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Freedom of press assured – The Daily Star

Posted on July 15, 2020 by Danzig

July 16, 1972

Prime Minister Bangabandhu Sheikh Mujibur Rahman today assures that his government would not curb the freedom of the press provided the press sticks to its ethics and act responsibly keeping in view the national interest. Inaugurating the Annual General Meeting of the Dhaka Union of Journalists at the Jatiya Press Club, Bangabandhu says as a democracy, one of the four state principles, presupposes adherence to a set of principles so the press is supposed to follow a set of principles. He asserts that press in Bangladesh enjoys maximum freedom because the government believes in democracy and the freedom of speech. Nobody can justifiably say that his government has interfered in the affairs of the press. He urges the press to shun the tendency of blackmailing and says that this unhealthy practice was prevalent in the presses of Karachi and Rawalpindi during Pakistani regime.

At the meeting, Gias Uddin Ahmed, outgoing president of Dhaka Union of Journalists, urges the government to set up a press council to address the problems faced by the press.

A letter from Indira Gandhi is delivered to Bangabandhu at the Gono Bhaban today by the Principal Secretary to the Indian Prime Minister PN Haksar who is now in Dhaka on a three-day visit. The content of the letter is not divulged. The Simla Summit and how it progressed must have figured prominently in the letter.

Bangabandhu says today, "I want to see that every citizen of Bangladesh plants a tree and maintains it to mark his cooperation to the development of the forest resources of the country and their participation in the tree plantation campaign." The prime minister addresses the inaugural ceremony of the tree plantation week launched throughout the country today. He also ceremoniously plants a seedling at the Suhrawardy Udyan.

SOURCES: July 17, 1972 issues of Bangladesh Observer, Dainik Bangla and Dainik Ittefaq.

Gene therapy innovations: Sarepta and Codiak partner on exosomes – Pharmaceutical Technology

Posted on July 15, 2020 by Danzig

]]> Vaccines are the most effective way to end the Covid-19 pandemic. Credit: Shutterstock.

In the six months or so since the Covid-19 pandemic broke out in Wuhan, China, the pharma industry and university researchers from across the world have thrown themselves head-first into developing vaccines.

As of 7 July, there are 139 pre-clinical candidates and 21 clinical vaccines in development against SARS-CoV-2, the virus which causes Covid-19, according to the World Health Organization (WHO).

Of the 21 Covid-19 vaccines in clinical trials, lead candidates include Chinese biotech Sinovacs CoronaVac and the University of Oxford and AstraZenecas ChAdOx1-S both of these are in Phase III development.

Other promising candidates in Phase II trials include US-based Modernas mRNA-1273, which is being supported by the National Institute of Allergy and Infectious Diseases (NIAID), and BioNTech and Pfizers Project Lightspeed BNT162 vaccine programme.

The speed at which these companies and researchers have been able to move into and through clinical development is completely unprecedented; milestones normally achieved in years, if not decades, have been surpassed in only months.

Time is of the essence since immunity conferred through vaccines is the primary way that the world can control the spread of this deadly viral disease in the long-term, enabling the world to get back to normal.

Without taking away from this incredible achievement of science, which has been enabled by previously unseen partnerships across industry, academia and the public sector, there are already some concerns about how effective these speedily developed vaccines will be, particularly in conferring long-term immunity.

This worry has been expressed by Dr Anthony Fauci, director of NIAID and the US Governments chief health advisor; in an interview with JAMA cited by CNBC, Fauci stated that, based on previous experience with developing vaccines for other coronaviruses, its likely [the vaccine] isnt going to be a long duration of immunity.

This is also linked to that fact that most of the candidates for which there is publicly available data are focusing on inducing neutralising antibodies against SARS-CoV-2s spike protein, as noted by Nature. As a result, STAT reports it is possible that although vaccines will reduce the risk of someone contracting the disease or experiencing severe symptoms if someone is infected, they will not prevent infection entirely.

Dr Patrick Soon-Shiong, CEO and chairman of sister biotechs ImmunityBio and NantKwest, noticed this problem and his team began looking at developing a so-called second-generation Covid-19 vaccine that overcomes the short-term duration challenge of the first set of vaccines.

To this end, ImmunityBio and NantKwest are working on a Covid-19 vaccine that does not only focus on the spike protein; their vaccine also works against SARS-CoV-2s nucleocapsid.

It is our fervent belief that you cant just kill this virus from the outside in, youve got to kill it from the inside out, explains Soon-Shiong. We have created the unique construct of both nucleocapsid and spike, so that you have not just antibody, but also a memory T cell [response].

The nucleocapsid is viewed as a particularly strong stimulator of cellular immunity and improves the generation of memory T cells, explains NantKwest director of cell-mediated therapies in virology Jeffrey Safrit. T cell mediated immunity, he adds, has been shown to last significantly longer than antibody-mediated immunity.

Allowing a broader immune response involving antibody and cell-mediated immunity that is directed against more than one target lessens the ability of the virus to escape, concludes Safrit.

Another benefit of focusing on both the spike protein and nucleocapsid is linked to potential future mutations of the SARS-CoV-2 virus. Focusing on spike alone will limit vaccine effectiveness should spike mutate to avoid the immune response, explains Safrit.

Whereas the nucleocapsid gene is highly conserved among coronaviruses, meaning it mutates much less often if at all, therefore, Safrit notes, inclusion of nucleocapsid makes our approach a more universal Covid vaccine, that could even be useful against related future, yet unseen SARS infections.

Soon-Shiong was also concerned about how many leading Covid-19 candidates, such as the University of Oxford/AstraZeneca project, are relying on the adenovirus approach.

Current adenovirus vaccines are based on the first generation of this vector [Ad5] that generate significant anti-vector immunity when administered which can dampen or the even negate the immune response [conferred by the vaccine] to the Covid-19 spike protein and nucleocapsid, explains Safrit. This situation is worsened when someone has been previously exposed to an adenovirus, such as that which causes the common cold.

To overcome this challenge, NantKwest and ImmunityBio have developed a second-generation Ad5 platform. It has demonstrated safety in Phase I and II studies in cancer patients. The companies also carried out a successful proof-of-concept during the 2009 H1N1 influenza pandemic.

The platform has additional deletions of adenovirus genes that generate little to no vector-specific immunity and focuses the immune response on the inserted genes of interest, SARS-CoV-2 spike protein and nucleocapsid, says Safrit.

Because of this, the second-generation Ad5 also overcomes any adenovirus pre-existing immunity, allowing a more effective first vaccination and multiple subsequent booster vaccinations without reduced immunogenicity, he explains.

Soon-Shiong is clear that long-term duration of immunity challenges will be solved by second-generation vaccines such as Immunity Bio and NantKwests candidate.

Their vaccine, which is part of the US Governments Operation Warp Speed, is ready to launch into Phase I clinical trials this summer with early safety and preliminary efficacy results expected before the end of the year.

However, there is a need for further innovations so that the vaccine can be administered without injections to overcome access challenges, particularly in developing countries.

If we could achieve an oral form, which is not unrealistic, that would be the third generation Covid-19 vaccine, Soon-Shiong notes.

This is an avenue that ImmunityBio and NantKwest are pursuing for their Covid-19 vaccine candidate, but it is currently early in development, according to Soon-Shiong. Their oral capsule approach would avoid significant cold chain requirements of all current vaccine approaches, Safrit states.

It would also introduce the prospect of conferring mucosal immunity, generation [of] which could significantly improve the ability of the vaccine to protect against infection and disease.

Other companies slightly further along with their oral vaccines include the UKs Stabilitech and US-based Vaxart.

Stabilitechs OraPro-COVID-19, which is developed using its proprietary OraPro technology platform, aims to confer both mucosal and systemic immunity to patients in a thermally stable way. Clinical trials for this vaccine are expected to begin in August this year.

The company has recently completed a fundraising round and signed a manufacturing agreement with BioCell Corporation in New Zealand. Talking about this news, Stabilitech chairman Wayne Channon stated: It brings us closer to providing a vaccine that gives both mucosal and systemic immunity to Covid-19.

This will target the virus exactly where we catch it: in the mucous membranes of the mouth, nose, throat and even the eyes.

By taking this approach, we believe OraPro-COVID-19 could prove to provide the fastest route to widespread global immunity, turning the tide on the pandemic.

Vaxarts oral vaccine approach relies on its VAAST delivery platform. It delivers two payloads to cells in the small bowel epithelium; the second of the payloads acts like an adjuvant to further activate the immune system against the selected viral antigen.

Like ImmunityBio and NantKwests candidate, Vaxarts oral approach is one of the projects chosen to be part of the US Governments Operation Warp Speed. Following on from positive pre-clinical results in April, Vaxarts candidate is on track to move into clinical studies this summer.

Talking about this announcement, Vaxart CEO Andrei Floroiu said: We are very pleased to be one of the few companies selected by Operation Warp Speed, and that ours is the only oral vaccine being evaluated.

SARS-CoV-2, the coronavirus that causes COVID-19, is primarily transmitted by viral particles that enter through the mucosa nose, mouth or eyes strongly suggesting that mucosal immunity could serve as the first line of defence.

In addition, our vaccine is a room temperature-stable tablet, an enormous logistical advantage in large vaccination campaigns.

Read the original here:

Gene therapy innovations: Sarepta and Codiak partner on exosomes - Pharmaceutical Technology

Industry News: Thermo Fisher Scientific and First Genetics JCS partner to develop next-generation sequencing-based – SelectScience

Posted on July 15, 2020 by Danzig

The agreement allows First Genetics to bring its F-Genetics NGS system and in vitro diagnostic assays for reproductive health testing to Russian labs

Thermo Fisher Scientificand First Genetics JCS, a manufacturer of diagnostic equipment and IVD kits intended to advance molecular genetic technologies into clinical practice, today announced a strategic partnership focused on commercializing next-generation sequencing (NGS)based diagnostics inRussia. The agreement enables First Genetics to market its F-Genetics NGS System and IVD assays to Russian labs for reproductive health testing and cancer diagnostics. The F-Genetics System is based on Thermo Fisher'sIon GeneStudio S5 System.

First Genetics has already received its first registration certificate for an IVD kit by Roszdravnadzor, the Russian medical device regulatory agency. The company's Reproline kit is now approved for detecting chromosomal abnormalities in embryos on the F-Genetics NGS System prior to IVF implantation. While IVF is now government-funded as part ofRussia'spolicy to help boost the national birth rate, preimplantation genetic testing for aneuploidies (PGT-A) had not previously been certified inRussia. The certification now enables Russian prenatal centers, which have doubled in number over the last decade, to leverage PGT-A.

