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Saturday, March 7, 2020

Public health experts warn of major disruptions from coronavirus

The coronavirus is sparking major disruptions around the world, closing schools, canceling events and causing havoc to the global economy.
Public health experts warn that Americans should also prepare for major disruptions as the number of cases tops 100,000.
Already, governments at home and around the world are taking drastic actions to limit the virus’s spread.
In China, the government has ordered travel restrictions and quarantines that have affected hundreds of millions of people. In South Korea, public gatherings have been banned.
Iran and Italy, sites of two major outbreaks, have closed schools. Regional officials in Italy have canceled Catholic Mass and soccer matches. Saudi Arabia has banned pilgrimages to Muslim holy sites.
“When Italy cancels Mass, you know that this is real, right? And that’s what they’ve done,” said Rebecca Katz, director of the Center for Global Health Science and Security at Georgetown University.
In the United States, a school district in the Seattle area has shuttered for two weeks, and the University of Washington said Friday it would cancel in-person classes. A cruise ship carrying 3,500 passengers and crew remained anchored off the coast of San Francisco after a passenger from a previous voyage became the first American to die of the virus. The National Basketball Association has urged players to avoid high-fives or accepting pens from fans to sign autographs.
Some public health experts said the virus is putting a new focus on state and local health departments, the front-line responders who must both confront the virus and also make significant decisions about what elements of everyday life get shut down.
“Public health entities have not been in the situation to make large-scale population-level decisions for about 100 years. The last time a health department was asked, ‘Should we quarantine your entire city or not,’ was 1918,” Katz said, referring to the Spanish flu outbreak that killed tens of millions around the globe.
Now, those departments have to consider taking drastic actions. In interviews with state health directors and secretaries last week, several said they were keeping their options open — including revisiting contingencies for shutting schools, canceling sporting events and concerts, and making preparations for the surrounding fallout.
“Many students receive their breakfast and lunch nutrition at school, free and reduced lunches. If we close schools, one of those impacts is student nutrition, and that’s a hard one to mitigate, but those are some of the factors we have to consider,” said John Wiesman, the Washington state secretary of health.
Katz said she was concerned that Americans have not yet fully grasped just how drastic the disruption might be, in part because the federal government has not offered strong guidance about the path ahead.
“The challenge here is the administration has taken a posture of keep calm and carry on, particularly if it influences the economy, and I am deeply concerned that we are not doing everything we need to do,” Katz said. “For weeks, we’ve been talking about don’t panic but prepare. And I think a lot of people in the U.S. have taken prepare as meaning go out and buy a lot of toilet paper.”
There are signs that the American public is willing to take drastic steps in order to protect themselves and their families. Polling conducted for the Centers for Disease Control and Prevention (CDC) in 2006 showed a huge majority of Americans would be willing to stay home for seven to 10 days if a member of their household was ill with a pandemic flu.
In that poll, conducted by the Harvard School of Public Health, more than three quarters of Americans said they would follow recommendations offered by public health officials that included significantly curtailing elements of their daily lives, like going to a mall, using transportation or even going to church.
“We know from influenza data that people are really willing to make life changes. They just need to know what to do,” said Prabhjot Singh, a health systems expert at the Mount Sinai Health System. “We’ve got a public that’s really willing to step up if it knows what it ought to do, and that means that state and local messaging down to the community level is probably the most important infrastructure we need to make sure is working right now, along with testing.”
Convincing an entire community to change its daily habits is difficult, public health experts say, but it can be done. During an Ebola outbreak in West Africa, health experts curtailed that virus’s spread by convincing residents to stop washing and burying their dead relatives, a major source of transmission that required communities to abandon centuries of tradition.
“People aren’t stupid. When they see people dying, they will change their behavior. What we want to do is communicate that before people start dying,” said Tom Frieden, the former CDC director who oversaw the American response to the Ebola outbreak and who now runs Resolve to Save Lives, a global public health nonprofit.
But health experts said delivering timely and actionable messages to prevent the spread of something like a coronavirus or a pandemic flu requires a consistent top-down message that has so far been lacking from the Trump administration.
Senior CDC officials and members of Trump’s Cabinet have demonstrated some of the behavior change likely to make a difference. Arriving in the Seattle area on Thursday, Vice President Pence shared an elbow bump with Gov. Jay Inslee (D), rather than shaking hands.
But Trump himself has raised questions about the cause for concern. On Wednesday, he offered a “hunch” that the virus was not as deadly as World Health Organization officials had suggested. In an interview on Fox News, he said “thousands or hundreds of thousands of people … get better just by, you know, sitting around and even going to work.” At a town hall meeting in Scranton, Pa., on Thursday, Trump shook hands with attendees.
State officials are taking firmer action. Inslee, whose state is suffering from the highest number of cases in the United States, signed an order extending workers compensation coverage to first responders who face quarantine after being exposed to the virus. California Gov. Gavin Newsom (D) has warned companies against price gouging on supplies like hand sanitizer.
“You have to make sure you are protecting individuals as much as you can. Making sure they’re protected against job loss and economic hardship and making sure that we’re thinking about vulnerable populations. What does it mean for the elderly, and what does it mean for prisons?” Katz said.
Maryland Gov. Larry Hogan (R) and Tennessee Gov. Bill Lee (R) have sought to calm residents Wednesday and Thursday as they announced the first confirmed cases in their states.
Public health experts pointed to China’s success in locking down its population, a harsh measure that has nonetheless contributed to a declining number of cases at the epicenter of the current outbreak. But China has an authoritarian government that controls its society with an iron grip. The United States does not.
The challenge in the United States is magnified, in part, because of constant tensions in the political system and a broad lack of trust in government institutions. That puts a premium on local governments, which are generally seen in a more positive light than a federal government riven by partisanship.
“If you don’t trust your institutions, then we have to be able to trust our neighbors and in a time of crisis what everybody’s assigned to do,” Singh said. “It’s your responsibility to know what to do, because we don’t live in an authoritarian society.”
https://thehill.com/policy/healthcare/486333-public-health-experts-warn-of-major-disruptions-from-coronavirus

