American infectious diseases specialists and vaccinologists raised alarms about Russia’s announcement that it would begin vaccinating its population against the coronavirus, rushing a relatively untested vaccine into mass production.
On Tuesday, Russian President Vladimir Putin announced the government had approved a COVID-19 vaccine for use, the first nation to do so. But the Russian vaccine, although based on widely accepted technology, has not completed clinical trials.
“What have [the Russians] done?” Paul Offit, chief of the division of infectious diseases at Children’s Hospital Philadelphia and a co-inventor of the rotavirus vaccine, said in an interview with Yahoo News. “They’ve done a small phase I trial in 38 people.”
The Russian vaccine used an adenovirus to induce neutralizing antibodies in the 38 people who were given it, Offit said. While “nobody died,” he said that relying on such a small sample of patients “doesn’t enable you to say anything about efficacy, doesn’t enable you to say anything about safety.”
Offit, who is a member of the National Institutes of Health COVID vaccine working group, said he worries about the precedent being set by the Russians in proclaiming victory on an untested vaccine. He said he was struck by 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 administration would interpret this as anything other than what it is, which is that Russia, if anything, is behind where we are in the United States on this vaccine. … This is just Vladimir Putin being political. I don’t think he’s honest when he says that they’ve shown that the vaccine’s effective. They can’t possibly know that yet.”
Putin’s announcement was framed as a victory lap in the race for a vaccine, despite the fact that just last week the World Health Organization warned Russia it must adhere to standard protocols for testing a vaccine. Russian officials have been signaling for weeks that they intended to claim a victory in the race for a vaccine, and they did so Tuesday despite the absence of data documenting late-phase testing. Typically, vaccines are subjected to rigorous phase III trials which compare a candidate vaccine to placebo in thousands of volunteers.
“It works effectively enough, forms a stable immunity and, I repeat, it has gone through all necessary tests,” Putin said Tuesday. He also said his daughter had taken the vaccine.
While he is dubious about the Russian vaccine, Offit said he is heartened overall by the progress being made globally.
“We’ll have a vaccine,” by the middle of next year, Offit said. “We know this — we know that these vaccines can develop neutralizing antibodies to the virus and that’s promising. If you can develop neutralizing antibodies — which is to say antibodies that neutralize the ability of the virus to infect — then that should be protective.”
Other leading doctors said the Russian distraction is unfortunate because vaccine research is already moving with unprecedented speed. David Walt, a pathologist at Harvard Medical School and Brigham and Women’s Hospital, said his biggest concern is “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 will crop up over longer periods of time just because of reliability issues or certain kinds of rare events that you don’t see when you use something for a short period of time,” Walt said. “Everyone’s trying to get there first, and there’s potential corner cutting that’s taking place as a consequence of trying to do that.”
Walt compared the Russian approval of a vaccine without phase III trials to playing with a partially loaded gun.
“It’s kind of like Russian roulette,” Walt said. “In some cases, it’s probably going to work perfectly, it will work well. But there may be situations in certain kinds of individuals who will exhibit adverse 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 shares the concern about corner-cutting. Schaffner said the Russian vaccine relies on the same adenovirus template that the Oxford vaccine uses, exposing the subject to a critical protein in the coronavirus.
“That protein is actually the vaccine,” Schaffner said. “Our immune system sees that protein and recognizes it as foreign and responds to it, making antibodies.”
A possible side effect, he said, was a minor cold.
Schaffner said the Russian president’s apparent willingness to give his citizens an untested vaccine was potentially dangerous, even if the model the Russian vaccine relies on is familiar.
“We don’t want that to happen anywhere, and it certainly should not happen in the United States,” he said. “It does feed my concern because our national leader has a seeming fondness for what happens in Russia and may be inclined to do something similar here.”
But Schaffner said he has been reassured by a recent article in the Journal of the American Medical Association co-authored by Stephen Hahn, the head of the Food and Drug Administration, which asserted “that candidate COVID-19 vaccines will be reviewed according to the 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 the government’s efforts to focus resources and funding to scale vaccine development from FDA’s review processes, which are rooted in federal statute and established FDA regulations.”
George Rutherford, an epidemiologist at the University of California, San Francisco, said the Russian vaccine is “a fairly standard technology” which the Russians have used before to vaccinate their population against Middle East Respiratory Syndrome (MERS). Rutherford said the vaccine may work well enough, but it could have problems that aren’t detected before it is given on a mass 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 at all,” Rutherford said. “You’re giving this to people who are well and who do not have pathology in order to protect them so you don’t want to give them pathology while you’re doing this.”
He said that the U.S. has learned to be cautious as a result of a swine influenza campaign in 1976 that Rutherford said many people still believe could be responsible for Guillain-Barre Syndrome, a condition in which the immune system attacks the nerves, sometimes causing paralysis.
“What happens when you immunize an entire population is that everything that ever happens to that entire population after the immunization is blamed on the immunization,” Rutherford said.
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