Abled.ALERT: C19 Rx Logs. Text against a 3D model of the COVID-19 virus against a blurred global map of hotspots.

Antibody Tests Status

With the White House unveiling its three-phase plan for “reopening the country”, an integral component will be the wide availability of reliable testing for the coronavirus that causes COVID-19 infection.

There are at least 70 antibody tests on the market, but some medical experts are concerned about the quality and accuracy of the tests.

CNN investigative reporter Drew Griffin takes a look at those concerns in the video below..

 

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Tests vs Tests

From The Guardian: There’s a lot of talk about coronavirus testing at the moment, but some people are getting confused about what they actually are.

How is the antibody test different to the PCR antigen test? What do they do? And why are they important?

Josh Toussaint-Strauss speaks with Professor David Smith to answer some of these covid-19 questions.

 

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Abled.ALERT: Photo of Abbott Laboratories' ID Now diagnostic test unit for COVID-19 which is about the size of a small toaster with a sloping front face and a small digital touchscreen.

Emergency OK For New Test

The U.S. Food and Drug Administration has given emergency use authorization (EUA) to Abbott Laboratories for the fastest available molecular point-of-care test for detecting the COVID-19 Coronavirus.

Abbott says its “ID Now” unit can deliver positive results in as quickly as five minutes, and negative results in 13 minutes.

The company says it’s ramping up production to deliver 50 thousand “ID Now” tests per day, starting next week.

Because the unit is about the size of a small toaster, it can be used in a variety of locations outside hospitals, such as doctors’ offices and urgent care clinics.

Abbott plans to use “ID Now” in conjunction with another system that received emergency use authorization last week to produce about five million tests in April.

 

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Abled.ALERT: Photo of an Apple laptop and iPhone showing the company's COVID-19 Screening tool on the screens.

Apple's C19 Screening Tool

Apple has launched a COVID-19 screening tool  website and app that allow users to screen themselves for symptoms of the coronavirus.

Developed in partnership with the CDC, FEMA, and the White House Coronavirus Task Force, Apple cautioned that it’s “designed to be a resource for individuals and does not replace instructions from healthcare providers or guidance from state and local health authorities.”

When you visit the website or download the app, the first thing you’re asked is whether you’re screening for yourself or someone else.

After you click your answer, a warning screen appears instructing anyone with constant chest pain or pressure, extreme difficulty breathing, severe and constant dizziness or lightheadedness, slurred speech or difficulty waking up to immediately call 911.

If you aren’t experiencing any of those symptoms, you’ll continue to a questionnaire that asks about symptoms, travel, preexisting conditions and contact with other people.

After you submit your answers, the tool shows recommendations from the CDC on how to proceed, including guidance on social distancing and self-isolation, how to monitor symptoms at home, whether to get tested and when to seek advice from a medical professional.

Apple says the screening tool does not require signing in with an Apple ID, and the company says “individual responses will not be sent to Apple or any government organization.”

 

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Abled.ALERT: Screen photo of the Baseline COVID-19 testing program. A woman is holding a tablet device.

Baseline Testing Launches

Earlier in March, President Trump said Google had 1,700 engineers working on a new website that would help Americans determine whether to seek testing for COVID-19.

That came as something of a surprise to Google, who like Dr. Michael Fauci had to do a bit of an . . .”ahem, not quite.”

Google quickly clarified that an affiliated company, Verily, was indeed at work on the project, but on a limited scale. The website is now functional in “select counties” in California.

Perhaps in an effort to make up some credibility for themselves and the President, Google quickly launched a very basic national website that provides users with information and alerts about the coronavirus.

 

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Remdesivir Gets EUA

The U.S. Food and Drug Administration (FDA) has given Emergency Use Authorization to the antiviral drug remdesivir to treat hospitalized patients with the coronavirus.

President Donald Trump made the announcement late Friday in an Oval Office briefing at the White House.

Gilead Sciences, the maker of remdesivir, is donating 1.5 million vials of the drug and will work with the federal government to distribute it to patients in need.

The authorization means remdesivir can be distributed in the U.S. and given intravenously to treat COVID-19 patients — both adults and children — who are hospitalized with severe disease.

The FDA defines that category as “patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator.”

The news comes days after preliminary results from a study of the drug showed it can help patients recover faster.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), hailed the findings earlier this week as “quite good news.”

We’ve curated a few videos below that detail how remdesivir works against the SARS CoV-2 coronavirus.

 

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Top 5 Potential Rx

Mike Hansen, MD, is a medical doctor who is both an internist and an intensivist, as well as a pulmonologist. In other words, he specializes in (and is board certified in) internal medicine, pulmonary disease, and critical care medicine.

