Category: Covid-19

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Europe warns of need for vigilance as Covid-19 cases rise sharply – The Guardian

July 24, 2020

Spanish health officials have warned the country could already be experiencing a second wave of coronavirus, as France, Germany and Belgium all reported steep rises in their number of cases.

Countries across Europe have reminded people of the need for vigilance amid rising cases as the summer holiday season continues.

On Friday, France said it was advising it citizens not to travel to the Spanish region of Catalonia in order to help contain the spread of the virus, while Norway said it was reimposing a 10-day quarantine requirement for people arriving from Spain measures that raised the spectre of renewed border restrictions across the continent.

Spains health ministry is tracking more than 280 active outbreaks across the country. On Friday, it logged 922 new Covid-19 cases slightly down from 971 over the previous 24 hours.

Mara Jos Sierra, the deputy head of Spains centre for health emergencies, said that while the curve had been flattened, community transmission was being seen in north-eastern areas.

It could already be a second wave, but thats not the most important thing, Sierra told reporters on Thursday. The most important thing is that we keep following whats going on, see what measures are necessary, and take them early.

She also said people needed to remember the incidence of the virus had tripled in just two weeks, from 8.76 cases per 100,000 people on 3 July to 27.39 per 100,000. Obviously, the curve is going up, but lets wait to see what kind of situation were in, she added.

Nearly 8,000 cases have been diagnosed in Catalonia over the past 14 days accounting for almost half of the 16,410 detected across Spain.

Catalonias public health secretary, Josep Maria Argimon, said the situation in and around Barcelona was at a critical moment and called on people to heed the regional governments request not to leave their homes unless strictly necessary.

There are growing fears the virus is being spread by people going to bars and nightclubs, and that restrictions may be needed to curb the rise in cases.

On Thursday, the government of the south-eastern region of Murcia ordered the 32,000 inhabitants of Totana back into the second phase of lockdown de-escalation after 55 cases were traced to a bar in the town.

Madrids regional government said on Friday it planned to rethink the guidelines on the number of people allowed to meet up at night.

Were going to introduce measures on nightlife, including limiting the number of people allowed on bar and restaurant terraces or other meeting places because the virus likes movement and large gatherings, said the regions deputy public health minister, Antonio Zapatero.

The regional government is also urging the central government to introduce more stringent controls at Madrids Barajas airport after it emerged that 77 people had arrived there with the virus since May.

Frances national health authority, Sant Publique, reported 1,062 new cases on Thursday and said that while there had been an increase among the over-75s and people in care homes, a rise had also been reported in cases among young adults.

The authority said there had been a slackening of the application of barrier gestures and reminded people that physical distancing needed to be maintained.

During the summer and holidays, it may seem artificial to greet each other at a distance, talk from a distance, wash hands regularly and wear masks in enclosed spaces, but this individual and collective effort is crucial to prevent the virus from encroaching on our freedom and the epidemic from rebounding, it said.

On Friday, the French president, Emmanuel Macron, held a meeting of the countrys defence council to discuss the increase in cases and consider fresh measures including whether to tighten controls on the borders with Belgium and Spain and possible quarantine measures for international passengers at airports.

Germanys Robert Koch Institute (RKI) reported 815 new cases on Friday, compared with 583 a week ago and 395 the week before.

Excluding recent outbreaks at meat processing plants, the rise was the biggest since mid-May. Figures tend to be higher on Fridays, due to reported cases stacking up during the week.

More than 40% of current cases are in the western state of North Rhine-Westphalia, but other states are also showing above-average rises.

Jonas Schmidt-Chanasit from the Bernhard-Nocht Institute for Tropical Medicine in Hamburg said the figures appeared to indicate an increase across the population rather than in specific locations such as around meat processing plants. If that was the case, it would make the virus more difficult to contain, he told Der Spiegel.

We need to see whether this is to do with large gatherings, that are now allowed, the reopening of kindergartens and schools, or is it to do with people returning from their holidays? he said.

People returning to Germany from the Balkans, Turkey and Mallorca have tested positive for the virus.

The RKI has put 100 countries on a list of risk areas, including the US, Israel and Luxembourg. The health ministry is widely expected to announce that tests for people returning from risk areas will soon be obligatory.

In Belgium, where the number of new weekly infections has risen by 89%, officials said a three-year-old girl had become the countrys youngest known victim.

The health spokesman Boudewijn Catry said three people were dying each day in Belgium from Covid-19, adding that recent deaths included those of the toddler and an 18-year-old.

Catry said the young girl had severe pre-existing conditions, but warned against complacency among the healthy, pointing out that 85% of new cases diagnosed last week were among people under 60.

