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Trump calls on India to release Covid-19 drug hydroxychloroquine

Financial Times  /  April 5, 2020

President Trump called on India to release orders of hydroxychloroquine, an antimalarial drug that has been identified as a potential treatment for coronavirus.

India has tightened export restrictions on hydroxychloroquine to combat rising infections there.

Trump in a phone call with Indian prime minister Narendra Modi on Saturday requested more of the drug because the country made it in “large amounts”.

“I said I’d appreciate it if they would release the amounts that we ordered and they are giving it serious consideration,” said Trump.

India has prioritised the supply of the drug for its own use as it counts a growing number of cases that threatens to overwhelm its underfunded healthcare system. The world’s second most populous country of 1.37 billion people has reported almost 3,600 coronavirus infections with 99 deaths as of Sunday — triple its caseload from last week.

The Indian Council of Medical Research has recommended hydroxychloroquine, which is also used to treat lupus and rheumatoid arthritis, can be used as a preventive medication for Covid-19 high-risk individuals such as healthcare workers.

On March 25, India limited exports with some exceptions, including for orders with full advance payment and on humanitarian grounds. But on Saturday the commerce and industry ministry issued a circular prohibiting all exports of “hydroxychloroquine and formulations made from hydroxychloroquine . . . without any exception”.

In a separate notice on the same day, it also put restrictions on the export of diagnostic kits.

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Related reading:

US drugmaker doubled price on potential coronavirus treatment

Financial Times  /  March 19, 2020

The only US drugmaker that makes hydroxychloroquine, a potential treatment for the coronavirus that was touted by President Donald Trump raised the price by almost 100 percent in January, as the virus caused havoc across China.

Rising Pharmaceuticals, a New Jersey based company, increased the price of chloroquine — an antimalarial, which is one of the drugs that is being tested against Covid-19 — on January 23. The drug price rose 97.86 per cent to $7.66 per 250mg pill and $19.88 per 500mg pill. 

But Rising alleges the price rise was “coincidental” and it restored the old price once it realized that the drug might be in demand because of the outbreak. The reversal of the price lift has not yet shown through in the data. 

One executive claims the company had originally increased the price because it wanted to be able to invest in new manufacturing facilities to keep the drug on the market. 

“As soon as we saw the increase in demand and the potential that this was going to be utilized in the way some folks are projecting it to be, we rescinded that price increase to the same price it has been on the market for since 2015,” he said. 

Studies have shown encouraging results, including one in France released on Wednesday that hydroxychloroquine had accelerated recoveries and reduced how long patients were contagious. 

Michael Rea, chief executive of RxSavings Solutions, which provides software for employers to lower their drug bills, said: “Hiking drug prices at such a pivotal time in world history will not play well in the market for any companies partaking in that activity long term.” 

In December 2019, Rising Pharmaceuticals admitted price fixing in a case in Pennsylvania and agreed to pay $3m in fines and restitution. 

The executive speaking on behalf of the company said it is not promoting the drug as a treatment for coronavirus. But Rising received five times as many orders as usual in the last week and it is ramping up production in India to meet demand, purchasing “extraordinary amounts” of more active ingredients, bottles and labels. 

It’s easy to say, after an event, that someone “should have done” this or that. However, there do appear to be some valid points here.

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U.S. ‘wasted’ months before preparing for virus pandemic

Associated Press  /  April 5, 2020

WASHINGTON — As the first alarms sounded in early January that an outbreak of a novel coronavirus in China might ignite a global pandemic, the Trump administration squandered nearly two months that could have been used to bolster the federal stockpile of critically needed medical supplies and equipment.

A review of federal purchasing contracts by The Associated Press shows federal agencies waited until mid-March to begin placing bulk orders of N95 respirator masks, mechanical ventilators and other equipment needed by front-line health care workers.

By that time, hospitals in several states were treating thousands of infected patients without adequate equipment and were pleading for shipments from the Strategic National Stockpile.

That federal cache of supplies was created more than 20 years ago to help bridge gaps in the medical and pharmaceutical supply chains during a national emergency.

Now, three months into the crisis, that stockpile is nearly drained just as the numbers of patients needing critical care is surging. Some state and local officials report receiving broken ventilators and decade-old dry-rotted masks.

“We basically wasted two months,” says former health and human services (HHS) secretary Kathleen Sebelius.