His website states that between medical school, postgraduate training, and his actual practice of medicine, Dr. Hansen has dedicated over 15 years of his life to understanding how to prevent, diagnose, and treat diseases that affect adults.

He also produces informative videos on a variety of medical subjects and has been particularly busy enlightening people about issues related to the current COVID-19 pandemic.

In this latest vide, he discusses the most important drugs that are being investigated in Randomized Control Trials to treat or prevent the viral infection.

This includes the following:

Hydroxychloroquine

Chloroquine

Ivermectin

Camostat mesylate

Nitazoxanide

Kaletra (Lopinavir/Ritonavir)

Ribavirin

Arbidol (Umifenovir)

Favipiravir

Tocilizumab

Sarilumab

Remdesivir

Lisinopril (Zestril)

Enalapril (Vasotec)

Benazepril (Lotensin)

Captopril (Capoten)

Fosinopril (Monopril)

Quinapril (Accupril)

Recombinant human ACE2

D4711

Technically not a drug, but: Convalescent Plasma (Hyperimmunoglobulin)

 

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Blood Purification EUA

The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for treating anyone 18 and older in ICU because of COVID-19 infection, and on the verge of, or in, lung failure with a blood “purification” device.

This method doesn’t treat the infection itself, but contends with the dangerous “overkill” response of the body’s immune system that causes life-threatening inflammation.

Colorado-based Terumo BCT‘s blood filtering device uses a process called “aphaeresis” by removing the patient’s blood from their body, splitting it into plasma and red blood cells, applying a therapy and then returning the “purified” recombined blood to the body.

What they’re trying to filter out are the cytokines in the bloodstream – proteins that are something of a biological signal corps during an infection. They activate immune cells such as macrophages and T-cells at the infection site.

But when those signals go haywire and the immune response becomes overkill, severe inflammation develops. What is happening with critically-ill C19 patients is that this so-called “cytokine storm” is clogging airways in the lungs, causing them to fill with fluid, requiring the patient to be put on a ventilator, if they weren’t already.

Terumo hopes that by combining their device with a cartridge made by Swiss company Marker Therapeutics, they can provide a treatment that helps coronavirus patients in respiratory failure.

 

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The Race For An Antiviral

Never before has “time been of the essence” in such an urgent and global way as the COVID-19 pandemic continues to claim victims in over 185 countries and regions.

In addition to the frontline responders, scientists are also working around the clock to seek out effective treatments and potential vaccines for this highly infectious killer.

The need for speed has directed part of that focus to repurposing drugs that have already been approved for treating other viral diseases, such as the antimalarial drugs that have captured headlines – chloroquine and its less toxic derivative hydroxychloroquine.

The science show Elements, part of the Seeker online network, takes a closer look at these antivirals.

 

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Abled.ALERT: Lab worker holds a rack of test tubes filled with blood plasma.

Plasma Approved For Sickest

The U.S. Food and Drug Administration has approved the use of what it calls “COVID-19 convalescent plasma” for patients with life-threatening forms of the illness.

The serum is derived from the donated blood of COVID-19 survivors who have built up antibodies to the new coronavirus.

The move comes after promising results in China where doctors began using the protocol last month.

It will take time to build-up plasma supplies across the country, as the medical community awaits FDA approval to use the treatment for frontline responders at risk from repeated exposure to infected patients.

Officials caution there is no guarantee of success.

 

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Abled.ALERT: Photo of syringes, bottles and ampoules of medicine on surgical cloths.

The HOPE Trial

The growing tally of COVID-19 cases, and an estimate by the Society of Critical Care Medicine that up to 960 thousand infected patients across the U.S. may require ventilators makes for a very scary scenario when you realize that there are only about 200 thousand machines in the country.

A doctor in Seattle thinks he has a quick and affordable solution.

Dr. Steven Quay is the Founder and CEO of biopharma company Atossa Therapuetics and has invented seven FDA-approved medicines. He’s seeking new approval for what he thinks can be a a one-two knockout combo for COVID-19 that would eliminate the need for patients to go on ventilators.

The first drug is an inhaled blood-thinner called nebulized heparin which coats the protein found on the surface of the new coronavirus. The second is N-acetylcysteine (NAC), often used to prevent asthma attacks and treat overdoses from Tylenol / acetaminophen.

It breaks down the protein and prevents it from entering the lungs. Dr. Quay told DailyMail.com, “It’s like putting the key into the car to start it, but the key is covered with peanut butter. It can’t get in and it won’t start the car.

Since both drugs are already FDA-approved and reasonably priced, and the fact there have been 12 clinical trials involving over 780 patients with lung damage who improved after being treating with one or both of the drugs without needed ventilation, Dr. Quay is hoping to get it fast-tracked.