Virus threat cancels classes at 2 big U.S. universities; more expected to follow

Class is out because of the coronavirus.
Major universities in two areas of high risk, Seattle and the San Francisco Bay Area, were shut down Friday — the beginning of what is expected to be a wave of campus closures in coming weeks.
Late Friday, Stanford University canceled classes for the last two weeks of the winter quarter, starting Monday. “To the extent feasible,” classes will be moved to “online formats in place of in-person instruction,” the university’s provost, Persis Drell, said. Stanford, with about 17,000 undergraduate and graduate students, confirmed a doctor in the medical school had the disease.
Earlier Friday, the University of Washington told its 50,000 students that courses would move online on Monday after a staffer tested positive for COVID-19. Seattle University, with 7,300 students, and the Seattle campus of Boston’s Northeastern University have also moved to online courses amid the outbreak. Washington state was the first to report a U.S. coronavirus case on Jan. 21. More than 84 people there are now infected, and 14 have died.
Meanwhile, another layer of schools with no reported coronavirus cases are testing online classes next week or warning students to be prepared for similar actions if they become necessary.
The University of Southern California on Friday said it would conduct lectures and seminars online rather than in classrooms March 11-13 as one of its “precautionary measures to ensure that we are prepared for any potential disruptions to teaching and learning at USC.”
Duke University issued a campus-wide alert Thursday with guidance for students leaving for spring break, advising them to cancel unnecessary travel and to avoid heavily populated events or venues.
Duke, the University of Chicago and New York University are asking students and faculty to register their travel plans, even locally.
Other schools are urging students to avoid leaving the country for spring break. Cornell University on Thursday advised “anyone who is planning to travel internationally for personal reasons to refrain from doing so.” The university said visitors from hard-hit countries, including China, South Korea, Italy, Iran and Japan, would not be allowed on its various campuses including the main one in Ithaca, N.Y.
Columbia University, which is also warning against international travel during spring break, is canceling spring campus tours for undergraduate admissions and programming for incoming, admitted students.
“Our campus does remain open. However, we are taking this temporary action to ensure the safety and well-being of our entire Columbia community and campus visitors,” the university said.
New York Law School temporarily closed its doors three days this past week, based on the concern that a student had come in contact with a lawyer who contracted COVID-19. The student in the Manhattan-based school tested negative, according to a Friday announcement. The campus has reopened, a spokeswoman said.
https://www.marketwatch.com/story/coronavirus-threat-cancels-classes-at-two-major-universities-with-more-expected-to-follow-2020-03-07

Dozens of Swiss companies keen on export channel to Iran

A Swiss channel to export food and medicine to Iran’s struggling population without running foul of U.S. sanctions is off to a good start, with dozens of companies keen to take part, a senior government official said on Saturday.

