Healthcare Environmental Solutions Summer 2020

healthcare

Environmental solutionsnews Covering infection prevention, medical waste management & sustainable practices

VOL. XVI NO.4 2 XII NO.

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Masks for Protection Against Covid-19 ...

The Great Deception!

by Kathleen Marquardt

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ue to an overwhelming amount of media and political outcry for the necessity of mask-wearing and the contradicting evidence over whether they are necessary or not, many healthcare workers are confused. In fact, many are wondering why there are so few – just two to be exact – experts from whom we are being given almost all of our information. And many wonder why these so called experts are all over the board on this issue.

Long before anyone ever heard of COVID-19, scientists had investigated the efficacy of mask-wearing, and then of masks versus respirators, for protection against influenza and other respiratory viruses. Studies involving face masks have been done in homes, elementary schools, hospitals, and at large public universities, throughout the world. Prior to the COVID-19 pandemic, use of the N95 mask was primarily limited to industries like mining, construction, and coatings. Though there are N95 masks designed for the healthcare industry, according to OSHA Respiratory Protection Standard requirements, users of these masks must first undergo a medical evaluation to determine if they are physically fit to wear such a respirator, and they must also be trained on the proper (safe) use and protective limitations of the device.

Before COVID-19, only those diagnosed with an infectious disease, were encouraged to

wear face masks. In fact, the CDC previously did not recommend wearing a face mask unless a person was known to be infected. So why did this virus outbreak cause some medical doctors, clinics and hospitals to move away from the guideline of ‘non-infected need not wear a mask’, to everyone needs to wear a mask and stay 6’ away from others?

At first, the only recommendations on wearing face masks (to protect the public from COVID-19), came from the World Health Organization (WHO) and Center for Disease

Control and Prevention (CDC), from Drs. Anthony Fauci and Deborah Birx. But even they flip-flopped on whether or not we should be wearing masks to protect against COVID-19.

Consequently, it has taken other (selfthinking) doctors and infection control experts to ask critical questions about mask-wearing: what are the risks? What are the benefits?

Are the benefits greater than the risks? If the benefits are not greater than the risks, why promote them?

N95 MASK

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s mentioned earlier, before using the N95 masks, workers are required to be evaluated to determine if they are going to be able to wear one without compromising their health.

According to a NIH, National Library of Medicine, (NIH/NLM) study, “Wearing N95 masks results in hypoxygenemia and hypercapnia, which reduce working efficiency and the ability to make correct decisions.”

The researchers found that the N95 mask reduced blood oxygen levels significantly; and the longer the wearer used the mask, the greater the fall in blood oxygen levels.

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Masks for Protection Against Covid-19 ... The Great Deception!

Continued from page 1 Also, according to a study on Medcrave (an online publishing library), there is an increase in nasal airflow resistance upon removal of N95 respirator and surgical face mask after 3 hours of continual use. This is potentially due to physiological changes of the nasal airways.

According to the study, “The nasal resistance was not recovered even after 1.5 hours removal of the respirator/face mask”.

Dr. Russell Blaylock, who was a clinical assistant professor of neurosurgery at the University of Mississippi Medical Center, goes further than other doctors. He contends that the combined science regarding face masks indicates that anything less than an N95 mask, used continually, would not help at all. Quoting a McIntyre study, he pointed out that, if everyone wore masks and followed all suggested procedures, as thoroughly as possible, it still would not reduce the spread of influenza germs.

According to a 1991 article on the use of surgical masks, by Drs. Daley and Norman, “Prolonged wearing of a surgical face mask causes loss of intellect potential and cognitive performance due to a decrease in blood oxygen and subsequent brain hypoxia. Note – some changes may be irreversible.”

According to a report in the American Journal of Infection Control, “Surgical masks are designed to prevent bacteria and other particles from contaminating a sterile field, as when a surgeon is performing an operation.

Surgical masks are not designed to prevent the wearer from inhaling viruses…. surgical masks should not be expected to provide respiratory protection. SURGICAL MASKS SHOULD NOT BE USED TO PROTECT PEOPLE FROM THE H1N1.”

