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The US now seems to be pinning all of its hopes on COVID-19 therapies and vaccines

Almost eight months after the White House first announced it would move from containment to mitigation efforts to stop the spread of the COVID-19 epidemic, the Administration is now pinning its hopes on vaccines to inoculate the population and therapies to treat the disease.

Months after announcing it would be working with technology giants Apple and Google on a contact tracing app (and nearly two months after Google and Apple rolled out their exposure notification features) and initiating wide spread testing efforts nationwide with the largest national pharmacies (which never received the coordinated support it needed),  the Administration appears to be giving up on a national effort to stop the spread of the COVID-19 epidemic.

In an interview with CNN’s Jake Tapper White House Chief of Staff Mark Meadows said that the US is “not going to control the pandemic… We are gonna control the fact that we get vaccines, therapeutics and other mitigation.”

The admission is a final nail in the coffin for a federal response that could have involved a return to lockdowns to stop the spread of the virus, or national testing and contact tracing and other mitigation measures. Meadows statement comes as the US experiences a second peak in infection rates. There are now over 8.1 million cases and over 220,000 deaths since the first confirmed infection on US soil on January 20. 

Now, the focus is all on the vaccines, therapies and treatments being developed by large pharma companies and startups alike that are making their way through the approval processes of regulatory agencies around the world.

The vaccines in phase three clinical trials

There are currently 12 vaccines in large scale, late-stage clinical trials around the world, including ones from American companies Novavax, Johnson & Johnson, Moderna Therapeutics, and Pfizer who are recruiting tens of thousands of people in the US and UK to volunteer for testing.

In China, the state run pharmaceutical company Sinopharm has filed its application to China’s regulatory commission for the approval of a vaccine and hundreds of thousands of civilians have already been vaccinated under emergency use approvals from the Chinese government, according to a report in the New Yorker. Meanwhile the privately held Chinese pharmaceutical company, Sinovac, is moving forward with phase three trials for its own vaccine in Brazil, Bangladesh and Indonesia. Another private Chinese company, CanSino Biologics developed a vaccine that was already being distributed to members of the Chinese military in late July,

A collaboration in the U.K. between the University of Oxford and European pharmaceutical company AstraZeneca is also recruiting volunteers in Brazil, India, the United Kingdom, the US and South Africa. And, in Australia, the Murdoch Children’s Research Institute is trying to see whether a vaccine used to prevent tuberculosis could be used to vaccinate against the coronavirus.

Finally in Russia, the Gamaleya National Center of Epidemiology and Microbiology in partnership with the state-run Russian Direct Investment Fund have claimed to have developed a vaccine that the country has registered as the first one on the market cleared for widespread use. Russia has not published any data from the clinical trials it claims to have conducted to prove the efficacy of the vaccine and the World Health Organization still considers the treatment to be in the first phase of development.

Therapies in phase three clinical trials

If vaccines can prevent against infection, a slew of companies are also working on ways to limit the severity of the disease should someone become infected with Sars-Cov-2, the novel coronavirus that causes COVID-19.

The Milken Institute lists 41 different therapies that have made it through to phase three of their clinical trials (the last phase before approval for widespread delivery).

These therapies come in one of five primary categories: antibody therapies, antivirals, cell-based therapies, RNA-based treatments, and repurposing existing treatments that may be in pharmaceutical purgatory.

Antibody therapies use the body’s natural defense systems either taken from the blood of people who have recovered from an infection or manufactured in a lab to neutralize the spread of a virus or bacteria. Antivirals, by contrast, stop a virus from spreading by attacking the viruses’ ability to replicate. Cell-based therapies are designed to boost the immune system’s ability to fight pathogens like viruses or bacteria. Meanwhile RNA-based treatments are another method to stop the virus from replicating by blocking the construction of viral proteins. Finally, several companies are mining their libraries of old drug compounds to see if any might be candidates for COVID-19 treatments.

So far, only three therapeutics have been approved to treat COVID-19. In the U.K. and Japan dexamethasone has received approvals, while favilavir is being used in China, Italy and Russia; and — famously thanks to its use by the President — remdesivir has been approved in the United States, Japan and Australia.

The US is also using convalescent plasma to treat hospitalized patients under emergency use authorizations. And special cases, like the President’s, have had access to other experimental treatments like Regeneron’s cell therapy under emergency use authorizations.

