West raises concern over Russia's race for coronavirus vaccine

Agencies
August 7, 2020

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. 

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News Network
July 14,2020

Washington, Jul 14: Florida on Sunday reported a record 15,300 new coronavirus cases, the most by any state in a single day even as the coronavirus cases in the country have surged to 3,363,056.

The Washington Post reported that the huge number was result of both increased testing and widespread community transmission. The numbers shattered previous highs of 11,694 reported by California last week and 11,571 reported by New York on April 15.

Natalie E. Dean, an assistant professor of biostatistics at the University of Florida wrote that with Florida largely open for business, he doesn't expect this surge to slow.

Nationally, the conversation over reopening has become increasingly fraught amid the newly soaring case numbers, with much of the debate centering on whether schools should open their doors in the fall, reported the Post.

The Health workers in California and Texas too are facing an influx of COVID-19 patients where officials reported seven day averages for new cases - 8,664 and 9060 respectively.

According to the report, Florida has reported nearly 70,000 cases in last week alone, the most of any state.

Even though the COVID-19 cases are surging, Florida Gov. Ron DeSantis has stuck to an aggressive reopening plan with state officials recently ordering schools to reopen five days a week in the new academic year.

The state is also set to hold the Republican National Convention next month in Jacksonville's VyStar Veterans Memorial Arena, an indoor facility that seats about 15,000, reported Washington Post.

Seven-day averages for new cases -- considered a more reliable indicator of the virus's impact than single-day totals -- hit new highs in Alabama, Florida, Mississippi, Montana, North Carolina, Oklahoma and Puerto Rico.

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News Network
February 18,2020

Beijing, Feb 18: A hospital director at the epicentre of China's virus epidemic died on Tuesday, state media said, the latest medical worker to fall victim to the new coronavirus spreading across the country.

The COVID-19 virus, which is believed to have originated in Wuhan late last year, has infected more than 72,000 people and killed nearly 1,900.

Liu Zhiming, the director of Wuchang Hospital in Wuhan, died Tuesday morning after "all-out rescue efforts failed," state broadcaster CCTV reported.

China said last week that six medical workers had died from the virus, while 1,716 have been infected.

Liu's death was initially reported by Chinese media and bloggers shortly after midnight on Tuesday -- but the stories were later deleted and replaced with reports that doctors were still trying to save him.

After initial reports of his death were denied, the hospital told AFP on Tuesday morning that doctors were giving him life-saving treatment.

Liu's death has echoes of that of Wuhan ophthalmologist Li Wenliang, who had been punished by authorities for sounding the alarm about the virus in late December.

Li's death prompted a national outpouring of grief as well as anger against the authorities, who were accused of mishandling the crisis.

People took to social media to mourn Liu on Tuesday, with many users on the Twitter-like Weibo platform drawing critical comparisons between Liu's death and Li's.

In both cases their deaths were initially reported in state media posts -- later deleted -- and their deaths denied, before being finally confirmed again.

"Has everyone forgotten what happened to Li Wenliang? They forcefully attempted resuscitation after he died," one Weibo commenter wrote.

Another commenter said, Liu "already died last night, (but) some people are addicted to torturing corpses".

A hashtag about Liu's death had 29 million views by Tuesday afternoon.

Doctors in Wuhan face shortages of masks and protective bodysuits, with some even wearing makeshift hazmat suits and continuing to work despite showing respiratory symptoms, health workers have told AFP.

Hubei province and its capital Wuhan have been the hardest hit by the virus, accounting for nearly 1,800 of the deaths from the virus so far.

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News Network
February 19,2020

Washington, Feb 19: Sri Srinivasan, a prominent Indian-American judge, has created history by becoming the first person of South Asian descent to lead a powerful federal circuit court considered next only to the US Supreme Court.

Srinivasan, 52, became the Chief Judge of the United States Court of Appeals for the DC Circuit.

An Obama appointee who has already been considered for a Supreme Court seat twice, donned the mantle of the chief judge of the DC federal court circuit on February 12.

Srinivasan succeeded Judge Merrick Garland, who has been a member of the DC Circuit since 1997 and Chief Judge since 2013. He will remain on the bench, a press release said.

Notably, Garland's nomination to the Supreme Court by the then president Barack Obama was blocked by Senate Republicans in 2016.

Srinivasan, was appointed to the US Court of Appeals for the District of Columbia Circuit in May 2013.

He was the first ever Indian-American to be appointed to the second most powerful court of the US.

Neomi Rao, nominated by President Donald Trump, is the second Indian American on this powerful judiciary bench.

History being made on the DC Court of Appeals. Congratulations, Judge Srinivasan! Senator Mark Warner said.

Congratulations to Judge Sri Srinivasan on becoming the Chief Judge of the U.S. Court of Appeals for the D.C. Circuit! A milestone for the Indian-American/Kansan community (and yet another piece of evidence my family can use that I'm underachieving), US Federal Communications Commission Chair Ajit Pai said.

According to The Washington Post, Srinivasan spoke recently about his path to the bench at an event celebrating women in the law, a field where men still dominate leadership positions.

"Everybody doubts their belonging and worthiness in some measure. I definitely did and still do. This is just going to be a part of the thing when you're looking out in the world in which everyone isn't like you. It's natural to doubt whether you belong and whether you're worthy, he said, "but you do belong and you are worthy.

Born in Chandigarh, and raised in Lawrence, Kansas, he received a B.A. from Stanford University, a J.D. from Stanford Law School, and an M.B.A. from the Stanford Graduate School of Business.

Following graduation, he served as a law clerk to Judge J. Harvie Wilkinson III of the US Court of Appeals for the Fourth Circuit, as a Bristow Fellow in the Office of the US Solicitor General, and as a law clerk to US Supreme Court Justice Sandra Day O'Connor.

From 2011 until his appointment to the US Court of Appeals, Judge Srinivasan served as the Principal Deputy Solicitor General of the United States.

He has argued 25 cases before the US Supreme Court. He has also taught appellate advocacy at Harvard Law School as well as a seminar on civil rights statutes and the Supreme Court at Georgetown University Law Center.

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