One point that isn’t mentioned much in the media, concerning face masks, is that surgical masks are designed and approved for sterile environments. Those sterile environments are operating rooms where additional oxygen (O) is pumped into the room to provide the necessary extra oxygen for the mask-wearing doctors and assistants. They are not designed for outdoor use, in crowds, or even the grocery store. In a non-sterile environment, a surgical mask quickly becomes saturated with particulates and contaminants, especially from crosscontamination associated with constant hand to mask contact. This is why the recommendation is to change the mask after just 20 minutes of use, and that’s if the user doesn’t contaminate the mask with his/her hands during the 20-minute period. And how many people do that?

It does not take an N95 mask to cause harm to the wearer.

First, and you may have heard it before, anyone with a respiratory health condition should NOT wear a mask of any kind, at any time. Yet, we see many businesses, healthcare facilities and doctor’s offices that will not allow summer 2020

anyone to enter without a mask. In the case of healthcare facilities and doctor’s offices, those with health conditions must either endanger themselves more by wearing a mask, or forego services that might be vital to their health.

Numerous sources, including Blaylock, ACS Chem Neurosci, Journal of Virology, NCIB/NIH, JAMA, CIDRAP, and others, have documented that mask-wearing can be harmful. From headaches, upon an hour of mask-wearing, to much more dangerous effects.

In one of the most quoted sources, binReza, et al, from 2012 concluded that, “None of the studies established a conclusive relationship between mask/respirator use and protection against influenza infection.” And, as Dr. Blaylock states: • Mask wearing causes hypoxia and hypocapnia. Hypoxia is a diminished availability of oxygen to the body tissues.

Hypocapnia is a deficiency of carbon dioxide in the blood, which eventually leads to alkalosis.

• Those with pulmonary disease – asthma, pulmonary edema, COPD, show decreased oxygenation and increased carbon dioxide (CO2) in the blood.

• Pregnant women have a need for a higher intake of oxygen (and their bodies normally have a lower CO2 accumulation to protect the baby). A study of pregnant women wearing masks showed a 35% decrease in their ability to exchange air. As their oxygenation levels fell, CO2 began to accumulate in their bodies. As they normally have lower CO2 accumulation to protect the baby, if their accumulation were to rise to normal levels, it would be harmful to the baby. These results alone limited the study; they didn’t dare do more. Yet, no state is telling pregnant women that they shouldn’t wear masks, especially for long periods of time.

• Those with obesity have poor oxygen intake to begin with. Wearing a mask could cause it to drop precipitously, causing a crisis.

• There are tens of millions of diabetics.

Dr. Blaylock says THEY SHOULD NOT BE WEARING MASKS. • The build-up of CO2 could damage the brain. Those who have seizures are particularly at risk. In normal people, it causes hyperexcitability in the cortex which precipitates seizures.

• An elevation in CO2 causes anxiety, blood pressure rise, breathlessness, and panic attacks. The bipolar person is highly sensitive to those effects.

• When CO2 levels rise and O levels fall, it

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Masks for Protection Against Covid-19 ... The Great Deception!

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suppresses immunity by inhibiting T-lymphocytes – the ones that fight viruses. Hypoxia makes it worse because it increases the level of a compound called hypoxia inducible factor, which inhibits T-lymphocytes. Not only that, it stimulates another type of cell, the T-regs (immune suppressor cells which exacerbate immune suppression). (Note: from the Journal of Immunology, “This sets the stage for contracting any infection, including COVID-19, and making the consequences of that infection much graver. In essence, your mask may very well put you at an increased risk of infection and, if so, cause a much worse outcome. People with cancer, especially if the cancer has spread, will be at a further risk from prolonged hypoxia as the cancer grows best in a microenvironment that is low in oxygen.”)

• Seemingly, no one in society is in any danger from the virus unless you already have an immune suppressing disorder. If worn too long, the mask itself is producing immune suppression. The rise in CO2 can cause cardiac arrythmia, and fragile heart patients can experience hypoxia and hypocapnia. There are cognitive effects – brain fog, confusion, difficulty thinking and speaking, along with anxiety.

