Russia moving too fast with COVID-19 vaccine, US experts warn
U.S. infectious disease specialists and vaccinologists have alarmed Russia’s announcement that it will start vaccinating its population against the coronavirus, precipitating mass production of a relatively untested vaccine.
Russian President Vladimir Putin announced on Tuesday that the government has approved the use of a COVID-19 vaccine, the first nation to do so. But the Russian vaccine, although based on widely accepted technology, has not completed clinical trials.
“What [the Russians] Gone? ”Paul Offit, head of the infectious disease division at Children’s Hospital in Philadelphia and co-inventor of the rotavirus vaccine, said in an interview with Yahoo News.“ They did a small Phase I trial. in 38 people. “
The Russian vaccine used an adenovirus to induce neutralizing antibodies in the 38 people who received it, Offit said. While “no one is dead,” he said relying on such a small sample of patients “doesn’t let you say anything about effectiveness, doesn’t let you say anything. whether it’s about security. “
Offit, who is a member of the National Institutes of Health’s COVID vaccine task force, expressed concern about the precedent set by the Russians by proclaiming victory over an untested vaccine. He said he was struck by the political nuances of Putin’s vaccine claims.
“It’s amazing that this is a political announcement,” Offit said. “What worries me is that our administration would interpret this as something other than what it is, meaning that Russia, on the contrary, is lagging behind what we are in the United States. United on this vaccine. … It is only Vladimir Putin who is political. I don’t think he’s being honest when he says they’ve shown the vaccine to work. They can’t know yet.
Putin’s announcement was conceived as a victory lap in the race for a vaccine, despite the fact that last week the World Health Organization warned Russia that it must adhere to standard protocols to test a vaccine. vaccine. Russian officials have been signaling for weeks that they intended to secure a victory in the vaccine race, and they did so on Tuesday despite the lack of data documenting late-phase testing. Typically, vaccines go through rigorous phase III trials that compare a candidate vaccine to a placebo in thousands of volunteers.
“It works quite efficiently, forms stable immunity and, I repeat, he has undergone all the necessary tests,” Putin said on Tuesday. He also said his daughter took the vaccine.
Although he doubts the Russian vaccine, Offit said he was generally encouraged by the progress being made around the world.
“We will have a vaccine,” by the middle of next year, Offit said. “We know that – we know that these vaccines can develop neutralizing antibodies against the virus and that is promising. If you can develop neutralizing antibodies – that is, antibodies that neutralize the ability of the virus to infect – then that should be protective. “
Other prominent doctors said the Russian distraction was unfortunate as vaccine research was already advancing at unprecedented speed. David Walt, a pathologist at Harvard Medical School and Brigham and Women’s Hospital, said his biggest concern was “the rush to approval” and the shortcuts that will be taken.
“If you have a new product, whether it’s a car or a vaccine, there are things that are going to show up over longer periods of time just because of reliability issues or some type of rare event that you don’t see. when you are using something for a short period of time, ”Walt said. “Everyone tries to get there first, and there’s a potential for a corner cut that’s happening as a result of trying to do it.”
Walt compared the Russian approval of a vaccine without Phase III trials to playing with a partially loaded pistol.
“It’s kind of like Russian roulette,” Walt said. “In some cases it will probably work perfectly, it will work well. But there may be situations in certain types of people that will experience unwanted effects or very serious consequences as a result of receiving the vaccine. “
William Schaffner, an infectious disease specialist and professor at Vanderbilt University, said he shared the concern about the corner cuts. Schaffner said the Russian vaccine was based on the same adenovirus model as the Oxford vaccine, exposing the subject to a critical coronavirus protein.
“This protein is actually the vaccine,” Schaffner said. “Our immune system sees this protein and recognizes it as foreign and responds to it by making antibodies.”
One possible side effect, he said, was a minor cold.
Schaffner said the Russian president’s apparent desire to give his citizens an untested vaccine was potentially dangerous, even though the model the Russian vaccine is based on is familiar.
“We don’t want this to happen anywhere, and it certainly shouldn’t be happening in the United States,” he said. “This feeds my concern as our national leader has an apparent fondness for what is going on in Russia and may be inclined to do something similar here.”
But Schaffner said he was reassured by a recent article in the Journal of the American Medical Association co-authored by Stephen Hahn, the chief of the Food and Drug Administration, which said that “candidate COVID-19 vaccines will be reviewed. according to established legal and regulatory standards for medical products. The article went on to say that while Operation Warp Speed is important, “there is a line separating government efforts to focus resources and funding to expand vaccine development from the review process. the FDA, which are rooted in federal law and regulations set by the FDA.
George Rutherford, an epidemiologist at the University of California at San Francisco, said the Russian vaccine is “fairly standard technology” that the Russians have used previously to vaccinate their population against Middle East Respiratory Syndrome (MERS). Rutherford said the vaccine could work well enough, but it could have issues that go undetected until it is given on a large scale.
“Cutting corners is not the way to go in vaccine development because you’re going to give it to a lot of people who have nothing wrong with them,” Rutherford said. “You give this to people who are fine and have no pathology in order to protect them so that you don’t want to give them pathology while you are doing this.
He said the United States learned to be cautious following a swine flu campaign in 1976 that Rutherford said many people still believe she may be responsible for Guillain syndrome -Bar, a disease in which the immune system attacks the nerves, sometimes causing paralysis. .
“What happens when you immunize an entire population is that whatever happens to that entire population after vaccination is blamed on the vaccination,” Rutherford said.
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