"High-throughput technologies for genetic analysis are the future of molecular diagnostics," saidNikolai Kuznetsov, CEO, First Genetics. "Today we have expanded applications of NGS into reproductive medicine inRussia, and in the future, we intend to offer clinically certified solutions for other clinical applications, such as oncology testing. This is our contribution to the development of clinical diagnostics inRussia."

Thermo Fisher has entered into a number of agreements with assay developers like First Genetics to expand the use of NGS-based molecular diagnostics in the clinic and to advance precision medicine globally. Similar partnerships with other organizations have led to approvals by regulatory agencies inChina,the United StatesandEurope.

"It is our mission to help bring molecular testing to all parts of the world so those who need it most can benefit from the genetic information next-generation sequencing provides," saidYan Zhang, general manager, reproductive health at Thermo Fisher. "We are pleased that couples inRussianow have access to First Genetics' solutions to assist in family planning and reduce the emotional burdens they face while undergoing fertility treatment."

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U.A.E. Sets Its Sights on Mars With Launch of Hope Orbiter – The New York Times

Posted on July 15, 2020 by Danzig

As a girl growing up in Abu Dhabi, one of the United Arab Emirates, Sarah al-Amiri looked at an astronomy book with a photograph of Andromeda, the giant galaxy neighboring our Milky Way.

I cant describe it, Ms. al-Amiri said in an interview, but just to realize that something that was printed on a page was larger than anything that Ive ever seen and dwarfs the planet that I live on.

When she was in college, there were few opportunities in the Middle East to pursue studies of the universe, and Ms. al-Amiri majored in computer science instead. But now, the U.A.E. is aiming to inspire its youth to pursue science and technology careers, and Ms. al-Amiri has forged a career pursuing the heavens.

Just 33 years old, she is the head of science operations and the deputy project manager for a space probe that the U.A.E. is about to send to Mars.

A rocket lifting a spacecraft called Hope is to begin its journey to Mars soon. Bad weather at the launchpad postponed the scheduled liftoff on Tuesday. The U.A.E. Space Agency announced that the next launch attempt would be on Thursday at 4:43 p.m. Eastern time. (It will be already Friday in the U.A.E. and at the launchpad on Tanegashima Island in Japan.)

The launch will be the boldest move yet by a country that is looking to establish a future that will long outlive its oil wealth, and sees a space program as one way to accomplish that goal.

Coverage of the launch was to be broadcast on the web at https://www.emiratesmarsmission.ae/.

Mars will be much in the news for the next month, a once-every-26-month interlude when Earth and Mars line up to allow robotic spacecraft to make a relatively quick trip. After several delays, NASAs next Mars rover, Perseverance, with instruments to search for chemical signs of past life, is scheduled to launch on July 30. China will also try to launch an ambitious mission to Mars, Tianwen-1, in about a week.

A fourth mission, which would put a Russian-European rover named Rosalind Franklin on Mars, was pushed off the calendar because of technical hurdles that could not be cleared in time.

Preparations for Hope, the smallest of the bunch, proceeded smoothly, and it was the first to be ready for liftoff.

Because the U.A.E. does not yet have its own rocket industry, it bought the launch for Hope aboard an H-IIA rocket from Mitsubishi Heavy Industries, a machinery maker in Japan.

About the size of a Mini Cooper car, Hopeis to arrive in orbit around Mars in February. The spacecraft which cost about $200 million to build and launch will carry three instruments: an infrared spectrometer, an ultraviolet spectrometer and a camera.

From its high orbit varying from 12,400 miles to 27,000 miles above the surface Hope will give planetary scientists their first global view of Martian weather at all times of day. Over its two-year mission, it will investigate how dust storms and other weather phenomena near the Martian surface speed or slow the loss of the planets atmosphere into space.

That, however, is not the main reason that the Emirates government built Hope.

A lot of you might ask us, Why space? Omran Sharaf, the Hope project manager, said during a news conference on Thursday. Its not about reaching Mars.

Rather, Mr. Sharaf said, the countrys primary aim is to inspire schoolchildren and spur its science and technology industries, which, in turn, will enable the Emirates to tackle critical issues like food, water, energy and a post-petroleum economy.

Its about starting getting the ball rolling, Mr. Sharaf said, and creating that disruptive change, and changing the mind-set.

The Emirates previously built and launched three earth-observing satellites, collaborating with a South Korean manufacturer and gradually taking on greater shares of the engineering. The country even has a nascent human spaceflight program. Last year, the U.A.E. bought a seat on a Russian Soyuz rocket and sent its first astronaut, Hazzaa al-Mansoori, for an eight-day stay at the International Space Station.

For the Mars mission, the country took a similar approach to the earlier satellites by working with the Laboratory for Atmospheric and Space Physics at the University of Colorado Boulder, where Hope was built before being sent to Dubai for testing.

By design, Emirati engineers worked side by side with their counterparts in Boulder, learning as they designed and assembled the spacecraft. One of the requirements that the government gave us since the beginning, Mr. Sharaf said, they told us, You have to build it and not buy it.

The science piece of the mission was an even bigger gap to fill for a country without Mars scientists, which until recently constituted an unfathomable career choice.

Ms. al-Amiri is the head of science even though she never formally studied planetary science.

After she graduated college with a computer science degree, the likeliest job prospects working at a networking company performing troubleshooting and maintenance did not enrapture her. She wanted to design and build new things.

She saw a job posting at what is now known as the Mohammed bin Rashid Space Center in Dubai. She joined in 2009, working as an engineer on the satellite programs. When that assignment wrapped up in 2014, she moved on to her current roles on the Hope mission.

She now also serves as the countrys minister of state for advanced sciences and chairs an advisory council of scientists.

If the U.A.E. had tried to train planetary scientists from scratch to work on Hope, the mission would have been long over before the scientists were ready. Instead, Emirati officials took a quicker approach: converting some of the space centers engineers into scientists by offering apprentice-like training with researchers in the United States.

I was put there to develop scientific talents within the organization and be able to transfer knowledge in a nontraditional way, Ms. al-Amiri said.

The coronavirus outbreak tossed in more challenges.

Once construction of the spacecraft was complete in Colorado, a large Ukrainian transport plane ferried it to Dubai, where it was to undergo a round of testing before heading to the launchpad in Japan.

But at the end of February not long before the European Space Agency and Russia postponed the launch of the Rosalind Franklin mission in part because of the logistical hurdles created by the pandemic Mr. Sharaf and Ms. al-Amiri realized the outbreak could disrupt their carefully planned schedules if airports were shut down.

Based on that, we started working on a plan to get the team across to Japan as soon as possible, Ms. al-Amiri said.

They shuffled some of the tests in order to hurry the spacecraft to Japan, three weeks earlier than originally planned, and where some of the testing would instead be completed.

Travel restrictions meant team members could not travel back and forth. A small team went ahead in early April to wait out a quarantine. Two weeks later, the cargo plane with Hope flew to Japan with another small team from the Emirates.

In Japan, the people who flew with Hope then went into quarantine and then those who had gone ahead joined the spacecraft on the barge trip to the island that is home to the launch site.

Mr. Sharaf and Ms. al-Amiri said the mission was now ready, and the nations space program would continue regardless of the outcome.

The Emirates fully understand the risk associated with this mission, Mr. Sharaf said. So does the team. Lets be honest. Fifty percent of the missions that have been to Mars have failed.

The greatest success is the training of the people, he said.

For the Emirates, its more about the journey, Mr. Sharaf said. Its more about the impact. Reaching there is one of the goals. But that doesnt mean that the mission has failed, if we didnt manage to get there. So failure is an option.

Excerpt from:

U.A.E. Sets Its Sights on Mars With Launch of Hope Orbiter - The New York Times

Sheikh Hamdan explains why the UAE wants to go to Mars – Khaleej Times

Posted on July 15, 2020 by Danzig

With the country eagerly waiting for its Mars probe's historic liftoff, the Dubai Crown Prince looked back on its six-year journey of building Hope and answered one big question: Why is the UAE going to Mars?

It wasn't only about exploring the cosmos and making new discoveries, Sheikh Hamdan bin Mohammed bin Rashid Al Maktoum said in a video he tweeted on Wednesday. Going to Mars is about shaping the future and creating a culture of conquering the impossible, he said.

In the moving two-minute video, Sheikh Hamdan laid out five key reasons behind the Hope probe mission, the first interplanetary mission of the Arab world.

"We are going to Mars because space programmes are the gateway to science and talent development. There's no future without science and no future without knowledge," he said, stating the first of five.

Launching the unmanned probe to the Red Planet has taken 5.5 million hours of work - and counting, with the dedication of 200 Emirati engineers. It is a milestone that has inspired the country, especially the youth, to make space dreams come true.

"We are going to Mars because we want to solidify a principle for our youth that the impossible is possible for the UAE and the people of the UAE. When we are determined, we execute. When we dream, we make our dreams come true," Sheikh Hamdan said, citing the second reason.

The country was supposed to send its Hope probe to Mars on July 17, after a 48-hour delay from the original launch date of July 15. However, the liftoff had to rescheduled again because of adverse weather conditions at its launch site on Tanegashima Island, Japan. A new date is expected in the next 24 hours, the country announced earlier today.

Read on:UAE's Mars probe team lists 3 reasons for liftoff delay

Lending proof to the country's determination to beat all odds to realise its dreams, the Mars mission team achieved its targets even as the pandemic brought the world to a standstill.

The UAE will go to Mars not only for its seven emirates, but for the rest of the Arab world, he added. "Our journey to Mars is a message of hope to all Arabs that we can compete with the world in science and technology. The UAE today leads the Arab knowledge transformation."

Sheikh Hamdan's video also featured snippets of the country's beloved founding fathers and leaders, as he narrated the vision that fuelled the UAE's space journey.

"We are going to Mars because Mars is the means to greater aims. Our aim is not merely to build a probe and launch it but build the foundation for tomorrow. This is the journey that Sheikh Zayed and Sheikh Rashid had started, and the journey that Sheikh Mohammed bin Rashid and Sheikh Mohamed bin Zayed are carrying on today to empower people with knowledge, capabilities and ambitions that reach the sky," the Dubai Crown Prince said.

The final reason, he said, is to start "a new journey". "The journey of the next 50 years and the last 50 years that passed in the history of our nation: We started from the desert of our country, and we want the next 50 years to start from the desert of Mars, because we are people who don't know the impossible, and nothing can stand ahead of our rising ambitions."

The Mars Mission will carry the flag of the UAE and the aspirations of its people to the Red Planet, Sheikh Hamdan said.

It will be a long journey that will take seven months of travelling more than 490 million kilometres into space, with a cruise speed of 121,000 kph. The UAE is set to become the fifth country to reach Mars.