• Repeated hypoxia stress, when oxygen levels fall, causes atherosclerosis (hardening of the arteries), heart attacks, and stroke from hypercoagulation of the blood.

• By wearing a mask, the exhaled viruses will not be able to escape and will concentrate in the nasal passages, enter the olfactory nerves and travel to the brain.

MASK SAFETY

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OVID-19 enters the body through the mouth, nose, or eyes, and, according to researchers at the University of Hong Kong, the virus can adhere to the outer layer of a face mask for a week. Because the mask is ‘catching’ the virus germs before they can enter the body, it could possibly be contaminated with the coronavirus or any other virus. So, improperly wearing the mask can increase the risk of contamination. If your hands touch the outside of the mask improperly (not using the elastic to put it on and take it off), or you adjust it frequently, you can be exposing yourself while thinking you are safely protected.

According to the CDC, “If the inside of the mask touches another part of the body that is contaminated with the virus – hair, forehead, chin, neck, hands, other clothing – and then returned to cover the nose and mouth area, infection can occur.”

WHY PROMOTE MASKS FOR THE MASSES?

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his brings us to the question, why the national fervor for wearing masks? Why the push, first by WHO and CDC, then governors, mayors, and down the line?

Never before in history have healthy people been told to wear masks.

The research shows us why both healthy people and the compromised should not wear masks. Only those who have a communicable disease should be wearing masks – and only when in close distance to healthy people, and never for any length of time.

The patent answer (to the above question) is to follow the money.

And there is a lot of money involved, both to design and then set up vaccines “for the whole world”.

Our civilization has gone through a lot of catastrophes. The most recent one regarding diseases was the Spanish Flu of 1918. Since then we’ve gone a century with polio, smallpox, AIDS, and some small scares more recently that were predicted to be devastating – SARS, Dengue Fever, Mad Cow Disease. But then the coronavirus COVID-19 came along right after the Bill and Melinda Gates Foundation, Johns Hopkins University, and the World Economic Forum staged Event 201, which simulated an outbreak of a novel zoonotic coronavirus transmitted from bats to pigs to people “that eventually becomes efficiently transmissible from person to person, leading to a severe pandemic. The pathogen and the disease it causes are modeled largely on SARS, but it is more transmissible in the community setting by people with mild symptoms”.

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This Event 201, conducted October 18, 2019, was ostensibly put together to help the world’s leading experts work out scenarios on how to deal with such an event, if one ever occurred. But one has to wonder how they managed to come up with a pandemic so closely mimicking real-life COVID-19. Then, some five months later in an interview with the Curator of TED Talks, Chris Anderson, Bill Gates “. . . outlined that, despite the comparatively small threat of coronavirus, he and his colleagues ‘don’t want a lot of recovered people’ who have acquired natural immunity. They instead are hoping we become reliant on vaccines and anti-viral medication.

At the coronavirus simulation, Event 201, a poll, which was part of the simulation, said that 65% of people in the U.S. would be eager to take a vaccine for COVID-19, “even if it’s experimental.”

Gates also said in the TED interview, “It is really tragic that the economic effects of this are very dramatic. I mean, nothing like this has ever happened to the economy in our lifetimes. But … bringing the economy back ,… that’s more of a reversible thing than bringing people back to life.

So we’re going to take the pain in the economic dimension, huge pain, in order to minimize the pain in disease and death dimension.”

The World Economy is dropping dramatically. In an article in OffGuardian, Kevin Ryan points out that, “By all accounts, the impact of the response will be great, far-reaching, and long-lasting.” Rosemary Frei, in her article, Did Bill Gates Just Reveal the Reason Behind the LockDowns? said, “Bill Gates outlined that, despite the comparatively small threat of coronavirus, he and his colleagues ‘don’t want a lot of recovered people’ who have acquired natural immunity. They instead are hoping we become reliant on vaccines and anti-viral medication. Shockingly, Gates also suggests people be made to have a digital ID showing their vaccination status, and that people without this ‘digital immunity proof’ would not be allowed to travel. Such an approach would mean very big money for vaccine producers.”