The new trial has been nicknamed the nebulized Heparin-N-acetylcysteine in COVID-19 Patients by Evaluation of pulmonary function, or the HOPE trial.

 

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Abled.ALERT: Photo of a Dyson ventilator attached to the side rails of a hospital bed.

New Dyson Ventilator

James Dyson, the British billionaire inventor known for revolutionary vacuums, hair dryers and air purifiers, has designed a new ventilator in 10 days.

It was prompted that long ago by a phone call from UK Prime Minister Boris Johnson whose government has ordered 10 thousand units to support the National Health Service (NHS) to cope with the increasing numbers of COVID-19 patients.

Dyson says the new device can be manufactured quickly, efficiently and at volume. In a letter to employees, he wrote “A ventilator supports a patient who is no longer able to maintain their own airways, but sadly there is currently a significant shortage, both in the UK and other countries around the world.”

He continued “The core challenge was how to design and deliver a new, sophisticated medical product in volume and in an extremely short space of time,” he added. “The race is now on to get it into production.”

Dyson also wrote that the company would donate 5,000 units to the international efforts to treat the pandemic.

 

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Abled.ALERT: mages of white blood cells adapted from an electron microscope that look like ping pong balls covered in shredded coconut.

HIV-Cancer Rx Impacts C19

An experimental drug being fast-tracked for HIV and breast cancer patients is showing potential in treating COVID-19 patients.

Leronlimab was given to seven critically-ill C19 patients in New York. Two of them went from ventilators in the ICU to a regular hospital room within days.

All but one of the patients are said to be improving.

========== UPDATE==========

In a statement released Monday, April 13,  CytoDyn gave an update on over 30 patients COVID-19 patients recently treated with Leronlimab in more than 4 hospitals and clinics across the U.S.  Patients have received leronlimab as part of Emergency Investigational New Drug (EINDs) treatments authorized by the FDA and two CytoDyn clinical trials.

“More than 25 patients have been administered leronlimab under EINDs authorized by the U.S. Food and Drug Administration (FDA),” the biotech explained. “Rate of response in mild-to-moderate patients under EIND has been very promising with the first five patients treated being removed from oxygen.”

“Southern California patients treated with Leronlimab for COVID-19 under Emergency IND: 4 patients with moderate indications removed from oxygen; 3 patients discharged from hospital; 1 patient scheduled for discharge today; 1 patient with severe indications discharged, for total of 5 patients discharged.”

============================

The drug works by calming inflammation caused by the body’s immune response to infection. If the immune response is too strong and the inflammation gets out of control, a patient develops pneumonia as fluid starts to fill the “breathing branches” of alveoli in the lungs.

This leads to respiratory distress syndrome, a condition that requires a ventilator, and one that is killing HIV and COVID-19 patients.

CytoDyn, the company that’s developed Leronlimab, is preparing to treat another 75 patients with mild or moderate coronavirus infection, and if they show the same improvements as the first set of patients, it could get fast-tracked FDA approval for emergency use very quickly.

 

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Abled Alert: A Doctor fills a syringe from a bottle of Remdesivir as a masked patient waits for the injection.

Rx Raises Hopes & Concerns

As researchers in a number of countries race to develop a vaccine, drugs approved for other conditions are making news as potential treatments for patients with the newest coronavirus.

At an earlier stage in the outbreak, Remdesivir, a drug approved to treat Ebola, was showing promising treatment results, but because of potential side-effects such as liver toxicity, it requires further clinical study before being used on the frontlines of treating COVID-19.

The drug had been developed to treat Ebola, and entered a clinical trial in February after anecdotal results from the first patients treated with it for COVID-19.

All three patients treated with remdesivir recovered, but they also reported significant gastrointestinal symptoms. Investigators also noticed elevated liver enzyme levels in their blood samples.

Andrew Joseph at statnews.com has done an excellent in-depth chronicle of the long and winding clinical journey Gilead Sciences is traveling with this drug that is raising as many concerns as it is raising hopes.

 

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Abled.ALERT: Photo of a box of Chloroquine injection ampoules with a bunch of the ampoules stacked on top of the box in a lab.

Chloroquine Overdoses

In the wake of the excitement surrounding Remdesivir, another drug – Chloroquine – approved for treating malaria, lupus and severe rheumatoid arthritis, was being hailed as a “miracle drug” after a number of COVID-19 patients in critical condition said it made the difference between life and death.

However, this drug is also not without serious side-effects, including liver toxicity. Officials in Nigeria report three cases of chloroquine poisoning after people overdosed on the drug.