As early as mid-January, U.S. officials could see that hospitals in China’s Hubei province were overwhelmed with infected patients, with many left dependent on ventilator machines to breathe. Italy soon followed, with hospitals scrambling for doctors, beds and equipment.

HHS refuses to respond to questions about why federal officials waited to order medical supplies until stocks were running critically low.

President Trump has asserted that the federal government should take a back seat to states when it comes to dealing with the pandemic.

Trump and his appointees have urged state and local governments, and hospitals, to buy their own masks and breathing machines, saying requests to the dwindling national stockpile should be a last resort.

“The notion of the federal stockpile was it’s supposed to be our stockpile,” Jared Kushner, the president’s son-in-law and adviser, said at a White House briefing Thursday. “It’s not supposed to be state stockpiles that they then use.” (???????????)

“States do not have the purchasing power of the federal government. They do not have the ability to run a deficit like the federal government. They do not have the logistical power of the federal government,” said Sebelius, who served as governor of Kansas before running the nation’s health care system.

Because of the fractured federal response to COVID-19, state governors say they’re now bidding against federal agencies and each other for scarce supplies, driving up prices.

“You now literally will have a company call you up and say, ‘Well, California just outbid you,’” Gov. Andrew M. Cuomo, D-N.Y., said Tuesday. “It’s like being on eBay with 50 other states, bidding on a ventilator.”

For nearly a month, Trump rebuffed calls from Cuomo and others to use his authority under the Defense Production Act to order companies to increase production of ventilators and personal protective equipment. He suggested the private sector was acting sufficiently on its own.

More than three months after China revealed the first COVID-19 cases, Trump finally relented last week, saying he will order companies to ramp up production of critical supplies. By then, confirmed cases of COVID-19 within the United States had surged to the highest in the world. Now, the number of people infected in the U.S. has climbed to more than 312,000 and deaths have topped 8,500.

Trump spent January and February playing down the threat from the new virus. He derided warnings of pandemic reaching the U.S. as a hoax perpetrated by Democrats and the media. As the World Health Organization (WHO) declared the outbreak a global public health emergency on Jan. 30, Trump assured the American people that the virus was “very well under control” and he predicted “a very good ending.”

His administration was so confident that Secretary of State Mike Pompeo announced on Feb. 7 that the U.S. government had airlifted nearly 18 tons of donated respirator masks, surgical masks, gowns and other medical supplies to China.

On Feb. 24, the White House sent Congress an initial $2.5 billion funding request to address the coronavirus outbreak. The next day, federal health experts at the Centers for Disease Control and Prevention (CDC) warned that the virus was spreading quickly in the U.S. and predicted that disruptions to daily life could be “severe,” including school and business closures.

Unfazed, HHS Secretary Alex Azar told lawmakers on Feb. 27 that “the immediate risk to the American public remains low.”

During those crucial early weeks when the U.S. could have been tracking the spread of the disease and containing it, hardly anyone was being tested after a series of federal blunders led to a shortage of tests and testing capacity, as AP reported last month.

Without data showing how widespread the disease was, federal and state governments failed to prepare.

By the middle of March, hospitals in New York, Seattle and New Orleans were reporting a surge in sick patients. Doctors and nurses took to social media to express their alarm at dwindling supplies of such basic equipment as masks and gowns.

Trump accused some Democratic governors of exaggerating the need and derided those that criticized the federal response as complainers and snakes.

“I want them to be appreciative,” Trump said on March 27.

At the start of the crisis, an HHS spokeswoman said the Strategic National Stockpile had about 13 million N95 respirator masks, which filter out about 95% of all liquid or airborne particles and are critical to prevent health care workers from becoming infected. That’s just a small fraction of what hospitals need to protect their workers, who normally would wear a new mask for each patient, but who now are often issued only one to last for days.

Trump during a White House briefing on March 26 claimed that he had inherited an “empty shelf” from the Obama administration, but added that “we’re really filling it up, and we fill it up rapidly.”

Federal purchasing records, however, show the Trump administration delayed ordering additional supplies until the virus had taken root and was spreading.

HHS first announced its intent to purchase 500 million N95 masks on March 4, with plans to distribute them over the next 18 months. The following day, Congress passed an $8.3 billion coronavirus spending bill, more than three times what the White House had originally asked for.

