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
March 28,2020

Washington, Mar 28: The world is in the face of a devastating impact due to the coronavirus pandemic and has clearly entered a recession, the International Monetary Fund said on Friday, but projected a recovery next year.

"We have reassessed the prospects for growth for 2020 and 2021. It is now clear that we have entered a recession as bad or worse than in 2009. We do project recovery in 2021," IMF Managing Director Kristalina Georgieva told reporters at a news conference.

Georgieva was addressing the press after a meeting of governing body of the IMF, the International Monetary and Financial Committee. Representing 189 members, the body met virtually to discuss the unprecedented challenge posed to the world by COVID-19.

The key to recovery in 2021, she said, is only if the international community succeeds in containing the virus everywhere and prevent liquidity problems from becoming a solvency issue.

"The US is in recession, as is the rest of the advanced economies of the world. And in a big chunk of developed and emerging markets in developing economies. How severe? We are working now on our projections for 2020, Georgieva said in response to a question.

The new projections are expected in the next few weeks.

Stressing that while containment is the main reason for the economy to stand still and get into a recession, she said containment is very necessary to come out of this period and step in to recovery. "Until the virus is not contained, it would be very difficult to go to the lives we love."

"A key concern about a long-lasting impact of the sudden stop of the world economy is the risk of a wave of bankruptcies and layoffs that not only can undermine the recovery. But can erode the fabric of our societies," the IMF chief said.

To avoid this from happening, many countries have taken far-reaching measures to address the health crisis and to cushion its impact on the economy, both on the monetary and on the fiscal side, she said.

The IMF chief said 81 emergency financing requests, including 50 from lower-income countries, have been received. She said current estimate for the overall financial needs of emerging markets is 2.5 trillion dollars.

"We believe this is on the lower end. We do know that their own reserves and domestic resources will not be sufficient," she added.

The G-20, a day earlier, reported fiscal measures totalling some 5 trillion dollars or over 6 per cent of the global GDP.

Responding to another question, Georgieva said the IMF is projecting recession for 2020.

"We do expect it to be quite deep and we are very much urging countries to step up containment measures aggressively so we can shorten the duration of this period of time when the economy is in standstill," she said.

"And also to apply well-targeted measures, primarily focusing on the health system to absorb that enormous stress that comes from coronavirus. And on people, businesses and the financial system, I am very pleased to say that when we went through countries' responses, that sense of targeted fiscal measures is there and are also very impressive to see the size of these measures," she added.

"Countries are doing all they can on the fiscal and on the monetary front. We have heard from our members' very impressive decisions taken over the last days," the IMF chief said.

"We also want to caution that as we are responding now, we want to make the recession as possibly short and not too deep. We also want to think about what is going to follow the recovery and make sure that we are putting forward measures that can be supportive in this regard," she said.

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News Network
June 19,2020

United Nations, Jun 19: Half of the world's children -- one billion every year -- are affected by physical, sexual or psychological violence, suffering injuries and death because countries have failed to follow established strategies to protect them, the first report of its kind from the UN has said, with experts noting that the coronavirus-related lockdowns have left far too many youngsters stuck with their abusers.

While nearly all countries (88 per cent) have laws in place to protect minors, less than half (47 per cent) say they strongly enforce them, said the Global Status Report on Preventing Violence Against Children 2020 launched on Thursday.

Because countries have failed to follow established strategies to protect children, about one billion are affected each year by physical, sexual or psychological violence, it said.

"There is never any excuse for violence against children," WHO Director-General Tedros Adhanom Ghebreyesus said.

"We have evidence-based tools to prevent it, which we urge all countries to implement. Protecting the health and well-being of children is central to protecting our collective health and well-being, now and for the future," he said.

The report -- launched by the World Health Organisation, the UNICEF, the UNESCO, the Special Representative of the UN Secretary-General on Violence against Children and the End Violence Partnership -- charted progress in 155 countries against the "INSPIRE" framework, a set of seven strategies for preventing and responding to violence against children.

The report signaled a clear need in all countries to scale up efforts to implement them. It included the first ever global homicide estimates specifically for children under 18 years of age -- previous estimates were based on data that included 18 to 19-year olds.

According to the findings, in 2017, around 40,000 children were victims of homicide.

"Violence against children has always been pervasive, and now things could be getting much worse," UNICEF Executive Director Henrietta Fore said.

"Lockdowns, school closures and movement restrictions have left far too many children stuck with their abusers, without the safe space that school would normally offer. It is urgent to scale up efforts to protect children during these times and beyond, including by designating social service workers as essential and strengthening child helplines," she said.

UNESCO Director-General Audrey Azoulay said during the COVID-19 pandemic, and the related school closures, "we have seen a rise in violence and hate online – and this includes bullying".

"Now, as schools begin to re-open, children are expressing their fears about going back to school. It is our collective responsibility to ensure that schools are safe environments for all children. We need to think and act collectively to stop violence at school and in our societies at large," Azoulay said.

Stay-at-home measures including school closures have limited the usual sources of support for families and individuals such as friends, extended family or professionals.

This further erodes victims’ ability to successfully cope with crises and the new routines of daily life. Spikes in calls to helplines for child abuse and intimate partner violence have been observed, the report said.

While online communities have become central to maintain many children's learning, support and play, an increase in harmful online behaviors including cyberbullying, risky online behavior and sexual exploitation have been identified.

“Whilst this report was being finalised, confinement measures and the disrupted provision of already limited child protection services exacerbated the vulnerability of children to various forms of violence," said Najat Maalla M’jid, Special Representative of the UN Secretary-General on Violence against Children.

Of the INSPIRE strategies, only access to schools through enrolment showed the most progress with 54 per cent of the countries reporting that a sufficient number of children in need were being reached in this way.

Between 32 per cent and 37 per cent of the countries considered that victims of violence could access support services, while 26 per cent of the countries provided programmes on parent and caregiver support; 21 per cent of the countries had programmes to change harmful norms; and 15 per cent of the countries had modifications to provide safe physical environments for children, the report said.

Although a majority of countries (83 per cent) have national data on violence against children, only 21 per cent used these to set baselines and national targets to prevent and respond to violence against children, it added.

The report said about 80 per cent of countries have national plans of action and policies but only one-fifth have plans that are fully funded or have measurable targets. A lack of funding combined with inadequate professional capacity are likely contributing factors and a reason why implementation has been slow.

"Ending violence against children is the right thing to do, a smart investment to make - and it's possible. We can and must create a world where every child can thrive," Howard Taylor of the End Violence Partnership 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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