My colleague and Medika co-founder Dr Jeff Livingston published an article yesterday morning that caught my eye. It’s about the Houston-based Methodist Hospital System and you can read the full article here. Essentially, here is the gist of the piece. The hospital’s Chief Executive Officer Dr. Marc Boom informed staff that they will now be required to be vaccinated. The new mandate will require all staff to receive their first vaccine dose by the middle of April.

They are the first hospital in the US to formalize this policy in writing, an important step that will be closely watched by other institutions, as this is in direct contravention to Federal Law and CDC guidelines, that state very clearly that experimental drugs — remember that none of the vaccines have finalized trials and only enjoy Emergency Use Authorization(EUA) approval with the FDA — may not be forced upon the public.

Individual rights and freedom of choice lie at the heart of this federal legislation. There is an unknown long-term element of risk (we have no idea if there will be any long-term adverse consequences to either of the two types of vaccine) in accepting the covid vaccine and the Federal government acknowledges and accepts this. As they don’t offer any form of compensation in the event things go wrong and have in fact indemnified drug makers against any claims relating to the covid-19 vaccines, it should only be considered fair that the choice to take the vaccine, be a personal one.

EUA MEDICINES CAN NOT BE MANDATED.

But it is happening, across the US, and various mechanisms are being employed to ensure you get your covid jab. Schools and universities will be at the forefront of the coming standoff. As early as September of 2020 articles were being published by NBC News, poorly researched and based on the flawed assumption that we’d be dealing with a normal vaccine and parents would have no legal foot to stand on. The truth is a very different beast.

Companies engaged in public-facing services are insisting, albeit less formally, that staff get vaccinated. Vaccine passports are on the verge of being released on an unsuspecting public and I’ve discussed the discriminatory mechanisms of these in-depth here.

Doctors tend to use the logic applied to mandatory vaccination for influenza and apply this to the covid vaccines. This is fundamentally flawed reasoning. We are not dealing with an influenza vaccine here, that has proven itself over decades and for which well-established risk profiles exist.

What are the facts?

• The covid vaccines, short term, have proven themselves both safe and very effective. FACT. There is however concern that they may not fare so well against variants and more data are required to answer this question definitively. You can validate existing reported data on adverse reactions recorded on the VAERS system via the CDC’s Wonder interface.
• We are dealing with a novel method of administration for two of the vaccines, mRNA is new and in a normally cautious medical environment, these products would have taken another four to five years to reach the market. FACT. We’ve rushed this, out of necessity. Another mRNA vaccine targeting Zika is in clinical trials. It will be interesting to see the timeline on this vaccine for final FDA approval.
• The SARS-CoV2 virus poses minimal risk to younger, healthy individuals with no co-morbidities. In fact, many older people who are otherwise healthy, also survive the virus. It poses a marginal, quantified risk unless you are obese and/or suffer from co-morbidities, a comprehensive list of which you can find here. FACT. The virus has already claimed over half a million lives in the US alone. There is clearly a risk, but it is a qualified one that we can now begin to statistically address.
• The covid vaccines we are offered are unapproved medicines. FACT. None have as yet completed trials (Long-duration Phase 3 findings). They all enjoy Emergency Use Authorization, which is not the same as a formally approved drug that has satisfied all the testing criteria.
• There is no existing data on the long-term efficacy and possible unforeseen side effects of an mRNA vaccine. FACT. While there may in fact, and we all hope this to be the case, be no side effects, we cannot exclude the possibility of negative unforeseen outcomes. It is an unquantified risk that will only be resolved over time and new research highlights our minimal understanding of the processes we are attempting to control.

The US government recognizes these facts and has passed legislation to protect its citizens accordingly. Sensible legislation, not influenced by pandemic paranoia, but a law that places the interests of the individual at the forefront. You can access the US legislation in full here and if you’re based in the EU. here’s the EU legislation passed to protect unvaccinated individuals against discrimination.

The Federal law is emphatic. Emergency Use Authorization (EUA) medications are not compulsory and your decision not to partake in vaccination, cannot be used to discriminate against you.

Dr. Amanda Cohn, the executive secretary of the CDC’s Advisory Committee on Immunization Practices, was asked if Covid-19 vaccination can be required, Her answer was emphatic.

“ under an EUA, “vaccines are not allowed to be mandatory. So, early in this vaccination phase, individuals will have to be consented and they won’t be able to be mandatory.” Cohn later affirmed that this prohibition on requiring the vaccinesapplies to organizations, including hospitals.”

What if companies, businesses, and hospitals persist?

The solution is a simple one. Accept liability for any potential future negative impacts the vaccines may have on the recipient’s health. One would assume from his policy that individuals like Dr. Marc Boom, from Houston Methodist, is completely convinced the covid vaccines are safe and will not produce any adverse reactions in the years to come?