Eight days later, on March 13, Trump declared the outbreak a national emergency. That was almost six weeks after the WHO’s action. By then, thousands of U.S. schools had closed, the National Basketball Association had put its season on temporary hiatus and there were 1,700 confirmed cases of COVID-19 in the country.

The government had already sent tens of thousands of masks, gloves and gowns from the stockpile to Washington state, which was hit early with a coronavirus outbreak. But state officials even then said the supplies weren’t enough.

Federal contracting records show that HHS had made an initial order March 12 for $4.8 million of N95 masks from 3M, the largest U.S.-based manufacturer, which had ramped up production weeks earlier in response to the pandemic. HHS followed up with a larger $173 million order on March 21, but those contracts don’t require 3M to start making deliveries to the national stockpile until the end of April. That’s after the White House has projected the pandemic will reach its peak.

HHS refused this past week to say how many N95 masks it has on hand. But as of March 31, the White House said more than 11.6 million had been distributed to state and local governments from the national stockpile — about 90% of what was available at the start of the year.

Dr. Robert Kadlec, the assistant secretary for preparedness and response at HHS, testified before Congress last month that the country would need roughly 3.5 billion N-95 respirators to get through the pandemic, but the national supply chain then had just about 1% of that amount.

The Strategic National Stockpile was created in 1999 to prevent supply-chain disruptions for the predicted Y2K computer problems. It expanded after 9/11 to prepare for chemical, biological, radiological and nuclear attacks. Congress provided money in 2006 to prepare for a potential influenza pandemic, but much of that stock was used during the H1N1 flu outbreak three years later.

As AP reported last month, much of the world’s supply of N95 masks and other basic medical supplies is made in China, the first nation hit by COVID-19. As a result, the Chinese government required its producers to reserve N95 respirators for domestic use. China resumed exports of the precious masks only in recent days.

Experts are now worried the U.S. will also soon exhaust its supply of ventilators, which can cost upward of $12,000 each.

The White House said Tuesday that it had already distributed nearly half the breathing machines in the stockpile, which at the beginning of March had 16,660; some of them dated back to the flurry of post-9/11 purchasing. An additional 2,425 were out for maintenance.

Cuomo said New York may need as many as 40,000 ventilators to deal with the outbreak that is already overwhelming hospitals there.

Throughout March, governors and mayors of big cities urged Trump to use his authority under the Defense Production Act to direct private companies to ramp up production of ventilators. It wasn’t until last week that Trump finally said he would use that power to order General Motors to begin manufacturing ventilators — work the company had already announced was underway. But GM says its first ventilators won’t be available before the summer.

The federal government had made an effort to prepare for a surge in the need for ventilators, but it was allowed to languish. Since 2014, HHS has paid a private company, Respironics Inc., $13.8 million to develop a cheaper, less complicated ventilator that could be bought in bulk to replenish the national stockpile. In September, HHS placed a $32.8 million order with the Dutch-owned company for 10,000 of the new model, set for delivery by 2022, federal contracts show.

Respironics’ parent company, Royal Philips, said it’s planning to double U.S. production of ventilators to 2,000 a week by the end of May.

Steve Klink, a spokesman for Royal Philips in Amsterdam, said the company is now focused on producing its other commercial models and will deliver the first ventilators to the national stockpile by August, long after the White House projects COVID-19 cases will peak.

Trump, who pledged on March 27 that his administration would ensure that 100,000 additional ventilators would be made available “within 100 days,” said on Thursday that he’ll use the Defense Production Act to order Respironics and other ventilator makers to step up production.

It’s not clear that Trump’s order would translate into the 100,000 new ventilators he promised. In a House Oversight and Reform Committee briefing last week, top Federal Emergency Management Agency (FEMA) officials hedged, saying 100,000 ventilators would be available by late June “at the earliest.”

Cuomo predicted on Friday that New York would run out within days. With coronavirus deaths in his state surging, the governor vowed to use his authority to seize ventilators, masks and protective gear from private hospitals that aren’t utilizing them.

Meanwhile, federal health authorities are lowering standards.

New guidance from the Food and Drug Administration allows hospitals to use emergency ventilators typically used in ambulances and anesthesia gas machines in place of standard ventilators. The agency also said nightstand CPAP machines used to treat sleep apnea and snoring could also be used to keep coronavirus patients breathing, as a last resort.

