Hubei, China’s first locked-down province to reopen on March 25

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The War Against Coronavirus is being successfully waged in countries. Thousands of scientists in countries are working round-the-clock while drugs are being tested at different levels including clinical test by Chinese and Russian scientists.

China is lifting travel restrictions on Hubei Province on Wednesday, as China’s fight against coronavirus, officially designated Covid-19, and is yielding positive results. Even constraints on the city of Wuhan, where the virus first emerged, will be lifted in April.

Residents will once again be allowed to travel in and out of the Hubei Province starting from March 25, the regional health commission announced on Tuesday.

Travel bans in the region’s capital, Wuhan, where the coronavirus outbreak started, will be lifted on April 8.

Wuhan was the first city in China to be quarantined, and along with several of Hubei’s other major cities, remained on lockdown since late January as part of a nationwide effort to slow down the spread of the disease.

China embarks on clinical trial for virus vaccine

China has started the first phase of a clinical trial for a novel coronavirus vaccine, records show, as the world’s scientists race to find a way to combat the deadly pathogen.

It comes after U.S. health officials said last week they had started a trial to evaluate a possible vaccine in Seattle.

The Chinese effort began on March 16 – the same day as the US announcement – and is expected to continue until the end of the year, according to a filing in the country’s Clinical Trial Registry, dated March 17.

“Volunteers of the COVID-19 phase one trial have already started receiving the vaccine,” a staff member involved in the government-funded project told AFP on Sunday.

The 108 participants, aged between 18 and 60, will be tested in three groups and given different dosages. They are all residents of the central city of Wuhan, where the new coronavirus first emerged late last year.

Pharmaceutical companies and research labs around the world are working at full tilt.

There are currently no approved vaccines or medication for the new disease.

The vaccine trial announcements come amid an escalating feud between the US and China over the pandemic, with President Donald Trump enraging Beijing by speaking of the “Chinese virus.”

An antiviral treatment called remdesivir, made by US-based Gilead Sciences, is already in the final stages of clinical trials in Asia and doctors in China have reported it has proven effective in fighting the disease.

Only randomized trials will allow scientists to know for sure if it really helps or whether patients would have recovered without it.

Russian coronavirus vaccine passes first phase of development – expected to be ready in ’11 months’

On Monday, some potentially good news came from Moscow where hopes are high that progress has been made on a vaccine.

The head of the Russian Federal Biological Medical Agency (FMBA), Veronika Skvortsova, announced that the remedy should be available before the end of next winter. The FMBA has two teams — in Moscow and Saint Petersburg — working simultaneously on the project.

“I would like to tell you about the development of the vaccine. The development of the vaccine has gone through the first phase,” Skvortsova told news agency TASS.

She added that all stages of testing and development will end in June, with the preparation of the remedy to be completed around the middle of fall.

This is a “recombinant vaccine, [which comes] not from a live virus, but from proteins that have so-called ‘epitopes,’ or virus-binding sites,” she stated. An epitope is the part of the antigen’s macro-molecule that is recognized by the immune system.

The FMBA’s mission is to protect public health and safety in Russia, with special responsibility for disease control and prevention. Skvortsova was Russian Health Minister, for eight years until stepping down in January. In 2017, she was elected as the 70th President of the World Health Organization.

As the first coronavirus vaccine human trials begin, manufacturer is preparing to produce millions

Last week, in the U.S, as the first volunteers in a study of an experimental coronavirus vaccine received their first doses the vaccine’s developer, Moderna Therapeutics, is already making plan for mass production.

Although testing on the vaccine will take at least a year to complete, the work could provide valuable information about how the immune system can fight coronavirus and could give scientists a head start if any new outbreaks of the virus were to occur.

Staff involved in manufacturing what may be the first vaccine against the coronavirus are preparing to scale up production of the vaccine at Moderna Therapeutics’ manufacturing facility, in Norwood, Mass., if the first phase of testing on the vaccine shows that it’s safe.

The vaccine will be studied first in a group of 45 healthy volunteers, who have not been infected with SARS-CoV-2, the virus that causes COVID-19.

