Daily Archives: January 29, 2021

The Buckeye Institute Files First Amendment Case on Behalf of Ohio Guidance Counselor – Buckeye Institute

Posted: January 29, 2021 at 12:15 pm

Jan 28, 2021

Columbus, OH On Thursday, The Buckeye Institute filed a complaint on behalf of Barbara Kolkowski, who objects to being forced to accept union representation and decisions made by union arbitrators in a contract dispute particularly given that she is not a member of said union. This case was filed in the Ashtabula County Court of Common Pleas.

Even though Ms. Kolkowski is not a member of the union, she is being forced to have a union representative speak for her. This unlawful arrangement contravenes the well-established First Amendment rights of public-sector employees and plainly violates Ohio statute, said Jay Carson, senior litigator with The Buckeye Institutes Legal Center and Ms. Kolkowskis lawyer. Ohios collective bargaining statute guarantees certain rights to all public-sector employees, among which is the right to present grievances and to have them adjusted without the intervention of the union.

Barbara Kolkowski is a high school guidance counselor in Ashtabula, Ohio. When a dispute arose regarding payment under a supplemental contract, Ms. Kolkowski pursued remedies through the contractual grievance process, andas required by her districts collective bargaining agreementrequested that the union submit her grievance to arbitration. Because she is not a member of the union, Ms. Kolkowski also requested that she be able to hire her own private attorney at her own expense in order to pursue her claim in the arbitration proceedings, rather than relying upon a representative chosen by the union of which she is not a member. The union refused her request and denied Ms. Kolkowski her right to associate with and speak through her own counsel.

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The First Amendment won’t save Trump – Salon

Posted: at 12:15 pm

Donald Trump is the only American president to be impeached twice. This time, he stands accused in a single article of impeachment of "incitement of insurrection" for delivering an incendiaryspeechon January 6 to an angry mob of supporters, sparking them to storm the U.S. Capitol building to prevent the certification of Joe Biden's Electoral College victory.

Trump will now be tried in the Senate. There, he will be given the opportunity to defend his shameless rhetoric and behavior. Among other claims, he willlikely mount a defense under the First Amendment, and argue that his speech was constitutionally protected by the Supreme Court's landmark 1969 decision inBrandenburg v. Ohio.

The Senate can be expected to consider Trump's position carefully and fully. But at the end of the proceeding, no matter who leads his legal team, any impeachment defense based onBrandenburgand the First Amendment will beto put it in the vernacularcomplete and utter garbage.

Clarence Brandenburgwas a small-time bigot who owned a television repair shop in theVillage of Arlington Heights, a tiny hamlet roughly 11 miles north of Cincinnati, Ohio. He was also a Ku Klux Klan leader.

OnJune 28, 1964,at Brandenburg's invitation, a reporter and a cameraperson from a Cincinnati TV station attended a Klan rally held on a nearby farm. Footage from the rally showed 12 hooded figures gathered around a burning cross,shoutingvarious epithets, including: "This is what we are going to do to the niggers," "Send the Jews back to Israel," "Save America," "Bury the niggers," "Give us our state [sic] rights," and "Freedom for the whites."

Brandenburg was also filmed,saying:

"The Klan has more members in the State of Ohio than does any other organization. We're not a revengent [sic] organization, but if our President, our Congress, our Supreme Court, continues [sic] to suppress the white, Caucasian race, it's possible that there might have to be some revengeance [sic] taken."

"We are marching on Congress July the Fourth, four hundred thousand strong. From there, we are dividing into two groups, one group to march on St. Augustine, Florida, the other group to march into Mississippi. Thank you."

Brandenburg was subsequently arrested and convicted of violating Ohio's criminal syndicalism law, which made it a crime to advocate violence as a means of achieving political reform. He was fined and sentenced to prison.

Five years later, the Supreme Court reversed his conviction. In its decision, the court articulated a new test for determining the constitutionality of subversive speech, holding that the First Amendment protects advocating the use of force or lawbreaking "except where such advocacy is directed to inciting or producing imminent lawless action and is likely to incite or produce such action."

As should be obvious to anyone this side of Rudy Giuliani, Brandenburg's prosecution was entirely different from the incitement case against Trump, both on the facts and the law.

Unlike Trump, Brandenburg never threatened imminent action of any kind. His diatribes were racist and repugnant, but also the stuff of addlebrained, semi-grammatical fantasy. Brandenburg had no minions at his command, let alone the 400,000 he had conjured in his speech. He posed no immediate danger to anyone.