Cheryl Chumley, in the Washington Times, declares that “In fact, COVID-19 will go down as one of the political world’s biggest, most shamefully overblown, overhyped, overly and irrationally inflated and outright deceptively flawed responses to a health matter in American history, one that was carried largely on the lips of medical professionals who have no business running a national economy or government.”

Kevin Ryan, in Is the Coronavirus Scare a Psychological Operation, notes that, “governments have used psychological warfare throughout history to manipulate public opinion, gain political advantage, and generate profits. Western governments have engaged in such tactics in the war on terrorism as well as in its predecessor, the war on Communism. It appears that the same kinds of effects are being seen as a result of the COVID-19 pandemic. In both cases, state-sponsored terrorism and propaganda were used to distort the public’s perception of the threats, leading to increased governmental control of society and huge financial benefits for corporations.” This is definitely something to consider.

Bill Gates isn’t the only technocrat involved. Dr. Anthony Fauci (CDC), Dr. Deborah Birx (White House coronavirus coordinator), Dr. Tedros Adhanom Ghebreyesus (Director General of WHO), Coalition for Epidemic Preparedness (CEPI ), George Soros, and nine pharmaceutical companies are all working to produce a coronavirus vaccine – including Moderna, Inovio, and SmithKline. But Bill Gates appears to be the main player.

Pat Wood, editor of Technocracy News and Trends believes, “It is imperative to understand that the ‘Great Panic of 2020’ is engineered around the pandemic by Technocrats who are driven to take over and control the whole planet, and especially the United States.”

Rosemary Frei points out that, “The increasing outsourcing of healthcare policy to medical bureaucrats during the COVID-19 crisis illustrates the dangerous temptation to remove control over policy from democratic deliberation in favor of a technocracy, i.e., rule by ‘experts.’ In health care, such a system would be particularly perilous since the experts placed in charge of policy would be ‘bioethicists’ whose predominant views disparage the sanctity of human life.”

News Briefs

July 2020: US New Coronavirus Cases Surpass 3.5M, Deaths Top 137K

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ashington, D.C. – Near-record increases in the daily number of new coronavirus cases have been occurring as U.S. hospitals face extreme capacity and staff shortages, according to a July 16 post the research firm, Advisory Board on its website.

In mid-July, Houston Methodist told Vox the hospital was running at more than full capacity. The CEO of El Centro Regional Medical Center in Imperial County, California said that 60% of the facility’s patients were infected with the new coronavirus and he was sending patients to other hospitals where ventilators were available. Arizona Department of Health Services (ADHS) reported that 90% of the adult ICU beds in the state were occupied.

The Department of Health and Human Services issues guidance July 17 that directed hospitals to send information regarding patients with Covid-19 to a central HHS database managed by the health data firm TeleTracking instead of to a CDC-managed database, as they›d been doing for the past few months. The instructions mean CDC will no longer oversee the daily collection of data from hospitals on their numbers of Covid-19 patients, available beds, ventilators, and other crucial information that the federal government uses to allocate resources to providers, according to the Advisory.com post.

On July 15, the United States reported more than 67,300 new coronavirus cases, which is the second-highest number of new cases that the country’s reported in a single day. On July 16, U.S. officials reported 3,512,700 total cases of the new coronavirus since the country’s epidemic first began—up from 3,445,500 cases reported the day before.

According to data gathered by The New York Times, Alabama and Idaho saw record-high increases in their numbers of new coronavirus cases, while California governments implemented restrictions to slow spikes in cases.

The Times’ data showed that the average daily numbers of newly reported coronavirus cases over the first two weeks of July remained mostly stable in eight states: Arizona, Connecticut, New Hampshire, New Jersey, New York, South Dakota, Utah, and Wyoming. Delaware and Maine saw their average daily numbers of newly confirmed cases decrease over the past 14 days.

Puerto Rico and 22 states saw their average daily numbers of newly reported deaths linked to the coronavirus rise since the beginning of July: Alabama, Arizona, California, Colorado, Florida, Georgia, Idaho, Iowa, Louisiana, Mississippi, Montana, Nevada, New Mexico, North Carolina, Oklahoma, Oregon, South Carolina, South Dakota, Tennessee, Texas, Utah, and Washington, according to Times’ data.