Its true that its rare that a young person dies of Covid-19, but its clear that no one is immune, he said.

Agence France-Presse contributed to this report

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Europe warns of need for vigilance as Covid-19 cases rise sharply - The Guardian

The COVID-19 Host Genome Structural Variant Consortium Formed by Dr. Ravindra Kolhe at Augusta University Creates a Massive Expansion in the Scope of…

July 24, 2020

SAN DIEGO, July 24, 2020 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO) announced today that a recently formed international consortium of clinical and research sites is using its Saphyr genome imaging system to identify genomic variants that influence resistance or sensitivity to the SARS-CoV2 virus, or COVID-19 disease progression and drug response. The consortium is comparing the genome structures of those patients who show no or mild symptoms and those who show severe illness, while controlling for the known risk factors of age and chronic illness such as asthma, heart disease, diabetes, or other immune-compromising disease. The team plans to analyze at least 1,000 patient genomes with Saphyr.

The consortium was founded by Dr. Ravindra Kolhe, the Vice-Chair of Pathology and Section Chief of Molecular and Genetic Pathology at Augusta University and Dr. Alka Chaubey, Scientific Director for the Georgia Esoteric & Molecular Lab at Augusta University. Additionally, it consists of co-investigators from Baylor College of Medicine, Bostons Children's Hospital of Harvard University, Childrens National Medical Center, Columbia University, George Mason University, MD Anderson Cancer Center, the National Cancer Institute, Oregon Health and Science University, Rockefeller University, San Francisco State University, Sanford Burnham Prebys, UC San Diego, UC Santa Cruz, and Virginia Commonwealth University, with many more in the process of joining.

A number of companies have committed to supporting this effort as part of a global Tech Against Covid initiative. Rescale, the High-Performance Computing cloud platform fully integrated with Saphyr, and Amazon, a leading provider of on-demand cloud computing, are donating compute time for the Bionano data analysis. Genoox, the platform for annotation and classification of genomic variants, is donating its compute resources to analyze available sequencing data combined with Bionanos structural variation calls for an integrated analysis of small and large genomic variants.

Initial unpublished findings from the first 30 patients that have been analyzed show that Saphyr detects large amounts of structural variation in many putatively relevant genes, demonstrating that point mutations alone are unlikely to explain disease differences between patients. Bionanos Saphyr system is expected to provide the crucial structural variation data needed for a full understanding of genome structure in patients.

Dr. Ravindra Kolhe, founder of the consortium commented: We strongly believe that Bionanos Saphyr platform is uniquely capable of identifying variants that play an important role in regulating COVID-19 in patients, and may be able to explain some of the extreme variation in disease severity and progression that we see in patients. Other studies of the host genome are based on short-read sequencing or SNP-microarrays, and those technologies are unable to detect and account for the large amounts of structural variation thats present in clinically important regions of the genome. We are hopeful that our initial results will translate into discoveries that truly advance our understanding of this devastating disease, and will improve our ability to treat the sickest patients.

Erik Holmlin, PhD, CEO of Bionano Genomics commented: The COVID-19 Host Genome Structural Variation Consortium is an important expansion of Bionanos efforts to help the scientific and medical community in the development of novel, targeted, antiviral therapies or vaccines. We believe that Bionanos genome imaging technology is the only technology capable of detecting the structural variants that could protect against or predispose patients to the viral infection and influence the severity of the disease. We are thrilled that our technology is being used in a global effort to help bring this pandemic to a halt.

About Bionano GenomicsBionano is a genome analysis company providing tools and services based on its Saphyr system to scientists and clinicians conducting genetic research and patient testing. Bionanos Saphyr system is a platform for ultra-sensitive and ultra-specific structural variation detection that enables researchers and clinicians to accelerate the search for new diagnostics and therapeutic targets and to streamline the study of changes in chromosomes, which is known as cytogenetics. The Saphyr system is comprised of an instrument, chip consumables, reagents and a suite of data analysis tools, and genome analysis services to provide access to data generated by the Saphyr system for researchers who prefer not to adopt the Saphyr system in their labs. For more information, visitwww.bionanogenomics.com.

Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as may, will, expect, plan, anticipate, estimate, intend and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: planned scope of the consortiums research; preliminary findings regarding COVID-19 through the use of Saphyr; and Saphyrs ability to contribute to research and treatment of COVID-19, including discoveries that can advance an understanding of COVID-19 and improve the ability to treat patients. Each of these forward-looking statements involves risks and uncertainties. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the risks and uncertainties associated with: the impact of the COVID-19 pandemic on our business and the global economy; general market conditions; changes in the competitive landscape and the introduction of competitive products; changes in our strategic and commercial plans; our ability to obtain sufficient financing to fund our strategic plans and commercialization efforts; the loss of key members of management and our commercial team; and the risks and uncertainties associated withour business and financial condition in general, including the risks and uncertainties described in our filings with the Securities and Exchange Commission, including, without limitation, our Annual Report on Form 10-K for the year ended December 31, 2019 and in other filings subsequently made by us with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

CONTACTSCompany Contact:Erik Holmlin, CEOBionano Genomics, Inc.+1 (858) 888-7610eholmlin@bionanogenomics.com

Investor Relations Contact:Ashley R. RobinsonLifeSci Advisors, LLC+1 (617) 430-7577arr@lifesciadvisors.com

Media Contact:Kirsten ThomasThe Ruth Group+1 (508) 280-6592kthomas@theruthgroup.com

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The COVID-19 Host Genome Structural Variant Consortium Formed by Dr. Ravindra Kolhe at Augusta University Creates a Massive Expansion in the Scope of...

‘The challenges that labs are facing are complex’: Why COVID-19 test results are so delayed – NBC News

July 24, 2020

The enormous number of Americans getting swabbed for the coronavirus has overwhelmed every step of the COVID-19 testing process, creating shortages of critical supplies in laboratories and inundating them with more specimens than they can process.

The testing spike, which experts say has been particularly dramatic over the past month as more coronavirus hot spots have popped up, has meant waits of up to two weeks or more for test results in some cases a far from ideal turnaround time.

Laboratories say they are working as fast as they can.

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"The challenges that labs are facing are complex," said Louise Serio, a spokesperson for the American Clinical Laboratory Association, a trade group that represents companies such as Quest Diagnostics and LabCorp. "There is a significant strain on the global supply chain."

Since the beginning of the pandemic, the American Clinical Laboratory Association's members have performed more than 23 million COVID-19 tests, Serio said. Testing capacity is increasing every week, she said, and employees are working round-the-clock to run as many tests as possible, but they are running out of necessary chemicals and other products faster than their manufacturers can replenish them.

"What we have consistently heard from members is that reagents, test kits, pipettes and platforms are all in great demand right now," she said.

The backlog could get worse if the outbreak continues on its current trajectory. On Thursday, the United States reached a somber milestone, surpassing 4 million confirmed coronavirus cases nationwide, according to data compiled by NBC News, just 15 days after hitting the 3 million mark.

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Dr. Scott Gottlieb, the former commissioner of the Food and Drug Administration, said on MSNBC's "Morning Joe" that access to testing and quick results is "likely to continue to be a challenging issue heading into the fall."

Testing lags will make it significantly harder to stop transmission of the virus, he said.

"After about 48 hours, the test really isn't that useful for the clinical management of the patient," Gottlieb said. "At that point, you're not going to be able to use the result to do effective contact tracing. Too much time has passed, and you're not giving information back to the provider and the patient that they could use."

His comments echoed those of Dr. Brett Giroir, the assistant secretary of health and human services for health, who is overseeing U.S. coronavirus testing and who has said three days is a "reasonable turnaround time" for results.

But given the surge in demand, that has been difficult to attain.

While some COVID-19 tests are done by a more rapid, cartridge-based method in hospitals for patients who are admitted, a much larger percentage in the U.S. are done by commercial labs.

Mike Geller, a spokesman for LabCorp, said LabCorp has so far performed 7.5 million molecular tests for COVID-19 and is processing 165,000 tests a day, with plans to increase capacity further. The average time to deliver results is three to five days from when a specimen was picked up; before the surge, the turnaround time was one to two days, he said.

Jim Davis, executive vice president of general diagnostics at Quest Diagnostics, said Quest has performed more than 8.5 million tests and is processing 130,000 tests a day. Quest anticipates that by the end of the month, it will have a daily capacity of 150,000 tests, which should help with the delays: Average turnaround time for test results right now is at least seven days, up from two to three days until several weeks ago, Davis said.

While Quest's test capacity has doubled over the last two months, demand has tripled, Davis said, with the last three to four weeks representing a steep increase. Labs are staffed 24/7, which they were not before the pandemic.

"We're asking everyone right now to work overtime," Davis said.

Federal funding and clearer guidance on testing from the federal government could help get turnaround times down. This week, the American Clinical Laboratory Association was among 50 health care organizations to call on Congress to dedicate more funding for testing.

"If the demand keeps increasing like it's been increasing over the last couple of weeks, the lab industry will never be able to keep up with it."

In the meantime, to best accommodate the backlogs, many testing sites are prioritizing certain patients.