Trump, by contrast, has millions of dedicated supporters at his disposal. In thefirst presidential debatein September, he told the Proud Boys to "stand back, and stand by."Starting in December, he began to urge his supporters to come to Washington on January 6, tweeting on December 19 that there would be a "[b]ig protest," and inviting them to "Be there, will be wild!" Referring to the protest again at a rally in Georgia on January 4, he pledged, "We're going to take what they did to us on November 3. We're going to take it back."

The MAGA zealots, white nationalists, and neofascists who showed up to hear Trump on January 6 were ready, willing and able to do his bidding. They were treated to arambling speech filled with violent imagery, as the sitting president of the United States urged his supporters to march down Pennsylvania Avenue to the Capitol and to "fight like hell" to "stop the steal" of the election. He even falsely promised to march alongside them, proclaiming, "I'll be there with you."

While Trump never mentioned specific acts of violence and only once, in a single brief mention, did he tell his supporters "to peacefully make your voices heard," the speech as a whole was a call to imminent lawless action, as many in the mob construed it. Boththe Washington Postandthe New York Timeshave reported that some of the Capitol marauders actually thought they were acting on direct orders from Trump.

In inciting the mob, Trump arguably violated two federal statutes that prohibitinsurrection and rebellion against the United Statesas well asseditious conspiracy.

Whether or not Trump is ever criminally prosecuted, he without question committed an impeachable offense. Thehistory of American impeachmentclearly establishes that such offenses may encompass both criminal and noncriminal conduct. According to theHouse of Representatives' procedural practice manual, "Less than one-third of all the articles [of impeachment] the House has adopted have explicitly charged the violation of a criminal statute or used the word 'criminal' or 'crime' to describe the conduct alleged."

InFederalist Paper No. 65, Alexander Hamilton described impeachable offenses as "those which proceed from the misconduct of public men, or, in other words, from the abuse or violation of some public trust. They are of a nature which may with peculiar propriety be denominated POLITICAL, as they relate chiefly to injuries done immediately to the society itself." [emphasis in original]

The First Amendment cannot be invoked to save Trump from an abuse of power so egregious and deadly. To do so would be to turn the amendment on its head. As Joshua Matz and Norm Eisen argued in aJanuary 13 op-ed in Politico, "the Free Speech Clause exists to protect private citizens from the government, not to protect government officials from accountability for their own abusive statements."

It's now up to the Senate to sit in judgment on Trump's defilement of the Constitution. To borrow a line from the Broadway musicalHamilton, each and every senator should know, "History has its eyes on you."

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The First Amendment won't save Trump - Salon

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Absolute Freedom to Tweet? Employers (and the NLRA) May Have Something to Say About It – JD Supra

Posted: at 12:15 pm

Do you need a social media policy or are the legal obstacles just too much? Now more than ever, people are exercising their First Amendment right to free speech, which, not surprisingly, can cause heartburn at the workplace. In times of contention, stress, and uncertainty, speech often multiplies, and, in an era where someones speech is accessible to the world with just a few clicks, an employees online speech is often cast as the speech or opinions of the employer. Additionally, the National Labor Rights Act (NLRA) presents another hurdle, as it protects employees rights to discuss the terms and conditions of their employment. What can and should a responsible employer do?

Many employers implement social media policies, addressing employees actions on social media to enforce their policies and protect their brand. Although important, an employees right to free speech or NLRA protection is not without limits. How do you balance the First Amendment and employees NLRA protections on the one hand and your business interests on the other? Below are some considerations to keep in mind.

The First Amendment says that Congress shall make no law . . . abridging the freedom of speech. Then came the 14th Amendment, which applied the First Amendment to state governments and their divisions. All of that to say, the First Amendment prohibits public entities, and therefore public employers, from infringing on their employees constitutionally protected rights to free speech. However, even public employers have some ability to control employee speech, such as when the speech is illegal, riot-inducing, or made as part of their official duties. For example, in Garcetti v. Ceballos, the U.S. Supreme Court held that the City of Los Angeles did not violate a public officials First Amendment rights by taking action against him for a speech made in his official duties, even though it addressed a matter of public concern. Speech not made as part of an official duty and that addresses a matter of public concern is protected by the First Amendment. For example, in Marquardt v. Carlton, the Sixth Circuit Court of Appeals held that the city may have violated an employees First Amendment rights when it terminated him for social media posts of his opinions on a recent police shooting, because it was a matter of public concern.

While private employers do not have to navigate First Amendment issues, they are not totally off the hook. The NLRA protects employees rights to engage in concerted activities for the purpose of . . . mutual aid or protection. Importantly, this has been interpreted to mean that employees have a right to discuss the terms and conditions of their employment, such as pay rates. For example, in Quicken Loans, Inc. v. National Labor Relations Board, the D.C. Circuit Court of Appeals sided with the NLRB and affirmed that an employers policy forbidding employees from discussing non-public employment information infringed on their rights to discuss terms and conditions of employment.

