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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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 24,2020

Kathmandu, Jul 24: At least 132 people lost their lives as a result of heavy rains triggering landslides, and flash floods in Nepal.

"132 people dead, 128 injured, 53 missing and 998 families affected due to rainfall, landslides and floods in the country as of 23rd July," Nepal Disaster Risk Reduction and Management Authority Within the last two weeks, the Myagdi district of western Nepal was the worst affected with 27 reported deaths.

Search and rescue operations are being conducted continuously with officials and police personnel who are looking through the debris to find missing people.

Monsoon-induced disasters are common in Nepal owing to the country's mountainous topography. Hundreds have been displaced as landslides have swept away their homes. They ended up taking refuge in local schools and community centers.

Nepal's Meteorological Forecasting Division earlier last week had predicted heavy downpour across the country. The Division had warned of monsoon winds being near the low-pressure line in the Terai belt, which would consequently cause more rainfall.

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News Network
April 2,2020

United Nations, Apr 2: The global economy could shrink by up to one per cent in 2020 due to the coronavirus pandemic, a reversal from the previous forecast of 2.5 per cent growth, the UN has said, warning that it may contract even further if restrictions on the economic activities are extended without adequate fiscal responses.

The analysis by the UN Department of Economic and Social Affairs (DESA) said the COVID-19 pandemic is disrupting global supply chains and international trade. With nearly 100 countries closing national borders during the past month, the movement of people and tourism flows have come to a screeching halt.

"Millions of workers in these countries are facing the bleak prospect of losing their jobs. Governments are considering and rolling out large stimulus packages to avert a sharp downturn of their economies which could potentially plunge the global economy into a deep recession. In the worst-case scenario, the world economy could contract by 0.9 per cent in 2020," the DESA said, adding that the world economy had contracted by 1.7 per cent during the global financial crisis in 2009.

It added that the contraction could be even higher if governments fail to provide income support and help boost consumer spending.

The analysis noted that before the outbreak of the COVID-19, world output was expected to expand at a modest pace of 2.5 per cent in 2020, as reported in the World Economic Situation and Prospects 2020.

Taking into account rapidly changing economic conditions, the UN DESA's World Economic Forecasting Model has estimated best and worst-case scenarios for global growth in 2020.

In the best-case scenario with moderate declines in private consumption, investment and exports and offsetting increases in government spending in the G-7 countries and China global growth would fall to 1.2 per cent in 2020.

"In the worst-case scenario, the global output would contract by 0.9 per cent instead of growing by 2.5 per cent in 2020," it said, adding that the scenario is based on demand-side shocks of different magnitudes to China, Japan, South Korea, the US and the EU, as well as an oil price decline of 50 per cent against our baseline of USD 61 per barrel.

The severity of the economic impact will largely depend on two factors - the duration of restrictions on the movement of people and economic activities in major economies; and the actual size and efficacy of fiscal responses to the crisis.

A well-designed fiscal stimulus package, prioritising health spending to contain the spread of the virus and providing income support to households most affected by the pandemic would help to minimise the likelihood of a deep economic recession, it said.

According to the forecast, lockdowns in Europe and North America are hitting the service sector hard, particularly industries that involve physical interactions such as retail trade, leisure and hospitality, recreation and transportation services. Collectively, such industries account for more than a quarter of all jobs in these economies.

The DESA said as businesses lose revenue, unemployment is likely to increase sharply, transforming a supply-side shock to a wider demand-side shock for the economy.

Against this backdrop, the UN-DESA is joining a chorus of voices across the UN system calling for well-designed fiscal stimulus packages which prioritize health spending and support households most affected by the pandemic.

Urgent and bold policy measures are needed, not only to contain the pandemic and save lives, but also to protect the most vulnerable in our societies from economic ruin and to sustain economic growth and financial stability, Under-Secretary-General for Economic and Social Affairs Liu Zhenmin said.

The analysis also warns that the adverse effects of prolonged economic restrictions in developed economies will soon spill over to developing countries via trade and investment channels.

A sharp decline in consumer spending in the European Union and the United States will reduce imports of consumer goods from developing countries.

Developing countries, particularly those dependent on tourism and commodity exports, face heightened economic risks. Global manufacturing production could contract significantly, and the plummeting number of travellers is likely to hurt the tourism sector in small island developing States, which employs millions of low-skilled workers, it said.

Meanwhile, the decline in commodity-related revenues and a reversal of capital flows are increasing the likelihood of debt distress for many nations. Governments may be forced to curtail public expenditure at a time when they need to ramp up spending to contain the pandemic and support consumption and investment.

UN Chief Economist and Assistant Secretary-General for Economic Development Elliot Harris said the collective goal must be a resilient recovery which puts the planet back on a sustainable track. We must not lose sight how it is affecting the most vulnerable population and what that means for sustainable development, he said.

The alarms raised by UN-DESA echo another report, released on March 31, in which UN experts issued a broad appeal for a large-scale, coordinated, comprehensive multilateral response amounting to at least 10 per cent of global gross domestic product (GDP).

According to estimates by the Johns Hopkins University, confirmed coronavirus cases across the world now stand at over 932,600 and over 42,000 deaths.

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