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|Dr. Anthony Fauci, Director of the US National Institute for Allergy and Infectious Diseases, testifies on the coronavirus crisis in Washington, D.C., July 31, 2020. Photo: Reuters|
Concocting a vaccine is not the same thing as proving a vaccine is safe and effective. That’s Anthony Fauci’s take on the news out of Moscow that Russia has approved and is ready to market a coronavirus vaccine.
Fauci, Director of the US National Institute of Allergy and Infectious Diseases, made the comments as part of a keynote interview for Stopping Pandemics, an exclusive event due to air August 13 via National Geographic.
“I hope that the Russians have actually definitively proven that the vaccine is safe and effective,” Fauci said to ABC News correspondent Deborah Roberts, who is moderating the event. “I seriously doubt that they've done that.”
|The vaccine against the coronavirus disease developed by the Gamaleya Research Institute of Epidemiology and Microbiology, Aug. 6, 2020, provided by the Russian Direct Investment Fund. Photo: AFP|
Russia's health ministry approved the vaccine after only two months of trials.
Russian President Vladimir Putin told officials at a televised meeting that the vaccine "forms strong immunity" and that the vaccine had already been administered to his adult daughter. The Russians plan to start administering dosages to front-line workers by the end of August.
Fauci, who is also a key member of the White House coronavirus task force, told Roberts that the US is pursuing at least a dozen vaccines of its own, according to ABC News.
“If we wanted to take the chance of hurting a lot of people, or giving them something that doesn't work, we could start doing this, you know, next week if we wanted to. But that's not the way it works."
Putin said the Russian drug has "passed all necessary tests," but with just two months of trials, experts are wary about it being safe for large-scale use.
Fauci said he hasn't heard any evidence to convince him it's truly ready, and that Americans need to understand that announcements from the Chinese or from the Russians that they have a vaccine differ from those made in the US "because we have a way of doing things in this country that we care about safety."
"It seems inconceivable, if you just think about it," Fauci continued, "that when you're trying to promote public health principles to save people's lives and keep them healthy ... that that's interpreted to be so far from your own way of thinking that you actually want to threaten the person. That's just no way that our society can really function well and go along that way -- we've got to get past that."
Fauci’s skepticism echoed
Scientists in Russia and other countries sounded an alarm, saying that rushing to offer the vaccine before final-stage testing could backfire. What’s called a Phase 3 trial — which involves tens of thousands of people and can take months — is the only way to prove if an experimental vaccine is safe and really works, AP reported.
By comparison, vaccines entering final-stage testing in the US require studies of 30,000 people each. Two vaccine candidates already have begun those huge studies, with three more set to get underway by fall.
“Fast-tracked approval will not make Russia the leader in the race, it will just expose consumers of the vaccine to unnecessary danger”, said Russia’s Association of Clinical Trials Organizations, while urging government officials to postpone approving the vaccine without completed advanced trials.
Scott Gottlieb, who led the Food and Drug Administration (FDA) under Donald Trump from 2017 until last year, told CNBC’s Squawk Box about the vaccination that Russia has claimed was the first to combat the novel coronavirus: “I wouldn’t take it, certainly not outside a clinical trial right now.”
He added: “It appears that it’s only been tested in several hundred patients at most.”
In a follow up tweet, the former commissioner wrote: “Russia was reported to be behind disinformation campaigns to sow doubts in US about our Covid vaccines.”
He added: “Today’s news that they ‘approved’ a vaccine on the equivalent of phase 1 data may be another effort to stoke doubts or goad US into forcing early action on our vaccines.”
The World Health Organization said on August 11 that it was monitoring Russia's progress in developing a COVID-19 vaccine. Progress in combating the virus "should not compromise safety," the health agency said. /.
Over 20 million people have been diagnosed with COVID-19 worldwide, the disease caused by the novel coronavirus, according to data compiled by the Center for Systems Science and Engineering at Johns Hopkins University. COVID-19 has killed more than 737,000 people globally.
In the US, the worst-affected country, at least 5,094,565 people have been diagnosed and at least 163,465 have died.
More than 100 possible vaccines are being developed around the world as part of efforts to offer immunity protection for the coronavirus.
Moderna, in collaboration with the National Institutes of Health, launched a phase three trial for a vaccine in July, making it the first U.S. candidate to reach that stage, The Hill reported.
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