Even though the NLRA is typically associated with unionized workers, employees have this right whether they are unionized or not. Thus, private employers beware: Although the First Amendment may not keep you from controlling employee speech, the NLRA does . . . but only to an extent.

The NLRA protects an employees right to engage in concerted activity by discussing the terms and conditions of his or her employment. These are commonly referred to as Section 7 rights. Lets unpack this:

Social media policies generally restrict, or attempt to control, what employees say online. When do these policies go too far and restrict employees Section 7 rights? The NLRB has published some reports summarizing its decisions on what social media policies and practices infringe on employees Section 7 rights to discuss the terms and conditions of their employment.

The NLRBs guiding rule: A social media policy is unlawful if a reasonable employee would interpret it as prohibiting the exercise of Section 7 rights. This almost always depends on the context surrounding the provisions. However, heres a list of some common provisions that the NLRB deemed overly broad:

Often, if a social media policys provision includes examples of prohibited behavior, which do not implicate Section 7 rights, or if it limits prohibited conduct to certain circumstances, such as speaking with the press, the NLRA will deem that an employee could not reasonably interpret it as infringing on their Section 7 rights.

It is important to note that, in some instances, the NLRB has held that, even though the social media policy was overbroad, the employer nonetheless lawfully disciplined an employee for his or her actions on social media (e.g., the employees speech was unrelated to employment, not concerted with other employees, or harassing). Thus, keep in mind that an overbroad policy alone is not the determinant of whether an action against an employee violated the NLRA; what is important is whether the action taken was because of or restricted a conversation between employees about the terms and conditions of their employment.

If you want to implement a social media policy, consider the First Amendment and the NLRA. Policies are good ideas and can give your employees some valuable guidance about what they should or shouldnt do. However, remember that the First Amendment applies if you are a public employer. If you are a private employer and want to discipline an employee pursuant to a social media policy, take a deep breath and think about NLRA Section 7 rights (and maybe call your legal counsel).

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Absolute Freedom to Tweet? Employers (and the NLRA) May Have Something to Say About It - JD Supra

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Coronavirus in Michigan: Heres what to know Jan. 29, 2021 – WDIV ClickOnDetroit

Posted: at 12:13 pm

DETROIT The number of confirmed cases of the coronavirus (COVID-19) in Michigan has risen to 556,109 as of Thursday, including 14,491 deaths, state officials report.

Thursdays update includes 1,872 new cases and 80 additional deaths, including 67 from a Vital Records review. On Wednesday, the state reported a total of 554,237 cases and 14,411 deaths.

New COVID-19 cases have plateaued and deaths are starting to slow. Testing has been steady with more than 40,000 diagnostic tests reported per day on average, with the 7-day positive rate average around 6%. Hospitalizations continue to decline over the last several weeks.

Michigans 7-day moving average for daily cases was 1,727 on Wednesday, near the lowest since October. The 7-day death average was 68 on Wednesday. The states fatality rate is 2.6%. The state also reports active cases, which were listed at 76,800 on Wednesday -- near the lowest its been since November.

According to Johns Hopkins University, more than 25.6 million cases have been reported in the U.S., with more than 429,000 deaths reported from the virus.

Worldwide, more than 101 million people have been confirmed infected and more than 2.1 million have died. More than 55 million have recovered, according to Johns Hopkins University. The true numbers are certainly much higher, because of limited testing, different ways nations count the dead and deliberate under-reporting by some governments.

Michigan COVID-19 vaccinations: How to find appointments, info on phases

Coronavirus headlines:

VIEW: Tracking Michigan COVID-19 vaccine doses

VIEW: Tracking coronavirus cases, outbreaks in Michigan schools

Michigans top doctor reported mostly positive news Monday when she updated the states most important COVID-19 metrics.

Dr. Joneigh Khaldun, the chief medical executive for the Michigan Department of Health and Human Services, said the states metrics are showing signs of improvement.

READ: 8 takeaways from Gov. Whitmers update on COVID-19 in Michigan

Michigans case rate is at 203 cases per million people, she said. Thats down 72% since the November peak.

The states percent positivity is at 6.2%, which is also coming down, according to Khaldun.

So thats a good sign, she said.

The percentage of inpatient beds currently occupied by COVID-19 patients is at 9.2%, she said.