The Swiss Humanitarian Trade Arrangement (SHTA) aims to ensure Swiss-based exporters and trading firms in the medical, pharmaceutical and food sectors have a secure channel with a Swiss bank to guarantee payment for exports to Iran.
The arrangement has been in the works since U.S. President Donald Trump reimposed sanctions in 2018 after walking away from a deal over Iran’s nuclear programme, well before the coronavirus outbreak which has hit the Islamic Republic badly.
The channel went live last month after a pilot deal in January involving Swiss bank BCP and drugmaker Novartis for shipments of cancer and organ transplant drugs worth 2.3 million euros (£1.99 million).
“There are 50 companies that are interested at the moment, and we think there will be more,” said Marie-Gabrielle Ineichen-Fleisch, director of the Swiss State Secretariat for Economic Affairs (SECO) agency that oversees the programme.
She did not name any of the companies.
“Iran has been especially hit by the coronavirus, and while there is no substance that helps against the virus, in general the health situation is difficult,” she said in an interview with broadcaster SRF on Saturday.
“If we can provide some support there and ensure exports take place then we are making a good contribution.”
Food, medicine and other humanitarian supplies are exempt from U.S. sanctions but the measures targeting anything from oil sales to shipping to finance have deterred many foreign banks from doing business with Iran – including humanitarian deals.
In the Swiss project, exporters and banks give the government information about their business activities and partners in Iran. Bern verifies it and shares it with the U.S. Treasury, which then signs off on which deals can go ahead without those involved being sanctioned.
https://www.marketscreener.com/NOVARTIS-9364983/news/Dozens-of-Swiss-companies-keen-on-export-channel-to-Iran-30126699/

White House considers tax relief for airlines, travel firms amid coronavirus

The Trump administration is weighing tax relief for airline, cruise and travel industries to help such companies cope with a growing coronavirus outbreak that has dried up bookings, a source familiar with the plan said on Friday.

The move, which could include tax deferrals, is one of several targeted steps that the administration is considering to try to limit the economic damage from the epidemic, which could stifle consumer spending and keep many workers at home.
White House Economic adviser Larry Kudlow said it was too early to determine the magnitude of the slowdown and the nation’s overall economy remained fundamentally strong and was not headed for a recession.
The Labor department released strong February payrolls data on Friday, reflecting surveys taken before the virus’ rampant spread outside China became apparent.
U.S. officials were concerned about people who may have to stay home because of the outbreak and lose wages, as well as about small business and airlines, among others, Kudlow told reporters at the White House.
“We’re worried about small business. We might be worried about small farms. We might be worried about some sectors of the economy that are really hard hit,” Kudlow said.
“There are a lot of things we can do for cash flow purposes, possibly deferred tax purposes, and we can set up mechanisms to do that,” Kudlow said, adding that they would be “micro-forms of assistance.”
Kudlow did not name the specific industries that could get tax deferments and a Treasury spokesman did not immediately respond to a request for comment. The Washington Post first reported https://www.washingtonpost.com/business/2020/03/06/white-house-could-seek-timely-targeted-aid-us-industries-hurt-by-coronavirus-outbreak-top-adviser-says that the administration is considering the idea.
Kudlow said the administration may have to go to Congress to seek additional funding, but aid would be “targeted micro-forms of assistance.”
“We are at the moment are not going to do these gigantic packages where we put in helicopter money for everyone,” he added.
The Federal Reserve this week announced an emergency half-percentage point rate cut to try to blunt the coronavirus’ impact.
U.S. and global markets have slid for the past two weeks as the spread of coronavirus outside of China has raised investors’ fear of the outbreak’s impact as the number of cases neared 100,000 worldwide. In the United States, the death toll from the respiratory illness rose to 15.
The U.S. market slide alone had wiped out nearly $4 trillion of value through Thursday.
(GRAPHIC: U.S. stocks have fallen hard – https://fingfx.thomsonreuters.com/gfx/mkt/13/2980/2945/Pasted%20Image.jpg)
U.S. President Donald Trump could act via an executive order, or he could also turn again to Congress, which this week approved an $8.3 billion bill aimed at efforts to boost the U.S. response to the outbreak, including money for drug and vaccine development as well as the public health efforts.
Trump signed the measure into law earlier on Friday.
“We’re looking at different options,” Trump said on Friday when asked whether he was considering deferring taxes for companies as he toured tornado damage in Tennessee.
Earlier, at the White House, Trump called for another Fed rate cut to eliminate a “competitive disadvantage” for the United States compared to Europe and China.
Kudlow said the administration was not inclined to enact a temporary payroll tax cut, or lowering tariffs on imports, which some experts have said could ease global supply chain problems.

https://www.marketscreener.com/news/White-House-considers-tax-relief-for-airlines-travel-firms-amid-coronavirus–30120643/?countview=0