The CDC advised health care workers last month to use homemade masks or bandanas if they run out of proper gear. Across the country, hospitals have issued urgent pleas for volunteers who know how to sew.

The Guardian   /  April 5, 2020

The US surgeon general warned the country on Sunday that it will face a “Pearl Harbor moment” in the next week, with an unprecedented numbers of coronavirus deaths expected coast to coast.

“The next week is going to be our Pearl Harbor moment. It’s going to be our 9/11 moment,” Jerome Adams said today.

“It’s going to be the hardest moment for many Americans in their entire lives, and we really need to understand that if we want to flatten that curve and get through to the other side, everyone needs to do their part.”

Adams’s thoughts were echoed by Dr Anthony Fauci, the country’s foremost infectious diseases expert.

“Things are going to get bad and we need to be prepared for that,” Fauci said. “It’s going to be shocking to some and it certainly is really disturbing to see that … Just buckle down. We’ve got to get through this week that is coming up because it’s going to be a bad week.”

On a positive note, New York state recorded 594 deaths on Saturday – down from 630 deaths the day before, the first day-on-day decrease since the pandemic began.

How much aid to we give India every year? Stop the aid and you will see how much of the drug we get,it just like every other country we give aid to and then I think that most of them vote against us when the UN has a vote.

 

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Using the University of Washington's Institute for Health Metrics's model , you can click on the down arrow in the "United States of America" box at the top to see detailed projections for each state. 

On another note, Bill Gates has a strong understanding of the situation.

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Financial Times  /  April 10, 2020

South Korea is desperately trying to find out why scores of cured coronavirus patients tested positive for the disease days later, raising questions over scientists’ understanding of the pandemic.

The Korea Centers for Disease Control this week is investigating why 51 people in the city and surrounding areas tested positive again.

Health officials do not believe the patients were reinfected or remained infectious.

“We say that a patient has fully recovered when he or she tests negative twice within 24 hours. But the fact that some of them tested positive again in a short period means that the virus remains longer than we thought.”

The surprise positive tests occurred between two days and two weeks after patients had been released from quarantine. Some had shown symptoms such as fevers and respiratory difficulties, while others were asymptomatic, officials said.

“There are just some things that we don’t know. Often when virus infections are waning, you will have intermittent positivity and negativity, particularly at the limit of detection . . . Maybe for infected people the government is going to need to look at that data, and say ‘we need two negative tests or three negative tests in a row over a week’.”

“We learn new things in the process of curing patients. At first, we thought that asymptomatic people don’t transmit the virus to others but we found in mid-February that we were wrong."

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The White House said yesterday that 11% of people under the age of 25, 17% of those in the 25 to 45 age group and 21% of those between 45 and 65 years who presented with symptoms have tested positive for Coronavirus.

Among people in the 65-85 age group, they reported 22% positive tests and a slightly higher 24% positivity level among people above 85 years of age.

Telling data is coming out of Iceland, thanks to its isolated location and sparse population.

Iceland has already tested 10% of its population, more than any other country.

Half of its citizens who have the coronavirus........are not showing any symptoms. That’s double the CDC’s recent estimate that as many as one in four people with COVID-19 may be asymptomatic.

 

3 hours ago, kscarbel2 said:

Telling data is coming out of Iceland, thanks to its isolated location and sparse population.

Iceland has already tested 10% of its population, more than any other country.

Half of its citizens who have the coronavirus........are not showing any symptoms. That’s double the CDC’s recent estimate that as many as one in four people with COVID-19 may be asymptomatic.

 

I read of Iceland got the same result when tested 1.3% of the population a couple of weeks back. They had 200 positive tested people with 100 non-symptomes. Now seems the fact continues standing the test of time.

Edited by Vladislav
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Никогда не бывает слишком много грузовиков! leversole 11.2012

Reuters  /  April 16, 2020

Parts of President Trump’s guidelines for re-opening the U.S. economy amid the coronavirus pandemic emerged on Thursday, revealing a three-phase plan that could allow some states to begin as early as this month lifting limits meant to contain the disease’s spread.

In the first phase of Trump’s guidelines, to be publicly unveiled on Thursday evening, larger venues like restaurants and movie theaters could operate again with strict social distancing, according to a copy seen by Reuters. Non-essential travel could resume and schools could open their doors again in phase two. In phase three medically vulnerable people could resume public interactions.