New COVID variant in Michigan: 13 cases in Washtenaw County, 4 cases in Wayne County

One cause of concern is the new variant of the virus. Officials have confirmed 17 cases of that variant, as of Monday. Khaldun is worried about how the spread of the variant will affect the case, positivity and hospitalization rates.

Michigan restaurants will officially be allowed to resume indoor dining Feb. 1 with a curfew and other COVID-19 safety restrictions in place.

The Michigan Department of Health and Human Services released its next COVID-19 order Friday. The revised restrictions go into effect Feb. 1 and last three weeks, until Feb. 21.

Gov. Gretchen Whitmer announced the order will allow indoor dining at restaurants, concessions at entertainment venues such as casinos, movie theaters and stadiums, personal services requiring mask removal and non-residential gatherings of up to 10 people from two households.

The pause has worked, Whitmer said. The efforts we have made together to protect our families, frontline workers and hospitals have dramatically reduced cases and we have saved lives. Now, we are confident that starting Feb. 1, restaurants can resume indoor dining with safety measures in place.

We are pleased to see the improvements in case rates, hospitalizations and percent positivity that have allowed us to reopen more activities, said Dr. Joneigh Khaldun, chief medical executive and chief deputy for health at MDHHS. However, we must remain vigilant, especially since we now have a new more easily transmitted variant of this virus present in our state.

Michigans risk for a coronavirus outbreak has recently decreased -- but has not altogether vanished -- nearly one month into the new year, according to data from Covid Act Now.

The state of Michigan is now labeled as high risk for a coronavirus outbreak by Covid Act Now -- a group of technologists, epidemiologists, health experts and public policy leaders that monitors and identifies each states risk level for a COVID-19 outbreak.

At the beginning of 2021, Michigan -- like much of the country -- was considered to be experiencing an active or imminent outbreak, which is a critical risk level. As of Thursday, Jan. 21, the states risk level has decreased due to fewer new COVID-19 cases reported each day, as the remainder of the country continues to struggle with virus spread.

Michigan is one of only five states labeled as high risk for an outbreak, which is the orange color on Covid Act Nows national map. Three states -- California, Arizona and South Carolina -- are colored maroon, meaning they are experiencing a severe coronavirus outbreak. All remaining states, except Hawaii, are colored crimson on the map, which is considered the critical risk level. Hawaii is labeled as experiencing slow disease growth.

J&J’s Covid vaccine is 66% effective, a weapon but not a knockout punch – STAT

Posted: at 12:13 pm

Johnson & Johnson said Friday that its single-dose Covid-19 vaccine reduced rates of moderate and severe disease, but the shot appeared less effective in South Africa, where a new coronavirus variant has become common.

Overall, the vaccine was 66% effective at preventing moderate to severe disease 28 days after vaccination. But efficacy differed depending on geography. The shot was 72% effective among clinical trial volunteers in the U.S, but 66% among those in Latin America, and just 57% among those in South Africa. Though markedly below the levels seen with the first two authorized Covid-19 vaccines, those rates are above the thresholds originally set by the U.S. Food and Drug Administration for a vaccine to be considered useful.The vaccine reduced severe disease alone by 85%, and prevented Covid-related hospitalization or death, Johnson & Johnson said.

In a pandemic, if you can, with a single-dose vaccine, very quickly eliminate the severe consequences of death, hospitalization, and severe disease, thats whats important for society, Paul Stoffels, the companys chief scientific officer, told STAT.

Eric Topol, director and founder of the Scripps Research Translational Institute, called the results disappointing, but added that a vaccine that prevents the most serious outcomes, such as hospitalization and death, is still valuable. It reinforces how lucky we were that the first two were more effective, he added.

Anthony Fauci, the director of the National Institute for Allergy and Infectious Diseases, cautioned at a press conference against making too much of comparisons to prior vaccines, calling the result extraordinarily important, noting that severe disease was reduced across the board, even in regions where new variants of the virus were common.

So this has really important domestic and global public health implications, Fauci said, things that we know about this particular candidate that even add to the importance globally, namely the minimal cold chain requirements, the inexpensive nature of it, the fact that it is one shot and that the company can actually produce in a reasonable period of time, billions of doses.

The results set off a new phase in the battle against the SARS-CoV-2 virus, which causes Covid-19. Different vaccines against the virus are proving to have varying levels of efficacy, but also distinct attributes that could make them more or less valuable in certain contexts.