Study: IL-7 May Help Severe COVID-19 Patients

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RUSSELS, Belgium – Interleukin 7 (IL-7) immunotherapy given to a small group of critically ill COVID-19 patients was associated with significantly restored lymphocyte counts, according to a JAMA Network Open research letter published on July 22, 2020.

Mounting evidence suggests that virus-induced immunosuppression may be the real cause of death in many COVID-19 patients, wrote the international team of scientists.

Led by investigators from The Université Catholique de Louvain in Brussels, Belgium, the team also consisted of researchers from the Washington University School of Medicine, St. Louis, Missouri and University Hospital of Limoges, Limoges, France.

Cytokine-storm mediated organ injury was found almost uniformly in a dozen severe COVID-19 cases studied. The team believes that profound and protracted lymphopenia, accompanied by depletion of CD4, CD8, and natural killer cells, leads to the immune collapse. In 50% of the patients who die, this condition impairs the ability to fend off secondary hospital-acquired infections.

Autopsy revealed viral load in the lungs of most patients, consistent with an inability to eliminate the SARS-CoV-2 pathogen. COVID-19 patients with low lymphocyte count received IL-7 and compared with a control group of 13 patients given usual care, the IL-7 group was associated with lymphocyte levels more than twofold greater than controls at day 30.

Patients in the IL-7 group were a mean age of 62, while controls were slightly younger (age 59).

Notably, 11 of 12 of the IL-7 group and nine of 13 of the control group were men.

IL-7 currently is being evaluated in randomized trials for both oncologic and infectious disorders, and the researchers noted that it is also being evaluated specifically for COVID-19 in a randomized trial in the U.K.

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News Briefs

High Blood Sugar Elevates COVID Mortality Risk

India’s Blood Collection System in Disarray

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UHAN, China – Patients with abnormally high blood sugar may have a higher risk of death from COVID-19 than patients not previously diagnosed with diabetes, according to study findings published in Diabetologia (the journal of the European Association for the Study of Diabetes).

For the first time, researchers from the Union Hospital and Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China, and colleagues have been able to confirm that patients with hyperglycemia, but not diagnosed with diabetes, are at higher risk of death from COVID-19.

The researchers analyzed death rates for 605 COVID-19 patients at two hospitals in Wuhan, China in January and February of this year, examining the association between fasting blood glucose (FBG) upon hospital admission and the 28-day mortality of COVID-19 patients without previously diagnosed diabetes in two hospitals.

A total of 605 COVID-19 patients were enrolled in the retrospective study, including 114 who died in hospital. The median age of participants was 59 years and 322 (53.2%) were men. A total of 208 (34%) had one or more underlying conditions (but not diagnosed diabetes), of which high blood pressure was the most common. Almost one third (29%) of patients fell into the highest category of FBG on admission (7.0 mmol/L) which, if found consistently, would result in a diagnosis of type 2 diabetes. A further 17% were in the range that would be considered prediabetic (6.1-6.9 mmol/L), while more than half (54%) were in the ‘normal’ FBG range of 6.0 mmol/L or below.

Blood clotting, the weakening of blood vessel linings, and cytokine storm syndrome – an overreaction of the immune system – could all play a role in complications from the disease, the study authors believe. The 29% incidence found in the highest FBG group is much higher than the estimated prevalence of diabetes in the Chinese population at 12%, they noted, and urged hospitals to test all COVID-19 patients for glucose levels, as opposed to only those known to have diabetes.

lood donations in India have dropped precipitously as a result of mandated social distancing, restrictions on transportation, cancellation of various blood drives and low donor turnout in response to the COVID-19 pandemic, reports an Economic Times article.

Even before the pandemic, India’s blood transfusion system (BTS) was hobbled by supply inconsistencies because of weak coordination between blood banks, barriers to accessibility by both donors and those in need, in addition to high cost of blood products. In 2015, a report by the Comptroller and Auditor General (CAG) found that 87% of Gujarat state talukas (districts) did not have a single blood bank. In 2016, government-run medical colleges across Madhya Pradesh were unable to use more than 10,000 liters of life saving blood plasma annually due to high costs of conversion and inter-agency coordination problems.