President Trump told governors of states that some could re-open their states by May 1 or earlier. He was also expected to soon announce hiring plans for tracking the disease’s spread

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Ending the US coronavirus lockdown too early could lead to an explosion of new coronavirus cases, according to an MIT study modelling the spread of the virus. 

Researchers from the Massachusetts Institute of Technology (MIT) created a model showing the spread of the deadly virus using publicly available data from Wuhan, Italy, South Korea and the USA.

The authors say that any immediate or near-term relaxation of quarantine measures already in place in the US would lead to an 'exponential explosion' in COVID-19 cases.

The model developed by the MIT team is the first to be based purely on COVID-19 data - all previous models used SARS and MERS information to chart the outbreak.

It uses a neural network to draw a direct correlation between quarantine measures and a reduction in the effective reproduction number of the virus. 

Most models predict the spread of disease by looking at people susceptible, exposed, infected and recovered but this model captures the number of infected individuals still in quarantine and unable to infect others.

This allows them to go beyond existing models and create a much more accurate system to predict the future impact of the virus if lockdowns are ended early.  

'Our model is the first which uses data from the coronavirus itself and integrates two fields: machine learning and standard epidemiology,' explains Raj Dandekar, a PhD candidate studying civil and environmental engineering. 

'The neural network is learning what we are calling the "quarantine control strength function".' 

It reveals that that in places like South Korea, where there was immediate government intervention in implementing strong quarantine measures, the virus spread plateaued more quickly. 

In contrast, places like the US and Italy where government interventions were slower the 'effective reproduction number' of COVID-19 was higher than one, meaning the virus has continued to spread exponentially. 

'Our model shows that quarantine restrictions are successful in getting the effective reproduction number from larger than one to smaller than one,' says Professor George Barbastathis. 

'That corresponds to the point where we can flatten the curve and start seeing fewer infections.' 

They predict COVID-19 infections will reach a plateau in the US and Italy next week but say this isn't a reason to relax lockdown measures already in place. 

The study authors say: 'Relaxing or reversing quarantine measures right now will lead to an exponential explosion in the infected case count.' 

New York Governor Andrew Cuomo has extended New York's coronavirus lockdown by two weeks until May 15.

Cuomo said on Thursday that while the rate of hospitalisations in New York is decreasing, it was still unclear how many people have actually been infected with COVID-19.

He said the unknown tally of infections is what is stopping him from reopening the economy because if people who don't know they are infected return to work, they risk infecting countless others and wiping out all the progress that has been made.   

According to Barbastathis, Singapore is a prime case study for the dangers that could stem from relaxing quarantine measures too quickly. 

While the team didn’t study Singapore’s COVID-19 cases in their research, 'the second wave of infection this country is currently experiencing reflects their model’s finding about the correlation between quarantine measures and infection rate.' 

'If the US were to follow the same policy of relaxing quarantine measures too soon, we have predicted that the consequences would be far more catastrophic,' Barbastathis adds.

The US shipped millions of masks to China earlier this year, despite warnings that a pandemic was about to hit

Michelle Mark, Business Insider  /  April 18, 2020

American manufacturers were encouraged by the United States government to ship millions of masks and other medical supplies to China this year, despite warnings that those items would soon be necessary, The Washington Post reported Saturday.

The US has for weeks suffered major shortages of protective items for frontline health care workers and first responders treating coronavirus patients. Meanwhile, hospitals and local US governments have reported major delays in receiving shipments of those products from China.

Doctors and nurses have reported widespread rationing and reusing of masks and other protective items, exposing them to increased risk of coronavirus transmission.

In January and February of 2020, US manufacturers exported $17.6 million in face masks and other vital medical supplies, according to a Post analysis of customs data.

"There's a possibility that the assault of the virus on our nation next winter will actually be even more difficult than the one we just went through. And when I've said this to others, they kind of put their head back, they don't understand what I mean. We're going to have the flu epidemic and the coronavirus epidemic at the same time."
 
CDC Director Robert Redfield

Oxford University-developed Coronavirus vaccine could be ready by September

The New York Times  /  April 27, 2020

In the worldwide race for a vaccine to stop the coronavirus, the laboratory sprinting fastest is at Oxford University.