At Northwell Health, New York's largest health care provider, screening tests for employment, travel or summer camp are considered lowest priority; those tests are typically sent out to the national commercial laboratories, while symptomatic patients awaiting clinical treatments are put at the top of the list, with their tests performed at Northwell's regional laboratories, said Dr. Dwayne Breining, executive director of Northwell Health Laboratories.

The turnaround time at the regional laboratories is one to two days, he said. (Northwell's hospitals, meanwhile, get results within thee hours using their cartridge tests.)

Breining said the U.S.'s maxed-out testing capacity reflects the country's struggle to contain the spread of the virus, and he urged Americans to take precautions.

"If the demand keeps increasing like it's been increasing over the last couple of weeks, the lab industry will never be able to keep up with it," he said. "I think the top priority is going to be mitigating the clinical spread of this virus by doing things we know work: things like social distancing, masking and monitoring.

"All those things make a huge difference," he added. "That would allow you to slow it down enough so that not only the lab testing industry, but the entire medical system, can catch up."

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'The challenges that labs are facing are complex': Why COVID-19 test results are so delayed - NBC News

Trump admits pandemic will ‘get worse’ at first Covid-19 briefing in months – The Guardian

July 22, 2020

Donald Trump has admitted that the coronavirus pandemic is likely to get worse before it gets better at his first press briefing devoted to the issue since April.

Facing dire poll numbers, surging cases and sharp criticism for lack of leadership, the US president returned to the White House podium attempting to show more discipline in both style and substance.

In several notable reversals, he urged people to wear face masks, promised his administration was working on a strategy and wrapped up in less than half an hour, avoiding his digressions in past briefings that culminated in a proposal to inject disinfectant in Covid-19 patients.

The pandemic will probably, unfortunately, get worse before it gets better, Trump said, reading from scripted remarks. Something I dont like saying about things, but thats the way it is.

It was a marked shift from his claims last month the virus is fading away and dying out. And having once dismissed its remnants as embers, he now conceded that it is raging in states led by Republican governors.

We have embers and fires and we have big fires and unfortunately now, Florida is a little tough or in a big tough position, he said. You have a great governor there, great governor in Texas.

Trump has been widely condemned for failing to lead with a national strategy and instead shifting responsibility to state governors. Among the problems is a lack of infrastructure to process and trace test results, leaving people waiting seven days or longer.

On Tuesday he claimed: We are in the process of developing a strategy thats going to be very, very powerful. We have developed it as we go along.

After months of refusing to wear a mask in public, Trump finally did so on 11 July and has since claimed it is patriotic. Were asking everybody that when you are not able to socially distance, wear a mask, he said. Get a mask, whether you like the mask or not, they have an impact. Theyll have an effect, and we need everything we can get.

Producing a mask from his suit pocket, he added: I carry the mask ... I have the mask right here. I carry it and I will use it gladly.

The belated appeal was insufficient to placate the presidents critics, however. Heather McGhee, the co-chair of the civil rights group Color of Change, told the MSNBC network: This is three months too late and 30 or 40,000 lives lost too late.

Despite the more subdued and realistic tone, Trump also offered upbeat words about a reduction in deaths and progress on vaccines and treatments for Covid-19. The vaccines are coming, and theyre coming a lot sooner than anybody thought possible, he said.

He also repeatedly used the racist term China virus and recycled his promise that one day it will disappear.

More than 3.8 million cases have been reported in the US, including 141,000 deaths. The briefing was the latest of several attempts to relaunch Trumps public response to the pandemic, after months of shifting from apparent denial to a wartime footing to a focus on the economy and other topics.

Trump has previewed the briefings as having a good slot at 5pm that previously boasted strong ratings. But on Tuesday, he was not joined by Anthony Fauci, the nations top infectious diseases expert, who had told an interviewer he was not invited, nor by the response coordinator, Deborah Birx, whom Trump claimed was right outside the briefing room.

Critics have suggested that briefings have returned, albeit in a different form, in an attempt to dominate the media limelight at the expense of Trumps election rival, Joe Biden. Asked whether he thinks Americans should judge him in November on his handling of the pandemic, Trump replied: This, among other things. I think the American people will judge us on this. But theyll judge us on the economy that I created.

Earlier on Tuesday, Biden reiterated his criticism of Trumps response to the pandemic. His own staff admits that Donald Trump fails the most important test of being the American president: the duty to care for you, for all of us, the former vice-president said in New Castle, Delaware. He has quit on you and he has quit on this country.