The director for the National Health Mission urges the government to build more awareness of safety protocols. Yet the news media has carried repeated reports of blood shortages over the years, giving evidence that support for India’s National Blood Policy of 2002 has been weak, if not absent.

In March, the National Blood Transfusion Council (NBTC) issued interim guidelines emphasizing the continuity of supply of safe blood and recommending resuming both outdoor and in-house donation. The guidelines stressed compliance with social distancing standards, biomedical-waste disposal rules and infection control best practices, stating that individuals are at no risk of developing COVID-19 through the blood transfusion or via a blood donation procedure.

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News Briefs

Wearing a Valved N95 Mask Does Not Protect Others

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EW DELHI, India – India’s Health ministry director general has issued a call against wearing valved respirator N-95 masks because the coronavirus can escape from the mask and possibly infect other individuals, reports Health Economic Times.

The health officer noted that the ministry is updating its advisories as new facts about the COVID-19 are verified.

N95 valve masks long have been marketed as personal protective equipment for use in industrial and hobby applications to filter out dust and certain vapors. They have a one-way valve allowing exhaled air to pass through a small round or square filter disc attached to the front. Certain commercially available cloth masks also feature this type of valve.

If fitted correctly, this type of mask protects the wearer, while allowing easier exhalation than traditional masks in addition to preventing humidity and reducing uncomfortable heat and carbon dioxide buildup inside the mask. However, they fall short of recommended coronavirus masking because the valve design only filters air inhaled, but not exhaled.

According to a May 9 ABC News interview with William Schaffner, MD, professor of preventive medicine and infectious disease at Vanderbilt University Medical Center, people should replace N95 valved respirators with surgical masks or cloth masks that have filter inserts.

California’s Bay Area counties banned use of N95 valved masks as part of their universal mask order that went into effect April 17. Violation of the order is punishable as a misdemeanor under the California Health and Safety Code, and can result in a fine up to $1,000, imprisonment up to 90 days or both.

Detroit Nursing Homes Initiative Reduced COVID-19 Infection Rate by Nearly Half

Russia Accused of Vaccine Hacking as India Locks Down 125 Million

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ONDON, England – A Russian hacking group called APT29 is thought to have targeted British labs conducting vaccine research in an attempt to steal intellectual property, according to an advisory issued by UK’s National Cyber Security Centre (NCSC).

The attack was discovered within hours of the announcement by Oxford University scientists that a trial had shown its prototype vaccine generated an immune response against the coronavirus.

In a statement published on July 16, NCSC detailed the activity of the threat group, which has exploited organizations globally. APT29, also named “the Dukes” or “Cozy Bear” is thought to be operating as part of Russian intelligence services. The British agency said that assessment was supported by partners at the Canadian Communication Security Establishment (CSE), the U.S. Department for Homeland Security (DHS), Cybersecurity Infrastructure Security Agency (CISA) and the National Security Agency (NSA).

The hacking group uses a variety of tools and techniques to predominantly target governmental, diplomatic, think-tank, healthcare and energy targets for intelligence gain. Throughout 2020, APT29 has targeted various organizations involved in COVID-19 vaccine development in Canada, the United States and the United Kingdom, in what NCSC cyber security experts believe is a most likely aimed at stealing information and intellectual property relating to the development and testing of COVID-19 vaccines, according to the NCSC post.

APT29 is using custom malware known as ‘WellMess’ and ‘WellMail’ to target a number of organizations globally. The malware has not previously been publicly associated to the group.

Publicly, the Russian government denied any involvement.

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ETROIT, MI – Comprehensive testing and infection-control collaboration helped dramatically reduce the rate of new COVID-19 positives in nursing homes from 35% to 18%, reports Skilled Nursing News.