Thanking the team behind the Emirates Mars Mission, the Dubai Crown Prince said "the mission has succeeded before the journey begins".

"We are immensely proud, and our achievements continue. We are blessed with leadership that only knows the first place.Congratulations to our men and women, Congratulations to our champions. Today is a day of celebrations in the UAE."

reporters@khaleejtimes.com

Sheikh Hamdan explains why the UAE wants to go to Mars - Khaleej Times

The 3D Printed Homes of the Future Are Giant Eggs on Mars – Singularity Hub

Posted on July 15, 2020 by Danzig

Last month, a 3D printed house that can float on a pontoon was unveiled in the Czech Republic. Last year, work started on a community of 3D printed houses for low-income families in Mexico. While building homes with 3D printers is becoming more scalable, its also still a fun way to play around with unique designs and futuristic concepts for our living spaces.

It doesnt get much more futuristic than living on Marsand guess what? Theres a 3D printed home for that, too. In fact, there are a few; last year saw the conclusion of a contest held by NASA called the 3D Printed Habitat Challenge.

The long-running competition, started in 2015, tasked participants with creating homes that would be viable to build on Mars. Teams had to consider not just the technology theyd use, but what type of material will be available on the Red Planet and what kind of features a Martian home will need to have for a human to survive (and ideally, to survive comfortably); the structures need to be strong enough to make it through a meteor collision, for example, and able to hold an atmosphere very different than the one just outside their walls.

The top prize ($500,000) went to AI Space Factory, a New York-based architecture and construction technologies company focused on building for space exploration. Their dual-shell, four-level design is called Marsha, and unlike Martian habitats weve seen on the big screen or read about in sci-fi novels, its neither a dome nor an underground bunker. In fact, it sits fully above ground and it looks like a cross between a hive and a giant egg.

The team chose the hive-egg shape very deliberately, saying that its not only optimized to handle the pressure and temperature demands of the Martian atmosphere, but building it with a 3D printer will be easier because the printer wont have to move around as much as it would to build a structure with a larger footprint. That means less risk of errors and a faster building speed.

Its important to be structurally efficient as a shape, because that means you can use less material, said David Malott, AI Space Factorys founder and CEO. If you think about an eggshell on Earth, [its] a very efficient shape. The eggshell can be very, very thin, and still it has the right amount of strength.

The homes layout is like a multi-level townhouse, except with some Mars-specific tweaks; the first floor is both a preparation area, where occupants can get suited up before heading outside, and a wet lab for research. Theres a rover docking port just outside the prep area, attached to the house.

On the second floor is what Id consider the most important roomthe kitchenand the third floor has a garden, bathroom, and sleeping pods that take the place of bedrooms (sorry, no space for your antique dresser or Ikea desk here). The top floor is a rec area where you can recreate either by watching TV or exercisingor perhaps both simultaneously.

It took 30 hours to build a one-third scale model of the home, but this doesnt mean it would take 90 hours to build the real thing; printing during the contest was done in 10-hour increments, and since the model contains all the same structural aspects of the full-size home, the 3D printer would just need to expand its reachable surface area and height to print the real thing.

If all goes as planned (which, really, there are no plans yet; just ideas), there will be plenty of material on hand to build the real thing in the real place (Mars, that is). AI Space Factory collaborated with a materials design company called Techmer PM to come up with a super-strong mix of basalt fiberwhich would come from rocks on Marsand a renewable bioplastic that could be made from plants grown on Mars. In NASAs tests, the material was shown to be stronger and more durable than concrete and more resistant to repeated freezes and thaws.

The company was set to open an Earth version of Marsha, called Tera, in upstate New York this past March, and people leaped at the chance to pay $175-500 to sleep in the structure for a night; but the plans were derailed by the coronavirus pandemic, and the company hasnt yet announced a re-opening of the Earthbound cabin.

Image Credit: AI Space Factory

An Update and Behind the Scenes: FDA’s Coronavirus Treatment Acceleration Program – FDA.gov

Posted on July 15, 2020 by Danzig

By: Stephen M. Hahn, M.D., Commissioner of Food and Drugs, Patrizia Cavazzoni, M.D., Acting Director, Center for Drug Evaluation and Research, and Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research

When the U.S. Food and Drug Administration learned of the novel coronavirus (COVID-19) and its potentially devastating effects, we acted swiftly to set the regulatory stage for drug and biologics manufacturers to develop products to treat this serious disease. To meet this urgent need, the FDA created the Coronavirus Treatment Acceleration Program (CTAP) to enable the FDAs Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) to leverage cross-agency scientific resources and expertise to bear on COVID-19 therapeutic development and review. Were excited to say that there are now more than 510 drug development programs in planning stages, and as of today, the agency has reviewed more than 230 trials of potential therapies for COVID-19.

While the FDA is part of a whole of government approach to COVID-19, CTAP is a distinct component of this effort focusing specifically on therapeutics, not vaccines or devices. Another major initiative of the U.S. government, Operation Warp Speed (OWS), funds and rapidly develops or co-develops vaccines, therapeutics, and diagnostics, while the FDA, through CTAP, regulates therapeutic development. There is a clear delineation between OWS executive actions and FDA regulatory decision-making.

The FDA recognized that there would be a need for early and frequent discussions between the agency and potential therapeutic product developers. So early on, we set up an email inbox for COVID-19 therapeutic development inquiries, COVID19-productdevelopment@fda.hhs.gov. It helps researchers and developers get directed to the right person on the first try and enables us to track inquiries.

Each inquiry the FDA receives is reviewed by a triage team that is composed of experienced clinical reviewers, other scientific reviewers, policy experts and regulatory project management staff. The team strives to acknowledge receipt within 24 hours. These staff help those with proposals for potential COVID-19 therapeutics identify and add any information necessary to ensure that the proposal is complete enough for productive discussion. Then, the team sends the proposal with a brief synopsis to the right organizational unit within the FDA for review by disease area experts.

Teams of experienced clinical reviewers and regulatory affairs experts in CDER and CBER provide outreach and regulatory advice to less experienced inquirers. Preliminary, partially-formed inquiries go to them before they are assigned to product review teams to determine next steps for engaging with the FDA, including what regulatory submission is appropriate, what to include in that submission, and how to submit it.

Once individual inquiries develop into proposals, our discussions with sponsors can then meet several key milestones:

We will continue to report the number of active drug development programs, studies underway, EUAs and approvals at our CTAP program dashboard monthly.

Behind the scenes of CTAP, office leaders within CDER and CBER align our efforts across therapeutic areas, scientific disciplines, and organizational units. Clinical, operations and policy supervisors meet regularly to discuss staffing support, trial design, endpoint selection, and consistency of practice and expectations for COVID-19 submissions. Clinical and biostatistical experts meet regularly to share information, advance our scientific understanding and develop consistent approaches. Senior leadership stay actively engaged on key drug and biologic development and review issues.

When CTAP started, we achieved extraordinary turnaround times for certain significant inquiries and proposals, to get key studies going rapidly. For therapeutic development programs with strong rationales and evidence, we continue to dramatically exceed standard timelines. We have found that a complete pre-IND submission is the key to expediting comprehensive pre-IND advice, more rapid review of the subsequent IND and more rapid clinical trial initiation.

While we have shortened our timelines, our regulatory review and decision-making processes have not changed. Interactions with review teams follow our usual stable, predictable, and flexible process. We give all researchers and developers our best advice, apply our legal and regulatory standards, and make decisions on the basis of the science and the data.

Safe and effective COVID-19 therapeutics and other medical products are a very high priority at the FDA. We understand the impact of this public health emergency and approach our role in facilitating the development and availability of important medical products with the strongest sense of urgency.

Go here to see the original:

An Update and Behind the Scenes: FDA's Coronavirus Treatment Acceleration Program - FDA.gov

Why You May Not Be Able to Get a Coronavirus Test in California – The New York Times

Posted on July 15, 2020 by Danzig

Good morning.

(This article is part of the California Today newsletter. Sign up here to receive it by email.)

Californians who dont have symptoms of Covid-19 will probably have a harder time getting tested for the coronavirus, according to new, stricter guidelines state officials unveiled on Tuesday.

It is critical we continue to be deliberate and creative about testing, Dr. Mark Ghaly, the states head of health and human services, said in a statement. We must do this so that testing is readily available and affordable to those who need it, especially those communities experiencing the worst impacts.

In a virtual news conference, Dr. Ghaly said California was also exploring opportunities for pooled testing, a strategy that could help identify infections in large groups more quickly.

The shift in testing strategy comes as more states around the country have scrambled to ramp up testing, which has resulted in tighter supply chains and longer turnaround times in California, the nations most populous state.

California has contended with an explosion in cases, prompting Gov. Gavin Newsom on Monday to announce the most sweeping rollback yet of reopening plans.

[Read about which businesses were ordered to close down.]

As of Tuesday, California was averaging 8,334 new cases per day over the past week, compared with 3,041 new cases per day on average just a month ago.

Heres what to know about the changes:

Why are they happening now?

Over the past two weeks, the state reported 107,600 tests per day on average a huge increase over the past couple of months. But the states percentage of tests that have come back positive for the virus has inched upward, as well, to 7.1 percent on average over the past two weeks.

Our testing capacity has increased exponentially, Dr. Ghaly said in the statement. At the same time, new national supply chain challenges and large volumes of specimens sent to commercial laboratories have resulted in growing delays in processing times.

What do the new guidelines say?

Previously, state and local officials had encouraged anyone who wanted to get tested to see if they were eligible, whether or not they had symptoms, as testing capacity ramped up across California and case numbers were less troubling.

Under the new guidelines, Dr. Ghaly said that testing would be much more strategically targeted at people in communities where risks of transmission are higher.

Of course, people who have severe symptoms will be prioritized for tests with quick results so they can get a diagnosis and be treated.

According to the new rules, people who have been hospitalized fall in the Tier 1 priority group, along with people who must be tested as part of investigations into specific outbreaks.

Tier 2 includes everyone else with Covid-19 symptoms, as well as people who live or work in the kinds of facilities where outbreaks have been most severe, such as nursing homes, prisons and homeless shelters. It also includes health care workers who have frequent interactions with the public or with people who may have Covid-19.

Tier 3 includes workers in remaining essential sectors, like grocery stores, logistics, manufacturing and education, if they dont have symptoms.

And then, theres Tier 4, which will be implemented only when the test turnaround time is less than 48 hours, as monitored by the state. Thats when anyone else who doesnt have symptoms, but is worried they may have been infected, can get tested.

How will these new rules help stop the spread of the virus?

While individual actions, like following distancing and mask-wearing rules, are critical for curbing the spread of the virus, increasingly, experts have recognized that many transmissions are taking place because Californians who work in low-wage, high-risk jobs havent been able to stop working.