Some doctors and individuals have been reporting successful treatment outcomes when using a combination of the less-toxic hydroxychloroquine and the antibiotic Azithromycin.

The Trump administration has taken measures to allow critically-ill COVID-19 patients to have access to these as-yet unproven therapies.

*UPDATE: Chloroquine Phospate Death

Arizona man (61) dies, and his wife (68) is in critical condition after ingesting a chloroquine phosphate aquarium product that the wife had used to treat parasites in her Koi fish.

Within 20 minutes of each mixing a teaspoon of the product with soda because they feared COVID-19 infection, the woman began vomiting and the husband had trouble breathing, and both were rushed to a hospital.

This comes after U.S. President Donald Trump had incorrectly stated that the Food and Drug Administration had fast-tracked approval of chloroquine and hydroxychloroquine, with the epilogue,”If things don’t go as planned, it’s not going to kill anybody.”

 

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Abled.ALERT: Photo shows a closeup of a lab worker holding a vial filled with liquid. A VGXI logo patch is visible on his lab coat.

DNA Vaccine Trials Begin

A Phase 1 clinical trial on healthy humans of a potential vaccine for the SARS CoV-2 virus that causes COVID-19 disease began rolling out today on two fronts.

Pennsylvania biotech firm Inovio, which has received funding from the Bill and Melinda Gates Foundation and CEPI (The Coalition for Epidemic Preparedness Innovations), is enrolling up to 40 people in Philadelphia at the Perelman School of Medicine at the University of Pennsylvania, and in Kansas City, MO at the Center for Pharmaceutical Research.

If you’re in these areas and want to enroll as a participant you can Contact The Research Team. You can also call the Kansas City office at 816-943-0770.

The Phase 1 study will see the vaccine candidate, called INO-4800, given to the participants in two doses, four weeks apart.  The initial immune responses and safety data from the study are expected by late summer.

This has been a fast-track rapid response effort with a remarkable timeline of ten weeks from funding to provision of the vaccine, and distribution to the trial centers.

VGXI, Inc., a wholly-owned Texas-based subsidiary of Seoul, South Korea-based GeneOne Life Science, and INOVIO’s manufacturing partner for the last 13 years, enabled the expedited manufacture, testing, and release of the INO-4800 plasmid clinical product. The U.S. Department of Defense (DOD) has also funded INOVIO’s collaborator Ology Bioservices to manufacture additional doses of INO-4800.

INOVIO plans to have one million doses of the vaccine available by year-end for additional trials and emergency use, pending appropriate regulatory guidance and funding.

How is the vaccine supposed to work?

That’s explained in the following INOVIA video, made in 2017, long before the COVID-19 pandemic, but based on the same proprietary DNA delivery protocol developed during the company’s vaccine efforts for HPV (Human Papilloma Virus, Zika, Lassa fever, Ebola, HIV and coronaviruses associated with MERS (Middle East Respiratory Syndrome). 

On smartphones, you can scroll down to view it. On tablets (in landscape orientation, and desktop monitors, you can view it in the column to the right.

 

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How DNA Vaccine Works

What’s unique about the INO-4800 vaccine candidate that INOVIO has begun testing in healthy humans in a Phase 1 Clinical Trial?

Well, two things. First, is the medicine itself.

As the company explains, “DNA medicines are composed of optimized DNA plasmids, which are small circles of double-stranded DNA that are synthesized or reorganized by a computer sequencing technology and designed to produce a specific immune response in the body.”

Second, is getting it to where it needs to go in the body.

As further explained, “INOVIO is the first and only company to have clinically demonstrated that a DNA medicine can be delivered directly into cells in the body via a proprietary smart device to produce a robust and tolerable immune response.

INOVIO’s DNA medicines deliver optimized plasmids directly into cells intramuscularly or intradermally using INOVIO’s proprietary hand-held smart device called CELLECTRA®.

CELLECTRA® uses a brief electrical pulse to open small pores in the cell reversibly to allow the plasmids to enter, overcoming a key limitation of other DNA and mRNA approaches.

Once inside the cell, the plasmids are used by the cell’s own machinery to generate specific coded antigens, which then stimulate an immune response. Administration with the CELLECTRA device ensures that the DNA medicine is delivered directly into the body’s cells, where it can go to work immediately mounting an immune response.

With more than 2,000 patients receiving INOVIO investigational DNA medicines in more than 6,000 applications across a range of clinical trials, INOVIO has a strong track record of rapidly generating DNA medicine candidates to meet urgent global health needs.”

 

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Abled.ALERT: Stock photo of a lab technician wearing gloves and holding a vial of blood labeled "Coronavirus TEST".