Results from the first two authorized vaccines, one from partners Pfizer and BioNtech and a second from Moderna, were considerably stronger, reducing symptomatic infection by about 95%. But those vaccines require two doses. They also come with distribution challenges since they are required to stay at ultra-cold temperatures.The new variant of the virus that was first identified in South Africa, B.1.351, throws another monkey wrench into the equation. It appears to make vaccines less effective. Novavax, another vaccine manufacturer, said Thursday that its vaccine was 90% effective in the U.K. but just 49% effective in South Africa. The existence of such a variant raises the possibility that vaccine makers will have to develop booster shots to protect against it. They might even need to do so regularly, as new strains of the coronavirus emerge.

The efficacy of authorized vaccines appears to be somewhat lessened by the B.1.351 strain in test-tube experiments, but have not been put to the test against it yet in clinical research.

The policy implications of having different vaccines with different levels of efficacy are huge, said Carlos del Rio, a professor of infectious diseases at the Emory University School of Medicine. To deal with this pandemic and stop the spread, I think you use all the tools in the toolbox.

The J&J results are from an interim analysis of a study of 44,325 volunteers in which 468 symptomatic cases of Covid-19 occurred. They are being unveiled Friday morning at a press conference with the National Institutes of Health, which helped run the study as part of the U.S. vaccine effort, known as Operation Warp Speed. Because the study is still ongoing, the data could still change.

Unlike the Pfizer/BioNTech and Moderna vaccines, which are based on a new technology called mRNA that uses the bodys own cells to produce a key viral protein, the J&J vaccine uses a type of virus called an adenovirus to deliver genes that produce those same viral proteins. A similar technology was used in the vaccine developed by Oxford University and AstraZeneca.

J&J said that the trial did not result in any significant safety concerns about the vaccine. A case of stroke in one volunteer, which prompted researchers to pause the trial this fall, was determined to be unrelated to the vaccine, Stoffels said. Fevers occurred in 9% of those who received the vaccine, and fevers of more than 104 degrees occured in 0.2% of vaccine recipients. Serious adverse events were more common among those who received placebo than the vaccine.

No matter the age of volunteers in the study, the vaccine appeared to have strong efficacy, Stoffels said. There had been concerns its effectiveness might be less robust in older people.

Akiko Iwasaki, a virologist at Yale University, said that the results for both the Novavax and J&J vaccines were strong. She noted that its difficult to compare the J&J results to those from other trials, because the earlier trials counted cases of mild Covid-19 whereas the J&J study included only sicker ones.

Regardless, Iwasaki emphasized the importance of simply vaccinating as many people as possible, because the current lack of immunity in the majority of the population, and the high number of cases, is giving the virus an opportunity to mutate more often.

Weve got to get the first dose to as many people as possible, Iwasaki said. These variants that are more transmissible and potentially even more lethal are on the rise. I think time is really what were fighting against.

Kert Viele, a statistician at Berry Consultants, made a similar point. Approving more vaccines, and expanding global supply, could mean communities reach herd immunity, in which enough people are inoculated against a pathogen to halt chains of transmission. If we can lower global cases, Viele said, we will reduce the emergence rate of all of these strains to everyones benefit, and thus the need for such reformulations in the future.

One hope is that the efficacy of the Johnson & Johnson vaccine could rise if it is given as a two-dose regimen. Johnson & Johnson is running another large study, enrolling 30,000 patients, testing two doses of the vaccine given 57 days apart. However, Stoffels said, waiting that long between doses will slow results. He expects results of the two-dose study to read out in the summer or fall.

The population in the study was diverse and broad, J&J said. Patients came from the U.S. (44%), Central and South America (41%) and South Africa (15%). Women made up 45% of the study, and men 55%. Among participants globally, 59% were white, 45% Hispanic or Latinx, 13% were Black, 6% were Asian and 1% were Native American. Volunteers had health conditions including obesity, type 2 diabetes, hypertension, and HIV.

The J&J vaccine will be far easier to distribute than the mRNA vaccines made by Moderna and Pfizer/BioNTech. The vaccine will remain stable for two years at -4 degree Fahrenheit, and will remain stable for up to three months if kept at between 36 degrees and 46 degrees Fahrenheit.

Johnson & Johnson expects to file with the FDA for an emergency use authorization in early February, and, assuming the vaccine is authorized, will have some product ready to ship immediately after getting a go-ahead. The company declined to give specifics on how much would be available, except to say it expects to make all of its 2021 supply commitments.

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J&J's Covid vaccine is 66% effective, a weapon but not a knockout punch - STAT

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How Covid-19 mutations are changing the pandemic – BBC News

Posted: at 12:13 pm

Early in its existence, Covid-19 gained an ability that would prove decisive in its relationship with human beings. The virus picked up a seemingly small change in its genetic code. It was likely an unfortunate accident a fragment of genetic information from another virus got muddled up with that of the coronavirus while they were both infecting a bat.