In this group, scientists are looking to see if the shots are safe, and to test three different dosages to see which seems to activate the strongest immune response. If these initial subjects do not develop any severe side effects or reactions, then researchers will recruit hundreds more healthy volunteers to confirm those results,

For the first phase, Moderna shipped hundreds of vials of the test vaccine to the U.S. National Institutes of Health (NIH), which is overseeing the study in multiple centers in the US. For the next, it will be several folds, maybe five-fold larger than the first phase. .

And if the vaccine proves not just safe, but also successful, the company is preparing for an anticipated “incredible demand to scale up the vaccine very, very quickly,” Hoge says, “we have already started to do work to scale up to producing millions of doses.”

That has made possible, in part, by the non-traditional technology used to make this particular vaccine. Moderna uses mRNA, a genetic form of the virus’ genome, in its vaccine. When it is injected into people, cells then process it so immune cells can recognize it and target it for destruction. Unlike the processes used to make most traditional vaccines, this method does not require growing huge amounts of the virus, which is time-consuming.

It is also, why the vaccine was developed in record time. Chinese researchers first posted the genetic sequence of SARS-CoV-2 in mid-January, and by February 7, Moderna had vials of the vaccine ready for the standards testing needed before the treatment could be cleared for human trials.

By the last week of February, the company sent vials to NIH for further review by its scientists.

Then both Moderna and NIH filed for a request to the Food and Drug Administration, which regulates trials of experimental therapies, to start injecting the vaccine in people for human testing.

Hogue is hopeful that his team can continue to shave valuable time off the process while producing a safe and effective vaccine. “The original goal when Dr. Anthony Fauci [director of the NIH’s National Institute of Allergy and Infectious Diseases] first announced the vaccine, was to get it into humans in roughly three months. We managed to do that in 63 days, so we already demonstrated the ability to move a little faster than expectations,” he says. “We have an ethical responsibility to build the data and show the vaccine is safe and effective, and to do that in a sequential way. Still, every chance we have to continue to demonstrate that we can pull the timeline in, we will take.”

Testing on patients who have contracted the virus may still be months away, and Fauci predicts that the trials may not conclude for another 12-18 months. In the meanwhile, every week, day and minute count. “From the very beginning, this was a race, a race against the virus,” says Hoge. “If there is anything we learned in the past month, it’s that we need to keep pressing every time advantage that we can.”

Coronavirus vaccine trials ‘to begin at British science base next week’

Scientists in the UK will start testing a vaccine for coronavirus this week.

The drug produced at Oxford University will initially be tested on animals at the Porton Down Science Campus, in Wiltshire, and if all goes well human trials will begin next month, the Times reported.

The second phase on humans will reportedly be fast-tracked before results are known for previous tests on animals due to the severity of the pandemic.

But the drug will only be approved once expanded Phase III trials are completed but key workers may have access to the vaccine earlier.

Researchers from Public Health England’s (PHE) and Liverpool and Bristol universities have already managed to produce a replica of COVID-19 that will be used in the tests.

Director of Oxford’s Jenner Institute Adrian Hill admitted the process to get a vaccine approved was being accelerated.

He told the Guardian: “We will follow all standard trial safety requirements, but as soon as we have a vaccine that’s working, we anticipate there will be an accelerated pathway to get it deployed to save lives.”

“The more vaccine we can provide sooner, the better,” he said.

Thousands of scientists are racing to find a vaccine for coronavirus and 41 possibilities are in the work

A report by Elizabeth Weise in USA TODAY on March 20, 2020 said:

There is an all-out effort by thousands of scientists worldwide working to create vaccines against the coronavirus, in what in research terms is a blindingly fast response to the global threat. As of last week, the World Health Organization had posted a list of 41 possible vaccine candidates on its site.

It will be at least a year to 18 months before any vaccine is ready for large-scale use, according to most estimates. Before being deployed, vaccines must go through multiple rounds of testing to make sure they are safe, effective and do not have unintended consequences.

