Russian President Vladimir Putin claimed on Aug. 11 that the country has officially approved the first COVID-19 vaccine in the world, about eight months since the start of the novel coronavirus pandemic. Experts worldwide don’t buy it. A Russian vaccine, they say, might not be ready for the masses.
The vaccine is appropriately named Sputnik V—a nod to the first orbital satellite launched by the Soviet Union in 1957 during the space race—and shows Russia’s focus to find a vaccine first.
The Associated Press reported that scientists modified the common cold-causing adenovirus to “carry genes for the ‘spike’ protein that coats the coronavirus” to create Sputnik V. After it enters the body, the modified adenovirus theoretically trains the immune system to recognize and combat future coronavirus proteins. Given in two doses, Russia says its vaccine should provide people immunity for two years.
Putin said Russia plans to give Sputnik V to millions of people—including tens of thousands of teachers and front-line health-care workers—according to the Washington Post.
“We expect tens of thousands of volunteers to be vaccinated within the next months,” Kirill Dmitriev, chief executive of the Russian Direct Investment Fund, told the Associated Press. “So people outside of clinical trials will have access to the vaccine in August, and some, already on the massive scale, in October.”
Putin assured the public that the Russian vaccine is safe and that one of his daughters had already received it, the Associated Press wrote.
“I know it has proven efficient and forms a stable immunity,” Putin said. “We must be grateful to those who made that first step very important for our country and the entire world.”
Being first doesn’t necessarily mean being best, and health experts are wary about Sputnik V for several reasons. The fact that the vaccine has not yet completed phase 3 clinical trials is the most concerning. Those trials will begin on Aug. 12.
Typically, potential vaccines face three clinical trial phases before moving onto the approval and licensure phase, according to the History of Vaccines. The third clinical trial phase is arguably the most important because it involves tens of thousands of people and allows developers to assess how common side effects of the vaccine could be. The third trial also tests the vaccine’s efficacy rate.
Instead, Russian officials say they will give the vaccine to thousands before they know if this vaccine has any severe side effects or is even effective long-term. According to the Associated Press, the vaccine was only given to 76 volunteers in its second trial.
Scientists are also concerned because multiple reports say Russian officials haven’t actually backed up these declarations with any proof. Additionally, the Washington Post reported that most knowledge obtained has only been from second-hand sources. The results from the first two clinical trials haven’t been published.
Russia’s Association of Clinical Trials Organizations told the Associated Press that it urged government officials to postpone administering the vaccine.
“Fast-tracked approval will not make Russia the leader in the (vaccine) race,” the organization said, “It will just expose consumers of the vaccine to unnecessary danger.”
American officials also expressed skepticism about the Russian vaccine. On Aug. 11, White House Counselor Kellyanne Conway told Fox News that U.S. standards were “more stringent” than Russia’s.
“What I understand from the Russia announcement is, this is nowhere near where we are,” she continued. “Which is, we have six different vaccine candidates into Phase 3 [trials]. And [the Russians] don’t seem to be there yet.”
America’s top infectious disease expert Dr. Anthony Fauci recently expressed his doubts that other countries’ vaccines will go through thorough testing, according to the Washington Post.
“I do hope that the Chinese and the Russians are actually testing the vaccine before they are administering the vaccine to anyone, because claims of having a vaccine ready to distribute before you do testing, I think, is problematic at best,” Fauci said.
But on Sept. 4, it was reported that early results of the Russian vaccine hadn’t shown any major negative side effects and that it actually had elicited an antibody response.
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