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Trump admits pandemic will 'get worse' at first Covid-19 briefing in months - The Guardian

FDA’s Ongoing Work to Support and Advance COVID-19 Diagnostic Test Accuracy and Availability – FDA.gov

July 22, 2020

By: Jeff Shuren, M.D., J.D., Director, Center for Devices and Radiological Health

The U. S. Food and Drug Administration has been proactive and supportive of test development by all comers including laboratories, and large and small commercial manufacturers to speed development and to quickly authorize tests that the science supports. The agency engaged with the lab and commercial manufacturer communities even before any cases of COVID-19 were diagnosed in the U.S., working with over 500 developers since January, and has been working around the clock to authorize over 180 Emergency Use Authorizations (EUAs) for tests, including molecular, serology, antigen, and tests with at-home specimen collection indications.

This pandemic has created a demand for new tests that is unprecedented in both volume and urgency. The FDAs important roles in testing include determining whether the tests developed for use in the U.S. provide sufficiently accurate and reliable results and helping to provide timely access to such tests.

In a public health emergency, getting an accurate test is important not only for the individual patient, but for the public at large. False positive or false negative results can contribute to the spread of COVID-19, so all tests used for COVID-19 should be validated before use. Similarly, timely access to diagnostic tests is also critically important. To best address these dual, and sometimes competing, needs, the FDA has used its EUA authorities. EUAs permit the emergency use of a product, in this case a test, when the FDA determines that certain criteria are met based on the totality of the scientific evidence available. The EUA process made it possible for molecular diagnostic tests to be developed, validated, and offered for clinical use within weeks rather than months or longer.

The FDAs EUA authorities allow the FDA to authorize the emergency use of tests more quickly than full FDA approval or clearance because the evidentiary standard is different. For full approval or clearance, we typically require validation testing using patient samples; however, due to the immediate need and the small number of patient samples available, we utilized our emergency authorities to authorize tests based on data from contrived clinical samples or smaller sets of patient samples. For example, early-on in the emergency, instead of using specimens from individuals infected with SARS-CoV-2, developers could add different amounts of inactivated SARS-CoV-2 RNA to human specimens, such as sputum, to assess how well their test could detect the virus. As a result, validation could be completed rapidly, in some cases in only a few days once inactivated RNA became available. This approach was less likely to accurately characterize test performance so the FDA has taken several actions now that clinical specimens have become more readily available.

Once multiple sources of positive patient samples were available, we asked developers of new tests to validate with these clinical samples. In addition, as part of each EUA for a COVID-19 test, the FDA requires that each test developer and its authorized distributors collect test performance information, including any suspected occurrence of false results, and report to the FDA as a condition of authorization. An additional condition of authorization requires test developers to track adverse events and report them to the agency. These actions have helped generate more robust evidence of test performance to help providers, patients, laboratories, and the government make better informed decisions.

Additionally, these conditions enable the FDA to detect trends and take swift action to prevent harm to patients, especially when device malfunctions may affect many tests across the nation (e.g., in sample collection swabs, or shared test reagents). For example, we were able to quickly alert the public about potential inaccuracies with the Abbott ID Now point-of-care test to diagnose COVID-19 when we began to see a trend in the adverse event reports we received. In some cases, such as tests that used contrived clinical samples for validation, we required developers to conduct post-authorization studies as a condition of their authorization to further evaluate the clinical performance of the test using clinical specimens. This approach gives patients timely access to potentially beneficial and high-volume tests while assuring a more robust understanding of test performance in a real-world setting. The agency monitors all of this information so that we are able to take action when a tests benefits no longer outweigh its risks. Finally, the FDA requires that manufacturers of certain tests provide evidence that their manufacturing processes will deliver consistent results, helping to ensure that accurate tests are produced in every manufacturing lot.

Another step the FDA took to support independent validation for SARS-CoV-2 diagnostic tests was providing developers with a reference panel. Starting with live SARS-CoV-2 virus we obtained, FDA personnel in the Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research worked collaboratively to create a reference panel from a validated inactivated viral stock, and made it available to developers of molecular diagnostic tests. The FDA-supplied reference panels include well-characterized samples of the SARS-CoV-2 virus genetic material (RNA). The FDA panel is available as an independent performance validation step for commercial and laboratory developers of SARS-CoV-2 nucleic acid diagnostic tests who previously validated their authorized tests with contrived samples, or who are currently having difficulty validating their new test. Data from use of the reference panel will provide the FDA with more accurate information on the comparative performance of different tests so that we will have a better understanding of which tests are more sensitive than others. The FDA will make this information available on our website.

