Answering Your Coronavirus Questions: 100000 Deaths, Religion And The Future Of Work – NPR

Answering Your Coronavirus Questions: 100000 Deaths, Religion And The Future Of Work – NPR

Coronavirus Testing Machines Are Latest Bottleneck In Troubled Supply Chain – NPR

Coronavirus Testing Machines Are Latest Bottleneck In Troubled Supply Chain – NPR

May 28, 2020

Coronavirus testing in the U.S. has run into a number of snags, from a lack of nasal swabs to not enough chemicals needed to run the tests.

Now there's a new bottleneck emerging: A shortage of the machines that process the tests and give results.

Civilian labs and the Pentagon say they've had trouble getting the sophisticated, automated machines that can run hundreds of diagnostic tests at once. Three machine manufacturers Hologic Inc., Roche and Abbott Laboratories have confirmed to NPR that demand is outstripping supply.

Public health experts say the machine shortages are upending a complicated supply chain just as the shortages of swabs, chemicals and other testing materials have begun to ease.

Experts warn the lack of machines will hold the U.S. back from ramping up diagnostic testing to better understand where the coronavirus is spreading and how to stop outbreaks.

"We're gonna get stuck again," said Ashish Jha, director of the Harvard Global Health Institute. "We keep sort of fixing one bottleneck, and testing gets a bit better, and then we get stuck with the next bottleneck."

The Trump administration has released a plan to ramp up testing, saying it would provide strategic direction and technical assistance, but mostly leaving responsibility for executing the plan to the states. Coronavirus testing in the U.S. is carried out by a patchwork of commercial labs, hospitals, local health departments and other institutions.

The administration's coronavirus testing coordinator, Admiral Brett Giroir, says that plan is working.

"Right now in America anybody who needs a test can get a test in America with the numbers we have. ... That's over three million tests per week," Giroir said at a White House briefing earlier this month.

Jha and other public health experts say that may be enough tests in some places but only because not enough people are getting tested.

"It is not nearly enough, certainly not enough to open up safely and remain open," Jha said.

At a minimum, Jha says the U.S. needs to be testing twice as many people 7 million per week. That means the country is going to need more swabs, more testing kits, and more testing machines to run them. Four months into the pandemic, Jha says, the nation still isn't ready.

Heather Pierce, senior director for science policy for the Association of American Medical Colleges, says labs at teaching hospitals have reported difficulties in getting testing machines. She says that has exacerbated supply chain problems.

"Those machines have been part of the bottleneck," she said. "In fact, even institutions that had ordered those machines prior to the pandemic found their orders were cancelled or delayed, and some still haven't been shipped."

Even the U.S. Army is finding it can't get some coveted testing instruments.

The Chief of Staff of the Army, Gen. James McConville, told NPR the Army has been unable to secure more of the machines that can handle a greater volume of tests.

More testing is needed to get back to training large numbers of troops. McConville toured the Fort Irwin National Training Center in California earlier this month, where he questioned the base staff about their capacity to test for the coronavirus.

The soldiers told him they want a machine known as the Panther, a top-of-the-line, automated testing instrument made by the pharmaceutical company Hologic. It can run more than 1,100 tests a day.

General McConville called it the "granddaddy" of testing machines.

But McConville said there aren't enough of them on the market. He told the soldiers: "Realistically, you won't get Panther."

Three manufacturers confirmed they have not been able to meet the demand for new testing machines. One of them was Hologic, the company that makes the Panther.

"Given the unprecedented demand, we cannot provide new instruments to every lab that wants one, at least not right away," Mike Watts, Hologic's vice president of investor relations and corporate communications said in an email.

Watts stressed that there are already more than 1,000 Panther machines, which are used for other medical tests as well, installed in labs in all 50 states.

"So overall, we believe availability of Panthers is accelerating, not constraining, national testing," Watts said.

Roche and Abbott Laboratories say they've also had trouble filling orders for some big instruments. All three companies say they're doing everything they can to scale up production.

Roche spokesman Mike Weist said the company is even shipping out demonstration and training models. "Every available instrument, including instruments repurposed from internal use (such as training, demonstration, clinical trials), has been shipped or allocated for shipment in order to increase testing capacity worldwide," Weist said in an email.

Still, Harvard's Jha says more needs to be done.

"This is a classic market failure," Jha said. "This is not something that the market is going to sort out onto itself."

It's not just about ramping up production of these machines, Jha says. To get testing to more than double where it is today, he says labs need to invest even more in a lot more equipment.

But the testing machines are expensive. And the pandemic has caused an economic meltdown. Now some labs are saying they're not sure they can justify the expense of adding more instruments.

What if infection rates decline? What if people don't come forward to get tested, or think they don't need to unless they're really sick? That is, after all, what many public health officials were saying for months when tests were scarce.

"This is a place where I think the government just needs to step in and pay companies buy the machines for companies, or pay large amounts for these tests," Jha said. "This is what many of us have been asking for from the federal government. ... And it's very frustrating."

He's not the only one who is looking to the federal government to play a bigger role.

"There's broad agreement about the need for testing," said Julie Khani, president of the American Clinical Laboratory Association, which represents commercial labs.

"There has been something of a disconnect, however, between the need for testing and providing the necessary support and resources for laboratories to grow and expand that testing," Khani said.

Khani's organization wrote to the Trump administration in April, asking for $10 billion in emergency relief funds to buy more testing machines for their labs. The group is still waiting for a response.

NPR Correspondent Tom Bowman and Senior Producer Walter Ray Watson contributed to this report.


See the original post here: Coronavirus Testing Machines Are Latest Bottleneck In Troubled Supply Chain - NPR
Overworked and mistrusted: Russia’s medical workers risk their lives with little applause – CNN

Overworked and mistrusted: Russia’s medical workers risk their lives with little applause – CNN

May 28, 2020

The novel coronavirus outbreak

The novel coronavirus outbreak

Commuters crowd a train station passageway during the morning rush hour on in Tokyo on May 26.

The novel coronavirus outbreak

Students take their spring exams in Vallhall Sports Arena in Oslo, Norway, on May 26.

The novel coronavirus outbreak

Preschool students wearing face masks wait to wash their hands at a makeshift sink before class in Abidjan, Cte d'Ivoire, on Monday, May 25. The country became one of the first in West Africa to restart lessons after a two-month coronavirus shutdown.

The novel coronavirus outbreak

A security official wearing stands guard as delegates leave after the second plenary session of China's National People's Congress at the Great Hall of the People in Beijing on May 25.

The novel coronavirus outbreak

Olivia Grant, right, hugs her grandmother, Mary Grace Sileo, through a plastic drop cloth hung up on a homemade clothes line on May 24 in Wantagh, New York.

The novel coronavirus outbreak

Retired US Marine Corps veteran Brian Carabine replaces flags at the South End Cemetery in East Hampton, New York, on May 23 ahead of Memorial Day weekend.