In a first-of-its-kind analysis, researchers at the University of California, Merced, Community and Labor Center found a connection between high concentrations of low-wage work in certain counties like at farms and in warehouses and the prevalence of Covid-19.

Our findings emphasized the importance of not just regulating business openings, but mitigating Covid spread by innovating health and safety reforms for workers, Ana Padilla, the centers executive director, told me.

One way to do that is to ensure that workers in those communities have access to testing and that workplace outbreaks are transparent. That would mean requiring counties to report test results by industry, the report said.

Although we have guidance and support, we know that testing in those environments is key, Dr. Ghaly said on Tuesday, adding that thats why the new testing strategy involves homing in on workplace outbreaks.

Updated July 15, 2020

Still, he said the state hadnt specifically asked counties to report test results by industry or employer.

[Read more about how the pandemic has put warehouse workers in the Inland Empire in a tough spot.]

We often link to sites that limit access for nonsubscribers. We appreciate your reading Times coverage, but we also encourage you to support local news if you can.

The Trump administration abandoned its plan to strip international college students of their visas if they didnt attend at least one class in person. It was a rare and swift reversal in response to fierce opposition. [The New York Times]

Most of the nations big school districts including in Los Angeles and San Diego arent ready to reopen, because the test positivity rates in the communities where theyre located are much too high. And reassuring examples of schools reopening abroad dont apply here. [The New York Times]

Bankruptcy forced Stockton to defund its Police Department, making it an inadvertent laboratory for pushes to reduce the roles of law enforcement officers in keeping communities safe. [The Los Angeles Times]

If you missed it, heres what Stocktons mayor had to say about calls to defund the police now. [The New York Times]

Transit agencies around the country are struggling. In the Bay Area, there are too many disjointed systems and not enough riders. [Bloomberg CityLab]

Wineries were beginning to settle into a new normal. Then they were told they had to shut down indoor operations.[The San Francisco Chronicle]

He goes by Bruce or Paco or Peter or Pierre or Abraham. He is a peacock. And hes tearing a North Oakland neighborhood apart. [SFGate]

We joke about it: How many years has it been since 2020 started? How many lifetimes?

Theres a sense that were living through a momentous period in history a global pandemic, uprisings over racial justice that have poured into every corner of society and broad recognition that the world is changing rapidly.

So museums and curators are asking us all to help them help future generations understand this time by documenting it. Everything, like protest signs, shopping lists, or snippets of video.

Whatever were taking to be ordinary within this abnormal moment can, in fact, serve as an extraordinary artifact to our childrens children, Tyree Boyd-Pates, an associate curator at the Autry Museum of the American West, told Lesley M.M. Blume, in this article. The Autry is asking for submissions to its Collecting Community History Initiative.

California Today goes live at 6:30 a.m. Pacific time weekdays. Tell us what you want to see: CAtoday@nytimes.com. Were you forwarded this email? Sign up for California Today here and read every edition online here.

Jill Cowan grew up in Orange County, went to school at U.C. Berkeley and has reported all over the state, including the Bay Area, Bakersfield and Los Angeles but she always wants to see more. Follow along here or on Twitter.

California Today is edited by Julie Bloom, who grew up in Los Angeles and graduated from U.C. Berkeley.

Nasal Coronavirus Vaccines May Work Better Than Injected Ones, Researchers Say – The New York Times

Posted on July 15, 2020 by Danzig

These mucosal immune responses seem to underlie the success of the oral polio vaccine, which contains a weakened form of polio virus and has helped most of the world eradicate polio. When it debuted in the 1960s, the vaccine was considered, in many ways, an enormous improvement over its injected predecessor because it targeted the bodys immune response in the gut, where the virus thrives. Many people who took the oral vaccine seemed to quash infections even before they felt symptoms or passed the germ on to others.

It was a fabulous vaccine to stop the transmission of polio, said Dr. Anna Durbin, a vaccine expert at Johns Hopkins University. It helped induce herd immunity, she said, referring to the threshold of the population that needs to be immune to a pathogen to keep it from spreading.

Vaccines given through muscle are great for prompting the body to churn out antibodies in the bloodstream, like IgG. If a pathogen shows up, hordes of these on-call molecules will rush to meet it.

For many respiratory infections, thats good enough.

The majority of respiratory vaccines, like the measles vaccine, are given intramuscularly, and it works, Dr. Iwasaki said. If enough antibodies reach the right mucosal surface, it doesnt really matter how they were induced.

Still, relying on that strategy alone can be risky a bit like shoring up a banks security at every entrance except for the one a thief would most likely hit. Sentinels roving throughout the building could subdue the interloper after they trip the alarm. But by that point, some damage has probably already been done.

Updated July 15, 2020

Its mainly a timing issue, Dr. Bhattacharya said. If you have circulating cells and molecules, theyll eventually find the infection. But youd rather have a more immediate response.

Without a strong mucosal response, injected vaccines may be less likely to produce so-called sterilizing immunity, a phenomenon in which a pathogen is purged from the body before its able to infect cells, Dr. Durbin said. Vaccinated people might be protected from severe disease, but could still be infected, experience mild symptoms and occasionally pass small quantities of the germ onto others.

More here:

Nasal Coronavirus Vaccines May Work Better Than Injected Ones, Researchers Say - The New York Times

‘Things have not gone according to plan’: America’s coronavirus reopening falls apart – The Guardian

Posted on July 15, 2020 by Danzig

In echoes of the early days of the Covid-19 pandemic, some American states and localities are reversing economic reopenings after spread of the coronavirus accelerated in some regions.

Americas Sun Belt, the region extending from southern California to Florida, has been particularly hard-hit, and now further flung and less populous states are joining the ranks rolling back reopenings.

New Mexico again banned indoor dining. Nevada closed bars in counties with major outbreaks. And Oregon, in the Pacific north-west, banned private indoor gatherings of more than 10 people. Arizona and Texas reimposed restrictions on indoor dining and bars in early July.

California, the most populous state, dramatically expanded restrictions. Indoor operations of theaters, wineries, restaurants and bars were all stopped this week. In addition, some of the nations largest school districts have announced classes will be virtual this fall. Students in Los Angeles, San Diego and Atlanta will not have in-person classes.

The reopening plan was great if everything went well, the Miami mayor, Francis X Suarez, told the Republican Florida governor, Ron DeSantis, at a public roundtable Tuesday. But I think the fact is things have not gone according to plan.

If things do not improve quickly I think were going to be under a significant amount of pressure to shut down, Suarez said.

Florida closed indoor dining in late June but has persisted with other reopening plans. DeSantis called on schools to reopen in a few weeks, and Disney World reopened some of its parks to thousands of visitors on Saturday.

Republican officials moved the national convention, where Donald Trump will formally accept the nomination of his party, from North Carolina to Florida to avoid social distancing and mask requirements. But with cases rising, officials moved the biggest events outdoors, the New York Times reported.

Louisiana, an early center of outbreaks after Mardi Gras this spring, has again seen a spike in Covid-19 cases. Vice-president Mike Pence traveled to the state on Tuesday but was not greeted by one of its top officials, attorney general Jeff Landry, who tested positive for Covid-19 despite showing no symptoms.

The governor, John Bel Edwards, enacted a statewide mask mandate for people aged eight and older, which took effect Monday. He also returned bars to takeout and delivery only. Restaurants, casinos, gyms, salons and other businesses remain open, with occupancy restrictions.

But Americas vast landscape and varied politics means even as many states across the south and west roll back reopening, places whose overburdened health systems became emblematic of the perils of Covid-19 have continued to reopen.

The New York governor, Andrew Cuomo, will allow malls to reopen in some parts of the state. New York City hit a hopeful milestone on Saturday: for the first time since 11 March, no one died of coronavirus.

Its something that should make us hopeful, but its very hard to take a victory lap because we know we have so much more ahead, said the mayor, Bill de Blasio, on Monday, according to NPR. This disease is far from beaten. While New York state announced only 677 new cases of coronavirus on Sunday, Florida reported more than 15,000.

In contrast to states in the south and west, some parts of the north-eastern economy never reopened. In New York City, Broadway shows are likely to remain closed until at least this winter, and indoor dining is still banned.

Across the river in New Jersey, gyms remain closed. Indoor dining in New Jersey was slated to reopen at very limited capacity, but the proposal was rolled back after photos emerged of unmasked crowds at beach bars on the Jersey shore.

Unlike in states such as New York, which has metrics that would trigger closures if the virus began to spread, Miami mayors said Florida had no such plan.

Renewed restrictions in the south and west have also brought renewed frustration. In New Mexico, businesses forced to close their doors again protested against the governors order. At some point you have to protect your livelihood, Kathy Diaz, owner of Monroes Restaurant, told local news station KOB4.

Parents of schoolchildren in Jacksonville, Florida, called for school reopenings, and anti-mask protesters have organized demonstrations against local mask mandates.

Marlyn Hoilette, a nurse who spent four months working in the Covid-19 unit of her Florida hospital until testing positive recently, said she worries about returning to work.

Nurses are getting sick, nursing assistants are getting sick and my biggest fear is that it seems we want to return folks to work even without a negative test, said Hoilette, who works at Palms West hospital in Loxahatchee, Florida. Its just a matter of time before you wipe the other staff out if youre contagious, so that is a big problem.

'Things have not gone according to plan': America's coronavirus reopening falls apart - The Guardian

The Terrifying Next Phase of the Coronavirus Recession – The Atlantic

Posted on July 15, 2020 by Danzig

Now the economy is traveling sideways, as business failures mount and the virus continues to maim and kill. New applications for unemployment insurance, for instance, are leveling off at more than 1 million a weekmore than double the highest rate reached during the Great Recession, a sign that more job losses are becoming permanent. After rising when the government sent stimulus checks and expanded unemployment-insurance payments, consumer spending is falling again, down 10 percent from where it was a year ago. Homebase, a provider of human-resources software, says that the rebound has hit a plateau, in terms of hours worked, share of employees working, and number of businesses open.

The next, terrifying phase of the coronavirus recession is here: a damaged economy, a virus spreading faster than it was in March. The disease itself continues to take a bloody, direct toll on workers, with more than 60,000 Americans testing positive a day and tens of thousands suffering from extended illness. The statistical value of American lives already lost to the disease is something like $675 billion. The current phase of the pandemic is also taking an enormous secondary toll. States with unmitigated outbreaks have been forced to go back into lockdown, or to pause their reopening, killing weakened businesses and roiling the labor market. Where the virus spreads, the economy stops.