We recently announced our participation in the COVID-19 Diagnostics Evidence Accelerator, a multi-stakeholder collaborative project to advance the development of diagnostics through the generation of real-world evidence. It is organized by the Reagan-Udall Foundation for the FDA in collaboration with Friends of Cancer Research to allow the community to analyze both diagnostic and clinical data in real time, which has the potential to contribute to the scientific evaluation of diagnostic tools and medical interventions for COVID-19. The Accelerator project will leverage FDA's SHIELD initiative, a multi-stakeholder collaboration to improve the quality, interoperability and portability of laboratory data within and between institutions so that diagnostic information can be drawn from different sources or shared between institutions. SHIELD harmonizes COVID-19 test data referenced in the HHS COVID-19 laboratory data reporting requirements, which can be used to evaluate the real-world performance of SARS-CoV-2 diagnostic tests and antibody tests.

Evidence generated by the Accelerator project is intended to be complementary to other studies that have been conducted or are underway as well as to provide actionable information about the prevalence of SARS-CoV-2 in specific populations and highlight individual risk factors for patients. This helps improve our understanding of the disease, tailor public health interventions and strategies to mitigate risks for individuals and communities and help stop the spread of SARS-CoV-2.

Taken together, these actions will, and already are, providing the clinical, patient and consumer communities with more accurate information about diagnostic test performance and allowing for the rapid availability of new, accurate and reliable tests.

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FDA's Ongoing Work to Support and Advance COVID-19 Diagnostic Test Accuracy and Availability - FDA.gov

COVID-19 immunity: Virus antibodies may fade fast but protection may not – NBC News

July 22, 2020

New research suggests that antibodies the immune system makes to fight the new coronavirus may only last a few months in people with mild illness, but that doesnt mean protection also is gone or that it wont be possible to develop an effective vaccine.

Infection with this coronavirus does not necessarily generate lifetime immunity, but antibodies are only part of the story, said Dr. Buddy Creech, an infectious disease specialist at Vanderbilt University. He had no role in the work, published Tuesday in the New England Journal of Medicine.

The immune system remembers how to make fresh antibodies if needed and other parts of it also can mount an attack, he said.

Antibodies are proteins that white blood cells called B cells make to bind to the virus and help eliminate it. The earliest ones are fairly crude but as infection goes on, the immune system becomes trained to focus its attack and to make more precise antibodies.

Dr. Otto Yang and others at the University of California, Los Angeles, measured these more precise antibodies in 30 patients diagnosed with COVID-19 and four housemates presumed to have the disease. Their average age was 43 and most had mild symptoms.

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Researchers found that the antibodies had a half-life of 73 days, which means that half of them would be gone after that much time. It dovetails with a previous report from China also suggesting antibodies quickly fade.

The results call for caution regarding antibody-based immunity passports, herd immunity, and perhaps vaccine durability, the California authors write.

Thats true, Creech said, but other parts of the immune system also help confer protection. Besides churning out antibodies, B cells develop a memory so they know how to do that again if needed.

They would get called into action very quickly when theres a new exposure to the virus. Its as if they lie dormant, just waiting, he said.

Other white blood cells called T cells also are better able to attack the virus the next time they see it, Creech said.

Although circulating antibodies may not last long, what we need to know is if and how people remake antibodies if exposed to the coronavirus again and if they protect against another infection, Alison Criss, an immunologist at the University of Virginia, wrote in an email. We also need to know if there is a protective T cell response that reappears.

Vaccines, which provoke the immune system to make antibodies, might give longer-lasting protection than natural infection because they use purified versions of what stimulates that response, she noted.

Creech agreed.

This shouldnt dissuade us from pursuing a vaccine, he said. Antibodies are only a part of the story.

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COVID-19 immunity: Virus antibodies may fade fast but protection may not - NBC News

What Is It That Keeps Most Little Kids From Getting Covid-19? – The New York Times

July 22, 2020

For starters, rather than prohibiting children from playing together and eliminating all social risk, Dr. Chiang and the A.A.P. schools-reopening guidelines focus on reducing risk and state that outdoor play is safer than indoor play. Jenkins said her family now socializes with another cautious family. Their summer plans include outdoor playground and beach visits, but not museums.

Some families who initially tried going without sitters and nannies have relented, and public-health experts acknowledge that the strain was significant. Parents and nannies should have honest discussions about their expectations for mask-wearing and distancing. But there is no way for a nanny to socially distance from a young kid shes taking care of, Dr. Chiang said. And there is no evidence that risk of transmission is lower for a younger nanny, she added.

Ultimately, parents have to weigh their threshold for risk when it comes to childrens interactions with others. And that same advice applies to day care, summer camp or school in the fall. Parents should consider the demands of their work, whether any household member is at high risk for severe Covid-19, the status of the outbreak in their community and administrators plans for keeping children and staffers at least in fixed and distanced groups. Also, look for policies requiring children and staffers to be screened for symptoms.