Included within this tiny piece of genome, however, were the instructions that altered a key part of the virus its spike protein. This important protein studs the outside of the coronavirus and is the part that attaches to the outside of cells, helping the rest of the virus to sneak inside where it can replicate.

This change to Covid-19's spike protein meant it could hijack an enzyme found in the human body called furin. This enzyme acts like a pair of molecular scissors, normally cutting open hormones and growth factors to activate them. But when furin snips part of the Covid-19 spike protein, which is normally folded in a series of loops on the outside of the virus, it opens like a hinge.

"This exposes a new sequence in the spike protein," says Yohei Yamauchi, a reader in viral cell biology at the University of Bristol, UK, who has been studying how this change may have led Covid-19 to become more infective in humans. "It is one of the changes that make this virus really different from previous coronaviruses that caused Sars and Mers."

This new mutation meant Covid-19 could suddenly latch onto an important molecule found scattered around the outside of human respiratory cells called Neuropilin 1. This molecule helps to transport material inside cells and deeper into tissues the mutation was like handing Covid-19 the keys to a new door into our cells and meant the virus could replicate in greater numbers in the human airways.

Although this mutation was just one in Covid-19's short existence, it proved to be important. Some researchers believe it may be one of the key mutations that allowed the coronavirus to jump species and begin causing a rapidly spreading disease in humans. But almost as soon as it did this, it began picking up other mutations.

Mammoth Biosciences teams with Agilent to deliver CRISPR-based coronavirus tests – FierceBiotech

Posted: at 12:13 pm

CRISPR-wielder Mammoth Biosciences will team up with Agilent Technologies to help launch its upcoming COVID-19 diagnostic test, designed to handle more than 4,000 samples per day.

Applying the gene editing technology allows the system to operate much faster than standard PCR-based molecular lab tests, according to Mammoth. The companys CRISPR-based DETECTR assay uses Cas12 enzymes to identify and tag the coronaviruss specific genomic sequences and provides a visual result that can be read by a machine.

The two companies hope to increase the tests throughput speed even more by connecting it with Agilents automated liquid handling systems and sample readers. Dubbed DETECTR BOOST, the platform aims to process about 1,500 samples over an eight-hour shift.

Blazing a Trail to Clinical Trial Diversity: Four-Part Webinar Series from Syneos Health, Featuring Pharma, Clinical Research and Community Health Leaders

This series will identify obstacles that stifle appropriate patient diversity in trials; unpack the organizational overhaul needed; share how sponsors, patients & investigators have come together to overcome hurdles; and explore how policy innovations can move the industry forward.

"A highly-automated workstation for SARS-CoV-2 testing provides the capacity needed to bring routine, robust testing to the broader market, said David Edwards, associate marketing vice president for Agilents mass spectrometry division. By partnering with Mammoth Biosciences, we will be able to provide a simplified workflow that addresses the specific needs of high-throughput clinical testing laboratories.

Similar methods have been explored for COVID-19 tests that can be read with a smartphone camera and a darkened box using fluorescent molecules that produce a faint glow when matched up with the viruss specific genetic material. Prior to the pandemic, the technology was being developed for HIV testing in low-resource areas.

GlaxoSmithKline has also tapped Mammoth to develop a CRISPR-based coronavirus test that could be available over the counter.

More recently, Mammoth announced a contract with MRIGlobal through the U.S. Defense Advanced Research Projects Agency, known as DARPA, to develop CRISPR-based diagnostics and biosurveillance technologies for the Department of Defense. This includes the development of a hand-held device capable of screening for 10 pathogens simultaneously and a lab system that can spot more than 1,000 targets at once.

RELATED: Pairing CRISPR with a smartphone camera, this COVID-19 test finds results in 30 minutes

Co-founded by CRISPR pioneer and Nobel laureate Jennifer Doudna, Ph.D., Mammoth previously received funding support from the National Institutes of Health through its Shark Tank-esque diagnostics competition known as the Rapid Acceleration of Diagnostics initiative, or RADx. The company said it plans to submit its test for an FDA emergency authorization in the near future.

Mammoths mission is to address challenges across healthcare by harnessing the full potential of the CRISPR platform to read and write the code of life," said Mammoths co-founder and CEO, Trevor Martin, Ph.D. This partnership will help address the need for more widespread testing options for COVID-19, helping to fill the gap in the market as testing labs run into supply issues or reach capacity.