If not, then he is knowingly subjecting an employee to a medication he is himself unsure of. Let’s clarify this even further. If the employee is in an established risk category, the argument becomes moot, as the benefit of taking the vaccine outweighs the risk. I am certain that the majority of Dr. Boom’s workforce is in fact healthy and not classified as being in a risk group for developing Covid.

Let’s see the employers put their money where their mouth is. If you are completely convinced the recipient will suffer no future ill effects from the vaccine, put it in writing. Accept liability. Except you won’t, will you? Not even the U.S. government is willing to go down this route. It is too fraught with risk and yet Dr. Brown seeks to remove the choice from his healthy employees, to roll the dice for them. What gives him the right?

Who gives any employer the right to ask this of their employees. It is offensive and completely at odds with medicines’ prime directive. To do no harm. If you are not 100% sure of the product and the disease poses negligible risk to the patient, can you in good faith proceed? What kind of medicine do you practice and what side of the fence are you on?

Time has just published an article suggesting people who won’t accept the vaccine now will be shamed into it later. Vaccine passports and schools will add to the pressure. All wrong, all hopelessly at odds with the law, and each process these institutions engage in, further distances people from the vaccines. The anti-vaccine brigade must be holding house parties celebrating your stupidity and arrogance.

The covid vaccine is a tool of health

It is not a political weapon to be wielded for commercial purposes, for political gain and to alter the global balance of power. It is a tool to combat the pandemic and to save lives. For those at risk, for the aged, for those who are obese, suffer from other risk factors, and struggle with immune disorders, this vaccine is a life-saving tool.

Despite this, it is still an unproven medicine, one not fully tested and one that cannot be enforced on any sector of the community. Getting the vaccine is a question of choice. It must remain this way. I look forward to your considered responses.

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BillionToOne’s unique testing protocol removes costly, time-consuming step of RNA extraction and significantly expands testing capacity

Date of Release: Sept 7, 2020

MENLO PARK, Calif/PRNewswire/ — Today, BillionToOne, Inc., the precision diagnostics company, received Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for their groundbreaking SARS-CoV-2 diagnostic test which eliminates the costly and time-consuming step of RNA extraction. As opposed to most other molecular assays that rely on RNA extraction and qRT-PCR, BillionToOne’s qSanger-COVID-19 assay uses a different set of instruments and chemicals from existing tests, therefore enabling labs to unlock a new, unused capacity for the detection of SARS-CoV-2, the virus that causes COVID-19. The test is easily adaptable with minimum training at any laboratories with Sanger Sequencers, which most major clinical laboratories have readily available. 

By utilizing Swift Biosciences’ unique custom manufacturing and distribution expertise, BillionToOne completed the development of its COVID-19 assay kits and began international distribution in May. DASA, the biggest medical diagnostics laboratory in Brazil, has already adopted BillionToOne’s qSanger-COVID-19 assay.

“Since March 2020, we have experienced a severe shortage of RT-PCR consumables, which is seriously restricting our capacity to provide molecular testing in Brazil. The qSanger-COVID-19 allowed us to increase the throughput while using reagents and equipment that do not compete with the RT-PCR needs. The BillionToOne team gave us support during all steps of the implementation and validation,” said Dr. Jose Levi, Head of Innovation in Clinical Analysis at DASA.

“A critical element of combating COVID-19 and enabling communities and economies to reopen is our ability to deliver widespread, cost-effective diagnostic testing across the United States and globally,” said Dr. Oguzhan Atay, CEO of BillionToOne. “With the emergency use authorization of our RNA extraction-free tests, we can now roll out the test in US laboratories in addition to international labs. We’re proud to be on the front lines of the effort to confront the coronavirus pandemic and have now unlocked a cost-effective, scalable way to expand testing in all major laboratories.”

BillionToOne developed the test based on their patent-pending qSanger™ technology. This test adopts the technology behind the Human Genome Project – Sanger sequencing – to the reliable detection of viral RNA. This approach vastly increases testing capacity because a single sequencer can process an average of 4,000 tests per day – 20 times more than qRT-PCR instruments. BillionToOne’s testing method also removes the costly, time-consuming process of RNA extraction, making BillionToOne’s tests more cost-effective, highly scalable, and requiring less manpower to conduct. The removal of the RNA extraction process also removes a critical bottleneck in expanding testing capacity across the United States.

BillionToOne and Swift Biosciences are currently working together with multiple clinical laboratories in the US and around the world to help them adopt the testing protocol. 