Most other teams have had to start with small clinical trials of a few hundred participants to demonstrate safety. But scientists at Oxford University’s Jenner Institute had a head start on a vaccine, having proved in previous trials that similar inoculations — including one last year against an earlier coronavirus — were harmless to humans.

That has enabled them to leap ahead and schedule tests of their new coronavirus vaccine involving more than 6,000 people by the end of next month, hoping to show not only that it is safe, but also that it works.

The Oxford scientists now say that with an emergency approval from regulators, the first few million doses of their vaccine could be available by September — at least several months ahead of any of the other announced efforts — if it proves to be effective.

Now, they have received promising news suggesting that it might.

Scientists at the National Institutes of Health’s Rocky Mountain Laboratory in Montana last month inoculated six rhesus macaque monkeys with single doses of the Oxford vaccine. The animals were then exposed to heavy quantities of the coronavirus that is causing the pandemic — exposure that had consistently sickened other monkeys in the lab. But more than 28 days later all six were healthy, said Vincent Munster, the researcher who conducted the test.

“The rhesus macaque is pretty much the closest thing we have to humans,” Dr. Munster said, noting that scientists were still analyzing the result. He said he expected to share it with other scientists next week and then submit it to a peer-reviewed journal.

Immunity in monkeys is no guarantee that a vaccine will provide the same degree of protection for humans. A Chinese company that recently started a clinical trial with 144 participants, SinoVac, has also said that its vaccine was effective in rhesus macaques. But with dozens of efforts now underway to find a vaccine, the monkey results are the latest indication that Oxford’s accelerated venture is emerging as a bellwether.

“It is a very, very fast clinical program,” said Emilio Emini, a director of the vaccine program at the Bill and Melinda Gates Foundation, which is providing financial support to many competing efforts.

Which potential vaccine will emerge from the scramble as the most successful is impossible to know until clinical trial data becomes available.

More than one vaccine would be needed in any case, Dr. Emini argued. Some may work more effectively than others in groups like children or older people, or at different costs and dosages. Having more than one variety of vaccine in production will also help avoid bottlenecks in manufacturing, he said.

But as the first to reach such a relatively large scale, the Oxford trial, even if it fails, will provide lessons about the nature of the coronavirus and about the immune system’s responses that can inform governments, donors, drug companies and other scientists hunting for a vaccine.

“This big U.K. study,” Dr. Emini said, “is actually going to translate to learning a lot about some of the others as well.”

All of the others will face the same challenges, including obtaining millions of dollars in funding, persuading regulators to approve human tests, demonstrating a vaccine’s safety and — after all of that — proving its effectiveness in protecting people from the coronavirus.

Paradoxically, the growing success of efforts to contain the spread of Covid-19, the disease caused by the virus, may present yet another hurdle.

“We’re the only people in the country who want the number of new infections to stay up for another few weeks, so we can test our vaccine,” Prof. Adrian Hill, the Jenner Institute’s director and one of five researchers involved in the effort, said in an interview in a laboratory building emptied by Britain’s monthlong lockdown.

Ethics rules, as a general principle, forbid seeking to infect human test participants with a serious disease. That means the only way to prove that a vaccine works is to inoculate people in a place where the virus is spreading naturally around them.

If social distancing measures or other factors continue to slow the rate of new infections in Britain, he said, the trial might not be able to show that the vaccine makes a difference: Participants who received a placebo might not be infected any more frequently than those who have been given the vaccine. The scientists would have to try again elsewhere, a dilemma that every other vaccine effort will face as well.

The Jenner Institute’s coronavirus efforts grew out of Professor Hill’s so-far unsuccessful pursuit of a vaccine against a different scourge, malaria.

He developed a fascination with malaria and other tropical diseases as a medical student in Dublin in the early 1980s, when he visited an uncle who was a priest working in a hospital during the civil war in what is now Zimbabwe.

“I came back wondering, ‘What do you see in these hospitals in England and Ireland?’” Professor Hill said. “They don’t have any of these diseases.”

The major drug companies typically see little profit in epidemics that afflict mainly developing countries or run their course before a vaccine can hit the market. So after training in tropical medicine and a doctorate in molecular genetics, Professor Hill, 61, helped build Oxford’s institute into one of the largest academic centers dedicated to nonprofit vaccine research, with its own pilot manufacturing facility capable of producing a batch of up to 1,000 doses.