Italy to impose lockdown on northern Italy

The Italian government wants to lock down the Milan region and several other northern areas in an effort to fight coronavirus, Corriere della Sera reports.
The proposal would ban entering or exiting the area. It would also limit internal movement to “undeferrable” business or health reasons.
Bars and restaurants will have to maintain a distance of at least one meter between people.
Italy fatalities have risen to 233, and total cases have risen to 5,883, the third-highest in the world after China and South Korea.
https://seekingalpha.com/news/3549547-italy-to-impose-lockdown-on-northern-italy

Ebola drug that’s become the top hope for a coronavirus treatment

No medicines are proven to treat the new coronavirus which emerged from China late last year and has since jumped to scores of other countries.
With little else but supportive care to check the virus’ rapid spread, doctors and scientists have launched hundreds of trials in search of an effective therapy, testing mostly repurposed HIV or flu drugs.
Hopes are highest for remdesivir, an experimental antiviral developed by Gilead for use against Ebola but since pressed into study for the new coronavirus.
“There’s only one drug right now that we think may have real efficacy. And that’s remdesivir.” said Bruce Aylward, a senior advisor and international leader of the World Health Organization’s joint mission to China, at a Feb. 24 press conference.
Clinical trials are now underway in the U.S., China and, soon, other Asian countries where high numbers of people are infected by the virus, now named SARS-CoV-2. Preliminary results from the first of those studies could come by April, Gilead expects.
Other drugs designed specifically to treat SARS-CoV-2 are now in development but, for the next few months at least, much of the focus will be on remdesivir. Here’s a primer on how it works, its potential against the illness COVID-19, as well as why it’s no sure thing.

What kind of drug is remdesivir?

Remdesivir is designed to slow the infection of healthy cells by blocking viral replication, checking the ability of an invading virus to co-opt the body’s cellular machinery to reproduce itself.
In technical terms, it’s known as a nucleotide analog — meaning it mimics a genetic building block, but with an unusual molecular group tacked on. The thinking goes that, as the invading virus tries to replicate itself, the drug gets in the way and stops the process.
Remdesivir emerged from work done by Gilead and U.S. government in the mid-2010s to test compounds discovered by the biotech against emerging viruses. Initial animal experiments seemed to show the drug could work against Ebola, leading Gilead to start Phase 1 testing in 2015 and advance it into a mid-stage trial the next year.
A large Phase 3 study conducted in the Democratic Republic of the Congo, however, showed remdesivir to be less effective in preventing deaths from the virus than two other drugs, leaving Gilead’s therapy with an uncertain future.
But the outbreak of SARS-CoV-2 made suddenly relevant a series of experiments in human cell cultures and mice that indicated remdesivir could have activity against coronaviruses like MERS and, possibly, the new one now spreading.

What evidence suggests remdesivir could treat COVID-19?

Gilead has taken pains to emphasize, when announcing new plans for remdesivir, that it lacks human data on whether the drug actually works to treat COVID-19.
What it does have is preclinical data showing the drug to be active against the MERS and SARS viruses, which share enough genetic similarities to SARS-COV-2 that researchers and the company think remdesvir could work against it too.
Testing by National Institutes of Health researchers, published in January, demonstrated remdesivir prevented MERS from developing in monkeys, and helped improve the condition of those animals that were already infected.
“Our results, together with replication inhibition by remdesivir of a wide range of coronaviruses in vitro and in vivo, may further indicate utility of remdesivir against the novel coronavirus […] emerging from Wuhan, China,” they wrote.
Most recently, an in vitro study conducted by scientists at the Wuhan Institute of Virology found remdesivir and an anti-malarial called chloroquine more likely to be effective against SARS-CoV-2 than a handful of other potential treatments.​
As remdesivir has drawn attention, many have focused on its use in treating a Washington man who tested positive for SARS-CoV-2 after returning from Wuhan. One week into his hospitalization, doctors gave him remdesivir through a compassionate use program that Gilead has been supporting.
The man’s condition began to improve the next day, sparking some optimism about remdesivir’s benefit. But it’s not clear if the patient had already begun to recover, as viral levels were declining before the drug’s use.

How is remdesivir being tested now?