That is not just due to government edicts, either. Some consumers have rushed back to bars and restaurants, and resumed shopping and traveling. Young people, who tend to get less sick from the coronavirus than the elderly, appear to be driving todays pandemic. But millions more are making it clear that they will not risk their life or the life of others in their community to go out. Avoidance of the virus, more so than shutdown orders, seems to be affecting consumer behavior. Places without official lockdowns have seen similar financial collapses to those with them, and a study by University of Chicago economists showed that decreases in economic activity are closely tied to fears of infection and are highly influenced by the number of COVID deaths reported in a given county.

Read: A devastating new stage of the pandemic

In other ways, the spread of COVID-19 is keeping Americans from going back to work. The perception of public transit as unsafe, for example, makes it expensive and tough for commuters to get to their jobs. Schools and day-care centers are struggling to figure out how to reopen safely, meaning millions of parents are facing a fall juggling work and child care. This is a disaster. The lingering uncertainty about whether in-person education will resume isnt the result of malfeasance, but utter nonfeasance, the former Department of Homeland Security official Juliette Kayyem has argued in The Atlantic. Four months of stay-at-home orders have proved that, if schools are unavailable, a city cannot work, a community cannot function, a nation cannot safeguard itself.

See the original post:

The Terrifying Next Phase of the Coronavirus Recession - The Atlantic

Coronavirus: Virus inquiry promised and office-worker face coverings rejected – BBC News

Posted on July 15, 2020 by Danzig

Here are five things you need to know about the coronavirus outbreak this Wednesday evening. We'll have another update for you on Thursday morning.

Boris Johnson has for the first time promised to hold an "independent inquiry" into the coronavirus pandemic. He told MPs during Prime Minister's Questions that the government would seek to learn lessons "in the future" and "certainly we will have an independent inquiry into what happened". However, the prime minister said it was not right to devote "huge amounts of official time" to an inquiry while the UK was "in the middle" of a pandemic.

There are no plans to make face coverings mandatory for office workers in England, Health Secretary Matt Hancock has told the BBC. He said face coverings helped prevent virus spread during short interactions with strangers, but that social distancing and hand washing were more effective for contact with people over long periods of time. Face coverings in shops will become mandatory in England on 24 July - but what's the best one for you and how should you wear it? Here is our handy guide.

Seventeen-year-old employees are the group most likely to have been put on furlough during the coronavirus crisis, official data shows. HM Revenue and Customs said men aged in their 40s and women aged 41 to 58 were least likely to have been put on the scheme. More than nine million workers who are unable to do their job because of the coronavirus outbreak have had their wages paid by the government.

Driving lessons in Wales will be able to resume from 27 July, with theory and practical driving tests phased in from 3 August, First Minister Mark Drakeford has said. Driving lessons resumed in England on 4 July. Scotland and Northern Ireland have separate arrangements.

Captain Sir Tom Moore, the 100-year-old who raised more than 32m for NHS charities, is to receive his knighthood from the Queen in his own personal ceremony at Windsor Castle on Friday. In May, the prime minister made a special nomination for the war veteran to be knighted.

Get a longer coronavirus briefing from the BBC in your inbox, each weekday morning, by signing up here.

You can find more information, advice and guides on our coronavirus page and get all the latest from our live page.

Plus, what can police do about coronavirus rule breakers? Our home affairs correspondent explains.

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Coronavirus: Virus inquiry promised and office-worker face coverings rejected - BBC News

Coronavirus testing is key to colleges reopening – The Boston Globe

Posted on July 15, 2020 by Danzig

Other schools, like Boston University, are forging ahead building their own high-capacity labs to regularly test their campus communities.

But whether there is enough laboratory capacity in Massachusetts to regularly test tens of thousands of college students is an open question. So, too, is the prospect of persuading hordes of students to regularly submit to nasal swabbing and to dutifully adhere to social distancing.

The higher education plans are being firmed up as waiting times grow for test results in Massachusetts and nationwide. Some national commercial laboratories used by businesses and health centers in Massachusetts to process the tests recently acknowledged waiting times stretching longer than five days as the surging virus in Southern and Western states fuels a demand for more testing.

Plentiful and timely lab results are crucial to quickly contain future clusters of COVID-19 on college campuses and beyond, and to prevent clusters from mushrooming into larger outbreaks, health experts say.

If we are going to [use] testing to control outbreaks, you have to get results back in one to two days, even three days is too slow, said Samuel Scarpino, a Northeastern University disease tracker. If I were ... anyone setting policy, I would have that on my daily dashboard and would make a lot of decisions about reopening based on that number.

Testing is just one facet of the complex plans colleges are developing this summer that they believe will make it safe to welcome students back to campus this fall. Some schools, like BU, Northeastern, and Tufts, plan to allow all undergraduates to return to campus if they wish, while others, like UMass Boston, plan to continue almost entirely online. Harvard plans to allow freshmen on campus, but all courses will be virtual. MIT will allow only seniors on campus this fall. In normal years, Massachusetts draws 500,000 college students per year who contribute $25 billion to the state economy.

A report last month from a task force of higher education leaders who advised Governor Charlie Baker on reopening colleges suggested a multipronged approach. The ideas included social distancing, masks, improved building ventilation, and reconfigured classrooms, residence halls, and dining facilities, in addition to robust coronavirus testing programs.

The report suggested several strategies for how schools should tackle the labor and cost of testing, which is expected to run about $25 per test for schools that use the Broads program, the report said.

It recommended that schools organize students and staff into groups that will be tested more or less frequently depending on their risk of exposure. Essential campus workers and students who live in dormitories, for example, would be tested most often.

The report also recommended three types of testing an initial test for everyone at the start of the semester, quick testing of symptomatic people, and routine testing at least once a week for everyone else.

Testing broadly is the sine qua non for safety, said Dr. Sandro Galea, dean of the Boston University School of Public Health and a member of the task force. The more capacity we have, the better.

The Broad Institute, known for cutting-edge biomedical research, has become a pivotal player for college coronavirus testing, recently negotiating testing contracts with several schools. In addition to Harvard and Clark, the institute is working with Emerson College, Tufts University, the University of Massachusetts Medical School, and Wellesley College.

The Broad recently expanded its daily capacity to 35,000 tests and can turn them around in less than 24 hours, a spokesman said in a statement. The lab has the ability to ramp up to 100,000 daily if needed, the spokesman said, but declined to comment further on its new college testing program.

The Broad, which opened its testing lab in March, has so far not processed more than 7,000 tests in a day, according to the website where it posts its daily output.

Dr. Ashish Jha, a global health professor at the Harvard T. H. Chan School of Public Health, said it is imperative that schools have a substantial amount of testing because relying on students to consistently practice social distancing is not practical.

And although this might be an unruly demographic, he said, students will likely submit to tests.

I generally think there is a way that if you implement your policy well, you can probably ensure that everybody does it, Jha said.

Maybe Im being too cynical, but I just feel like 20-year-olds really adhering to strict social distancing guidelines is going to be a tall order, and therefore it is that much more important that we do aggressive testing, he added.

Jha said he is pretty confident the Broad will be able to handle the daily testing load it is taking on.

But if the Baker administration believes it is important for colleges and universities to reopen, officials should figure out how to increase testing capacity statewide, he said.

"The state's got to keep pushing on that, and keep trying to drive toward higher capacity," he said.

A plan the state recently submitted to federal regulators raises questions about the scope of campus testing. It indicates the administration anticipates that only about 10,000 individuals in total will be tested daily statewide in September and about twice that come October long after campuses reopen. It is silent on expected turnaround times for results.

A Baker administration spokeswoman declined to comment about testing on campus. She said in a statement the administration is seeking to expand testing capacity but did not touch on turnaround times.

Oversight of the testing varies among local campuses. In many instances, colleges and universities are outsourcing the screenings. Several plan to ask students to swab their own noses with shorter swabs than are used in many public testing sites, where medical workers typically collect samples deep within the nasal cavity. Some schools will have medical staff observing as the students swab their own noses.

Anthony Monaco, the president of Tufts University who was a member of the higher education task force, said the group believes the biggest risk for spread on campuses will be within dorms. But he said it will be important for schools to also test students who live off campus.

Monaco said Tufts is developing an app that will let students know when they are scheduled to be tested and send reminders. The details are not finalized, he said, but there would likely be repercussions for missing a test, such as not being able to participate in a campus activity.

The testing will be a significant investment for schools, he said, on top of other adjustments like extra housing they are building to quarantine students.

They all add up, but for one semester, perhaps two, its an investment we need to make, Monaco said.

Kay Lazar can be reached at kay.lazar@globe.com Follow her on Twitter @GlobeKayLazar. Laura Krantz can be reached at laura.krantz@globe.com. Follow her on Twitter @laurakrantz.

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Coronavirus testing is key to colleges reopening - The Boston Globe

Florida, Texas and California account for about one-fifth of the world’s new coronavirus cases – NBC News

Posted on July 15, 2020 by Danzig

Almost 1 in 5 new cases of the coronavirus reported around the world came from just three U.S. states Florida, Texas and California a new NBC News tally revealed Tuesday.

The 27,574 cases recorded in those states Monday accounted for 18.9 percent of the global total and represented more than a third of the 61,751 new cases reported in the U.S.

Meanwhile, the two-week death total in Texas was up by 99 percent over the previous two weeks.

In Florida, the two-week death total rose by nearly 84 percent, and in California it jumped by nearly 27 percent.

As of Tuesday afternoon, there had been 3,407,556 confirmed coronavirus cases in the U.S., and the death toll was 136,832, NBC News figures showed.

Florida reported 9,194 more cases and 133 deaths from Monday. Texas added 7,489 cases and 59 deaths. California recorded 5,063 more cases and 40 deaths.

On Tuesday evening, Los Angeles County alone announced a new single day record with 4,244 cases and 73 deaths.

Arizona, which has also had big increases in new cases in recent weeks, reported 4,273 more infections and 92 more deaths.

Texas' Latino community has been hit especially hard of late, and Rep. Joaquin Castro, a Democrat whose district includes San Antonio, blamed President Donald Trump and Gov. Greg Abbott for being "slow to test people, slow to trace the infection and slow to treat people."

Let our news meet your inbox. The news and stories that matters, delivered weekday mornings.

They "tried to pretend like it wasn't a big problem because they didn't want to end up on the news every day the way New York did, and that's had an incredible effect on this community, and in the last three weeks, it's really exploded," Castro told MSNBC's Garrett Haake.

Full coverage of the coronavirus outbreak

Trump and Abbott have been accused of not having moved quickly enough to combat the coronavirus, and it wasn't until this month that Abbott mandated that people wear masks in public. Trump wore a mask for the first time in public just two days ago, and he predicted this month that the pandemic would "just disappear."