C19 Antibody Tests Begin

Despite researchers and the government in the U.K. finding that blood antibody tests “haven’t performed well” and “wouldn’t meet the criteria for a good test”, the U.S.  Centers for Disease Control and Prevention (CDC) has begun rolling out just such a test for people who don’t show any symptoms of the new coronavirus.

The difference from current swab tests that take a sample from the nose or throat looking for genetic presence of the virus, is that these tests require a blood draw and can only be analyzed to hunt for antibodies in certified labs.

These serology tests can determine if people have been previously infected with the coronavirus and have built up antibodies to it. The results will provide data in tracking how the virus has spread  and how its affected different people.

Three groups will be targeted, with the first being people in hotspots such as New York City, Florida, Louisiana and Michigan who were not diagnosed with the virus.

The second will be people in lower-affected areas, and the third will be healthcare workers.

British researchers and health officials have said the antibody tests were not accurate enough on people who had only had mild illnesses, and none were good enough for public use.

However, Dr. Anthony Fauci, the leading infectious disease expert on the White House Coronavirus Task Force, has stated he’s optimistic about the antibody tests and told The Daily Show’s Trevor Noah recently “If this virus acts like every other virus that we know, once you get infected, get better, clear the virus, then you’ll have immunity that will protect you against re-infection.”

That, of course, remains to be seen.

 

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Moderna Titles Transcript

Here is a transcript for blind and visually-impaired users of the onscreen text titles used in this video supplied by Moderna.

The video consists of animated illustrations explaining how the company creates synthetic components from the genetic coding of the COVID-19 virus and injects them into the body enabling patients to essential make their own vaccine.

Onscreen Text:

(Moderna logo animation at beginning and end of video.) About mRNA-1273, Moderna’s Potential Vaccine Against COVID-19.

 

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1st Human Trial Expands

The first human clinical trial for a COVID-19 coronavirus vaccine has been underway in Seattle since mid-March, and is now being expanded to Atlanta.

The trial aims to enroll a total of 45 participants across the two cities at Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle, and Emory University and the Hope Clinic in Decatur, Georgia to “ensure efficient enrollment”.

Participants will receive two shots of the experimental vaccine approximately one month apart and will be followed for approximately one year.

Adults in the Atlanta area who are interested in joining this study should contact [email protected] (for the Hope Clinic in Decatur) or [email protected] (for the Emory campus in Atlanta). 

One of the first vaccine production projects to receive funding from CEPI, the Coalition for Epidemic Preparedness Innovations in Oslo, Norway, the clinical trial is a partnership between Moderna, a biotech research company based in Cambridge Massachusetts, and scientists at the National Institute of Allergy and Infectious Diseases.  NIAID Director, Dr. Anthony Fauci, is the man you’ve often seen and heard as part of the White House Coronavirus Task Force briefings.

If you watched the video above, you will have learned that the approach uses Messenger RNA, written as mRNA, which plays a fundamental role in human biology. It  delivers the instructions stored in DNA to make the proteins required in every living cell.

The trial’s approach uses mRNA medicines to instruct a patient’s own cells to produce proteins that could prevent, treat, or cure disease, So, in the case of the COVID-19 coronavirus, the patient  essentially produces their own vaccine for the virus.

 

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This Is Essential Viewing!

If you haven’t already watched the preceding video, then the following will explain why you should.

It was conducted on March 6 in London by Channel 4 News presenter Cathy Newman. The guest is Dr. Richard Hatchett, CEO of CEPIThe Coalition for Epidemic Preparedness Innovations based in Oslo, Norway. It is currently overseeing eight projects around the world to produce a COVID-19 coronavirus vaccine.

Because the interview was conducted before the World Health Organization declared the growing coronavirus outbreak a global pandemic emergency, some of the infection rates will be dated, but the core information and additional context provide a clear and deeper understanding of how this differs from the “normal” flu, and how the response should be shaped.

Cathy Newman also raises questions about potential conflict of interest and whether it’s in the best interests of Dr. Hatchett and the Coalition to “scare people” to enable more funding.

His answer is dispassionate, credible and full of integrity. And if you read his biography that’s linked to his name, you’ll understand why he has the position he does, and why Dr. Hatchett’s words garner respect.

The next time you hear someone spouting off some new conspiracy theory related to C19, have them watch this interview, and hear his assessment that “this is the most frightening outbreak” he’s dealt with in his 20-year career.

 

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CEPI Leads 8 Vaccine Efforts

Throughout this “Vaccine” section, you’ll see frequent mention of CEPI, the Coalition for Epidemic Preparedness Innovations based in Oslo, Norway, because it’s overseeing eight vaccine development projects around the world.