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Mammoth Biosciences teams with Agilent to deliver CRISPR-based coronavirus tests - FierceBiotech

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Coronavirus (COVID-19) Update: FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of…

Posted: at 12:13 pm

For Immediate Release: January 26, 2021

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As part of the U.S. Food and Drug Administrations continuing efforts to protect consumers from potentially dangerous or subpotent hand sanitizers, the agency has placed all alcohol-based hand sanitizers from Mexico on a countrywide import alert to help stop products that appear to be in violation from entering the U.S. until the agency is able to review the products safety. Over the course of the ongoing pandemic, the agency has seen a sharp increase in hand sanitizer products from Mexico that were labeled to contain ethanol (also known as ethyl alcohol) but tested positive for methanol contamination. Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin and life-threatening when ingested. Methanol is not an acceptable ingredient in hand sanitizer or other drugs.

Under the import alert, alcohol-based hand sanitizers from Mexico offered for import are subject to heightened FDA scrutiny, and FDA staff may detain the shipment. As part of their entry review, FDA staff will consider any specific evidence offered by importers or manufacturers that the hand sanitizers were manufactured according to U.S. current good manufacturing practice requirements. This marks the first time the FDA has issued a countrywide import alert for any category of drug product.

"Consumer use of hand sanitizers has increased significantly during the coronavirus pandemic, especially when soap and water are not accessible, and the availability of poor-quality products with dangerous and unacceptable ingredients will not be tolerated," said Judy McMeekin, Pharm.D., FDA Associate Commissioner for Regulatory Affairs. Todays actions are necessary to protect the safe supply of alcohol-based hand sanitizers. We will continue to work with our stakeholders to ensure the availability of safe products and to communicate vital information with the health and safety of U.S. consumers in mind.

The FDAs analyses of alcohol-based hand sanitizers imported from Mexico found 84% of the samples analyzed by the agency from April through December 2020 were not in compliance with the FDAs regulations. More than half of the samples were found to contain toxic ingredients, including methanol and/or 1-propanol, at dangerous levels. The agency has posted and regularly updates a list of hand sanitizer products that consumers should not use, which include those that FDA has found to contain methanol and/or 1-propanol. In most cases, methanol does not appear as an ingredient on the product label.

The agency continues to take action to help prevent potentially dangerous or violative hand sanitizers from entering the United States by placing specific products on import alert, proactively working with companies to recall products and encouraging retailers to remove violative products from store shelves and online marketplaces. As part of these actions, the agency has also issued 14 warning letters since July 2020 for distributing hand sanitizer with undeclared methanol, inappropriate ethanol content, misleading claimsincluding incorrectly stating FDA approvaland improper manufacturing practices. The FDA continues to proactively work with Mexican government authorities, manufacturers and retailers to ensure potentially dangerous or violative products are not distributed to consumers.

The agency reminds manufacturers, distributors, repackagers and importers they are responsible for the quality of their products and urges manufacturers to test their raw ingredients to ensure they meet labeling specifications and are free from harmful contamination. The FDA recently issued a guidance outlining the agencys policy for drug manufacturers and compounders to test alcohol or isopropyl alcohol for methanol contamination prior to using the alcohol to produce drugs, including hand sanitizer products.

Methanol-contaminated hand sanitizers are a serious safety concern, and the FDA is aware of adverse events, including blindness, cardiac effects, effects on the central nervous system and hospitalizations and death, primarily reported to poison control centers and state departments of health. Methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although people using these products on their hands are at risk for methanol poisoning, young children who ingest these products and adolescents and adults who drink these products as an alcohol substitute are most at risk.

Consumers who have been exposed to hand sanitizer contaminated with methanol and are experiencing symptoms should contact their local poison control center and seek immediate medical treatment for potential reversal of the toxic effects of methanol poisoning. The FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDAs MedWatch Adverse Event Reporting program (please provide the agency with as much information to identify the product as possible). For more information, consumers should refer to the FDAs guidelines on safe use of hand sanitizer as well as a question and answer page.

Need help now? Call 9-1-1 if the person is unconscious or has trouble breathing. Call Poison Help at 800-222-1222 to connect to your local poison center. Learn more at https://poisonhelp.hrsa.gov/.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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How to get the COVID-19 vaccine from Walgreens – WFLA

Posted: at 12:13 pm

by: Rachel Estrada, KIAH, Nexstar Media Wire

HICKSVILLE, NEW YORK MARCH 18: An image of the sign for a Walgreens as photographed on March 18, 2020 in Hicksville, New York. (Photo by Bruce Bennett/Getty Images)

HOUSTON (NEXSTAR/KIAH) You may have seen signs on Walgreens doors indicating its pharmacies dont yet have the COVID-19 vaccine available. But get ready, because it could be soon.

