Over 5,000 volunteers in Wuhan sign up for clinical trials over Covid19 vaccine

News Network
March 25, 2020

Beijing, Mar 25: Around 5,000 people have signed up for the phase I clinical trial of recombinant novel coronavirus vaccine in Chinese city Wuhan where the virus first emerged late last year.

The recruitment for participants ended this week with nearly 5,000 volunteers signing up for the trial, state-run Beijing News reported on Wednesday.

A single-centre, open and dose-escalation phase I clinical trial for recombinant novel coronavirus vaccine (adenoviral vector) will be tested in healthy adults aged between 18 and 60 years, according to the ChiCTR (China Clinical Trial Register).

The trial, led by experts from the Academy of Military Medical Sciences, gained its approval on March 16 and the research is expected to last half a year.

Requiring at least 108 participants, the trial will be conducted in Wuhan, capital of Hubei province, the region worst-affected by the virus in the country, state-run China Daily reported.

Participants will experience 14-day quarantine restrictions after being vaccinated and their health condition will be recorded every day.

Chinese scientists are hastening the development of COVID-19 vaccines through five approaches --- inactivated vaccines, genetic engineering subunit vaccines, adenovirus vector vaccines, nucleic acid vaccines and vaccines using attenuated influenza virus as vectors.

So far, most teams are expected to complete preclinical research in April and some are moving forward faster, Wang Junzhi, an academician with the Chinese Academy of Engineering said.

Wang noted that research and development of COVID-19 vaccines in China is not slower than foreign counterparts and has been carried out in a scientific, standardised and orderly way.

China has stepped up the process to finalise vaccines to counter COVID-19 after Kaiser Permanente research facility in Seattle and Washington stole the march and began human trials.

China lifted tough restrictions on the Hubei province on Wednesday after a months-long lockdown as the country reported no new domestic cases.

But there were another 47 imported infections from overseas, the National Health Commission said. In total, 474 imported infections have been diagnosed in China -- mostly Chinese nationals returning home.

Comments

Y UDAYA CHANDAR
 - 
Monday, 13 Apr 2020

Dear Sir,

 

I am 77 but a very healthy person with remarkable immunity. I contracted Malaria fever in 1994 because of mosquito biting and I have not been sick anytime there after, not even for ordinary fever in the last 26 years.

 

I am sure you would like to conduct the trials on persons of varying criteria. I am sure you don't want to carry out the trials on perfectly healthy young individuals only. 

 

I am certain that  you want to try the vaccine on a 'common man' from 'general public.' I am ready for the trial and you can take me. I will be delighted. 

 

If you are not handling this matter kindly forward this mail to the correct agency.

 

I look forward to hearing from you.

 

Best regards.

 

If you are not moving forward, you are really moving backward.

Y Udaya Chandar

 

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News Network
April 29,2020

Apr 29: US President Donald Trump doubled down on China for failing to tame the coronavirus at its very origin, saying it has led to 184 countries "going through hell", as several American lawmakers demanded steps to reduce dependence on Beijing for manufacturing and minerals.

Trump has been publicly blaming China for the global spread of the "invisible enemy" and launched an investigation against it. He has also indicated that the US may be looking at "a lot more money" in damages from China than the USD 140 billion being sought by Germany from Beijing for the pandemic.

Leaders of the US, the UK and Germany believe that the deaths and the destruction of the global economy could have been avoided, had China shared the information about the virus in its early phases.

"It's in 184 countries, as you hear me say often. It's hard to believe. It's inconceivable," Trump told reporters at White House Tuesday. "It should have been stopped at the source, which was China. It should have been stopped very much at the source, but it wasn't. And now we have 184 countries going through hell.”

The virus, which originated in China's Wuhan city in mid-November, has killed more than two lakh people and infected over three million globally. The largest number of them are in the US: nearly 59,000 deaths and over one million infections.

The massive outbreak in the US has put Trump under increasing pressure from American lawmakers to decrease US dependence on Beijing and they have also sought compensation from China.