In other words, Dr. Chiang said, if the spread of coronavirus in your community is low, if administrators seem to be taking risk reduction seriously and if parents have to work from home or are essential workers, sending young kids to day care or school may make sense.

The logistics of keeping kids out of school, but still trying to educate them, go far beyond just infectious diseases, Dr. Starke. They go into economics, they go into social structure, and they go into families.

Dr. Chiang has the same decisions to make. When her daughters day care reopened, she spoke with the facilitys director about distancing, disinfection and other coronavirus-related policies. Statistics, family composition, and the age of her daughter also must be considered.

With her being 2 1/2, the risk that shes going to have severe disease from Covid-19 or develop MIS-C is tiny, Dr. Chiang said. We dont have any older family members living with us or in town, so we dont have to consider her getting infected at day care and infecting grandma and grandpa. And the benefits she gets from day care are amazing.

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What Is It That Keeps Most Little Kids From Getting Covid-19? - The New York Times

COVID-19 Daily Update 7-20-2020 – 10 AM – West Virginia Department of Health and Human Resources

July 22, 2020

TheWest Virginia Department of Health and Human Resources (DHHR) reports as of 10:00 a.m., on July 20,2020, there have been 233,490 total confirmatory laboratory results receivedfor COVID-19, with 5,080 total cases and 100 deaths.

In alignment with updated definitions fromthe Centers for Disease Control and Prevention, the dashboard includes probablecases which are individuals that have symptoms and either serologic (antibody)or epidemiologic (e.g., a link to a confirmed case) evidence of disease, but noconfirmatory test.

CASESPER COUNTY (Case confirmed by lab test/Probable case):Barbour (25/0), Berkeley (549/19), Boone(60/0), Braxton (7/0), Brooke (38/1), Cabell (220/7), Calhoun (5/0), Clay(16/0), Fayette (102/0), Gilmer (13/0), Grant (23/1), Greenbrier (80/0),Hampshire (50/0), Hancock (58/4), Hardy (48/1), Harrison (140/1), Jackson(149/0), Jefferson (269/5), Kanawha (524/12), Lewis (24/1), Lincoln (21/0),Logan (46/0), Marion (136/3), Marshall (82/1), Mason (28/0), McDowell (12/0),Mercer (72/0), Mineral (71/2), Mingo (53/2), Monongalia (739/15), Monroe(16/1), Morgan (20/1), Nicholas (20/1), Ohio (178/0), Pendleton (19/1),Pleasants (5/1), Pocahontas (37/1), Preston (90/23), Putnam (115/1), Raleigh(98/3), Randolph (197/2), Ritchie (3/0), Roane (12/0), Summers (2/0), Taylor(29/1), Tucker (7/0), Tyler (10/0), Upshur (31/2), Wayne (151/2), Webster(2/0), Wetzel (41/0), Wirt (6/0), Wood (199/9), Wyoming (8/0).

As case surveillance continues at thelocal health department level, it may reveal that those tested in a certaincounty may not be a resident of that county, or even the state as an individualin question may have crossed the state border to be tested.Such is the case of Boone, Cabell,and Wetzel counties.

Pleasenote that delays may be experienced with the reporting of information from thelocal health department to DHHR.

Please visit thedashboard at http://www.coronavirus.wv.gov for more detailed information.

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COVID-19 Daily Update 7-20-2020 - 10 AM - West Virginia Department of Health and Human Resources

6 burning questions for Covid-19 vaccine developers headed to the House – STAT

July 22, 2020

Some drug companies say well have a coronavirus vaccine by the winter. Others say thats an irresponsible prediction. Some promise to forgo profits on a vaccine, but others believe theyre entitled to their monetary due.

Now, lawmakers can force the industry to get its story straight. On Tuesday, executives from five drug companies leading the vaccine race are due at a congressional hearing to talk about their progress in developing a product the entire world desperately needs. Representatives from AstraZeneca, Johnson & Johnson, Merck, Moderna, and Pfizer will appear in front of the House Energy and Commerce Oversight and Investigations Subcommittee.

People weary of the constraints Covid-19 is placing on lives are pinning a lot of hopes on the promises those companies have made, particularly when it comes to when a vaccine might be ready. But there are still looming questions, from who will get a successful vaccine first to how much it might cost.

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Here are six burning questions the panel could pose.