The novel coronavirus outbreak

Graduates turn their tassels during a drive-thru graduation ceremony for Faith Lutheran High School at the Las Vegas Motor Speedway on Friday, May 22.

The novel coronavirus outbreak

The novel coronavirus outbreak

Workers wear protective gear as they start a cremation oven in Ecatepec, Mexico, on Thursday, May 21.

The novel coronavirus outbreak

A health worker wears a face shield while checking a patient's temperature at a hospital in Toluca, Mexico, on May 21. Mexico had reported its highest number of new daily cases.

The novel coronavirus outbreak

On May 21, people lower the coffin of a woman who died from the coronavirus in Srinagar, India.

The novel coronavirus outbreak

The novel coronavirus outbreak

Levi Tinker, resident historian and general manager of the TCL Chinese Theatre in Hollywood, makes an announcement inside the theater's empty auditorium on Monday, May 18. It was the theater's 93rd birthday celebration.

The novel coronavirus outbreak

People practice social distancing in New York's Domino Park on Sunday, May 17.

The novel coronavirus outbreak

Nurses in Nairobi, Kenya, take part in a Zumba fitness class in the parking lot of the Kenyatta University Teaching, Referral and Research Hospital on May 17.

The novel coronavirus outbreak

The novel coronavirus outbreak

The novel coronavirus outbreak

Mary Faye Cochran sings "You Are My Sunshine" to her son Stacey Smith from her senior-living facility in Smyrna, Georgia, on May 10. It was Mother's Day in the United States.

The novel coronavirus outbreak

Pope Francis delivers a blessing from the window of his studio overlooking an empty St. Peter's Square on May 10.

The novel coronavirus outbreak

The San Isidro cemetery in Mexico City, which was temporarily closed to the public to limit the spread of Covid-19, is seen in this aerial photo from May 10.

The novel coronavirus outbreak

Mary Washington speaks through a window to her daughter Courtney Crosby and grandchild Sydney Crosby during a Mother's Day celebration at her senior-living facility in Smyrna.

The novel coronavirus outbreak

A Briarcliff High School student participates in a parade of graduating seniors through Briarcliff Manor, New York, on May 9.

The novel coronavirus outbreak

People wear face masks while watching a Victory Day military parade in Minsk, Belarus, on May 9. The parade marked the 75th anniversary of the Allied victory over Nazi Germany in World War II.

The novel coronavirus outbreak

A man rides past social-distancing markers in front of a shop in Brussels, Belgium, on May 9.

The novel coronavirus outbreak

A man pauses as he places the casket of a relative into a van at a busy New York funeral home on May 9.

The novel coronavirus outbreak

Health-care workers wait for citizens to arrive at the Anna International Airport in Chennai, India, on May 9. People were arriving in Chennai from Dubai, United Arab Emirates.

The novel coronavirus outbreak

A man wearing a face mask cycles through Chinatown in Yokohama, Japan, on May 8. Prime Minister Shinzo Abe announced that Japan will extend its state of emergency until the end of May.

The novel coronavirus outbreak

American citizens who were stranded in Syria due to the pandemic arrive at the Lebanese border on their way to the Beirut airport, where they would be leaving for the United States.

The novel coronavirus outbreak

During a protest in Washington on May 7, members of National Nurses United stand among empty shoes that they say represent nurses who have died from Covid-19.

The novel coronavirus outbreak

A worker helps disinfect a subway train in New York on May 6. The subway syatem was shut down for a deep-cleaning.

The novel coronavirus outbreak

High school students study in a classroom in Wuhan, China, as they returned to school on May 6.

The novel coronavirus outbreak

A nursery is disinfected in Cannes, France, on May 6. Nurseries in France were to gradually reopen on May 11.

The novel coronavirus outbreak

Refrigerated trucks are seen at a morgue that opened in New York to assist overwhelmed funeral homes.

The novel coronavirus outbreak

The novel coronavirus outbreak

The novel coronavirus outbreak

Michigan state police prevent protesters from entering the chamber of the Michigan House of Representatives on April 30. The protesters were unhappy with the state's stay-at-home order. Gov. Gretchen Whitmer recently extended the order through May 15, though restrictions were relaxed so some businesses could reopen.

The novel coronavirus outbreak

This aerial photo shows surfers accessing Sydney's Tamarama Beach on April 29. Several Sydney beaches reopened for exercise only.

The novel coronavirus outbreak

The novel coronavirus outbreak

A barber wears protective equipment as he cuts a customer's hair in Lausanne, Switzerland, on April 27.

The novel coronavirus outbreak

The novel coronavirus outbreak

Health workers at a coronavirus testing center in New Delhi attend to a colleague who fainted due to exhaustion on April 27.

The novel coronavirus outbreak

The novel coronavirus outbreak

The novel coronavirus outbreak

Pitrik van der Lubbe waves from a boom lift to his 88-year-old father, Henk, at his father's nursing home in Gouda, Netherlands, on April 24. Pitrik had not seen his father in more than four weeks.

The novel coronavirus outbreak

Protesters shout slogans against Lebanese Central Bank governor Riad Salam as they block Hamra Street in Beirut, Lebanon, on April 23. Anti-government protesters have been demonstrating in Beirut as they continue to endure one of its worst-ever economic crises.

The novel coronavirus outbreak

A boy plays hopscotch at his home in A Coruna, Spain, on April 23.

The novel coronavirus outbreak

A dentist wears protective equipment while treating a patient in Den Bosch, Netherlands, on April 22.

The novel coronavirus outbreak

Biology teachers prepare to hold an exam at a secondary school in Berlin on April 22.

The novel coronavirus outbreak

A volunteer in Yangon, Myanmar, spreads calcium oxide on a road to help prevent the spread of the coronavirus on April 22.

The novel coronavirus outbreak

Migrants wave from balconies at a hotel in Kranidi, Greece, on April 21. The shelter, which hosts 470 asylum seekers, was placed in isolation after a pregnant resident tested positive for the novel coronavirus.

The novel coronavirus outbreak

A man disinfects a ceiling lamp at the obanija Mosque in Sarajevo, Bosnia and Herzegovina, on April 21.

The novel coronavirus outbreak

A nurse holds a newborn baby, wearing a face shield as a protective measure, at a maternity facility in Jakarta, Indonesia, on April 21.

The novel coronavirus outbreak

Health workers at Madrid's La Paz Hospital hold a minute of silence to remember Joaquin Diaz, the hospital's chief of surgery who died because of the coronavirus.

The novel coronavirus outbreak

A woman applauds from the balcony of her Paris home to show support for health care workers on April 20.