The analysis by the Centers for Disease Control & Prevention (CDC) was based on numbers derived from a collaborative effort between the CDC and the Detroit Health Department, academics, health care systems, and local government officials from March until May. During that time, skilled nursing facility staff and residents were tested for COVID-19 regardless of whether they reported symptoms while infection control support to 12 facilities in the Detroit metropolitan region was increased substantially.

That initiative included “point prevalence surveys,” or blanket coronavirus tests that covered all staffers and residents regardless of their symptoms — or lack thereof. Analysis revealed that the virus positive rate had dropped from 35% to 18% between the first and second efforts.

Among 26 facilities in metropolitan Detroit, 44% of residents and staff members tested positive for the novel coronavirus between March 7 and May 8. Of that total, 24% were dead within three weeks of their first positive test, with 37% in the hospital.

Researchers say success was achieved in large part due to using data from the first round of point prevalence surveys to support and prioritize infection-control and “cohorting” strategies, aimed at helping local officials focus on those facilities in greatest need. Initiatives were launched to focus on optimizing floor plan use to separate positive residents from those without the virus, staffing planning, hand hygiene practices, and education on use of personal protective equipment. The second round of testing showed that the initiatives worked – the virus positive rate dropped from 35% to 18%.

“With the increased availability of SARS-CoV-2 testing, repeated point prevalence surveys and enhanced and expanded IPC support should be standard tools for interrupting and preventing COVID-19 outbreaks in SNFs,” the researchers concluded.

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News Briefs

Pfizer and BioNTech Announce an Agreement with U.S. Government to Supply mRNA-based Vaccine Candidate Against SARS-CoV-2

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EW YORK & MAINZ, Germany – (BUSINESS WIRE) Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) recently announced the execution of an agreement with the U.S. Department of Health and Human Services and the Department of Defense to meet the U.S. government’s Operation Warp Speed program goal to begin delivering 300 million doses of a vaccine for COVID-19 in 2021. Under the agreement, the U.S. government will receive 100 million doses of BNT162, the COVID-19 vaccine candidate jointly developed by Pfizer and BioNTech, after Pfizer successfully manufactures and obtains approval or emergency use authorization from U.S. Food and Drug Administration (FDA).

The U.S. government will pay the companies $1.95 billion upon the receipt of the first 100 million doses, following FDA authorization or approval. The U.S. government also can acquire up to an additional 500 million doses.

Americans will receive the vaccine for free consistent with U.S. government’s commitment for free access for COVID-19 vaccines.

The BNT162 program is based on BioNTech’s proprietary mRNA technology and supported by Pfizer’s global vaccine development and manufacturing capabilities. The BNT162 vaccine candidates are undergoing clinical studies and are not currently approved for distribution anywhere in the world. BioNTech is the market authorization holder worldwide and will hold all trademarks for the potential product. Both collaborators are committed to developing these novel vaccines with pre-clinical and clinical data at the forefront of all their decision-making.

The Pfizer/BioNTech vaccine development program is evaluating at least four experimental vaccines, each of which represents a unique combination of messenger RNA (mRNA) format and target antigen.

On July 1st, Pfizer and BioNTech announced preliminary data from BNT162b1, the most advanced of the four mRNA formulations. The

early data demonstrates that BNT162b1 is able to produce neutralizing antibodies in humans at or above the levels observed in the plasma from patients who have recovered from COVID-19, and this was shown at relatively low dose levels. Local reactions and systemic events were dosedependent, generally mild to moderate, and transient. No serious adverse events were reported. On July 20th, the companies announced early positive update from German Phase 1/2 COVID-19 vaccine study, including first T Cell response data.

Recently, two of the companies’ four investigational vaccine candidates (BNT162b1 and BNT162b2) received Fast Track designation from the U.S. Food and Drug Administration (FDA). This designation was granted based on preliminary data from Phase 1/2 studies that are currently ongoing in the United States and Germany as well as animal immunogenicity studies.

Further data from the ongoing Phase 1/2 clinical trials of the four vaccine candidates will enable the selection of a lead candidate and dose level for an anticipated large, global Phase 2b/3 safety and efficacy study that may begin within a month, pending regulatory approval.