Most of the manufacturers in the hunt for Covid-19 vaccines are making very bold promises about how quickly vaccines will be ready to be deployed and how rapidly theyll be able to produce their vaccines to the kind of scale needed to combat the pandemic. Many are promising tens, even hundreds of millions of doses by early 2021, and some even predict they can scale to the billion-dose range within the next calendar year.

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But in a recent interview with Harvard professor Tsedal Neeley, Merck CEO Ken Frazier warned that these predicted timelines are doing a grave disservice to the public.

For one thing, he said, vaccine development takes time. The fastest vaccine ever developed before now was the mumps vaccine, which took four years.

Cutting corners is a risky business, Frazier suggested: If youre going to use a vaccine in billions of people, you better know what that vaccine does.

Implied in the statement is the risk that any problems that might arise from use of the vaccines would throw fuel on the fire of the anti-vaccine movement, which is already sowing doubts about the safety of these fast-tracked Covid-19 vaccines.

Frazier also warned that giving people the sense a vaccine may be coming soon allows politicians to downplay other tools that can suppress spread of the disease, such as [wearing] the damn masks.

The most pressing question facing the drug industry is how soon it can come up with an effective vaccine. But right behind that is just how much itll cost. And the industry could answer now by committing to a price before a vaccine is approved.

The U.S. government has some leverage for such a demand. With the exception of Pfizer, each of the companies at the table has received substantial federal funding to support its vaccine development. Through the governments Operation Warp Speed project, taxpayers are on the line for more than $3 billion in research support, and the National Institutes of Health is picking up the tab for at least three massive vaccine studies.

So, what does the American public get in exchange? Some manufacturers have promised to sell their vaccines on a not-for-profit basis, at least for the extent of the pandemic. Others have not. Either way, its looking increasingly likely that the novel coronavirus will not simply vanish once the current crisis subsides, meaning there will demand for vaccines for years to come. If thats the case, will companies come to charge whatever the market will bear? Or are they willing to make pricing commitments now?

Since the start of the crisis, news about vaccine trials has made global headlines, moved markets, and seeped into politics. But the process of disseminating that data has been inconsistent. In May, Moderna put out a press release with vague positive language about its early-stage trial, frustrating experts who wanted more. Pfizer chose to upload its data to a preprint server, where scientific papers are posted without peer review, while AstraZeneca is holding out for publication in the Lancet.

A working vaccine is key to restoring anything resembling normalcy, and the public is desperate for information on the process. But without standardizing the current system, the public is left to parse press releases, rumors, and, worst of all, Twitter. Can the companies developing vaccines establish a system whereby the world gets clear, timely updates on their progress?

The second a coronavirus vaccine proves to be safe and effective, the entire world is going to be calling its manufacturer. The U.S. has already moved to secure millions of future doses, and the European Union is reportedly negotiating to do the same, but whats the plan for the world at large?

Scaling up manufacturing is a time-consuming process, meaning drug makers will be dealing with a constrained supply in the months following a vaccines approval. Beyond the wealthy nations that are already locking in bids, how can countries in the developing world ensure they get access?

That may seem like a question beyond the scope of a House hearing, but the U.S. has a public health interest in vaccines being widely available. With an economy deeply reliant on global trade and travel the U.S. will be at risk of another Covid-19 outbreak as long as the virus persists anywhere in the world.

Some manufacturers are suggesting that there may be enough data to warrant emergency use authorizations as soon as October. If that happens, vaccines destined for use in potentially billions of people will be deployed after mere months of human testing.

In the U.S., manufacturers are shielded from liability if a vaccine or drug developed in response to a health emergency causes injuries to people who receive it. That protection comes from the Public Readiness and Emergency Preparedness Act of 2005.

If that protection were not in place, would vaccine manufacturers be willing to roll out vaccines on such a slight evidence base? Will they make them available to countries that dont offer similar protection against liability?

The major manufacturers are all making vaccine at-risk, meaning they are already working to produce at commercial scale, even before they determine whether their vaccine candidate actually works. The goal is to have large amounts available for use as soon as the Food and Drug Administration green-lights a vaccine. If some candidates fail to clear the FDAs bar, that product will be destroyed.

But manufacturing vaccines is a notoriously unpredictable enterprise. During the 2009 H1N1 flu pandemic, the start of mass vaccination was delayed by several months because the manufacturers had trouble scaling up production. The doses arrived as the fall wave of the pandemic was subsiding in the U.S. That happened with a vaccine that manufacturers had decades of experience producing. So it wouldnt be surprising if some of the companies have or will hit snags. In fact, it would probably be surprising if all the projects sailed through on the very ambitious timelines that have been laid out.

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6 burning questions for Covid-19 vaccine developers headed to the House - STAT

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