Researchers are not starting from scratch. Work on two previous coronaviruses, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS) provide a road map for how to create an immune response to SARS-CoV-2, the virus that causes the illness COVID-19.

The process was immensely sped up by the decision of professor Yong-Zhen Zhang at the Shanghai Public Health Clinical Center in China to publish the virus’ genome on January 10.

Early financial support from the Oslo-based Coalition for Epidemic Preparedness Innovations (CEPI), a nonprofit global partnership to develop vaccines, also has been crucial.

Several companies and groups are off to strong starts, particularly those already working on SARS and MERS vaccines. Here are some of the noteworthy efforts underway:

Moderna

This Boston-based company already was working on RNA therapies and vaccines. It began working with the National Institutes of Allergy and Infectious Disease in February to create an experimental SARS-CoV-2 vaccine. It began testing its first vaccine candidate on humans Monday. If after several weeks it appears to be safe, another round of testing will begin to see whether it stimulates their immune system to make antibodies against the virus. It was one of three groups that received funding for the effort January 23 from the CEPI.

University of Queensland, Australia

The Australian research group was working on “molecular clamp” vaccines against MERS for several years and had a version showing results in animal studies. It got funding from CEPI and retooled its research for SARS-CoV-2 in February. The “clamp” method uses a sequence of amino acids to lock down the spikes SARS-CoV-2 uses to infect cells, allowing the immune system to target it before the virus can activate itself. Testing of the trial vaccine in mice is underway. The group is hoping to begin human trials by mid-year.

Inovio

This Pennsylvania-based biotech company also received one of the early CEPI grants. Inovio, was working on a DNA-based vaccine against MERS. The company president said it designed a COVID-19 vaccine in three hours after the genetic sequence was published by the Chinese. The company plans to begin human trials in April.

CureVac

This German-based company was in the news last week after reports surfaced President Donald Trump suggested the U.S. might buy access to its vaccines only for Americans. CureVac, which was mainly working on anti-cancer vaccines, uses messenger RNA to make vaccines. It signed a development agreement with CEPI on January 31 to work on SARS-CoV-2. The company hopes to have a possible vaccine ready to test within several months.

Novavax

Maryland-based Novavax was working on vaccines against SARS and MERS. On March 10, it announced a $4 million award from CEPI to work on a SARS-CoV-2 vaccine. It hopes to begin testing in late spring.

Oxford University

A team at Oxford’s Jenner Institute in Britain is creating SARS-CoV-2 vaccine seed stock in conjunction with Italian medical product manufacturer Advent. The Jenner Institute was working on a vaccine against MERS and currently has a trial underway in Saudi Arabia.

EU Horizon 2020 consortium

A large consortium of European research universities and biotech companies is working on a vaccine for SARS-CoV-2. The effort received nearly $3 million in European funding on March 9 and includes German, Dutch and Danish universities and biotech companies.

GlaxoSmithKline

This UK-based company is one of the world’s largest vaccine producers. It has signed an agreement with CEPI to bring GSK’s adjuvant system into the SARS-CoV-2 mix. Adjuvants can be added to vaccines to boost the immune response they produce. This could decrease the amount of vaccine (once one becomes available) needed per dose, allowing more doses to be produced more quickly.

Academy of Military Medical Sciences 

Researchers at the China’s Academy of Military Medical Sciences are working with scientists at CanSino Biologics, a Hong Kong-based biotech company that licensed a vaccine for the Ebola virus in 2017. According to China’s clinical trial registration database, the experimental COVID-19 vaccine is in the early stages of safety testing and tests were approved to begin on March 17.

Search for coronavirus vaccine becomes a global competition

A report by David E. Sanger, David D. Kirkpatrick, Sui-Lee Wee and Katrin Bennhold in The New York Times on March 20, 2020 said:

A global arms race for a coronavirus vaccine is underway.

In the three months since the virus began its deadly spread, China, Europe and the United States have all set off at a sprint to become the first to produce a vaccine. But while there is cooperation on many levels — including among companies that are ordinarily fierce competitors — hanging over the effort is the shadow of a nationalistic approach that could give the winner the chance to favor its own population and potentially gain the upper hand in dealing with the economic and geostrategic fallout from the crisis.