About BillionToOne

BillionToOne, headquartered in Menlo Park, California, is a precision diagnostics company with a mission to make molecular diagnostics more accurate, efficient, and accessible for all. The company’s patent-pending QCT molecular counter platform is the only technology platform that can accurately count DNA molecules to the single-count level. BillionToOne’s flagship product, UNITY, is the first and only noninvasive prenatal screening that tests fetal cell-free DNA for cystic fibrosis (CF) and spinal muscular atrophy (SMA) through a single sample of the mother’s blood. BillionToOne was co-founded by Oguzhan Atay, Ph.D., and David Tsao, Ph.D. For more information, visit www.billiontoone.com.

Inquiries:

For any questions regarding partnership and test adoption, please contact covid19@billiontoone.com. 

For any media inquiries, contact media@billiontoone.com

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Convalescent plasma is the liquid portion of the blood of individuals who have recovered from COVID-19. In the plasma are hundreds of proteins, including the antibodies that are developed by the body after it has fought off the infection. It is assumed that the plasma of those who have recovered from COVID-19 will have antibodies against the SARS-CoV-2 virus.

The theory is that if we give the plasma of those who have recovered from COVID-19 to other people suffering from the disease, those antibodies will presumably help fight off the infection. Makes sense, right? The problem is, the studies conducted did not show that it worked.

The EUA was based on a number of studies, but there were only two of the gold standard: randomized, controlled trials. And those studies did not show a benefit for convalescent plasma.

In fact, in one study, there was a trend toward worse outcomes with plasma in patients with life-threatening COVID-19. I have spoken to colleagues who have seen that very outcome: their patients becoming worse — much worse — after getting plasma. Full disclosure, I have also had colleagues tell me that they have had patients get better with plasma as well.

And then there is the Mayo Clinic data. First of all, it is not even a controlled trial. And, if you read the fine print, the 7-day mortality rate was higher in those patients admitted to an intensive care unit vs not being in the ICU (10.5% vs 6.0%), and it was also higher in those patients on a ventilator compared to those not on a ventilator (12.1% vs 6.2%). So, how is this a “breakthrough”?

That’s why this move by the FDA — suddenly and curiously right before the Republican National Convention — is very concerning. They were right to be slow to authorize the emergency use of plasma because the data is not that great. This treatment can do some good, but it can also do a great deal of harm. We need better data, and I am very disappointed at the FDA for issuing this EUA. If they do this same move for an eventual COVID-19 vaccine, then count me out.

The post Convalescent Plasma Is Hardly A “Breakthrough” appeared first on Medika Life.

• Abbott’s BinaxNOW™ COVID-19 Ag Card is a rapid, reliable, highly portable, and affordable tool for detecting active coronavirus infections at massive scale.
• Test delivers results in just 15 minutes with no instrumentation, using proven lateral flow technology with demonstrated sensitivity of 97.1% and specificity of 98.5% in clinical study.
• Abbott to offer a no-charge complementary phone app, which allows people to display their BinaxNOW test results when asked by organizations where people gather, such as workplaces and schools.
• Company will ship tens of millions of tests in September, ramping to 50 million tests a month at the beginning of October.

DATE OF RELEASE: Aug. 26, 2020 

ABBOTT PARK, Ill/ — Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its BinaxNOW™ COVID-19 Ag Card rapid test for detection of COVID-19 infection. Abbott will sell this test for $5. It is highly portable (about the size of a credit card), affordable and provides results in 15 minutes. BinaxNOW uses proven Abbott lateral flow technology, making it a reliable and familiar format for frequent mass testing through their healthcare provider. With no equipment required, the device will be an important tool to manage risk by quickly identifying infectious people so they don’t spread the disease to others.

Abbott will also launch a complementary mobile app for iPhone and Android devices named NAVICA™. This first-of-its-kind app, available at no charge, will allow people who test negative to display a temporary digital health pass that is renewed each time a person is tested through their healthcare provider together with the date of the test result. Organizations will be able to view and verify the information on a mobile device to facilitate entry into facilities along with hand-washing, social distancing, enhanced cleaning and mask-wearing.

“We intentionally designed the BinaxNOW test and NAVICA app so we could offer a comprehensive testing solution to help Americans feel more confident about their health and lives,” said Robert B. Ford, president and chief executive officer, Abbott. “BinaxNOW and the NAVICA app give us an affordable, easy-to-use, scalable test, and a complementary digital health tool to help us have a bit more normalcy in our daily lives.”

In data submitted to the FDA from a clinical study conducted by Abbott with several leading U.S. research universities, the BinaxNOW COVID-19 Ag Card demonstrated sensitivity of 97.1% (positive percent agreement) and specificity of 98.5% (negative percent agreement) in patients suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.

