Russia boasts that it's about to become the first country to approve a Covid-19 vaccine, with mass vaccinations planned as early as October using shots that are yet to complete clinical trials -- and scientists worldwide are sounding the alarm that the headlong rush could backfire.
Moscow sees a Sputnik-like propaganda victory, recalling the Soviet Union's launch of the world's first satellite in 1957.
But the experimental Covid-19 shots began first-in-human testing on a few dozen people less than two months ago, and there's no published scientific evidence yet backing Russia's late entry to the global vaccine race, much less explaining why it should be considered a front-runner.
“I'm worried that Russia is cutting corners so that the vaccine that will come out may be not just ineffective, but also unsafe,” said Lawrence Gostin, a global public health law expert at Georgetown University. “It doesn't work that way... Trials come first. That's really important.”
According to Kirill Dmitriev, head of Russia's Direct Investment Fund that bankrolled the effort, a vaccine developed by the Gamaleya research institute in Moscow may be approved in days, before scientists complete what's called a Phase 3 study.
That final-stage study, usually involving tens of thousands of people, is the only way to prove if an experimental vaccine is safe and really works.
Health Minister Mikhail Murashko said members of “risk groups,” such as medical workers, may be offered the vaccine this month.
He didn't clarify whether they would be part of the Phase 3 study that is said to be completed after the vaccine receives “conditional approval.”
Deputy Prime Minister Tatyana Golikova promised to start “industrial production” in September, and Murashko said mass vaccination may begin as early as October.
Dr Anthony Fauci, the top US infectious disease specialist, questioned the fast-track approach last week.
“I do hope that the Chinese and the Russians are actually testing a vaccine before they are administering the vaccine to anyone, because claims of having a vaccine ready to distribute before you do testing I think is problematic at best," he said.
Questions about this vaccine candidate come after the US, Britain and Canada last month accused Russia of using hackers to steal vaccine research from Western labs.
Delivering a vaccine first is a matter of national prestige for the Kremlin as it tries to assert the image of Russia as a global power capable of competing with the US and China.
The notion of being “the first in the world” dominated state news coverage of the effort, with government officials praising reports of the first-step testing.
In April, President Vladimir Putin ordered state officials to shorten the time of clinical trials for a variety of drugs, including potential coronavirus vaccines.
According to Russia's Association of Clinical Trials Organizations, the order set “an unattainable bar” for scientists who, as a result, "joined in on the mad race, hoping to please those at power.”
The association first raised concern in late May, when professor Alexander Gintsburg, head of the Gamaleya institute, said he and other researchers tried the vaccine on themselves.
The move was a “crude violation of the very foundations of clinical research, Russian law and universally accepted international regulations" the group said in an open letter to the government, urging scientists and health officials to adhere to clinical research standards.
But a month later, the Health Ministry authorized clinical trials of the Gamaleya product, with what appeared to be another ethical issue.
Human studies started June 17 among 76 volunteers. Half were injected with a vaccine in liquid form and the other half with a vaccine that came as soluble powder.
Some in the first half were recruited from the military, which raised concerns that servicemen may have been pressured to participate.
Some experts said their desire to perform well would affect the findings. “It's no coincidence media reports we see about the trials among the military said no one had any side effects, while the (other group) reported some," said Vasily Vlassov, a public health expert with Moscow's Higher School of Economics.
As the trials were declared completed and looming regulatory approval was announced last week, questions arose about the vaccine's safety and effectiveness.
Government assurances the drug produced the desired immune response and caused no significant side effects were hardly convincing without published scientific data describing the findings.
The World Health Organization said all vaccine candidates should go through full stages of testing before being rolled out.
“There are established practices and there are guidelines out,” WHO spokesman Christian Lindmeier said Tuesday.
“Between finding or having a clue of maybe having a vaccine that works, and having gone through all the stages, is a big difference.”
Offering an unsafe compound to medical workers on the front lines of the outbreak could make things worse, Georgetown's Gostin said, adding: “What if the vaccine started killing them or making them very ill?”
Vaccines that are not properly tested can cause harm in many ways — from a negative impact on health to creating a false sense of security or undermining trust in vaccinations, said Thomas Bollyky, director of the global health program at the Council on Foreign Relations.
Comments
Countries like USA, Russia, Israel and India are ruled by murderers engaging in destabilizing the world in the name of Islam. Anti Islam agenda is their prime aim.
@comment #3
Boppanna seems to be right going by the number of mindless terror attacks by Muslims. Terror has no religion but the terrorists are always Muslim. Shame on such a bike cult, where the majority abets the criminality of terrorists.
S
Muslims are like cockroaches and have no place in a civilized society.
They should be removed from civil society and put on islands
Moshanba you are the frustrated one not me. Taqiiyya always as usual
I can give u the verses if u want
where are jihadis in mangalore ... hahaha ... zakir naik skype video nodtha ummah ge jai , lakadi pakadi jummah ohh ummah ankondu kootirbeku ... or 4 options jothe population jaasthi madodu helkodtha irbahudu i mean appa amma aata... hahaha ... france incident proves who is real blood thirsty and it is another henious crimes committed by muslims ... very shocking and discgusting ... they can stoop anylevel ... kachada galu ...mekka and madina dalle bomb madagthave andre .. maklu yaav range nalli corrupted mind and frustrated souls agirbeku ...
Being in Saudi Arabia our frustrated Bopanna might not aware of the punishment for twisting the verses of holy quran (blasphemy) .
this is gruesome... some psycho can only do this kind of heinous acts.....but media doesn't have any ryt to put d blame on entire religion.... ISIS does not represent Islam at all....ISIS is not Islam...jus cos few bastards grow beard n waive black flags doesn't mean that they r muslims.....
ISlam is the religion Of Allah,,,, n Allah alone will protect His religion.....
All \peace \" commentators left India to join IS?"
Why are the followers of Religion of \Piece\" not commenting here ?
It's written in the Koran that the month of Ramadan should be one to sow the seeds of terror in the hearts of non Muslims.
Can you tell the truth rather than taqiiyya ?"
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