CEPI is a global partnership between public, private, philanthropic, and civil society organizations launched in Davos in 2017 to develop vaccines to stop future epidemics. Their Mission, according to their website, “is to accelerate the development of vaccines against emerging infectious diseases and enable equitable access to these vaccines for people during outbreaks.

In February, 2020, CEPI made an urgent call for $2 billion to support the development of a vaccine against the virus responsible for COVID-19.

To date, CEPI has initiated eight COVID-19 vaccine development projects with Curevac, Inovio Pharmaceuticals, Moderna, Novavax, The University of Hong Kong, The University of Oxford, The University of Queensland and a consortium led by Institut Pasteur to develop COVID-19 vaccine candidates.

You’ll read about some of them in the section, as well as the recent £210 million(US$270 million) boost in funding for CEPI from the British government. Previous financial support for CEPI’s COVID-19 efforts has been provided by the Governments of Germany, Norway, Denmark, and Finland. CEPI has so far received over $430 million towards its $2 billion funding goal.

As CEPI CEO Dr. Richard Hatchett said of the UK contribution, “This financial boost from the UK will help us continue our rapid progress towards producing safe and effective vaccines, which are globally accessible, within the next 12 to 18 months.

 

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J&J Titles Transcript

Here is a transcript for blind and visually-impaired users of the onscreen text titles used in this video supplied by Johnson and Johnson. The video consists primarily of scenes of researchers working in laboratories intercut with interviews of company executives in a meeting room background.

Onscreen Text:

With our commitment to fighting established and emerging epidemic threats, we are mobilized and already working on a vaccine for the novel coronavirus outbreak.

Paul Stoffels, M.D., Vice-Chairman of the Executive Committee and Chief Scientific Officer, Johnson and Johnson.

Hanneke Schuitemaker, Ph.D., Head of Viral Vaccines, Janssen Vaccines and Prevention B.V., Johnson & Johnson.

Johan Van Hoof, M.D., Global Head, Janssen Vaccines and Prevention B.V., Johnson & Johnson.

 

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J&J Vows 1B Vaccine Doses

The U.S. government has contracted pharmaceutical giant Johnson & Johnson to develop a vaccine for the COVID-19 coronavirus.

Forbes magazine says the $456 million dollar funding is the largest vaccine contract to-date, and also includes funding for J&J’s pharmaceutical branch Janssen to work on a new anti-viral treatment for C19.

Johnson & Johnson will match the funding, meaning that over $1 billion dollars will go into the effort. The company earlier announced a lead candidate vaccine that looks promising and expects to begin human clinical trials by September.

By contrast, Moderna, a biotech company based in Cambridge, Massachusetts, already began human trials in Seattle on March 17 with a vaccine based on synthetic mRNA that can be injected into patients to help them create their own therapies. Our report on their efforts follows this one.

The company says it’s ramping-up production at its 125 facilities world-wide and hopes to be ready to distribute a billion doses by 2021.

As a result, MarketWatch reports: “The Dow Jones Industrial Average is soaring Monday afternoon with shares of Johnson & Johnson and Merck delivering strong returns for the index.

Shares of Johnson & Johnson JNJ, +7.99% and Merck MRK, +7.27% have contributed to the blue-chip gauge’s intraday rally, as the Dow DJIA, +3.19% is trading 720 points, or 3.3%, higher.

Johnson & Johnson’s shares are up $10.07 (8.2%) while those of Merck have gained $5.30 (7.4%), combining for a roughly 104-point boost for the Dow.”

 

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Abled.ALERT: Photo of U.K. Prime Minister working at a circular desk as he looks at a large video screen at Number 10 Downing Street in London as he participates in a global teleconference with G20 leaders.

UK's £210 Million Vaccine Boost

On the day he would test positive for COVID-19 infection, UK Prime Minister Boris Johnson announced a £210 million(US$270 million) boost in funding for the Coalition for Epidemic Preparedness Innovations (CEPI), an international organization based in Oslo, Norway.

The announcement followed a virtual conference with G20 leaders and acknowledged the coalition’s recent global call for $2 billion to progress COVID-19 vaccines through to manufacture.

10 Downing Street issued a statement: “To date, this is the largest single contribution by any country to the key international fund to find a coronavirus vaccine. It will ensure British scientists and researchers continue to lead the global fight against the virus.

The Prime Minister is calling on governments to work together to create a vaccine as quickly as possible and make it available to anyone who needs it.

The UK, along with many other countries, is channelling funding to CEPI which is supporting the development of vaccines that will be available throughout the world.

Future vaccines will be made available at the lowest possible price to the NHS and other countries’ healthcare systems.