The COVID-19 vaccine is on the way, Walgreens said in a statement posted on its website.

However, you wont be able to just walk in and receive it. There will be a process in place for you to get your vaccine injection.

Walgreens, with more than 9,000 pharmacies, is offering in-store coronavirus vaccinations at some locations, but you have to set up an account online and be pre-screened.

The company said its following state and local eligibility requirements, which vary by state.

Walgreens is following directives for Phase 1 distribution, saying as of Friday, it had administered over 1 million vaccinations in long-term care facilities and to other vulnerable populations.

Walgreens is working closely with state governments to expand access to COVID-19 vaccines as states advance their Phase 1A and 1B distribution and administration plans for additional vulnerable populations, the company said. Prioritized populations vary based on state guidelines and may include healthcare workers, people ages 65 and older, and individuals with pre-existing conditions.

In a recent press conference, Texas Gov. Greg Abbott said only a fraction of vaccines set aside for long-term care facilities in the state has actually been used.

There are 412,188 of those doses for long-term care and nursing home residents that either have not yet been reported or are waiting to be given, he said.

Even so, Walgreens said it expects vaccines to be available to the general public in spring 2021, depending on guidance from the Centers for Disease Control and Prevention (CDC), and federal, state and local governments.

Walgreens says people who get vaccinated still need to wear a mask, practice social distancing and wash their hands. The company also said you cannot get the COVID-19 from the vaccine.

For more on commonly asked questions, watch Walgreens COVID-19 information video.

9-year-old boy dies suddenly from COVID-19 complications – WFLA

Posted: at 12:13 pm

Posted: Jan 29, 2021 / 11:17 AM EST / Updated: Jan 29, 2021 / 11:20 AM EST

The number of children infected by COVID-19 is increasing and experts are concerned about a new strain of the virus that seems to be spreading faster in kids.

According to the American Academy of Pediatrics, nearly 2.7 million children have tested positive for COVID-19.

Over the latest two-week period, there were nearly 377,000 new cases among children a 16% increase.

Still, children are highly unlikely to die from the virus. Children account for only .19% of all COVID-19 deaths, the academy said.

But in Fort Worth, two children have died in recent days at Cook Childrens Hospital. Only one other child had died at the hospital in the months since the virus started.

J.J. Boatman of Vernon celebrated his ninth birthday just a few weeks ago.

He was full of energy, said his aunt Annette Cliver. He was always running around smiling, playing, always playing with his sisters and cousins. And he was full of life.

But Monday morning, he suddenly got very sick, Cliver said.

One minute he was OK, you know, and then the next minute he woke up not feeling so good and didnt look so good, she said.

His family rushed him to the hospital and he was airlifted to Cook Childrens. He died Tuesday.

Another boy younger than one also died at the same hospital in recent days.

Experts say children generally do much better fighting the virus, but they are hardly immune to it.

One doctor said the recent increase in pediatric cases could be due to the same reason adult cases have gone up.

Youve got to look at the timing of the uptick, said Dr. Curtis Galke of the University of North Texas Health Science Center. Weve just come off of a holiday season where a lot of people were together. So it would be expected we would have an uptick in all ages of people being diagnosed.

Theres also concern about a new strain of the virus.

While the new type is known to spread faster, especially in children, doctors say theres no evidence its any more deadly.

The dynamic of the virus really hasnt changed, Galke said. Kids get it just like adults get it. But the majority of the kids dont have the same types of symptoms and recover very, very quickly from it.

Its not clear which version of the virus J.J. Boatman had.

His family said he had asthma but otherwise was healthy and active until he got so sick, so fast.

You dont think its going to happen to you or somebody you know. But it does, his aunt said.

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9-year-old boy dies suddenly from COVID-19 complications - WFLA

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Daily Archives: January 29, 2021

The Buckeye Institute Files First Amendment Case on Behalf of Ohio Guidance Counselor – Buckeye Institute

The First Amendment won’t save Trump – Salon

Absolute Freedom to Tweet? Employers (and the NLRA) May Have Something to Say About It – JD Supra

Coronavirus in Michigan: Heres what to know Jan. 29, 2021 – WDIV ClickOnDetroit

J&J’s Covid vaccine is 66% effective, a weapon but not a knockout punch – STAT

How Covid-19 mutations are changing the pandemic – BBC News

Mammoth Biosciences teams with Agilent to deliver CRISPR-based coronavirus tests – FierceBiotech

Coronavirus (COVID-19) Update: FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of…

How to get the COVID-19 vaccine from Walgreens – WFLA

9-year-old boy dies suddenly from COVID-19 complications – WFLA

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