The staggering new sums were reported as Dr. Brett Giroir, the assistant secretary of health and human services for health, insisted on NBC's "TODAY" that "we're turning the corner on the current outbreak."

"We are all very concerned about the outbreak," Giroir said. "About half the cases are in four states: Texas, California, Florida and Arizona. But we are in a much different place now than we were several months ago, a much better place."

Maybe. But 41 states have had increases in cases over the last two weeks, and eight states have had spikes of more than 100 percent over the last 14 days, according to NBC News' Medical Unit.

And when Vice President Mike Pence arrived Tuesday in Louisiana to meet with officials about the pandemic, state Attorney General Mike Landry wasn't there to greet him on the tarmac because he has tested positive, The Advocate newspaper of Baton Rouge reported.

"Out of an overabundance of caution with the Vice President coming to our state, I was tested for Cornavirus," Landry wrote in an email to staffers. "Though experiencing no symptoms, I tested positive for COVID-19."

In other developments:

"The amount of time it is taking to receive testing results is hurting the ability of long term facilities to fight the virus," the letter states. "For nursing homes and assisted living communities to protect residents and staff, we need on-site testing with reliable and rapid results.

"We don't have a Dr. Fauci problem," Graham said. "I have all the respect in the world for Dr. Fauci. I think any effort to undermine him is not going to be productive, quite frankly." Trump has also denied trying to torpedo Fauci.

There was also a smidgen of troubling news out of New York, which in April was posting Texas-size case numbers and since then has succeeded in flattening the coronavirus curve.

Download the NBC News app for full coverage and alerts about the coronavirus outbreak

Gov. Andrew Cuomo reported that 1.5 percent of the 60,045 COVID-19 tests performed Monday came back positive. That is the highest positive rate in the state since June 5.

Cuomo also reported five more coronavirus deaths Monday.

On Sunday, the State Department of Health reported that there were zero COVID-19 deaths Saturday, the first time that has happened since March 13.

CORRECTION (July 14, 2020, 9:45 p.m.): An earlier version of this article misspelled the first name of a senator from South Carolina. He is Lindsey Graham, not Lindsay.

Nigel Chiwaya is a data reporter for NBC News.

Corky Siemaszko is a senior writer for NBC News Digital.

See the original post:

Florida, Texas and California account for about one-fifth of the world's new coronavirus cases - NBC News

Texas hospitals are running out of drugs, beds, ventilators and even staff – The Texas Tribune

Posted on July 15, 2020 by Danzig

A coronavirus patient in Anahuac was flown by helicopter to a hospital in El Campo 120 miles away because closer facilities could not take him.

Ambulances are waiting up to 10 hours to deliver patients to packed Hidalgo County emergency rooms.

And short-staffed hospitals in Midland and Odessa have had to turn away ailing COVID-19 patients from rural West Texas facilities that cant offer the care they need.

As the tally of coronavirus infections climbs higher each day, Texas hospitals are taking extraordinary steps to make space for a surge of patients. Some facilities in South Texas say they are dangerously close to filling up, while hospitals elsewhere are taking precautionary measures to keep their numbers manageable.

Doctors warn of shortages of an antiviral drug that shows promise for treating COVID-19 patients. And epidemiologists say the states hospitals may be in for a longer, harder ride than places like New York, where hospitals were stretched to capacity in the spring and some parked refrigerated trailers outside to store bodies of people who died from COVID-19.

It used to [be that] if one hospital got kind of overwhelmed you would start transferring out ICU patients to other facilities that had ICU beds available, said Dr. Robert Hancock, president of the Texas College of Emergency Physicians. And there really is none of that now, because everybodys in the same boat and theyre struggling to get their own patients admitted.

Cases of the new coronavirus have surged in Texas since Memorial Day weekend at the end of May, one month after Gov. Greg Abbott allowed a phased reopening of businesses. In June, Abbott scaled back parts of that plan, first pausing elective procedures in the states biggest cities in an attempt to conserve hospital capacity for COVID-19 patients, then ordering bars to close and capping restaurant occupancy at 50%.

Last week, he expanded the ban on elective procedures to more than 100 counties across broad swaths of the state, a sign of the increasing urgency of the virus toll on Texas hospitals. Then he warned that if the trend continues, he might order another economic lockdown.

Its going to be a rough few weeks, said John Henderson, president of the Texas Organization of Rural and Community Hospitals. Most everything were seeing is worrisome or scary.

State data shows the hardest-hit regions include most of Texas biggest cities, as well as large swaths of South and Central Texas and the Gulf Coast.

Dr. John Zerwas, the executive vice chancellor for health affairs at the University of Texas System and a former state representative who is advising Abbott on coronavirus response, forecasted that July will be a month for peak activity related to the epidemic.

Probably toward the end of the month, well be seeing ourselves get into a bit more comfortable place, he said.

Local officials in urban centers throughout Texas say more restrictions are needed now to slow the virus spread and keep hospitals from being overwhelmed in the future. On Sunday, Houston Mayor Sylvester Turner called on the governor to shut down businesses for two weeks.

Many Texas hospitals have stopped accepting transfer patients in order to maintain space for a surge thats expected to come. In the Rio Grande Valley, that moment has already arrived, with hospital beds in short supply.

The tsunami is here, Hidalgo County Judge Richard Cortez said last week.

DHR Health, based in Edinburg, the county seat, is creating a third special COVID-19 ward in a facility normally used for physical therapy after spending more than $9 million to convert a hospice center and rehabilitation facility into COVID-19 units.

Were full to the gills, said Dr. Carlos J. Cardenas, chairman of the board at DHR Health.

In neighboring Cameron County, all of the hospitals were at or above capacity and holding patients in their emergency departments Monday, said Dr. James Castillo, the county health authority. Some were converting or eyeing areas not typically used for patient care, like conference rooms or lobbies, he said.

At Valley Baptist Medical Centers in Brownsville and Harlingen which keep opening new units to care for critically ill patients there were people waiting in the emergency room hallways for treatment this week, said Dr. Jamil Madi, medical director of the ICU in Harlingen. The hospitals are nearly out of ventilators and are starting to consider older models and disaster ventilators that are less optimal for treating the virus, he said.

Theres nothing else other than COVID. You treat COVID, you look at COVID, you see COVID, you smell COVID, you hear COVID. Everythings COVID, Madi said. There are two parallel worlds: The world inside the hospital and the world outside. We need people to understand that it is a dire situation going on inside the hospital.

Ambulances are sometimes waiting hours to deliver patients to the emergency rooms, said Mack Gilbert, chief operating officer of Med-Care EMS, which services most of Hidalgo County. Normally, the wait is less than 30 minutes, he said.

You cant blame the hospitals for being full. The ICUs are full, Gilbert said. But the longer [the patients are] with us, the longer it takes to get them the care they need. Were not really set up for long-term care like that, for four to six to eight hours.

The extended delay also leaves medics in the confined space of an ambulance with a COVID-19 positive patient for longer, increasing their risk of exposure to the virus even though they wear full protective gear, Gilbert said.

The state sent hundreds of medical personnel to South Texas earlier this month to alleviate staffing shortages. It also deployed a fleet of 10 ambulances to Hidalgo, of which Med-Care can use two for 12 hours a day.

Gilbert is grateful these guys are doing a great job. But in a 12 hour shift, they're only able to do three calls, because each call is taking four hours, he said.

In Houston, major hospitals have had to treat hundreds of COVID-19 patients in their emergency rooms as they await space in intensive care units. Data shows the dozen busiest hospitals in the area are increasingly telling emergency responders that they cannot safely accept new patients.

Ripple effects can be felt throughout the region, including at El Campo Memorial Hospital, about 75 miles southwest of Houston.

Under normal circumstances, hospitals in Houstons world-renowned Texas Medical Center would accept transfers of medically complex patients from smaller regional hospitals that are less equipped to handle them. But with many Houston hospitals diverting patients away, smaller facilities like the 49-bed El Campo Memorial Hospital have taken them on.

On Monday, the hospital was caring for 18 coronavirus patients, including at least two who were admitted from Houston and the Anahuac patient who was transported by helicopter, said Nathan Tudor, chief executive of the Mid Coast Health System, which includes the hospital.

Traditionally, if the complex cases need to go out, they do go to Houston, Tudor said. Were just praying that this virus gets behind us sooner rather than later.

In Dallas, some hospitals are gearing up for crisis as the number of admitted patients climbs. After requests from Abbott and Dallas Mayor Eric Johnson, federal medical teams are heading to Parkland Memorial Hospital, one of the citys biggest facilities, to help treat an onslaught of patients.

Additional staff is our primary need, said Donna Richardson, chief nursing officer for Parkland Health and Hospital System.

Similar teams were already sent to Houston and San Antonio.

And for the next two weeks, Medical City Healthcare is suspending elective surgeries at 10 of its 16 North Texas facilities, even though the governors order allows such surgeries to take place outside Dallas County.

The pause will enable us to safely and quickly expand capacity and staff to care for hospitalized patients, spokeswoman Janet St. James said. While we currently have adequate capacity, staff, and [personal protective equipment] we are concerned that there is a misconception in the community that this rate of growth can continue.

Meanwhile, short-staffed West Texas hospitals have been forced to turn away patients from rural areas, where small regional hospitals lack the resources to treat the sickest patients.

Earlier this month, Medical Center Health System in Odessa went on diversion meaning it did not accept transfer patients from regional hospitals outside the county as it faced severe staffing shortages. Currently, more than 20 staff members are out because either they or their family members have been exposed to COVID-19, said Trevor Tankersley, a spokesperson for the Medical Center Health System in Odessa.

When MCHS resumed accepting transfer patients, 15 arrived in one day, from West Texas towns as far-flung as Kermit and Alpine. Soon after, the citys other major hospital, Odessa Regional Medical Center, stopped accepting transfers.

Nearby Midland Memorial Hospital stopped accepting transfers of critical patients Thursday, spokeswoman Tasa Richardson said. At that point, the 286-bed hospital was treating 34 coronavirus patients. By Monday, the number had grown to 44.

Its important that the numerous rural hospitals in the region have somewhere to send their patients, hospital representatives said.

We know what its like to be in a small hospital outside of this area and not have the resources, and its difficult to turn down a request for a transfer to a higher level of care, said Dr. Rohith Saravanan, Odessa Regional Medical Centers chief medical officer. There is really no option for that patient at that point theres no care they can provide that would give these patients a good fighting chance.

But even larger hospitals face severe staffing limitations. At ORMC, nurses in the intensive care unit are working with twice as many patients as they normally would. In remote West Texas, there is a severe shortage of nurses, respiratory therapists, and radiology and medical technicians, he said. So the hospital is turning to more expensive contract labor.

