Russia's race for virus vaccine raises concerns in the West
Moscow: 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 U.S., 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.
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3 US troops killed, 5 seriously wounded during Iran attacks, military says
Washington (AP): Three American service members have been killed and five others seriously wounded during the US attacks on Iran, the military said Sunday, marking the first American casualties in a major offensive that has sparked retaliation from the Islamic Republic.
US Central Command, which oversees the Middle East, announced the deaths in a post on X but did not say when and where they occurred. The statement said “several others sustained minor shrapnel injuries and concussions” and were going to return to duty.
Central Command described the situation “as fluid” and said it would withhold the identities of the service members who were killed for 24 hours after their families were notified.
The US military also denied Iranian claims that the USS Abraham Lincoln aircraft carrier was struck with ballistic missiles, saying on X that the “missiles launched didn't even come close.”
President Donald Trump had warned that American troops could be killed or injured in the operation.
“The lives of courageous American heroes may be lost, and we may have casualties,” the Republican president said in a video address released early Saturday. “That often happens in war. But we're doing this not for now. We're doing this for the future.”
Following the US-Israeli strikes that killed Iran's supreme leader, Ayatollah Ali Khamenei, and other leaders, Iran's counterattacks have struck US bases in Bahrain and the United Arab Emirates.
Iran's paramilitary Revolutionary Guard has threatened to launch its “most intense offensive operation” ever targeting Israeli and American military installations.
Before the strikes, Trump had built up the largest US military presence in the Middle East in decades. The arrival of the Lincoln and three accompanying guided-missile destroyers at the end of January bolstered the number of warships in the region.
The world's largest aircraft carrier, the USS Gerald R. Ford, and four accompanying destroyers later were dispatched from the Caribbean Sea to head to the Middle East.
The Ford was part of the US raid in Venezuela that captured leader Nicolás Maduro, who was brought to New York to face drug trafficking charges. The operation in January claimed no American lives but left seven US troops with gunshot wounds and shrapnel-related injuries.
One of those injured received the Medal of Honor during Trump's State of the Union address last week. Trump said Army Chief Warrant Officer 5 Eric Slover piloted the lead CH-47 Chinook helicopter that descended on the “heavily protected military fortress” where Maduro was staying.
Trump has launched several military operations during his second term, including strikes on members of the Islamic State group in Syria in retaliation for an ambush attack that killed two US troops and an American civilian interpreter in December.
The US military has also struck IS forces in Nigeria, after Trump accused the West African country's government of failing to rein in the targeting of Christians.