Senator Ted Cruz and his colleagues have urged Defence Secretary Mark Esper and Interior Secretary David Bernhardt to support the development of a fully domestic supply chain of rare earths and other minerals that are critical for manufacturing defence technologies and supporting national security.

“It is clear that our dependence on China for vital rare earths threatens our US manufacturing and defence-industrial base. As the October 2018 Defence Industrial Base Report states: ‘China represents a significant and growing risk to the supply of materials deemed strategic and critical to US national security.' [...] Ensuring a US supply of domestically sourced rare earths will reduce our vulnerability to supply disruptions that poses a grave risk to our military readiness," the Senators wrote.

The US is 100 percent import-dependent for rare earths as well as 13 other metals and minerals on the US Government Critical Minerals List and more than 75 percent import reliant for an additional 10 minerals.

Congressman Brian Mast on Tuesday introduced a legislation to hold China accountable for its "coronavirus deception". The resolution would empower the US to withhold payments on debts owed to China equal to the costs incurred by the US in response to COVID-19.

“China's total lack of transparency and mishandling of the coronavirus outbreak has cost tens of thousands of lives, millions of jobs and left untold economic destruction. Congress must hold China accountable for their cover-up and force them to pay back the taxpayer dollars that have been spent as a result,” Mast said.

Cruz, member of the Senate Foreign Relations Committee, announced his intention to introduce a legislation to cut off Hollywood studios from assistance they receive from the Department of Defence if those studios censor their films for screening in China.

This legislation is part of Sen. Cruz's comprehensive push to combat China's growing influence over what Americans see and hear, which includes legislation targeting information warfare from the Chinese Communist Party across higher education, sports, films, radio broadcasts, and more.

Indian-American Congressman Ami Bera and Congressman Ted S. Yoho, both members of the House Foreign Affairs Committee, will lead a bipartisan virtual Special Order to highlight the importance of US global leadership during the COVID-19 pandemic.

“If we abdicate our place as a leader in global health, there is another country eager to take the reins. China has not been subtle in asserting itself on global health issues, and often not for the benefit of other nations. China's recent coronavirus debacle should be evidence enough that their communist regime cannot be trusted to lead with accountability, transparency, or pragmatism, traits that are essential when fighting widespread disease,” Yoho said.

“As for how China would fare as a global health leader, look no further than the disastrous initial response by the WHO to coronavirus, one that was clearly influenced by Beijing. Information was slow-walked, warnings from nations like Taiwan were ignored at crucial turning points, and cooperation with outside health experts was spurned until it was too late. And it has resulted in the largest public health disaster the world has seen in over a century,” he said.

In an interview to Fox News, Senator Marco Rubio alleged that if China had acted when those warnings were being made, instead of silencing the people that were talking about it, they could have limited the spread.

“So there was no doubt that that was a deliberate decision made on their part. The one way to hold them accountable is to do what we should be doing anyway. That is moving the means of production to become less and less dependent upon them. What you're going to see after this pandemic is that more and more countries are going to prioritize their healthcare manufacturing capabilities and other industries,” he said.

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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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Agencies
February 10,2020

Hubei, Feb 10: The death toll in the deadly coronavirus outbreak in China and other parts of the world has reached 904, CNN reported citing Chinese authorities on Monday.

The number of infected people globally has now hit the 40,000 mark.

According to the country's health officials, the number of people, who died from coronavirus in the Hubei Province, has risen to 871.

"As of 24:00 on February 9, Hubei Province reported a total of 29,631 cases of new coronavirus pneumonia, including 16,902 cases in Wuhan. 22,160 patients are still being treated in hospitals. 73,127 people remain under medical observation," read the statement from the Chinese Regional Health Committee.

The novel coronavirus was first detected in China's Wuhan city in late December and has since spread to more than 25 countries.

On Sunday, the new coronavirus even surpassed the fatalities caused by the SARS epidemic in 2003.

The World Health Organisation (WHO) has declared a global health emergency in the wake of the outbreak.

Meanwhile, WHO's international expert mission led by Dr Bruce Aylward embarked for China.

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