CEPI has announced that it requires $2 billion additional funding from international governments to develop the crucial vaccine.

If all G20 governments pledged $100 million funding this shortfall would be met instantly. The UK has already gone beyond its share by committing £250 million to CEPI to date, and the UK is asking all governments to contribute to this important international goal.”

 

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Abled.ALERT: Photo of lab workers dressed in protective gear in the midst of metal tanks, plastic bottles and other equipment at the University of Queensland in Australia.

$17M Injection To Speed Vaccine

The race is on to develop a vaccine for the COVID-19 virus as it races across the globe getting progressively closer to one million cases of infection.

One effort at the University of Queensland in Australia has just been fast-tracked with a $17 million cash injection to shave six months off getting to human trials. If achieved it could mean a vaccine in the hands of medical professionals by early 2021.

That may not sound like fast-tracking, but in the world of vaccine development, that’s light speed compared to the 10 to 20 years it can normally take.

The funding package includes $10 million from the State Government, $3 million from the Federal Government and $3.5 million from the Paul Ramsay Foundation. UQ is the only Australian organization, and one of only six globally, to be tasked by the Oslo-based Coalition for Epidemic Preparedness Innovations (CEPI) to develop a COVID-19 vaccine.

British pharmaceutical giant GSK (GlaxoSmithKline) has provided the technology to UQ program which also has additional funding from Clover Biopharmaceuticals, a Chinese biotech company that’s making a vaccine called Covid-19 S-Trimer.

 

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Abled.ALERT: Photo of a male researcher looking into an electron microscope as a female researcher wears protective goggles in the background while she works with lab samples at the Pasteur Institute.

Measles Leads C19 Effort

As mentioned in the previous two reports, CEPI, the Coalition for Epidemic Preparedness Innovations based in Oslo, Norway, has added an eighth COVID-19 vaccine candidate to its portfolio.

CEPI will invest an initial US$4.9 million in a partnering agreement with a consortium led by the Institut Pasteur that will include Themis and the University of Pittsburgh to develop a vaccine candidate against COVID-19 based on measles-vector technology.

This collaboration brings CEPI’s total investment in COVID-19 vaccine R&D to US$29.2 million.

In a first step, CEPI funding will support the preclinical testing, initial manufacture of vaccine materials, and preparatory work for phase 1 studies.

To date, CEPI has provided initial funding to Curevac, Inc., Inovio Pharmaceuticals, Inc., Moderna, Inc., Novavax, Inc., The University of Hong Kong, The University of Oxford, and The University of Queensland to develop COVID-19 vaccine candidates.

Measles vector platform
The measles vaccine is used here as a vehicle. Using the measles vaccine virus (also called MV) as a vector, recombinant vaccines can be designed to express antigens from other pathogens (Chikungunya virus, Lassa fever, MERS, HIV, dengue, West Nile, yellow fever, or other emerging diseases).

The use of the modified MV as a vehicle for vaccination against these pathogens makes it possible to deliver the antigens directly in the compartments of the immune system capable of inducing a protective memory response.

With its broadly applicable technology platform licensed to Themis, the Institut Pasteur has successfully collaborated for 10 years with Themis.

This approach was used to develop a vaccine candidate against SARS, and CEPI has previously partnered with Themis and Institut Pasteur to harness this technology to develop vaccine candidates against Chikungunya, MERS, and Lassa fever.

 

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THE LATEST

COVID-19 Attacking Kids

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Growing clusters of cases are emerging in a number of countries where children are being hospitalized with symptoms of Kawasaki Disease and testing positive for COVID-19. In New York State, 110 such cases have been reported and as many as five children have died. We detail what parents need to know.

Parents Be Vigilant

Case reports are coming in from around the world as more children develop what may be a COVID-19 related illness that shows symptoms common in Kawasaki Disease and Toxic Shock syndrome.

Three children have died of the illness (test results are awaited from 2 others who died last weekend) in New York State and a total of 73 110 cases have been reported so far.

Doctors in Montreal are studying 20 cases in Canadian children, and scientists are examining a similar number of cases in the U.K., as well as earlier cases in Italy and Spain.

The children are not suffering the respiratory distress that many adult patients develop. They are being ravaged by the so-called “cytokine storm” – the over-reaction of the body’s immune system and it’s triggering a “multi-system inflammatory state” that attacks multiple organs, weakens blood vessels and the lining of the heart.

In all cases, the children have tested positive for SARS CoVid-2 antibodies.

Most of them are toddlers to elementary school age, however a previously healthy 14 year-old boy in the U.K. died of a stroke after being admitted to hospital. And at least seven other cases at the hospital where he was treated involved children who were clinically obese and from minority ethnic backgrounds.