Early last month, doctors in Wuhan and Beijing opened two Phase 3 studies of remdesivir in coronavirus-infected patients with either mild to moderate illness or with severe disease. The former began enrolling on Feb. 6 and the latter a week later, on Feb. 13.
Together the trials aim to treat about 850 people and measure whether intravenous remdesivir can improve or resolve the symptoms of COVID-19 over the course of roughly a month.
Investigators and Gilead expect results by April, which would give an early signal of how likely the drug is to play a role in checking the fast-spreading epidemic. Yet enrollment has not been as smooth as might be expected. The WHO’s Aylward noted last month that a surge in studies of other potential treatments has made recruiting more difficult, as have restrictions limiting who can join the two trials.
In the U.S., a study sponsored by the National Institutes of Allergy and Infectious Disease recently began recruiting patients at hospitals in Nebraska and Washington, with sites planned in Maryland and Texas. The first participant was an American repatriated from Japan after being quarantined on the Diamond Princess cruise ship in Yokohama harbor.
Other treatments could be added into the study in the future, which is designed to allow modifications over time.
Gilead, meanwhile, recently announced plans to start two of its own Phase 3 studies in Asian countries where there are high numbers of diagnosed cases. Those will enroll about 1,000 patients and begin “within days,” Gilead CEO Daniel O’Day told reporters at a briefing in Washington, D.C. on Thursday.
“By the time we get to the end of April, we should have a preliminary idea of the safety and efficacy of this medicine against coronavirus,” O’Day said.

How would remdesivir be used, if tests show a beneficial effect?

Despite the evidence suggesting remdesivir could work, it’s still an open question whether that potential will translate into real efficacy. There was preclinical and early clinical data suggesting the drug would protect patients from Ebola, too, but results from that Phase 3 study still disappointed.
“It is too early to place much confidence in the compound’s likely activity against this virus, and even if it does prove active, we would expect relatively modest activity in larger populations, rather than an immediate and potent response such as could be seen with an antibacterial,” wrote analysts at SVB Leerink in a recent note to clients.
The drug’s dosing could also limit use, should tests show it to be beneficial. The Phase 3 studies in China are using a 10-day course of intravenously infused remdesivir, while Gilead is testing a 5-day course in its trials.
Patients receiving the drug, therefore, would have to be in a hospital and would likely need to be experiencing more serious symptoms of COVID-19, such as pneumonia or shortness of breath.
And while remdesivir was used in hundreds of patients with Ebola, its safety and appropriate dose have not been studied for COVID-19 as much as typically would be the case with late-stage testing.

If remdesivir is proven, how would Gilead respond?

Gilead built up clinical supplies of remdesivir as part of its testing the drug in Ebola, a stockpile that it is now using to provision the studies in China.
But should those tests or trials in the U.S. and elsewhere prove positive, Gilead will need to manufacture enormous quantities of the drug to meet what would likely be extremely high demand from governments and patients.
Gilead has said it is expanding its network of manufacturing partners and has started internal production of remdesivir in preparation of getting coronavirus data.
“We’re investing heavily in our supply chain and manufacturing such that, should it work, we can respond immediately,” said Gilead’s O’Day.
“We’re investing tens of millions of dollars today, hundreds of millions of dollars in the very near future to scale up manufacturing facilities — both at Gilead and through a variety of partners — to make this happen,” he added.
Another pressing question is remdesivir’s potential price, if proven and approved for emergency use.
Analysts at RBC Capital Markets expect Gilead would price the drug at around $900 to $1,000 or lower per course, a cost above oral flu drugs but below new intravenous antibiotics.
How Gilead approaches this question could be a potential flash point between it and national governments, although the pressure of the moment would likely factor into any decision Gilead might make.
For now, O’Day says the company hasn’t been discussing pricing in its conversations with governments about clinical trials and compassionate use.
“The topic of pricing comes up once you know whether the medicine works,” O’Day said.
“It’s very difficult to talk about pricing until you know what value this medicine may or may not bring to patients and to societies,” he said. “Having said that, we understand the public health need here and we have to be very conscious about, should this work, how do we get this in the hands of as many patients around the globe as fast as we can.”
https://www.biopharmadive.com/news/coronavirus-remdesivir-gilead-antiviral-drug-covid-19/573261/

Coronavirus spreads in French parliament

A second member of France’s National Assembly has been taken to hospital after contracting coronavirus and five other lawmakers are being tested for the illness, the lower house’s presidency said in a statement on Saturday.
The Assembly did not name the two legislators who have caught the disease but local media in the eastern region of Alsace have reported that the first of the two lawmakers is Jean-Luc Reitzer, who represents one of the departments most affected by the outbreak and is currently under intensive care.
The second lawmaker is a woman, according to the statement by the parliament. The Assembly said on Friday that a snack bar worker had also contracted the virus.
Sessions in the lower house will be interrupted for two weeks from March 9 and March 22 due to municipal elections that are taking place across France, reducing activity and the number of people present in the building, the assembly said.

France’s health ministry said earlier that two more people had died from the coronavirus, bringing the total death toll to 11 people.
France now has 716 confirmed cases of coronavirus, an increase of 103 compared with a day earlier.
https://www.reuters.com/article/us-health-coronavirus-france/coronavirus-spreads-in-french-parliament-idUSKBN20U0RP