportunity to protect themselves, or letting them play roulette with this deadly infection,” he told Reuters.
Russia initiated the Phase III study at the beginning of September. The goal was to include 40,000 people in the study. According to Reuters, the first of 5,000 volunteers was vaccinated on Sept. 9. That means the interim results could be issued after Oct. 21. If the first 6-week data is released soon, that would be the earliest Phase III data published. Moderna and Pfizer and BioNTech have indicated Phase III data for its COVID-19 vaccine candidates could be available in November and October, respectively.
If the interim data is strong, Reuters said there is a plan for Russia to begin inoculating the general populace as quickly as possible, beginning with people over the age of 60. Russia has already begun to inoculate hundreds of high-risk members of the general public with Sputnik V who are not taking part in the late-stage study.