The novel coronavirus outbreak


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Overworked and mistrusted: Russia's medical workers risk their lives with little applause - CNN
Coronavirus (COVID-19) Update: FDA Provides New Tool to Aid Development and Evaluation of Diagnostic Tests That Detect SARS-CoV-2 Infection – FDA.gov

Coronavirus (COVID-19) Update: FDA Provides New Tool to Aid Development and Evaluation of Diagnostic Tests That Detect SARS-CoV-2 Infection – FDA.gov

May 28, 2020

For Immediate Release: May 27, 2020

Today the U.S. Food and Drug Administration took a new step to support the agencys evaluation of diagnostic tests for COVID-19, by providing a SARS-CoV-2 reference panel. Reference panels are an additional step to ensure the quality of the tests, validation of new assays, test calibration, and monitoring of assay performance. Nucleic acid tests identify infection by confirming the presence of a virus genetic material (RNA) and the FDA-supplied reference panel provides developers access to this material. The FDAs reference panel is an independent performance validation step for diagnostic tests of SARS-CoV-2 infection that are being used for clinical, not research, purposes. The FDA panel is available to commercial and laboratory developers who are interacting with the FDA through the pre-emergency use authorization (EUA) process.

The FDA has taken many steps during this pandemic to ensure that Americans have access to trustworthy diagnostic tests. Todays reference panel will provide test developers with well-characterized reagents to compare the performance of different molecular diagnostic tests under the same conditions, said Jeffrey Shuren, M.D., J.D., director of the FDAs Center for Devices and Radiological Health (CDRH). We are continuously evaluating our policies and approaches on diagnostic tests during this pandemic, including addressing poorly performing tests. We are committed to remaining flexible and providing more resources to developers as necessary, based on our regulatory expertise, real-world experience, and data, in order to protect and promote public health.

These types of reference panels have proven to be an invaluable resource in the development of accurate, reliable, and validated diagnostic tests for detecting infectious diseases. The FDA has provided similar tools to assist industry in developing tests for other infectious diseases. For example, since the Zika outbreak in 2015, through the collaborative work between CDRH and the Center for Biologics Evaluation and Research (CBER), the FDA has responded to the need to directly compare the performance of different diagnostic assays by developing and producing reference panels. This work resulted in the FDA making available first a Zika reference panel for molecular-based diagnostic tests, and then a panel of human plasma samples to support the regulatory evaluation of serological tests to detect recent Zika virus infection.

By providing this new tool to aid in the evaluation of diagnostic tests for SARS-CoV-2, the FDA continues its public health mandate in combatting this pandemic.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

###

05/27/2020


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Coronavirus (COVID-19) Update: FDA Provides New Tool to Aid Development and Evaluation of Diagnostic Tests That Detect SARS-CoV-2 Infection - FDA.gov
Asheville zeroes in on $185M coronavirus austerity budget; Here’s what’s in it – Citizen Times

Asheville zeroes in on $185M coronavirus austerity budget; Here’s what’s in it – Citizen Times

May 28, 2020

ASHEVILLE - With a budget deadline a month away the City Council is zeroing in on a $185 million spending plan.

The proposed operating budget represents a year-over-year decrease forced by declining taxes and other public revenues.

City Manager Debra Campbell proposed the austerity budget at a May 26 council meetingamid the economic fallout of the coronavirus. It includes no tax or fee increases.

The council is set to hold a public hearing on the proposalJune 9 with a final vote June 23. By state law local governments must pass balanced budgets by June 30.

City Manager Debra Campbell(Photo: Angeli Wright/awright@citizen-times.com)

"This is essentially a continuation budget," Campbell told the seven council members who attended through video links. "There are very, very limited service enhancements not because we don't want to enhance services, but we just cannot afford to do it. And it would be generally, considering what is happening in our community and country, not a good thing at this time."

- The current year's budget was expected to be $192 million, but end of year revenue losses, including $1.6 million less in sales taxes, caused city budget officials to slash that. Federal assistance filled some of the holes bringing this current year'sbudget to $189million.

- Next year the biggest revenue loss will actually not be from the pandemic. The settlement of a class action lawsuit means the city must eliminate its water capital fee, causing a $7.4 million drop.

- Harrah's Cherokee Center - Asheville has been closed, though staff hope for "strong third and fourth quarters with numerous rescheduled and annual events," according to the proposed budget. Still, next year center is anticipated to be down $1 million in spending. A$100 million renovation of the center's Thomas Wolfe Auditorium planned before the pandemic is in limbo.

- City parking fees are down after being suspended. The parking fund which was set to bring in$7.2 million this year and normally helps subsidize transit is now losing $500,000 a month. Some recovery next year couldbring it to $6.6 million.

Cots are lined 6 feet apart in a hallway as Harrah's Cherokee Center is prepared to house homeless in the midst of the coronavirus pandemic Asheville April 8, 2020.(Photo: Angela Wilhelm/awilhelm@citizentimes.com)

More: Pandemic shelter for homeless moved from Harrah's Center to hotel

- Sales tax, a top revenue source after property taxes and water, is estimated to be $27.3million next year. This year's original estimate was $28.5 million (though that has been reduced to $26.8 million)

- Interest earnings will be down $1.1 million due to rate decreases.

- A slowdown in development will mean a 7% drop in city development fees, a loss of $250,000

- Alcoholic Beverage Control revenues will be down 10% or $200,000 due to closure of bars and restaurants, the biggest customers.

- Across-the-board city pay increases are frozen, except for a raise to $31,200 ($15 an hour) for 92 lowest-paid city workers.That, plus increases for slightly betterpaid workers with higher positions or longer tenure, will cost $574,000.

- Despite the freeze, firefighters are continuing to push for a raise for the 77 lowest-paid firefighters. They make $33,935, but because of the time they spend overnight in fire stations, they work the equivalent of 56 hours a week,Asheville Fire Fighters Association President Scott Mullins said. "Every city employee makes $15 an hour except 77 fire fighters," Mullins said. City Manager Campbell has said she first wants to see the results of a pay and compensation study before making any recommendations. The study is scheduled to be finished by early June.

- Hiring is also frozen with the exception of seven new positions to maintain the River Arts District transportation improvements:three laborers, an equipment operator, atradesworker, a labor crew supervisor, and a labor crew coordinator.

- Property taxes, the biggest source of city revenue, are expected to rise from $68.5 million to $71.4 million. That's because of personal property belonging to the formerly nonprofit Mission Hospital becoming taxable now that the hospital's owned by the private company HCA.

- Transit has faced losses after the city made buses fare free and limited passenger numbers and service to reduce the chance of infection. But federal CARES Act funding has and will continue to bolster the system. Spending is set to grow from $11million to $12.3 million next year. That includes a $1.7 million increase from property taxes and other general fund revenues.