The institute’s effort against the coronavirus uses a technology that centers on altering the genetic code of a familiar virus. A classic vaccine uses a weakened version of a virus to trigger an immune response. But in the technology that the institute is using, a different virus is modified first to neutralize its effects and then to make it mimic the one scientists seek to stop — in this case, the virus that causes Covid-19. Injected into the body, the harmless impostor can induce the immune system to fight and kill the targeted virus, providing protection.

Professor Hill has worked with that technology for decades to try to tweak a respiratory virus found in chimpanzees in order to elicit a human immune response against malaria and other diseases. Over the last 20 years, the institute has conducted more than 70 clinical trials of potential vaccines against the parasite that causes malaria. None have yet yielded a successful inoculation.

In 2014, however, a vaccine based on the chimp virus that Professor Hill had tested was manufactured in a large enough scale to provide a million doses. That created a template for mass production of the coronavirus vaccine, should it prove effective.

A longtime colleague, Prof. Sarah Gilbert, 58, modified the same chimpanzee virus to make a vaccine against an earlier coronavirus, MERS. After a clinical trial in Britain demonstrated its safety, another test began in December in Saudi Arabia, where outbreaks of the deadly disease are still common.

When she heard in January that Chinese scientists had identified the genetic code of a mysterious virus in Wuhan, she thought she might have a chance to prove the speed and versatility of their approach.

“We thought, ‘Well, should we have a go?’” she recalled. “‘It’ll be a little lab project and we’ll publish a paper.’”

It did not stay a “little lab project” for long.

As the pandemic exploded, grant money poured in. All other vaccines were soon put into the freezer so that the institute’s laboratory could focus full-time on Covid-19. Then the lockdown forced everyone not working on Covid-19 to stay home altogether.

“The whole world doesn’t usually stand up and say, ‘How can we help? Do you want some money?’” Professor Hill said.

“Vaccines are good for pandemics,” he added, “and pandemics are good for vaccines.”

Other scientists involved in the project are working with a half dozen drug manufacturing companies across Europe and Asia to prepare to churn out billions of doses as quickly as possible if the vaccine is approved. None have been granted exclusive marketing rights, and one is the giant Serum Institute of India, the world’s largest supplier of vaccines.

Donors are currently spending tens of millions of dollars to start the manufacturing process at facilities in Britain and the Netherlands even before the vaccine is proven to work, said Sandy Douglas, 37, a doctor at Oxford overseeing vaccine production.

“There is no alternative,” he said.

But the team has not yet reached an agreement with a North American manufacturer, in part because the major pharmaceutical companies there typically demand exclusive worldwide rights before investing in a potential medicine.

“I personally don’t believe that in a time of pandemic there should be exclusive licenses,” Professor Hill said. “So we are asking a lot of them. Nobody is going to make a lot of money off this.”

The Jenner Institute’s vaccine effort is not the only one showing promise. Two American companies, Moderna and Inovio, have started small clinical trials with technologies involving modified or otherwise manipulated genetic material. They are seeking both to demonstrate their safety and to learn more about dosing and other variables. Neither technology has ever produced a licensed drug or been manufactured at scale.

Armed with safety data from their human trials of similar vaccines for Ebola, MERS and malaria, though, the scientists at Oxford’s institute persuaded British regulators to allow unusually accelerated trials while the epidemic is still hot around them.

The institute last week began a Phase I clinical trial involving 1,100 people. Crucially, next month it will begin a combined Phase II and Phase III trial involving another 5,000. Unlike any other vaccine project now underway, that trial is designed to prove effectiveness as well as safety.

The scientists would declare victory if as many as a dozen participants who are given a placebo become sick with Covid-19 compared with only one or two who receive the inoculation. “Then we have a party and tell the world,” Professor Hill said. Everyone who had received only the placebo would also be vaccinated immediately.

If too few participants are infected in Britain, the institute is planning other trials where the coronavirus may still be spreading, possibly in Africa or India.

“We’ll have to chase the epidemic,” Professor Hill said. “If it is still raging in certain states, it is not inconceivable we end up testing in the United States in November.”

MarketWatch  /  April 28, 2020

President Trump on Tuesday said he would sign an executive order to keep meat processing plants open.

The order is meant to stave off a shortage of chicken, pork and other meat on U.S. supermarket shelves because of the coronavirus. The order will use the Defense Production Act to classify meat processing as critical infrastructure to keep production plants open.