And there are several US-based startups developing potential COVID-19 therapies in each of these areas.

Adaptive Biotechnologies, Cytovia Therapeutics, and SAB Biotherapeutics are all developing antibody treatments. Applied Therapeutics is using an understanding of existing compounds to develop treatments for specific conditions associated with COVID-19. Cellularity has a cell-therapy that could reduce a patient’s viral load by stimulating so-called natural killer cells to attack infected cells. Humanigen has developed a new drug that could reduce fatalities in high-risk COVID-19 patients with severe pneumonia. Meanwhile Partner Therapeutics is working on a drug that could improve lung function in COVID-19 patients — and potentially boost antibody production against the virus and restore damaged lung cells. Finally, Sarepta Therapeutics has been working with the United States Army Medical Research Institute of Infectious Diseases to find ways for its RNA-based treatment to stop the spread of coronaviruses by attacking the ability for the virus to replicate.

Beyond therapies, startups are finding other ways to play a role in helping the nation address the COVID-19 epidemic.

“At this point the U.S. doesn’t have the best public health system, but at the same time we have best-in-class private companies who can sometimes operate a lot more efficiently than governments can,” Carbon Health chief executive Eran Bali told the audience at TechCrunch’s Disrupt 2020 conference. “We also just recently launched a program to help COVID-positive patients get back to health quickly, a rehabilitation program. Because as you know even if you survive it doesn’t mean your body was not affected, there are permanent effects.”

Indeed the drive for more effective at-home tests and remote treatments for consumers are arguably more important when the federal government refuses to make the prevention of viral spread a priority, because consumers may voluntarily lock down if the government won’t.

“This is an opportunity to take a technology that naturally is all about detecting viruses — that’s what CRISPR does in [its native environment] bacteria — and repurposing it to use it as a rapid diagnostic for coronavirus,” said the Nobel Prize-winning co-inventor of some foundational CRISPR gene-editing technology, Jennifer Doudna. “We’re finding in the laboratory that that means that you can get a signal faster, and you can also get a signal that is more directly correlated to the level of the virus.”

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The changing face of employment law during a global pandemic

Prompted by Jeff Bezos’s plans to test all Amazon employees for the virus that causes COVID-19, we wondered whether employers can mandate employee testing, regardless of symptoms. The issue pits public safety against personal privacy, but limited testing availability has rendered the question somewhat moot.

But as the World Health Organization and U.S. Centers for Disease Control and Prevention have noted, asymptomatic COVID-19 carriers can spread the virus without realizing they’re infected. To learn more about workers’ rights in this arena, we spoke to Tricia Bozyk Sherno, counsel at Debevoise & Plimpton, who focuses on employment and general commercial litigation.

The answer, for now, is not entirely straightforward, though updates from the U.S. Equal Employment Opportunity Commission could make the situation clearer going forward as more tests are made available and state governments begin pushing to reopen businesses.

Sherno offered a fair amount of insight into the EEOC’s updated guidance and made some predictions about how things may look for both employers and workers going forward.

TechCrunch: Prior to the COVID-19 pandemic, what sorts of laws governed an employer’s ability to test employees for infectious diseases?

Tricia Bozyk Sherno: Covered employers (employers with 15 or more employees) must comply with the requirements of the Americans with Disabilities Act (ADA), which limits an employer’s ability to make disability-related inquiries or require medical examinations. (Note that certain states may also have similar statutes in place.) Generally, disability-related inquiries and medical examinations are prohibited by the ADA except in limited circumstances. A “medical examination” is a procedure or test that seeks information about an individual’s physical or mental impairments or health — so infectious disease testing would fall into this category.

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Coronavirus Live Updates: Trump Suspends U.S. Funds for W.H.O.

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Credit…Doug Mills/The New York Times

President Trump on Tuesday said that he planned to stop United States funding of the World Health Organization while reviewing its role in what he described as “severely mismanaging and covering up the spread of the coronavirus.”

The announcement came as Mr. Trump continued to be angered by criticism of his response to the pandemic and as he sought to gain credit for how he has performed. “Everybody knows what is going on there,” he said, blaming the organization for what he described as a “disastrous decision to oppose travel restrictions from China and other nations.”

