American infectious disease specialists and vaccinologists alarmed Russia’s announcement that it would vaccinate its population against the coronavirus and bring a relatively untested vaccine into mass production.
On Tuesday, Russian President Vladimir Putin announced that the government would be the first country to approve a COVID-19 vaccine for use. But the Russian vaccine, although based on generally accepted technology, has not completed clinical trials.
“To have something [the Russians] Done? “Paul Offit, director of the infectious diseases division at Children’s Hospital Philadelphia and co-inventor of the rotavirus vaccine, said in an interview with Yahoo News.” They did a small phase I study of 38 people.
The Russian vaccine used an adenovirus to induce neutralizing antibodies in the 38 people it was given, Offit said. While “nobody died,” he said that relying on such a small sample of patients “puts nothing in a position to say anything about effectiveness and nothing about safety”.
Offit, who is a member of the National Institutes of Health’s COVID vaccine working group, said he was concerned about the precedent the Russians had set in proclaiming victory over an untested vaccine. He said he was impressed with the political undertones in Putin’s vaccine claims.
“It’s amazing that this was a political announcement,” Offit said. “What worries me is that our government would interpret this as something other than what it is, that Russia, if anything, is behind our stand in the United States on this vaccine. … That’s just Vladimir Putin who is political. I don’t think he’s being honest when he says they showed the vaccine is effective. You can’t know that yet. “
Putin’s announcement was phrased as a winning lap in the race for a vaccine, despite the World Health Organization warning Russia just last week that it must adhere to standard protocols for testing a vaccine. Russian officials have been signaling for weeks that they wanted a victory in the race for a vaccine, and they did so on Tuesday, despite no data to document the late-stage testing. Typically, vaccines undergo rigorous Phase III trials that compare a vaccine candidate with a placebo in thousands of volunteers.
“It works effectively enough, creates stable immunity and, I repeat, it has passed all the necessary tests,” Putin said on Tuesday. He also said his daughter took the vaccine.
Although he has doubts about the Russian vaccine, Offit said he was generally encouraged by the progress made around the world.
“We’ll have a vaccine by the middle of next year,” Offit said. “We know that – we know that these vaccines can develop neutralizing antibodies to the virus, and that looks very promising. If you can develop neutralizing antibodies – that is, antibodies that neutralize the infectious ability of the virus – that should be protective. “
Other senior doctors said the Russian diversion was unfortunate as vaccine research was already advancing at an unprecedented rate. David Walt, a pathologist at Harvard Medical School and Brigham and Women’s Hospital, said his greatest concern was “the rush to get admission” and the shortcuts that are being taken.
“When you have a new product, be it a car or a vaccine, there are things that keep popping up for long periods of time just because of reliability issues or certain rare occurrences that you don’t see when you’re using something in a short period of time,” said Walt . “Everyone tries to get there first, and there are potential corner cuts that happen as a result.”
Walt compared Russian approval of a vaccine with no Phase III trials to playing with a partially loaded gun.
“It’s a bit like Russian roulette,” said Walt. “In some cases, it will probably work perfectly, it will work fine. For certain people, however, there may be situations that show side effects or very serious consequences as a result of the vaccination.
William Schaffner, an infectious disease specialist and professor at Vanderbilt University, said he shared concerns about corner cutting. Schaffner said the Russian vaccine is based on the same adenovirus template that the Oxford vaccine uses, exposing the subject to a critical protein in the coronavirus.
“This protein is actually the vaccine,” said Schaffner. “Our immune system sees this protein and recognizes it as foreign and reacts to it by making antibodies.”
A possible side effect is a mild cold.
Schaffner said the Russian President’s apparent willingness to give its citizens an untested vaccine was potentially dangerous, even if the model on which the Russian vaccine was based is known.
“We don’t want anywhere, and it certainly shouldn’t be happening in the United States,” he said. “It feeds my concern because our national leader appears to have a predilection for what is happening in Russia and may be inclined to do something similar here.”
But Schaffner said he was reassured by a recent article co-authored by Stephen Hahn, head of the Food and Drug Administration, in the Journal of the American Medical Association, which alleged “that candidates for COVID-19 vaccines were established under the established law legal and regulatory standards for medical devices. ”The article went on to say that while Operation Warp Speed is important,“ there is a limit that government efforts to pool resources and funding to scale vaccine development have Separates FDA review processes that are enshrined in federal law and established FDA regulations. “
George Rutherford, an epidemiologist at the University of California at San Francisco, said the Russian vaccine was “pretty standard technology” that Russians previously used to vaccinate their populations against Middle East Respiratory Syndrome (MERS). Rutherford said the vaccine might work well enough, but problems could arise that are not recognized before it is given on a large scale.
“Abbreviations are not the way to go in vaccine development because you will give them to a lot of people who don’t mind,” Rutherford said. “You are giving this to people who are fine and who have no pathology to protect them, so you don’t want to give them pathology while you are doing this.”
He said the US learned to be cautious because of a swine flu campaign in 1976, which Rutherford said many people still believe they could be responsible for Guillain-Barre syndrome, a disease in which which attacks the immune system’s nerves and sometimes leads to paralysis.
“If you immunize an entire population, everything that happens to that entire population after vaccination is attributed to the vaccination,” Rutherford said.
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