UPDATE: We’ve made this our Featured Story on our Abled.Health page, with more updated information, including an exclusive report from the MailOnline about a UK study that has confirmed the condition, now being called Pediatric Inflammatory Multisystem Syndrome (PIMS-TS), IS triggered by COVID-19 infection.

 

WHAT TO WATCH FOR:

New York Governor Andrew Cuomo released the following advisory for parents:

Remain Vigilant. Seek care immediately if your child has:

*Prolonged fever (more than 5 days)

*Difficulty feeding (infants) or is too sick to drink fluids

*Severe abdominal pain, diarrhea or vomiting

*Change in skin color – becoming pale, patchy and/or blue

*Trouble breathing or is breathing very quickly

*Racing heart or chest pain

*Decreased amount or frequency of urine

*Lethargy, irritability or confusion

In the cases in the U.K., all the children had unrelenting fever, rash, vomiting, diarrhea and generalized extremity pain. And there are additional symptoms more specific to Kawasaki disease or Toxic Shock Syndrome that may present, including bloodshot eyes, red hands and feet that were also swollen, a large body rash, swollen lymph nodes in the neck, a “strawberry tongue” and red, cracked lips.

Hospitals are now reporting cases to their respective health departments, and as Governor Cuomo said, “This is the last thing we need at this time.”

For more information about Kawasaki disease you can check out the Kawasaki Disease Foundation and the Kawasaki Kids Foundation.

 

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WHO Pauses Trial

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The World Health Organization is temporarily suspending its trial of Hydroxychloroquine over safety concerns. The announcement comes a day after U.S. President Donald Trump announced he has finished taking his two week prescription of the drug in combination with a zinc supplement.

Higher Mortality Rates

Hydroxychloroquine was first developed to treat malaria and was later approved to treat autoimmune diseases such as rheumatoid arthritis and lupus.

After seeing a tv report about a politician who beat an almost fatal COVID-19 infection after being administered the drug, , President Donald Trump became its biggest proponent.

However, the World Health Organization (WHO) has just suspended the hydroxychloroquine arm of its Solidarity trial which is examining the efficacy and safety of four potential drugs to fight the SARS CoV-2 coronavirus and the COVID-19 disease it triggers in the body.

Citing a study published the previous Friday in The Lancet, the WHO said the initial results of the study showed higher mortality rates among COVID-19 patients who were administered the drug.

The decision was announced a day after President Trump announced he had finished a two-week preventative course of the drug combined with a daily zinc supplement.

The study published in The Lancet looked at more than 96,000 people hospitalized with COVID-19, including those treated with hydroxychloroquine or its analog chloroquine.

Researchers didn’t find any benefit for those patients.

The did find that patients had a higher risk of death and heart arrhythmia (abnormal heart rhythm) than patients who did not receive the drug.

The authors suggested that hydroxychloroquine and chloroquine should not be used to treat COVID-19 outside of clinical trials until studies confirm their safety and efficacy in such patients. 

It’s not clear if the study used hydroxychloroquine in combination with zinc.

In our C19 Video Logs tabs section, under C19 Treatment Updates, Dr. Anthony Cardillo, an ER Specialist and CEO of MEND Urgent Care in Los Angeles, explained to ABC7 news how he was seeing significant success using hydroxychloroquine in combination with zinc and explained the “one-two punch of the combo, with the zinc messing up the SARS CoV-2 virus’ ability to replicate itself.

 

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HEROES Act Passes House

Abled.money: Illustration shows a blue -ridged respirator mask super-imposed on the face of Benjamin Franklin on the U.S. $100 dollar bill.

Senate Democrats jettisoned the Monthly Economic Crisis Support Act that would have given $2,000 monthly to eligible Americans during the pandemic, and for three months after it’s over. Instead, the House passed the HEROES Act on Friday. How it differs is explained below.

HEROES Act

The Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act passed the U.S. House of Representatives before the Memorial Day holiday weekend.

But it won’t include the monthly checks of $2,000 and up until three months after the pandemic ends that was part of the Democrats’ proposal in the Senate.

The HEROES Act includes another round of one-time, $1,200 stimulus checks, and vows to increase the maximum stimulus amount paid to households with dependent children to $6,000.

The $3 trillion dollar cost means that efforts to get it through the Republican-controlled Senate are set to face stiff GOP opposition.

Indeed, the bill has been described by Republican senators as “dead on arrival” in the upper chamber, while Senate majority leader, Mitch McConnell, has dismissed the package as “another big laundry list of pet priorities”.

The Republican senators take the position that seems to mirror that of the President’s that reopening states for business is the best way to get the economy back on its feet.

 

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