Mr. Trump has repeatedly pointed to his decision to impose travel restrictions on China as proof that he responded early to warnings about the dangers of the coronavirus.

He said that decision saved “thousands and thousands of lives,” and the W.H.O. “fought us.” The president blamed the organization for a “20-fold” increase in cases worldwide.

As recently as February, the W.H.O. had advised against imposing travel restrictions to places with outbreaks of the coronavirus, saying it was not an effective way combat its spread.

On Tuesday, the president said the organization “willingly took China’s assurances” and that it “defended the actions of the Chinese government, even praising its so-called transparency.”

Mr. Trump has been defensive about his decision to institute early travel restrictions on China, crediting himself with saving hundreds of thousands of lives while sustaining criticism for being xenophobic and racist.

But Mr. Trump has not addressed his administration’s inaction after that decision and the gap in the timeline of his response between the travel restrictions announced on Jan. 31 and the declaration of a national emergency on March 13.

Slowly, tentatively, a handful of European countries began lifting constraints on daily life this week for the first time since the start of the coronavirus crisis, providing an early litmus test of whether Western democracies can gingerly restart their economies and restore basic freedoms without reviving the spread of the disease.

On Tuesday, Italy, the epicenter of Europe’s crisis, reopened some bookshops and children’s clothing stores. Spain allowed workers to return to factories and construction sites, despite a daily death toll that remains over 500. Austria allowed thousands of hardware and home improvement stores to reopen, as long as workers and customers wore masks.

In Denmark, elementary schoolteachers readied classrooms so young children could return to school on Wednesday, while in the Czech Republic, a restless public relished the reopening of sports centers and some shops.

When Lukas Zachoval, a sales manager in the Czech Republic, lost a tennis match to his father this week — in a 6-4, 6-3 drubbing — defeat had seldom tasted sweeter. After all, it was his first match since the Czech government began lifting sweeping restrictions on society, including a ban on communal sports, that had been in place for nearly a month.

The easing of the lockdowns was watched with interest and trepidation across Europe and beyond, and posed profound and knotty questions. Among them: Now that the rate of infection has ebbed in several countries, to what extent should political leaders prioritize concern for public health over worries about the economy?

The moves to loosen restrictions came despite a warning a week earlier by the World Health Organization’s regional director for Europe, Hans Kluge, who said, “Now is not the time to relax measures.”

The fledgling, country-by-country loosening, enacted without any coordination between nations, underscored the absence of any common agreement, or even understanding, about the challenge of keeping economies alive while stemming the disease.

When Guayaquil, Ecuador’s business capital, was first hit by the coronavirus, the devastation was so great that bodies were piling up in the streets.

Now, as the authorities begin to grapple with the scale of the crisis, they have reason to believe that the toll for the province that includes Guayaquil is likely many times larger than the official government figure of 173 dead.

The numbers are skewed because only those who test positive — dead or alive — are counted as coronavirus victims.

The usually bustling port city of about three million had 1,500 more deaths in March of this year than in the same month in 2019, Guayaquil’s mayor, Cynthia Viteri, said in an interview.

“They are not only dying from Covid,” she said, referring to the disease caused by coronavirus. “People with diabetes, hypertension, heart disease are dying from lack of medical attention, because the hospitals are saturated with the critically ill, because there aren’t places where women can give birth without getting infected.”

In addition, in the past two weeks, a special emergency team collected or authorized the burial of nearly 1,900 bodies from Guayaquil’s hospitals and homes, according to Ecuador’s government, which said that figure represented a fivefold increase in the city’s usual mortality rate.

To combat the spread of the virus, the city will resort to some of the most draconian quarantine measures in Latin America.

Security forces on Tuesday began cordoning off the contagion hot spots for up to three days at a time while medics looked door to door looking for potential cases and sanitary workers disinfected public spaces.

Ms. Viteri, the mayor, said movement to and from the hard-hit neighborhoods, located mostly in the city’s poor periphery, will be completely cut off. City authorities will provide residents with food while the operation lasts.

“The situation isn’t grave — it’s extremely grave,” said Ms. Viteri. “And we still haven’t reached a high point of infections in Guayaquil.”