We have the bed capacity, we have [personal protective equipment]. ... The capacity is limited mostly by staffing, Saravanan said. There isnt any talent in the area that we can tap into.

Farther west, El Pasos University Medical Center is doing OK on capacity and ... able to handle all patients under a surge planning process that was set up early on, said Ryan Mielke, the hospitals director of public affairs.

Neighboring El Paso Childrens Hospital is prepared to offer up a number of its own units for adult COVID-19 patients if that becomes necessary, but we are not close to reaching that right now, said Audrey Garcia, director of marketing for El Paso Childrens.

You just gotta pray that it stays on that curve, Garcia said.

Health care workers urged Texans to wear masks, wash their hands frequently and avoid contact with others as much as possible to help prevent new coronavirus infections.

The community has an expectation of us as a hospital. The expectation is that well have beds to take care of them, staff to take care of them, medications, Saravanan said. They need to have an expectation of themselves to say, Were gonna do everything we can so we dont have to utilize those resources. The only way we can do that is by preventing the spread of this disease.

Disclosure: The Texas College of Emergency Physicians, the University of Texas System, the Texas Organization of Rural and Community Hospitals, and Parkland Health and Hospital System have been financial supporters of The Texas Tribune, a nonprofit, nonpartisan news organization that is funded in part by donations from members, foundations and corporate sponsors. Financial supporters play no role in the Tribune's journalism. Find a complete list of them here.

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Texas hospitals are running out of drugs, beds, ventilators and even staff - The Texas Tribune

I Cant Keep Doing This: Small-Business Owners Are Giving Up – The New York Times

Posted on July 15, 2020 by Danzig

On the last Friday of June, after Gov. Greg Abbott of Texas said that bars across the state would have to shut down a second time because coronavirus cases were skyrocketing, Mick Larkin decided he had had enough.

No matter that Mr. Larkin, an owner of a karaoke club in Wichita Falls, Texas, had just paid $1,000 for perishable goods and protective equipment in anticipation of the weekend rush. No matter that the frozen margarita machine was full, that 175 plastic syringes with booze-infused Jell-O were in place, or that there were masks for staff members and hand sanitizer for guests.

That day, June 26, Mr. Larkin and his partner dumped what they had just bought into the trash and decided to close their club, Krank It Karaoke, for good.

We did everything we were supposed to do, Mr. Larkin said. When he shut us down again, and after I put out all that money to meet their rules, I just said, I cant keep doing this.

It was harrowing enough for small businesses the bars, dental care practices, small law firms, day care centers and other storefronts that dot the streets and corners of every American town and city to have to shut down after state officials imposed lockdowns in March to contain the pandemic.

But the resurgence of the virus, especially in states such as Texas, Florida and California that had begun to reopen, has introduced a far darker reality for many small businesses: Their temporary closures might become permanent.

Nearly 66,000 businesses have folded since March 1, according to data from Yelp, which provides a platform for local businesses to advertise their services and has been tracking announcements of closings posted on its site. From June 15 to June 29, the most recent period for which data is available, businesses were closing permanently at a higher rate than in the previous three months, Yelp found. During the same period, permanent closures increased by 3 percent overall, accounting for roughly 14 percent of total closures since March.

Researchers at Harvard believe the rates of business closures are likely to be even higher. They estimated that nearly 110,000 small businesses across the country had decided to shut down permanently between early March and early May, based on data collected in weekly surveys by Alignable, a social media network for small-business owners.

Christopher Stanton, an associate professor at Harvard Business School who was one of the researchers, said it was difficult to accurately gauge how many small businesses were closing because, once they shut their doors for good, the owners were hard to reach. He added that it could take up to a year before government officials knew the true toll the pandemic was taking on small businesses.

At the moment, 39 states continue to record growing numbers of new cases daily.

It is not clear how many of the businesses Yelp is tracking count as small defined by the Small Business Administration as those with 500 or fewer employees. But the company found that, among the tracked businesses which include restaurants, retailers and other independent, consumer-facing operations retail businesses, led by beauty supply stores, have been closing at the highest rate since the pandemic began. Restaurants are the next hardest-hit group.

Small businesses account for 44 percent of all U.S. economic activity, according to the S.B.A., and closures on such an immense scale could devastate the countrys economic growth. If they were grouped together, small businesses would be among the countrys biggest employers, said Satyam Khanna, a resident fellow at the Institute for Corporate Governance and Finance at New York University School of Law who has written about the effects of the pandemic on small businesses.

So when small businesses close en masse, an entire sector of the economy suffers, Mr. Khanna said. There is lower cash flow, higher debt and more unemployment. That leads to a big drag on the eventual recovery, he said. Because they are such an important source of jobs, losing them the way we are losing them now is going to make things far worse than they otherwise need to be.

Because small businesses depend heavily on foot traffic and operate on thin margins, they are especially vulnerable to the ripple effects of a widespread shutdown.

For nearly two decades, Rich Tokheim and his wife sold sports memorabilia hats, T-shirts, coffee mugs and other trinkets to fans in Omaha at their store, The Dugout. Since 2011, The Dugout has occupied prime real estate across the street from the citys 24,000-seat baseball stadium, which usually hosts the College World Series each spring.

The 2020 World Series was canceled in March. In the weeks that came after, other sporting events were scrapped starting with college sports and extending to professional leagues that have struggled to relaunch their activities.

Mr. Tokheim, 58, watched his business fall off with growing unease, but it was only after a friendly chat with a retired college athletic director in May that the gravity of his situation hit home. He was already worried about the state of the virus in Nebraska, and whether there was enough tracking. Then the athletic director predicted that if college football was canceled for the year, it would be the end of Division I sports as a whole.

That really put me in overdrive, Mr. Tokheim said. He negotiated an early exit on his store lease and announced a clearance sale at the store. The Dugout closed for good on June 30.

The governments Paycheck Protection Program, rolled out in April and administered by the S.B.A., earmarked $660 billion of aid for small businesses, but stipulated that a loan would be forgiven only if most of it was used to pay employee wages for eight weeks. The rules were later relaxed, but in a sign of how many small-business owners did not feel confident that they would be on steady ground by the time repayment was due, roughly $130 billion of aid money remained untapped when the program ended in June.

Even for those who took a P.P.P. loan, survival is no guarantee. Nick Muscari, a 38-year-old restaurateur in Lubbock, Texas, received one. His restaurant, Nicks Sports Grill and Lounge, had been the culmination of Mr. Muscaris lifes work his years of toil as a waiter, pizza cook and manager at restaurants and bars beginning in his teenage years. Three years ago, he bought out the two partners who helped him start the restaurant in 2010. He considered it a crowning achievement, but to do so, he had to borrow money. He still owes a bank $80,000.

Mr. Muscari tried to ride out the spring lockdown that temporarily shuttered his restaurant with the help of the P.P.P. money. But when the states second closure order took effect on June 26, he decided to close for good.

It had been in the back of our minds, just like, you know, if this happens again, can we make it? Mr. Muscari said. We were following all the rules and people were spread out. We never had anybody catch the virus in our establishment."

Mr. Muscari, with the business closed and its 30 employees jobless, has nothing left but his house and his car. He also expects his landlord to try to sue him for the eight years worth of rent he is contracted to pay on his defunct restaurants space.

Many small businesses are also finding it onerous keep up with constantly changing local guidelines, while others are deciding that no matter what their local officials say, it just is not safe to keep going. Gabriel Gordon, the owner of a tiny but popular barbecue restaurant in Seal Beach, Calif., decided to close permanently after studying the restaurants layout. He had determined that the kitchen would never be safe for multiple staff members to occupy at once while the virus was still active in the area.

Its essentially two hallways that are 11 feet wide, Mr. Gordon said, describing the shape of the restaurant, Beachwood BBQ. There are food trucks that are larger than my kitchen.

Whatever the specific reasons may be for each closure, Justin Norman, Yelps vice president of data science, said that the federal government should offer small businesses more help. Mr. Norman said Yelp was concerned about the effects of small-business closures, especially those owned by people of color, on society. Yelp, however, also has a financial interest in maintaining a robust small-business environment, because it relies heavily on advertising by businesses on its platform.

The time is right now to inject more capital or we may lose them forever, Mr. Norman said. Its going to make our economies worse, its going to make our communities worse.

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I Cant Keep Doing This: Small-Business Owners Are Giving Up - The New York Times

What you need to know about COVID-19 health care rationing – MarketWatch

Posted on July 15, 2020 by Danzig

Due to theCOVID-19 pandemic, Arizona has become the first state in U.S. history to implement whats known as Crisis Standards of Care, which some refer to as a way of rationing health care. This policy kicks in when a health care system is overwhelmed and expected to be severely impacted for a sustained period of time.

As a patient, or a potential patient, learning that your doctor and hospital system are operating under Crisis Standards of Care can be alarming. Many people believe it could mean that some older people, particularly those who are sickest, will be denied health care resources, such as ventilators, in favor of others.

Heres a Q and A to help address questions you or your loved ones may have about Crisis Standards of Care:

Local and state jurisdictions know that planning in advance for disasters can save lives. During normal operations, health care is a highly regulated and slow-moving system that often can compete for patients. In a pandemic or a disaster, those same characteristics can cost lives.

Crisis Standards of Care plans are a way for hospitals and health care systems to decide in advance how to move faster and work more closely together during a crisis. Their goals are to improve communication, optimize and share resources, including staff, and identify which regulations and standards might need to change to save as many lives as possiblewhen a health care system is overwhelmed.

Also read: Survivors talk about the aftereffects of COVID-19

Crisis Standards of Care plans often have some common elements. These can include:

Triage:A key component of Crisis Standards of Care is that the focus moves from delivering individual patient care to delivering the best care for the patient population. Crisis Standards of Care will often have three stages of triage: at the ambulance level, at the hospital level and at the ICU level. Each stage will assess a patient to see if there is a likelihood that the patient would substantially benefit from the treatment that is available.

Treatments and supplies:Crisis Standards of Care can mean using alternate drugs or devices when shortages occur to save lives. Re-using equipment, such asN95 masks, is also a way to extend scarce supplies.

Liability:Hospitals and health care systems are given broad protection and even qualified immunity from liability during Crisis Standards of Care. In addition to liability protection, there can be financial implications for reimbursing hospitals.

Although Crisis Standards of Care are meant to save the most people possible, it can mean a big change for individuals and their health care needs compared to the traditional approach.

Exactly what Crisis Standards of Care might mean if theyre activated where you live depends on how your state defines them and how the standards would be implemented.

Although Arizona has activated its Crisis Standards of Care, it has not yet implemented triage.