Trump said the order would address what he called “liability problems” in the food supply chain.

Meat-processing plants have weighed the risks of prosecution if they are blamed for spreading infection during the pandemic. Tyson, for example, suspended production at an Iowa pork processing plant due to a coronavirus outbreak among employees.

“We’re working with Tyson, which is one of the big companies in that world,” Trump said.

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Mainz, Germany-based BioNTech and US pharmaceutical Pfizer have begun human trials of a potential Covid-19 vaccine that could supply millions by the end of the year.

Pfizer says it will begin testing the experimental vaccine in the United States next week, and says a vaccine could be ready for emergency use in the fall.

The Trump administration plans to accelerate the development of a potential coronavirus vaccine and manufacture billions of doses by January.

The U.S.'s top infectious disease expert Dr. Anthony Fauci today said:

We're in the early phases of a trial — Phase 1. When you go into the next phase, we’re going to safely and carefully, but as quickly as we possibly can, try and get an answer as to whether it works and is safe. And if so, we’re going to start ramping up production with the companies involved. You don’t wait until you get an answer before you start manufacturing -- you at risk proactively start making it, assuming it’s going to work, and if it does, then you can scale up and hopefully get to that timeline. So we want to go quickly, but we want to make sure it’s safe and it’s effective. I think that is doable. Remember go back in time, I was saying in January and February that it would be a year to 18 months. January is a year — so it isn't that much from what I had originally said." 

Bloomberg  /  May 3, 2020

President Trump has raised the expected U.S. death toll from the Coronavirus to 100,000.

FEMA has ordered 100,000 body bags for next winter...........https://www.wsj.com/articles/u-s-buys-more-body-bags-preparing-for-worst-case-cornavirus-scenario-11588172780

U.S. Vice President Pence now says that he should have worn a mask when visiting the Mayo Clinic, per their policy.”

The White House is expecting 3,000 deaths a day by 1 June. Between 1,000 and 2,000 deaths are currently being reported in the US each day.

The Centers for Disease Control and Prevention (CDC) and Federal Emergency Management Agency (FEMA) are forecasting 200,000 new cases each day by the end of May, up from about 25,000 cases now.

https://www.nytimes.com/2020/05/04/us/coronavirus-live-updates.html

New York Governor Andrew Cuomo said Friday that Coronavirus arrived in his state from Europe and that 2.2 million people flew in from European countries in January and February, while the world was oblivious to the threat and assumed it could only come from China.  

Cuomo says that between January and March, 2.2 million people arrived in New York on flights from Europe. At the time, Europe was mistakenly not being considered a hotspot. 

“Last November, December... we knew China had an outbreak. Researchers now say the virus was spreading wildly in Italy in February. Researchers now say there were likely 28,000 cases in the US in February including 10,000 in the state of New York. It came from Europe. When you look at the number of flights that came from Europe to New York in January and February, up until the close down in March... 13,000 flights bringing 2.2 million people. We acted two months after the China outbreak. When you look back, does anyone think the virus was still in China, waiting for us to act? Two months later? We all talk about the global economy and how fast people move and how mobile we are. How can you expect that when you act two months after the outbreak. The horse had already left the barn by the time we moved. Those are the flights coming from Italy and Europe in January and February. We closed the front door with the China travel ban, which was right, but we left the backdoor open because the virus had left China by the time we did the China travel ban. That's what the researchers are now saying. What is the lesson? An outbreak anywhere is an outbreak everywhere. When you see November and December in China, just assume the next day that it's in the US. When they say it's in China, assume that the virus got on a plane that night and flew to New York or Newark and it's now in New York. That has to be the operating mentality because you don't know the virus didn't get on a plane. All you need is one person to get on that plane in China and come to New York. You can't assume two months after the virus is going to be sitting on a park bench in China waiting for you to get there. It will happen again. Bank on it. Let's not put our head in the sand and say this is the only global pandemic we'll ever have to deal with.”

Coronavirus was spreading silently through US cities including New York, Chicago, Boston, San Francisco and Seattle in February when the world was worried only about China.

Researchers from Northwestern University have estimated that based on lockdown orders, confirmed cases and people's traveling and moving habits, the true number of people infected across those five cities by March 1 was 28,000, even though only 23 cases had been confirmed at the time via testing. 

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