“The massive scale of this test and app will allow tens of millions of people to have access to rapid and reliable testing,” said Joseph Petrosino, Ph.D., professor and chairman, Molecular Virology and Microbiology, Baylor College of Medicine, whose labs have been leading efforts to provide COVID-19 testing for the college and Harris County. “With lab-based tests, you get excellent sensitivity but might have to wait days or longer to get the results. With a rapid antigen test, you get a result right away, getting infectious people off the streets and into quarantine so they don’t spread the virus.”

Under FDA EUA, the BinaxNOW COVID-19 Ag Card is for use by healthcare professionals and can be used in point-of-care settings that are qualified to have the test performed and are operating under a CLIA (Clinical Laboratory Improvement Amendments) Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Within these settings, the test can be performed by doctors, nurses, school nurses, medical assistants and technicians, pharmacists, employer occupational health specialists, and more with minimal training and a patient prescription.  

“Our nation’s frontline healthcare workers and clinical laboratory personnel have been under siege since the onset of this pandemic,” said Charles Chiu, M.D., Ph.D., professor of Laboratory Medicine at University of California, San Francisco. “The availability of rapid testing for COVID-19 will help support overburdened laboratories, accelerate turnaround times and greatly expand access to people who need it.”

Currently, AdvaMed (The Advanced Medical Technology Association) estimates that test manufacturers are shipping about 1 million tests per day. Abbott will ship tens of millions of tests in September, ramping to 50 million tests a month at the beginning of October. The company has invested hundreds of millions of dollars since April in two new U.S. facilities to manufacture BinaxNOW at massive scale.

The BinaxNOW COVID-19 Ag Card can be used as a first line of defense to identify people who are currently infected and who should isolate themselves to help prevent the spread of the disease. It is intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in nasal swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.

As a near-person rapid antigen test, BinaxNOW was engineered for point-of-care settings, near-patient, and not for reference labs. Patient samples should be tested immediately and should not be diluted in viral transport media.

NAVICA mobile app will help facilitate return to daily activities
Abbott is also offering a mobile app at no charge that will allow people to display their results obtained through a healthcare provider when entering facilities requiring proof of testing. The NAVICA app is optional and an easy-to-use tool that allows people to store, access and display their results with organizations that accept the results so people can move about with greater confidence. The app is supported by Apple and Android digital wallets and will be available from public app stores in the U.S.

“While BinaxNOW is the hardware that makes knowing your COVID-19 status possible, the NAVICA app is the digital network that allows people to share that information with those who need to know,” said Ford. “We’re taking our know-how from our digitally-connected medical devices and applying it to our diagnostics at a time when people expect their health information to be digital and readily accessible.”  

If test results are negative, the app will display a digital health pass via a QR code, similar to an airline boarding pass. If test results are positive, people receive a message to quarantine and talk to their doctor. As they’re required to do for all COVID-19 tests, healthcare providers in all settings will be required to report positive results to the CDC and other public health authorities, regardless of whether they use the app. The digital health pass is stored in the app temporarily and expires after the time period specified by organizations that accept the app.

The app’s user interface is supported by a back-end digital infrastructure that is cloud-based, scalable and secure. It’s been designed to support a very large number of users and enable access from anywhere. The app is not for contact tracing and only collects a person’s first and last name, email address, phone number, zip code, date of birth and test results.

About the BinaxNOW COVID-19 Ag Card Test
The BinaxNOW COVID-19 Ag Card is an assay for the qualitative detection of specific antigens to COVID-19 in the human nasal cavity. A simple nasal swab is used to collect specimens from people suspected of having an active infection. No equipment is required to process samples or read test results. In addition, minimal chemical reagents are required, which lessens exposure to biohazardous materials and improves safety for those administering the test.

The BinaxNOW COVID-19 Ag Card is the sixth test that Abbott is launching in the U.S. to help fight the coronavirus pandemic. Abbott’s tests are performed on its high-volume m2000™ and Alinity® m molecular laboratory systems; its ID NOW™ rapid molecular point-of-care platform; antibody tests for its high-throughput ARCHITECT® i1000SR and i2000SR and Alinity™ i laboratory instruments.

Abbott has provided more than 27 million COVID-19 tests in the U.S. to date, including 14 million detection tests and 13 million antibody tests.  

About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The BinaxNOW™ COVID-19 Ag Test Card EUA has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories and patient care settings. The test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

SOURCE Abbott

For further information: Abbott U.S. Media: John Koval, 224-668-5355, Jackie Lustig, 224-668-9857, Darcy Ross, 224-667-3655; For all other countries, see: https://www.abbott.com/corpnewsroom/utilities/media-contacts.html; Abbott Investor Relations: Laura Dauer, 224-667-2299

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