An Asheville Regional Transit driver wears a mask while driving down Haywood Road in West Asheville March 26, 2020. ART buses began limiting riders to 10, including the driver, March 25.(Photo: Angela Wilhelm/awilhelm@citizentimes.com)

- General fund money that goes to nonprofits should be reallocated to "support equity and address opportunity gap goals," Asheville Chief Financial Officer Barbara Whitehorn who gave much of the May 26 budget presentation to the council. Specifics:$35,000 to support Asheville City Schoolsafter-school coordinator; $43,000 to Parks and Recreation for extended community center hours andsummer youth and teen programming; $15,000 to Pisgah Legal Services Tenant Eviction Response Team.

Joel Burgess has lived in WNC for more than 20 years, covering politics, government and other news. He's written award-winning stories on topics ranging from gerrymandering to police use of force. Please help support this type of journalism with asubscriptionto the Citizen Times.

Read or Share this story: https://www.citizen-times.com/story/news/local/2020/05/28/asheville-zeroes-185-m-coronavirus-austerity-budget-whats-it/5266988002/


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People who smoke may have more receptors for the new coronavirus – Medical News Today

People who smoke may have more receptors for the new coronavirus – Medical News Today

May 28, 2020

The lungs of people who smoke may contain more of the receptors that the new coronavirus uses to invade cells. This could explain why people with the virus who also smoke appear to be particularly vulnerable to severe illness.

The majority of people who acquire SARS-CoV-2, the virus that causes COVID-19, experience mild-to-moderate symptoms and will fully recover without hospital treatment.

However, several studies suggest that people who smoke are significantly more likely than people who do not to develop a severe form of the illness.

For example, according to a recent study of COVID-19 cases in hospitals in mainland China, 11.8% of people who smoked had a nonsevere form of the disease, while 16.9% had severe disease.

To break into cells and start replicating itself, the virus latches onto a protein receptor called angiotensin-converting enzyme 2 (ACE2), which is present in the cells membranes.

Researchers at Cold Spring Harbor Laboratory in New York wanted to find out if people who smoke have more of these receptors in their lungs. This would potentially make them more vulnerable to the infection.

Their results have undergone peer review and will appear in the journal Developmental Cell. A preprint of the paper is available on bioRxiv.

We started gathering all the data we could find, says senior study author Dr. Jason Sheltzer. When we put it all together and started analyzing it, we saw that both mice that had been exposed to smoke in a laboratory and humans who were current smokers had significant upregulation of ACE2.

First, the researchers reviewed data from a genetic study that exposed mice to diluted cigarette smoke for 2, 3, or 4 hours per day for a period of 5 months.

They found that the longer the mice had exposure to cigarette smoke, the more ACE2 receptors were expressed in their lungs.

The scientists later investigated whether or not the same dose-dependent relationship between smoking and ACE2 applied in humans.

They analyzed two existing genetic datasets: one based on lung tissue samples from people who smoke who are undergoing thoracic surgery, and one based on lung tissue from people in the National Cancer Institutes Cancer Genome Atlas Program.

The researchers report that lung samples from those who smoked most heavily expressed the highest levels of ACE2. Even after accounting for the participants age, sex, ethnicity, and body mass index (BMI), there remained a strong association between smoking and ACE2.

They also discovered that quitting smoking reversed the increase in ACE2 expression. Among those who had not smoked for a year, quitting was associated with a decrease in ACE2 expression of around 40%, compared with those who currently smoke.

Dr. Sheltzer and colleagues managed to trace the additional ACE2 receptors in people who smoke to goblet cells. These are lung cells that secrete mucus. Smoking increases the number of goblet cells, which helps protect the airways from the irritants in smoke.

An unfortunate consequence of this may be to make people who smoke more vulnerable to severe SARS-CoV-2 infections. Having more goblet cells means that they have more of the ACE2 receptors that the virus uses to invade cells.

There is a debate, however, over whether smoking is protective or harmful in the context of COVID-19.

For example, a study in The Lancet Infectious Diseases found that people who smoke and who have symptoms of influenza or a respiratory infection were less likely than people who do not smoke to test positive for SARS-CoV-2 in primary care.

However, the authors of this study point out that this may be because people who smoke are more likely to have a cough and may be more likely than others to submit themselves for testing. This would lower their apparent risk of testing positive.

Another study, which has not undergone peer review, claims that people who smoke were underrepresented among patients hospitalized with the infection in China. On the basis of this, the authors speculate that the nicotine in cigarettes protects people who smoke.

In his review of this study, Dr. Sheltzer questions the validity of a figure for the prevalence of smoking in China that the scientists rely upon to make their conclusions.

The claim that smoking protects against COVID-19 has gotten so much press attention largely because its counterintuitive, but its very likely to be wrong, Dr. Sheltzer told Medical News Today. An abundance of data including high-quality meta-analyses demonstrate that smokers tend to have more severe cases of COVID-19 than non-smokers do.

Dr. Sheltzer and colleagues acknowledge that their own study also had some limitations. For example, it relied on data for the expression of the gene that makes ACE2, rather than direct measurements of the amount of the receptor within cell membranes.

For live updates on the latest developments regarding the novel coronavirus and COVID-19, click here.


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Coronavirus Pushed This Palo Alto Chinese Restaurant to the Brink, But It Never Closed – Eater SF

Coronavirus Pushed This Palo Alto Chinese Restaurant to the Brink, But It Never Closed – Eater SF

May 28, 2020

The headline of the March 10 Palo Alto Online story didnt leave much room for hope: In bold-faced letters, it stated that Taste, a Sichuan restaurant in downtown Palo Alto, was on the brink of permanently shutting down amidst coronavirus spread. The owner, Sandy Liu, told the publication that the restaurants revenue was down to as little as $600 a day and said she might be forced to shut the entire operation down in a matter of days.

Basically nobody is dining out for my restaurant, a Chinese restaurant, Liu said at the time. Who can afford to keep losing money every day? This, of course, was a week before the region-wide shelter in place went into effect. If Taste had called it quits at that point, it would have been one of the very first Bay Area restaurants to shutter specifically because of coronavirus-related financial losses.

What happened next was somewhat unexpected: Even as other restaurants up and down University Avenue temporarily closed, Taste stayed open. It didnt even close for a single day.

Everything is changing, but fortunately our business is still okay, Liu tells Eater SF. Its not very good, but it still can survive. It can still pay the rent. It can still make a little bit of profit.

According to Liu, there wasnt any single moment that helped the restaurant turn the tide on its miserable February and March, but rather a combination of factors. Once the shelter in place went into effect, the demand for takeout increased, though Liu stresses that business goes up and down: One day will be very good, one day will be very bad. She was also able to secure a federal stimulus loan through the Paycheck Protection Program (PPP), but that, too, has been a mixed blessing: Since she isnt in a position to hire all of her workers back, she isnt expecting that the loan will be forgiven.

Perhaps the most important factor is that Liu hasnt had to pay her full rent a make-or-break issue during the crisis, according to restaurant owners who are pushing for rent abatement legislation. In Lius case, her landlord was willing work with her on a month-to-month basis, and didnt expect her to pay more than she could handle based on the revenue the restaurant was generating. As Taste landlord John Felt tells Eater SF, I didnt come to Sandy and say its full rent or its no rent. Each month we said, what can we do? Where can we meet?