The images are compelling: Fire trucks in Tehran or Manila spray the streets. Amazon tests a disinfectant fog inside a warehouse, hoping to calm workers’ fears and get them back on the job. Families nervously wipe their mail and newly delivered groceries.

These efforts may help people feel like they and their government are combating the coronavirus. But in these still-early days of learning how to tamp down the spread of the virus experts disagree on how best to banish the infectious germs.

“There is no scientific basis at all for all the spraying and big public works programs,” said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

Other experts are not ready to confidently dismiss disinfecting. There are just too many unknowns about this virus, said Marc Lipsitch, an infectious disease epidemiologist at the Harvard T.H. Chan School of Public Health.

Dr. Lipsitch said it will be difficult to study the effectiveness of disinfecting outdoor spaces because “everyone is throwing a mix of interventions at the problem, as they should.”

Most transmission of the virus comes from breathing in droplets that an infected person has just breathed out — not from touching surfaces where it may be lurking. “Transmission of novel coronavirus to persons from surfaces contaminated with the virus has not been documented,” the Centers for Disease Control and Prevention notes on its website.

The rule of thumb, or rather feet, has been to stand six feet apart in public. That’s supposed to be a safe distance if a person nearby is coughing or sneezing and is infected with the novel coronavirus, spreading droplets that may carry virus particles.

And scientists agree that six feet is a sensible and useful minimum distance, but, some say, farther away would be better.

Six feet has never been a magic number that guarantees complete protection. The Centers for Disease Control and Prevention, one of the organizations using that measure, bases its recommendation on the idea that most large droplets that people expel when they cough or sneeze will fall to the ground within six feet.

But some scientists, having looked at studies of air flow and being concerned about smaller particles called aerosols, suggest that people consider a number of factors, including their own vulnerability and whether they are outdoors or in an enclosed room, when deciding whether six feet is enough distance.

“Everything is about probability,” said Dr. Harvey Fineberg, who is the head of the Standing Committee on Emerging Infectious Diseases and 21st Century Health Threats at the National Academies of Sciences, Engineering and Medicine. “Three feet is better than nothing. Six feet is better than three feet. At that point, the larger drops have pretty much fallen down.”

Reporting was contributed by Karen Weintraub, Knvul Sheikh, James Gorman and Kenneth Chang

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Researchers develop emergency ventilator based on resuscitation bags used in ambulances

The need for innovative solutions to address shortages in crucial medical equipment is greater than ever, and a new initiative from a global team of biomedical engineering experts is a perfect example. The team developed a way for resuscitation bags – common pieces of equipment carried by ambulances and paramedics around …

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Estimote launches wearables for workplace-level contact tracing for COVID-19

Bluetooth location beacon startup Estimote has adapted its technological expertise to develop a new product designed specifically for curbing the spread of COVID-19. The company created a new range of wearable devices that co-founder Steve Cheney believes can enhance workplace safety for those who have to be co-located at a …

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Africa turns to mobile payments as a tool to curb COVID-19

Africa is using digital finance as a means to stem the spread of COVID-19.
Governments and startups on the continent are implementing measures to shift a greater volume of payment transactions toward mobile money and away from cash — which the World Health Organization flagged as a conduit for the spread …

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Coordinated response required to optimize telehealth during COVID-19 pandemic

Eric Perakslis
Contributor

Eric Perakslis, PhD is a Rubenstein Fellow at Duke University, Lecturer, Department of Biomedical Informatics at Harvard Medical School and Innovation Advisor to Médecins Sans Frontières. He has significant experience leading technology efforts in infectious disease outbreaks.

As the COVID-19 epidemic scales exponentially across the United …

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White House provides an update on COVID-19 testing in the U.S., says there’s been a ‘dramatic ramp’

During a White House press briefing on the state of the COVID-19 pandemic in the U.S., members of the White House coronavirus task force provided updates about the current state of coronavirus testing in the U.S., which is a crucial metric to track given that the World Health …

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Nunes Encourages People to Dine Out as Experts Urge Them to Stay Home

Representative Devin Nunes, a California Republican, on Sunday encouraged healthy people to dine out at restaurants, contradicting public health advisories that strongly encouraged social distancing and discouraged Americans from attending mass gatherings.In an appearance on Fox News, Mr. Nunes said Americans should stop fighting over groceries and toilet paper.“ …

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