What began as a question of who would get the scientific accolades, the patents and ultimately the revenues from a successful vaccine is suddenly a broader issue of urgent national security. And behind the scramble is a harsh reality: Any new vaccine that proves potent against the coronavirus — clinical trials are underway in the United States, China and Europe already — is sure to be in short supply as governments try to ensure that their own people are the first in line.

In China, 1,000 scientists are at work on a vaccine. Researchers affiliated with the Academy of Military Medical Sciences have developed what is considered the nation’s front-runner candidate for success and is recruiting volunteers for clinical trials.

China “will not be slower than other countries,” Wang Junzhi, a biological products quality control expert with the Chinese Academy of Sciences, said Tuesday at a news conference in Beijing.

U.S. President Trump has talked in meetings with pharmaceutical executives about making sure a vaccine is produced on American soil, to assure the U.S. controls its supplies. German government officials said they believed he tried to lure a German company, CureVac, to do its research and production, if it comes to that, in the United States.

The company has denied it received a takeover offer, but its lead investor made clear there was some kind of approach.

Asked by the German magazine Sport 1 about how the contact with Trump had unfolded, Dietmar Hopp, whose Dievini Hopp BioTech Holding owns 80% of the company, said: “I personally didn’t speak to Mr. Trump. He spoke to the company and they immediately told me about it and asked what I thought of it, and I knew immediately that it was out of the question.”

The report of the approach was enough to prompt the European Commission to pledge another $85 million to the firm, which has already had support from a European vaccine consortium.

The same day, a Chinese company offered $133.3 million for an equity stake and other consideration from another German firm in the vaccine race, BioNTech.

“There has been a global wake-up call that biotechnology is a strategic industry for our societies,” Friedrich von Bohlen, the managing director of the holding company that owns 82% of CureVac.

Some experts view the geopolitical competition as healthy, as long as any successes are shared with the world — which government officials routinely assure they will be.

But they do not say how, or more important, when. And many analysts recall what happened during the swine flu epidemic in 2009, when a company in Australia that was among the first to develop a single-dose vaccine was required to satisfy demand in Australia before fulfilling export orders to the United States and elsewhere.

Executives of the world’s leading pharmaceutical companies said Thursday that they were working together and with governments to assure that a vaccine is developed as quickly as possible and distributed equitably. But they implored governments not to hoard a vaccine once it is developed, saying that to do so would be devastating for the broader goal of stamping out the coronavirus pandemic.

Speaking in a teleconference Thursday, executives from the five biggest pharmaceutical companies said they were working to increase the industry’s manufacturing abilities by sharing available capacity to ramp up production once a successful vaccine or antiviral is identified. They argued for multiple testing programs to increase the chances of success, and then for immediate licensing to allow a quick scaling up of production.

Once a vaccine is approved, “we’ll need to vaccinate billions of people around the world, so we are looking at alternatives to where and how we produce,” Loew said.

But it is governments that get to decide how a vaccine is approved, and where it can be sold.

“If countries say, ‘Gee, let’s try to lock up a supply so we can protect our populations,’ then it can be a challenge to get the vaccine to the places where it can make the most difference epidemiologically,” said Seth Berkley, the chief executive of GAVI, a nonprofit organization that supplies vaccines to developing countries.

All of which left unclear exactly what Trump sought from CureVac, if anything, and why the company ousted its American chief executive, Daniel Menichella, days after he met with the White House coronavirus task force, in a session where Trump dropped by. The White House declined to comment.

The company itself has issued carefully drafted denials of a takeover offer. “Maybe someone said something,” Von Bohlen said. “But there is no written offer from the United States.”

There did not need to be. The mere hint of it was enough to get European officials to offer more funding.

“The fact that other countries tried to buy that company shows that they are the front-runner in the research,” said Ursula von der Leyen, the president of the European Commission. “It is a European company — we wanted to keep it in Europe, it wanted to stay in Europe. It was very important to give it the necessary funding, and that has happened.”


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