Liu has only been in the restaurant business for two years, taking over Taste from two friends in March of 2018 after spending the previous decade in financial services. Her previous job also helped cushion the blow, as she has cashed out some of the retirement funds that shed built up.

Of course, Liu recognizes that her restaurant is far from out of the woods. Known for chile-laden dishes like its spicy fish fillet with pickled veggies, Taste used to get a lot of catering and lunch business from the tech companies in the area tech companies whose employees will be working from home for the foreseeable future. Liu doesnt know how shell make up that income, but shes fairly upbeat given the circumstances. Her business went right up to the brink of complete disaster, after all, and its still standing.

Since March, how many people got infected millions of people and how many people died? she says. The whole world, all the news is very, very negative. But we keep going.


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Coronavirus Pushed This Palo Alto Chinese Restaurant to the Brink, But It Never Closed - Eater SF
Judy Chicago: Art in the Time of Coronavirus Should Wake Us Up – The New York Times

Judy Chicago: Art in the Time of Coronavirus Should Wake Us Up – The New York Times

May 28, 2020

This essay is part of The Big Ideas, a special section of The Timess philosophy series, The Stone, in which more than a dozen artists, writers and thinkers answer the question, Why does art matter? The entire series can be found here.

Since I wrote the first draft of this essay in early March, the world has turned upside down. I have revised the original text, guided by a single question: Does art matter when we are facing a global crisis such as the current Covid-19 pandemic?

Obviously, there is a great deal of art that doesnt matter. This includes the work issuing from those university art programs that every year pump out thousands of graduates, taught only to speak in tongues about formal, conceptual and theoretical issues few people care about or can comprehend. Then there is the art created for a global market that has convinced too many people that a pieces selling price is more important than the content it conveys.

But when art is meaningful and substantive, viewers can become enlightened, inspired and empowered. And this can lead to change, which we urgently need.

My education about the potential power of art began in the early 1970s, when I delivered a lecture in Grand Forks, N.D. It was not a place where I would have assumed art would matter. Nonetheless, more than 200 women and men attended my talk. I showed images from Great Ladies, my series of abstract portraits of some important and forgotten women in history, such as Christina of Sweden, the 17th century queen and patron of the arts who widely influenced European culture. At that time, womens studies as an academic field was in its infancy; I had discovered those figures through my own research, driven by a desperate need to find out about women before me who had faced obstacles like the ones I had encountered in my career.

After my talk, I did something artists rarely do; I asked the audience what they thought of my work. After a few minutes, someone said my stated aim of depicting significant women in history was interesting, but that without my spoken explanation people would never have been able to understand my work. That interaction was a revelation, and it inspired me to figure out how to make my imagery more accessible, starting with The Dinner Party, my symbolic history of women in Western civilization. Since its premiere in 1979, countless people have told me that seeing it changed their lives.

Communities across the United States, Canada, Europe and even Australia mounted a phenomenal grass-roots movement, as was documented by Dr. Jane Gerhard in her 2013 book The Dinner Party: Judy Chicago and the Power of Popular Feminism, 1970-2007. Those who participated in it raised money, pressured public institutions and, when unsuccessful, moved to find alternative spaces to exhibit The Dinner Party. Millions of people viewed my piece as a result of these worldwide efforts.

One might ask what this has to do with the global pandemic afflicting us. The answer lies in arts power to shed light on the problems we are confronted with at this difficult time.

Much of my art has been directed at interrogating issues related to abuses of power, as well as the victimization and erasure of certain groups. PowerPlay focused on the ways that toxic masculinity is literally Driving the World to Destruction, as the title and imagery of one painting in the series suggests. Holocaust Project: From Darkness into Light, created with my husband, the photographer Donald Woodman, was an effort to warn the world about the global system of injustice and oppression that had produced the Holocaust, which Virginia Woolf once aptly described as patriarchy gone mad.

I am not citing my own art as an egocentric exercise. Rather, I am pointing out that I have been trying to use it to educate, inspire and empower viewers to effect change. Significant change can only occur if we shift our focus to the work of those artists who have had the courage to show us who we are and what we are doing. Artists like Goya, whose masterpiece series The Disasters of War is a powerful reminder that those who have the least to say about human events suffer the gravest of consequences. Or Kthe Kollwitz, whose vivid portraits of the effects of poverty on the working classes should be viewed as part of any discussion of income inequality to more powerfully illustrate what those words really mean.

Art that raises awareness of the state of our planet can be especially important in todays world. One example of this is the work of the contemporary artist and illustrator Sue Coe, whose pieces on animal mistreatment have been ignored or, at best, marginalized by an art community that seems to privilege meaninglessness over consequential work. My most recent project, The End: A Meditation on Death and Extinction, also sought to bring attention to what we humans do to other sensate creatures on our shared planet.

This is the kind of art that matters most as we confront the devastating force of the coronavirus. The philosopher David Benatar recently wrote in The New York Times that the pandemic is a consequence of our gross maltreatment of animals. As the primatologist Jane Goodall put it in a YouTube video addressing the outbreak: All over the world weve been destroying the places where animals live in order to get materials to build our homes, our cities and to make our own lives more comfortable.

We must wake up; this pandemic offers us the opportunity to realize that the path we as humans have taken a path that has rendered our leaders unable to confront, let alone reverse, climate change or to alter the way we treat our fellow creatures will result in endless havoc. Art matters if artists use their talents to help us find our way.

Judy Chicago is an artist, author, feminist and educator.


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Judy Chicago: Art in the Time of Coronavirus Should Wake Us Up - The New York Times
What’s needed to prove a COVID-19 vaccine worksand are top players across 3 continents there yet? – FiercePharma

What’s needed to prove a COVID-19 vaccine worksand are top players across 3 continents there yet? – FiercePharma

May 28, 2020

In the global hunt for COVID-19 vaccines, all developers are throwing enthusiasm around about their candidates. Critics say they're too optimistic. So, what do scientists really need to demonstrate before we can call a shot effective?

It's not a short answer. Let's review the state of play.

Right now, three leading projects across three continents are catching most of the limelight. Chinese company CanSino Biologics was the first to push its adenovirus-based recombinant vaccine into phase 2 testing. Massachusetts biotech Moderna recently unveiled preliminary phase 1 data for its mRNA shot. And another adenovirus-vectored vaccine from Oxford University and AstraZeneca just nabbed $1.2 billion in funding from the U.S. government.

Understanding the Importance of Crystallization Processes to Avoid Unnecessary Cost, Risk and Development Delays

A well-developed crystallization process can produce suitable particles that can facilitate consistent filtration, drying and formulation of the API and allow confident and reliable manufacturing of the final drug product, while avoiding unnecessary cost, risk and development delays.

