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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Karnataka ex-MLA, a doctor, saves life of American co-passenger mid air
Bengaluru (PTI): A Karnataka ex-MLA, Anjali Nimbalkar, a doctor by profession, has saved the life of an American woman passenger, who suffered a medical emergency mid-air during a Goa–New Delhi flight, official sources said on Sunday.
The incident happened when Nimbalkar, AICC secretary co-incharge of Goa, Daman & Diu, Dadra Nagar Haveli, was travelling to Delhi to attend the "Vote Chori" rally organised by Congress at Ramleela Maidan on Sunday, they added.
Nimbalkar performed cardiopulmonary resuscitation (CPR) and revived the co-passenger, who complained of uneasiness and shivering, fainted and lost her pulse, they said.
Nimbalkar reportedly remained by the patient’s side for the entire duration of the flight, constantly paying attention to her medical needs and comforting her.
Soon after landing at Delhi, the unwell foreign passenger was shifted to a hospital by an ambulance, sources said, adding that Nimbalkar's timely action received praise from passengers and crew members.
Lauding Nimbalkar, Chief Minister Siddaramaiah, in a post on 'X' said, "Deeply moved and incredibly proud to hear about the remarkable presence of mind and compassion shown by former Khanapur MLA Dr Anjali Nimbalkar during a Goa–New Delhi flight. When an American woman suffered a medical emergency mid-air, Dr Anjali instantly rose to the occasion and administered timely CPR, saving a precious life."
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What makes this even more inspiring is that, despite having stepped away from her medical profession and being actively engaged in politics, the doctor within her responded without a second thought, he said, adding that "this selfless act reflects not just professional expertise, but a profound sense of humanity, service, and responsibility toward fellow beings."
"Whether in power or not, leaders like Dr Anjali Nimbalkar stand as shining examples of true public service—always ready to help, without expecting anything in return. Such individuals set a powerful standard for society and remind us of the true meaning of leadership," he further added.
Thanking the CM, Nimbalkar said, she has done her duty as a Doctor.
"It (is) also my job and duty as a doctor to serve in this capacity whenever required. Means a lot coming from you, who himself is an example of social commitment," she said in a post on 'X', replying to the CM.
