The former commissioner of the Food and Drug Administration (FDA) has warned a Russian vaccination for COVID-19 may not prove to be effective, while suggesting its reported approval could be a further attempt by the Kremlin to “stoke doubts” about US vaccine trials.
Scott Gottlieb, who led the 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.”
Russia’s president, Vladimir Putin, announced the Health Ministry’s approval and said one of his two adult daughters already was inoculated. He said the vaccine underwent the necessary tests and was shown to provide lasting immunity to the coronavirus, although Russian authorities have offered no proof to back up claims of safety or effectiveness.
“I know it has proven efficient and forms a stable immunity,” Mr Putin said. “We must be grateful to those who made that first step very important for our country and the entire world.”
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However, 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.
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.
While Russian officials have said large-scale production of the vaccine wasn’t scheduled until September, Deputy Prime Minister Tatyana Golikova said vaccination of doctors could start as early as this month. Officials say they will be closely monitored after the injections. Mass vaccination may begin as early as October.
“We expect tens of thousands of volunteers to be vaccinated within the next months”, Kirill Dmitriev, chief executive of the Russian Direct Investment Fund that bankrolled the vaccine, told reporters.
The vaccine, developed by the Gamaleya Institute in Moscow with assistance from Russia’s Defense Ministry, uses a different virus — the common cold-causing adenovirus — that’s been modified to carry genes for the “spike” protein that coats the coronavirus, as a way to prime the body to recognise if a real COVID-19 infection comes along.
That’s a similar technology as vaccines being developed by China’s CanSino Biologics and Britain’s Oxford University and AstraZeneca — but unlike those companies, Russian scientists haven’t published any scientific information about how the vaccine has performed in animal tests or in early-stage human studies.
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