Having a vaccine ready as early as possible is crucial. The first country to the finish line will be first to restore its economy and global influence, former FDA commissioner Scott Gottlieb wrote in an article in The Wall Street Journal. However, despite the rosy picture companiesand countriesare painting, there are still hurdles ahead before any one meets the timeline of having a useable vaccine within a year and a half.

Vaccine development is a long process. After evaluation in test tubes and animals, a vaccine is tested in humans in a phase 1 trial, which is a small study that assesses safety and immune response to gauge its potential.

In a phase 2, scientists usually aim to find the optimal dosing and further understand a vaccines safety and immunogenicity in more healthy subjects. Given the urgency of a global pandemic, many are compressing the two phases into a continuous trial design.

Now, how have the three frontrunners been performing so far?

CanSino was first to post detailed phase 1 data in a peer-reviewed journal. According to a recent The Lancet study, the vaccine was generally well-tolerated in 108 healthy adults. All participants receiving three dosing strengths developed binding antibodies against the SARS-CoV-2s spike protein.

More importantly, they developed neutralizing antibodies, as well as T-cell responses. While a binding antibody only binds to a specific antigen and tags it for potential destruction by other immune cells, a neutralizing antibody can keep a pathogen from infecting a cell by inhibiting its biological effects.

The problem with this vaccine? Like many gene therapies, it uses an adenovirus as a vector to carry the genetic information of the spike protein to trigger an immune response. Many people already have developed immunity against adenovirus. Theoretically, these peoples immune system can attack the vaccine's vector, dampening the effects ofits protective payload.

RELATED:China's CanSino Bio advances COVID-19 vaccine into phase 2 on preliminary safety data

In the CanSino study, about half of the participants had high pre-existing neutralizing antibodiesagainst the Ad5 vector. As the researchers noted, such adenovirus immunity compromised the immune response triggered by the vaccine.

Oxford University and AstraZenecas ChAdOx1 nCoV-19 candidate is also based on adenovirus. Results published on theBioRxiv (PDF) preprint site found that all vaccinated rhesus monkeys challenged with the coronavirus became infected, as determined by a swab test. But the researchers argue human tests are still warranted because the vaccine did ameliorate the disease.No vaccinated animals showed signs of viral pneumonia, compared to about two-thirds of unvaccinated monkeys.

On that point, a COVID-19 vaccine may resemble a flu shot. According to the CDCs retrospective tally, seasonal flu vaccines are usually only around 30% to 40% effective at preventing infections at best, but they can help people get milder symptoms when infected.

However, as former Harvard Medical School professor William Haseltine noted in aForbes article, levels of neutralizing antibodies in the animals appear to be low. That leads to a new question to which nobody has a definite answer right now: What kind of neutralizing antibody level is necessary to actually protect against the virus?

RELATED:It's too soon to assume success for Moderna's COVID-19 vaccine: analyst

Moderna recently said its mRNA-1273 elicited neutralizing antibodies in eight subjects at or above convalescent serum from people who had recovered from COVID-19. Problem is, we simply dont know whetherrecovered people are protected from infection, or whetherneutralizing antibody is a good marker to predict protection. For example, five sailors on the USS Theodore Roosevelt who previously appeared to have recovered latertested positive again.

Currently, correlates of protection for a vaccine against COVID-19 are unknown, and the roles of the specific antibodies or T cells in building effective protection are not yet defined, investigators in the CanSino vaccine study wrote in their paper.

Even if the level seen in convalescent serum is a good benchmark to draw correlations of immunity, the question remains as to how long such a response would last. Moderna said the convalescent blood was drawn within a month or two after the disease. But Evercore ISI analyst Umer Raffat questioned whether thats an easier comparison. Convalescent antibodies may have hit higher levels early on and then droppedover that month or two.

Experience with two other coronaviruses, SARS and MERS, suggests that neutralizing antibodies can decline quickly in patients after recovery, whereas CD4 and CD8 T cells appeared to play an essential role in immunity, the CanSino researchers said.

For vaccines, the CanSino study team has only reported strong immune response within 28 days after vaccination and is following the vaccine recipients for at least six months to determine how that response fares over time.

The Moderna candidate and all other ongoing mRNA programs share one more uncertainty over their future: There is not a single mRNA vaccine approved anywhere in the world.

RELATED:AstraZeneca's COVID-19 vaccine enters phase 2/3 clinical trial

The questions could be answered by a large phase 3 study, in which scientists will measure infection rates directly rather than looking for clues from immune cells. But to do that, scientists need patients to be infectedwith the virus, so that a difference between the vaccine and a dummy shot can be determined. Ironically, thats becoming more difficult now as strict social distancing requirements are in place and the number of new confirmed cases trends downward in many parts of the world.

The challenge is, how do I ensure I have enough cases? If I go and vaccinate a lot of people, it doesnt matter how many if there is no circulating virus, Modernas chief medical officer, Tal Zaks, said in a conference call about the interim phase 1 results.

The Oxford-AstraZeneca program leader, Prof. Adrian Hill, expressed similar concerns. At the moment, theres a 50% chance that we get no result at all, he told The Telegraph. Its a race against the virus disappearing, he said.

CanSino knows all too well what that situation looks like. In 2017, the Chinese vaccine maker won domestic approval for its Ad5-based Ebola vaccine for emergency use without phase 3 data, as the filovirus quieted down in Africa.


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What's needed to prove a COVID-19 vaccine worksand are top players across 3 continents there yet? - FiercePharma
What are the Top 5 most promising COVID-19 vaccine candidates? – Alliance for Science

What are the Top 5 most promising COVID-19 vaccine candidates? – Alliance for Science

May 28, 2020

More than 100 vaccine efforts are currently underway in the global push to stop the COVID-19 pandemic, according to the World Health Organization. Which are most likely to work? And how long will it take? Weve compiled a list of the top 5 most promising candidate vaccine platforms, with a brief summary of relevant details. Well keep this page updated so come back regularly to learn the latest developments.

Adenoviruses, which exist in the wild in humans and typically cause mild infections such as the common cold, have been genetically engineered to express viral antigens found in SARS-CoV-2, usually those of the infamous spike protein that the coronavirus uses to break into human cells. These engineered adenoviruses, when put into a vaccine, trigger an immune response in the human body, protecting against COVID-19.

This is a new technology: no adenovirus vector vaccines for other diseases are yet widely available, though vaccines for HIV, influenza, Ebola and malaria using this platform are in clinical trials and an Ebola vaccine has been briefly deployed.

Probably the highest-profile effort is the ChAdOx1 nCoV-19 vaccine candidate from Oxford Universitys Jenner Institute. (ChAdOx1 stands for chimpanzee adenovirus Oxford 1.) The Chinese company CanSino Biologics the medical science arm of the Peoples Liberation Army, no less has completed Phase 1 trials with an adenovirus vector vaccine called Ad5-nCoV.