See:Letter from Arizona: Hospitals grapple with a surge in coronavirus cases, while life outside continues as normal

In California, another COVID-19 hotpot, its Crisis Standards of Care guidelines (which have not yet been activated) emphasize equity, including the need to avoid discrimination based on age. The guidelines also state that it is important to avoid resource-allocation decisions that make assumptions about a persons quality of life, which might discriminate against people with disabilities. The guidelines also emphasize the risk of moral distress for the health care team.

When or if California or other states will activate Crisis Standards of Care is unknown. But many states have prepared a crisis plan if theyll need it.

Both Arizona and California have Crisis Standards of Care approaches that encourage using an organ system approach to triage. Its not based on gender, race or many other potentially discriminatory characteristics.

An organ system approach looks at how many organs are impacted, or even failing in a patient, in order to help a health care team decide who might benefit from scarce resources, and who may not.

Some states, like Arizona, use whats known as a SOFA Score, for sequential organ failure assessment. Patients are assigned points according to their SOFA Score, with priority treatment given to people with lower scores.

As a family member, caregiver or a loved one of a patient who is very sick, you may have a doctor or member of the health care team talk to you about how sick your loved one is based on their organ system score. While hearing your loved one discussed in terms of their organs may feel abstract and impersonal, it is important to remember that an organ system approach is our best measure for avoiding discrimination and avoiding making value-based judgments about who gets care.

Doctors, nurses and other health care professionals may be repositioned into roles they would not normally perform. For example, an internal medicine outpatient doctor might be working in an ICU or an emergency room nurse might be assisted by EMTs.

You might be sent somewhere you might not expect, like an alternative care site in a parking lot or a newborn ICU instead of an adult ICU.

Also see: Travelers from four more states added to N.Y.s mandatory quarantine

You may be given something like a home kit with a pulse oximeter to self-monitor until there are signs, like a low oxygen saturation, indicating its time to get more advanced care.

Dont avoid getting health careuntil the last minute. If you do, care that could save your life might not be available because youre at the extreme end of sickness and your organs may be failing.

On the other hand, none of us want to go to a hospital too early or unnecessarily overload a health care system that is already struggling.

The best advice for yourself and your loved ones is to call your clinic and outpatient doctor early if you have a health problem. Stay in communication. You want to make a plan for when symptoms are serious enough to mean it is the best time to get the lifesaving care you need.

Stay home whenever and however you can. Anddont schedule elective procedures or surgeries that can wait. Also, dont do risky things, like cleaning gutters on a shaky ladder.

Right now, we save lives when we avoid getting sick.

Also see: Health officials clamor for U.S. states to pause reopenings amid spikes in COVID-19 infections

When you must go out, wear a mask and stay six feet away from others, wash your hands often. Our health care system needs us to do our part to help those who are sickest.

TheArizona Crisis Standards of Care Planspells out in detail many steps that are being taken.

TheCalifornia Crisis Care Guidelinesare also very detailed, with a significant portion devoted to equity and non-discrimination.

And theU.S. Department of Health and Human Services Guidance on Non-Discriminationcovers rights and expectations.

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What you need to know about COVID-19 health care rationing - MarketWatch

Pandemic hits women harder in jobs, health care – WAVY.com

Posted on July 15, 2020 by Danzig

Women more likely to be exposed to virus as they're on front lines

by: Alexandra Limon

WASHINGTON (Nexstar) History shows economic recessions tend to worsen inequities that already exist. Statistics show the pandemic is having a greater impact on women than men.

Congresswoman Dina Titus said the coronavirus recession is just making things worse. Data from the US Labor Department shows women experienced higher unemployment rates than men in April, May and June. Women are also more likely to be exposed to the virus because they tend to work in front line jobs.

Women already make less than men, we know that. And women of color make even less than men, for the same work, for the same amount of time, said Titus, a Nevada Democrat. About two-thirds of health care workers, two-thirds of social workers, also grocery store and fast food workers all are women.

Dr. William Spriggs, the chief economist for the AFL-CIO, said those women are also less likely to have access to proper health care.

A very frightening share of women who show up to work and report that they have symptoms, because they fear losing their job, Spriggs said.

But White House economic adviser Larry Kudlow said reopening schools is one way to help women.

Traditional families, too, but single moms who have to work but if the kids are home Kudlow said.

The solution isnt simple.

More than 75% of teachers are women. The Kaiser Family Foundation said one in four teachers may be at risk of severe illness from COVID-19.

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Pandemic hits women harder in jobs, health care - WAVY.com

Resident and employee at Universal Health Care of Brunswick dies from COVID-19 – WWAY NewsChannel 3

Posted on July 15, 2020 by Danzig

BOLIVIA, NC (WWAY) Brunswick County Health Services is reporting the death of two more county resident associated to the novel coronavirus.

The first person was a resident at the Universal Health Care of Brunswick congregate living facility who received a positive test result for COVID-19. The county says the person was considered a person at high risk for severe illness as they were over the age of 65 and had underlying medical conditions.

The second person was an employee at Universal Health Care of Brunswick who had received a positive test result for COVID-19. The person was in the 25-49 year age range and also had pre-existing medical conditions.

This is exceptionally sad news that we have to report today, Chairman Frank Williams said. The commissioners and I extend our condolences to the families and colleagues of these individuals. We remain grateful to those who continue to respond to this pandemic and care for those affected by this virus.

As of Tuesday, Brunswick County has had five active outbreaks at nursing homes or residential care facilities since the pandemic began. Meanwhile, cases involving county residents in general have increased by nearly 620 percent since early June.

Its more important now than ever to stay home and limit your travel as much as possible, even in your home town, Health Services Director Cris Harrelson said. We continue to see cases rise due to social gatherings among people of different households, those who work in higher risk public settings, or that are attributed to community spread.

There are 828 total positive cases of COVID-19 among county residents (377 considered recovered, 428 isolating, 13 hospitalized, 10 deaths) and 14 cases among non-residents (1 isolating in county, 8 considered recovered, 3 transferred monitoring to home county, 2 deaths).

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Resident and employee at Universal Health Care of Brunswick dies from COVID-19 - WWAY NewsChannel 3

OMRON Healthcare and Mount Sinai Health System Collaborate to Help High-Risk Patients Monitor Their Blood Pressure from Home with VitalSight -…

Posted on July 15, 2020 by Danzig

LAKE FOREST, Ill, & NEW YORK--(BUSINESS WIRE)--OMRON Healthcare, Inc., the global leader in personal heart health and wellness technology, and Mount Sinai Health System, New York Citys largest academic medical system, have teamed together to offer patients the new VitalSight home blood pressure monitoring solution. Mount Sinai recently rolled out the VitalSight program to support the needs of their patients with hypertension.

Were excited to collaborate with such a prestigious healthcare institution as Mount Sinai, who played an instrumental role in shaping the value of VitalSight from early in its development. Now, they are leading the way for patients to use VitalSight from the privacy of their home, while staying closely connected to their physician, explained OMRON Healthcare President and CEO Ranndy Kellogg.

VitalSight is the newest addition to the comprehensive line of OMRON Healthcare home blood pressure monitors (the #1 doctor and pharmacist recommended brand1,2) designed to advance the companys mission of Going for Zero the elimination of heart attack and stroke. The VitalSight kit complements Mount Sinais commitment to remotely monitor patients as part of its recent telehealth initiative, especially as providers care for COVID-19 patients who are recovering at home.

The effort to provide VitalSight to patients is led by Dr. Rob Fields, SVP and Chief Medical Officer for Population Health at Mount Sinai, and a dedicated team of clinical pharmacists, who are responsible for the day-to-day management of the program and coordination with physicians to ensure that patients receive individualized care. The ability to monitor patients at home during the pandemic and on an ongoing basis is critical. Our collaboration with OMRON Healthcare helps make patients active participants in their own health care and extends the reach of clinicians, who receive a continuous stream of their patients real-time health data so that they can proactively intervene as necessary, he said. Additionally, we are focusing first on our most vulnerable patients, who bear the consequences of disparities in care in part, due to lack of technology access. This program requires no technology and comes at no cost for the device, with little-to-no cost for service.

1Frost & Sullivan Survey, Blood pressure clinician perception tracker surveys. 17 July 2019.2 U.S. News Staff 2019, U.S. News & World Report <https://health.usnews.com/health-products/top-rec-blood-pressure-monitors-14>, accessed 8 August 2019.

VitalSight is a HIPAA-compliant, Medicare-reimbursable home blood pressure monitoring solution that generally comes at no cost to the patient, depending on their coverage. The kit typically includes a digital blood pressure monitor with cuff, weight scale and digital medication tracker, as well as a data hub. Exact devices may vary based on what the physician deems appropriate for each patients hypertension monitoring needs. VitalSight directly links to a physicians Electronic Medical Record (EMR), and is compatible with leading systems. Patients measure their blood pressure, weigh themselves and continue to take their medication as ordered by their physician. Securely encrypted data is automatically sent to the doctors EMR in real time, where its stored for reference unless a health concern is detected, in which case the physicians office is alerted.

For more information, please visit http://www.omronhealthcare.com and http://www.mountsinai.org.

About OMRON Healthcare, Inc.

OMRON Healthcare, Inc., is the worlds leading manufacturer and distributor of personal heart health and wellness products. Its market-leading products include a full-range of home blood pressure monitors and pain management devices. Since OMRON invented its first blood pressure monitors more than 40 years ago, the company has been passionate about empowering people to take charge of their health at home through precise technology. OMRON is the number one doctor and pharmacist recommended brand of blood pressure monitors for home use. The companys mission is Going for Zero, the elimination of heart attacks and strokes. For more information, visit OmronHealthcare.com and follow OMRON Healthcare on Facebook, Twitter and LinkedIn.

About the Mount Sinai Health System

The Mount Sinai Health System is New York City's largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai is a national and international source of unrivaled education, translational research and discovery, and collaborative clinical leadership ensuring that we deliver the highest quality carefrom prevention to treatment of the most serious and complex human diseases. The Health System includes more than 7,200 physicians and features a robust and continually expanding network of multispecialty services, including more than 400 ambulatory practice locations throughout the five boroughs of New York City, Westchester, and Long Island. The Mount Sinai Hospital is ranked No. 14 on U.S. News & World Report's "Honor Roll" of the Top 20 Best Hospitals in the country and the Icahn School of Medicine as one of the Top 20 Best Medical Schools in country. Mount Sinai Health System hospitals are consistently ranked regionally by specialty and our physicians in the top 1% of all physicians nationally by U.S. News & World Report. For more information, visit https://www.mountsinai.org or find Mount Sinai on Facebook, Twitter and YouTube.

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OMRON Healthcare and Mount Sinai Health System Collaborate to Help High-Risk Patients Monitor Their Blood Pressure from Home with VitalSight -...

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