A big-name corporate player is Johnson & Johnson, via its subsidiary Janssen, which uses a genetically modified human adenovirus technology it calls AdVac. This is a proven platform, which was used to produce thousands of doses of companys Ebola vaccine deployed in the Congo in November 2019.

Adenoviruses are not the only viral vectors that can be used: pharmaceutical giant Merck says it is working on a potential COVID vaccine using an engineered vesicular stomatis virus, previously used successfully in its Ebola vaccine. Another collaboration Merck is involved in uses an attenuated live measles vaccine.

CanSino reported positive results in a Lancet paper on May 22. This is the first Phase 1 COVID vaccine clinical trial anywhere in the world to report full results in a peer-reviewed paper, with 108 healthy adults all showing an immune response to the adenovirus vector vaccine. There was a stumbling block, however. Because the adenovirus (which causes common cold symptoms) is already widespread in the human population, some of those in the trial had already been naturally infected with it, dampening their immune response. Will Oxfords chimp adenovirus vaccine perform better? Time will tell, but meanwhile CanSino is proceeding to Phase 2 trials with a six-month study of 500 adults in Wuhan.

The Oxford team published a preprint on May 13 showing that ChAdOx1 prevented rhesus macaques monkeys from getting pneumonia when infected with SARS-CoV-19. Thats the good news the vaccine protected against disease. The bad news was that the vaccinated monkeys still became infected, and nose swabs showed the same amounts of virus in samples taken from both vaccinated and non-vaccinated animals. This means in theory that vaccinated people could still be infectious even if they dont actually get symptoms of the disease. Still, it would be a massive step forward if we could just push the disease from pneumonia to a common cold, in the words of one expert. Phase 1 trials in over a thousand United Kingdom-based human volunteers are ongoing.

Oxford University has partnered with the global pharmaceutical company AstraZeneca. The company is making a big bet on Oxfords vaccine, which is now being renamed AZD1222. On May 21it announced an agreement to produce 400 million doses and claims to be able to manufacture 1 billion doses with current facilities. The US government is also betting big on Oxford: its Biomedical Advanced Research and Development Authority (BARDA) put $1billion behind the Oxford/AstraZeneca effort, with a Phase 3 trial involving 30,000 participants now in development.

Johnson & Johnson, while it has the corporate muscle to produce vaccine doses in large quantities, doesnt expect to start Phase 1 trials until September, which it says could possibly allow vaccine availability for emergency use in early 2021.

Live viruses, even if attenuated, can be risky in immunocompromised people. It is also notable that neither Oxford nor CanSino scored full successes with their first attempts.

While conventional vaccines work by presenting the bodys immune system with the inactivated real virus or antigens derived from it, injecting mRNA into cells means that they produce the required viral proteins directly inside the human body. mRNA (the m stands for messenger) is the molecule that takes instructions from DNA to the cells protein factories (called ribosomes). As Dr. Sanjay Mishra from Vanderbilt University explains: A big advantage of mRNA vaccines is that scientists can skip the laboratory production of proteins by directly injecting the molecular instructions to make the protein into the human body itself.

In this case the RNA sequence is taken from the SARS-CoV-2 virus genome, stimulating an immune response that should later stop the COVID-19 disease. One advantage to mRNA vaccines is a cheaper, faster production process, making them potentially the most scalable to tackle a global pandemic.

Moderna a biotech startup now worth tens of billions, though it has yet to sell a single product is in the lead. Other teams pursuing the mRNA approach include one based at Imperial College, London; the German-based company BioNTech, which is working in alliance with the drugs giant Pfizer; and CureVac, another German-based company. A Chinese consortium from Fudan University, Shanghai JiaoTong University and RNACure Biopharma is employing a second strategy of using mRNA to create virus-like particles in the body to activate an immune response.

Modernas vaccine was the first to be injected into human volunteers, way back in mid-March. Its May 18 announcement that its vaccine candidate had stimulated an immune response with the production of neutralizing antibodies in eight human volunteers in its Phase I trial generated global media coverage and a stock market rally. Others were more skeptical, however, pointing to incomplete data and demanding more context from this interim result, which was not yet for the full trial and not published in a peer-reviewed journal.

CureVac announced positive pre-clinical results for its lead COVID vaccine candidate on May 14 and aims to start Phase 2/3 clinical trials in human volunteers in June. BioNTech announced on May 5 that volunteers for its Phase 1/2 study have begun taking their first doses of its mRNA vaccine candidate, called BNT162, in the United States and Germany.

No mRNA vaccines have ever been used before, so failure is a big risk. Modernas mRNA vaccine did lead to some negative side-effects in some of the trial volunteers. This isnt unsual, but the fact that so-called Grade 3 reactions were observed in one case including pain, nausea and high fever might dampen enthusiasm somewhat.

The most traditional vaccine approach one utilized over many decades is to inject someone with the inactivated virus. This stimulates the immune system to produce antibodies, while the virus is either killed before injection or weakened sufficiently so that it cannot cause a serious infection. Inactivated viruses are used against influenza, for example, and in the global effort to eradicate polio.

Here once again the Chinese are in the lead. The Chinese company Sinovac, in partnership with a number of leading medical research institutes in China, designed a vaccine by isolating SARS-CoV-2 samples from infected hospital patients and growing the virus in cell lines before inactivating it with a chemical agent. It is called PiCoVacc (for purified inactivated SARS-CoV-2 vaccine).

An international team has a different approach, using a vaccine that is already widely deployed: the BCG vaccine against tuberculosis. It has been shown to protect against other respiratory diseases, too, so researchers are hoping it might be effective against COVID. (BCG is an inactivated bacterial pathogen, not a virus.)

The Chinese team has made impressive progress with its inactivated viral COVID vaccine. In a paper published in Science on May 6, the team reported that their candidate vaccine had induced SARS-CoV-2-specific neutralizing antibodies in mice, rats and non-human primates. It also provided partial or complete protection in macaques against deliberate infection with the virus. A Phase 1/2 clinical trial with 744 human participants is underway in China, with the first results predicted for August.

Because BCG already has a decades-long history of safe use as a vaccine, trials to see whether it is effective against COVID have gone straight to Phase 3. Trials are currently underway among 10,000 frontline health workers in Australia, run by Murdoch Childrens Research Institute, and in the Netherlands among a further 1,500 health workers.

Growing large volumes of viruses to use in vaccines is a long and arduous process, so the traditional approach will be the slowest to scale up globally. Believe it or not, most attenuated virus vaccines are made using huge numbers of chicken eggs.

As we recently told Reuters in an interview, No, DNA vaccines will not lead to genetically engineered humans. However, the technique does involve injecting a fragment of circular DNA, called a plasmid, into human cells. This introduced DNA codes for SARS-CoV-2 viral proteins that are then expressed by the cell and help prime the immune system to fight off an attack by COVID-19. Like mRNA, this is a new technology no DNA vaccines have ever been fully developed and utilized in humans to prevent disease.

The leading developer is Inovio, which worked with a DNA candidate vaccine against MERS. Several other teams are also working on DNA vaccine candidates for the novel coronavirus, including one at the Harvard Medical School.

On May 20, Inovio scientists published trial results in the journal Nature Communications for its COVID candidate DNA vaccine, INO-4800. This showed robust binding and neutralizing antibody as well as T cell responses in mice and guinea pigs, according to the company, raising hopes that INO-4800 might also stimulate a strong immune response in humans. Inovios vaccine is already in human trials, with a Phase 1 study testing on 40 volunteers in Philadelphia and Kansas City results are expected in late June. After that, Inovio plans a large, randomized Phase 2/3 clinical trial this summer.

Separately, the Harvard-led team announced in a paper published in Science on May 20 that various DNA candidate vaccines expressing different forms of the SARS-CoV-2 spike protein had succeeded in immunizing rhesus macaque monkeys. This adds further to hopes that at least some of these DNA vaccines will also work in humans. Some have called this a moon shot, but hey, thats worked before

As with mRNA, there have never yet been DNA vaccines and the chance that this will work first time is anyones guess.

This is another traditional method for vaccinations: genes that code for proteins from the pathogen in COVIDs case, mostly the notorious spike protein are spliced into different viruses, which are then mass-produced. The approach has been used successfully in the HPV vaccine, for example. Virus-like particles can also be produced in plants.

Sanofi Pasteur, the vaccines division of Sanofi, is repurposing its earlier SARS vaccine efforts into COVID. Its recombinant DNA approach in cell lines has already been licensed to produce an influenza vaccine, distributed since 2017 in the US under the brand FluBlok. This should produce a quicker and more stable product than vaccines traditionally produced in chicken eggs.

This approach is also being used by a team at the University of Pittsburgh, whose members had already worked on SARS and MERS and quickly repurposed their spike protein vaccine to target SARS-CoV-2. Its purified protein can be delivered in a microneedle array, a fingertip-sized patch of 400 tiny soluble needles that affixes to the skin like a Band-Aid.

Separately, Novavax has developed a way to package SARS-CoV-2s spike proteins into nanoparticles that should enhance the immune response by better mimicking the virus. In Canada, Medicago began producing virus-like particles of the coronavirus expressed in leaves of Nicotiana benthamiana, a wild relative of tobacco just 20 days after the viral genome was published.

Sanofi says its candidate vaccine is expected to enter clinical trials in the second half of 2020 and to be available by the second half of 2021, making it a backup perhaps if quicker mRNA and DNA vaccine approaches prove to be duds.

The Pittsburgh team won the race to produce the first peer-reviewed paper on a COVID vaccine trial, reporting in mid-March that its microneedle vaccine had elicited potent antigen-specific antibody responses when tested in mice. However, Phase 1 human trials have not yet begun, and the scientists warn that getting results would typically require at least a year and probably longer.

Novavax has received investments totalling $388 million from the Coalition for Epidemic Preparedness (CEPI) to advance clinical development of its candidate vaccine NVX-CoV2373. Phase 1 trials began on May 26 in Australia in 131 human volunteers, with results expected in July. The company is developing scaled-up production that could potentially deliver 100 million vaccine doses by the end of 2020, and 1 billion doses starting in 2021.

Medicago announced positive results for a trial of its COVID candidate vaccine in mice on May 14, and aims to start human trials in the summer. It can already produce 120 million doses of the vaccine per year in its current facilities, and aims to scale up to 1 billion per year by 2023.

As with growing viruses directly, growing large amounts of viral proteins takes time. Cell lines may be quicker than chicken eggs but scaling up to the billions of doses will take a lot longer than the mRNA/DNA approach.

Image: Shutterstock


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Possible COVID-19 vaccines need a challenge trial. Heres why I will volunteer. – The Denver Post

Possible COVID-19 vaccines need a challenge trial. Heres why I will volunteer. – The Denver Post

May 28, 2020

As the COVID-19 pandemic continues, so does uncertainty about whether we will be able to return to normal life in the near future. A vaccine would be the surest way to eliminate the virus, and development of a COVID-19 vaccine has already been significantly faster than the development of other vaccines, but we need an additional step: to let willing volunteers be intentionally infected with the virus.

In this situation, called a human challenge trial, volunteers are first injected with the vaccine, and then exposed to the virus in order to judge the vaccines efficacy. The intentional exposure is the main difference between a challenge trial and the other existing human trials of COVID-19 vaccines. It would greatly speed up vaccine development. Developing a vaccine even one day sooner would save thousands of livesa challenge trial has the potential to be one of the most impactful interventions that anyone can be involved in, which is why I signed up as achallenge trial volunteer through the organization 1Day Sooner. I am young and healthy, and I wanted to share my good fortune with other people by donating my health. Participating in a challenge trial might be the most important thing I ever do.

Human challenge trials do come with ethical concerns; for example, it must be clear that volunteers made a free and informed decision to participate, and both researchers and volunteers have to be convinced that the potential benefits are worth the risk to the volunteers. But ultimately, the trials risks may be equal to or even less than the dangers of simply living in our virus-filled world. Volunteers, chosen to be healthy people with low health risks, would be briefed on all the potential risks of participating in the trial, receive a carefully calculated viral dose, and stay under medical observation and care for the duration of the trial. Exposing volunteers in a controlled environment and keeping them under full medical quarantine with the best possible care means that volunteers might even be safer than people who are exposed through day-to-day activities and unable to receive treatment because of overcrowded hospitals.

It is striking that, despite the trials risks, volunteers are among the loudest, most enthusiastic voices calling for a challenge trial. We ought to be involved in conversations that purport to be concerned for our health and our rights. It must be at least partially up to us to determine whether the risks are worth the benefits of a challenge trial. We say the benefits are worth it.

The world is reminded of those benefits with every day that passes. The death toll is only one measure of the damage this virus causes. People are dying and losing loved ones to COVID-19, but even people who recover can develop long-term or permanent disabilities, such as lung damage, due to this virus. The possibility of permanent health problems is my biggest fear involved in volunteeringbut protecting other peoples lives is more important than my fear.

The economic devastation will damage lives even further, and the repercussions of a global economic crash might far outlive the virus itself. Any time that can be saved in that process of developing a vaccine directly translates to peoples lives saved and substantially improved. We should accept the help of the volunteers, who are willing to use their own health to protect others. As the sages of Judaism, my religious tradition, say: if someone saves a single life, it is as if that person has saved an entire world. I believe that we need to run a COVID-19 vaccine human challenge trial, for the sake of every single person.

Gavriel Kleinwaks is a graduate student in the mechanical engineering department at the University of Colorado Boulder.


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Possible COVID-19 vaccines need a challenge trial. Heres why I will volunteer. - The Denver Post