If the ongoing studies are successful, Pfizer and BioNTech expect to be ready to seek Emergency Use Authorization or some form of regulatory approval as early as October 2020. The companies currently expect to manufacture globally up to 100 million doses by the end of 2020 and potentially more than 1.3 billion doses by the end of 2021, subject to final dose selection from their clinical trial.

Proliferation of Portable Negative Pressure Rooms for Coronavirus Isolation

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he need for containing coronavirus inside healthcare facilities has been crucial to infection control, and this has spurred the rapid construction of negative pressure rooms, reports an Infection Control Today article.

Negative pressure rooms are portable anterooms used as an extra layer of protection between the coronavirus patents in an isolation space and the rest of the hospital. Ventilation generates “negative pressure,” making the air pressure inside the room lower than the air pressure outside the room.

This physics dynamic allows air to flow into the room, but not escape from the room, thereby containing contaminated air.

Some hospitals built in the past ten years anticipated the need for negative pressure environments. One such facility is Toronto’s Humber River Hospital, newly opened in 2015. The hospital, according to a spokesperson, was purpose-built to be “pandemic safe.” Capable of isolating entire departments under negative pressure, the facility’s ambulance bay and adjoining “hazmat room” were customized for “seamless transformation” into a pandemic-ready area.

Preparation for a 300% to 500% increase in ICU and isolation room capacity is a challenge, especially for older facilities. Yet in a real time-crunch, a temporary isolation area can be set up surprisingly fast.

Researchers from University of Colorado, Boulder and the Veteran Administration’s National Center for Occupational Health and Infection Control got a temporary 30-bed negative pressure ward up and running in less than an hour, for example.

The American Society for Health Care Engineers says that standard patient rooms can be retrofitted as negative pressure isolation rooms.

The American Society of Heating, Refrigerating and Air-Conditioning Engineers’ Standard allows for using recirculated room air, provided the air first passes through a high efficiency particulate air (HEPA) filter. This can be accomplished with a recirculating HEPA filter unit, the association says.

Whether retrofitted or new, maintaining efficient infection control in negative pressure rooms depends on regular maintenance of HVAC equipment, staff training and surveillance to ensure infection control practices are followed.

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summer 2020

News Briefs

Russia First Nation to Complete Human Trials for Covid-19 Vaccine

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OSCOW, Russia – According to an ET Healthworld article, human trials for a coronavirus vaccine were completed at the Sechenov University in Russia, as of July 13, making Russia the first nation to complete clinical trials proving the medication’s effectiveness.

Chief researcher Elena Smolyarchuk, who heads the Center for Clinical Research on Medications at the university, told Russian news agency, TASS, that the vaccine is safe, and the study volunteers would be discharged on July 15 and July 20.

In June, Russia’s Health Ministry issued a permit for clinical trials of two forms of a potential Covid-19 vaccine developed by the Gamalei National Research Center for Epidemiology and Microbiology jointly with the Russian Defense Ministry’s research institute No. 48, a July 20 TASS article reported. The first vaccine, in the form of a liquid solution for intramuscular administration, was carried out at the Burdenko Military Hospital. Another vaccine, in the form of a freeze-dried powder for the preparation of a solution for intramuscular administration, was carried out at Sechenov First Moscow State Medical University.

The second phase of the anti-coronavirus vaccine tests will be finished on August 3 and national regulatory agency is expected to issue a permit for the vaccine’s use in late August or early September, head of the Russian Direct Investment Fund Kirill Dmitriyev, told TASS. In March, the head of the Russian Federal Biological Medical Agency (FMBA), Veronika Skvortsova, was quoted in Russia Times as predicting that a COVID-19 remedy could be available before the end of next winter.

Skvortsova explained that the teams were testing a “recombinant vaccine that comes from proteins that have so-called ‘epitopes,’ or virus-binding sites. An epitope is the part of the antigen’s macro-molecule that is recognized by the immune system. Skvortsova was Russian Health Minister, for eight years until stepping down in January. In 2017, she was elected as the 70th President of the World Health Organization.

Worldometer COVID-19 statistics for Russia as of July 20, 2020: 777,486 total cases; 12,427 deaths; 553,602 recovered. Total 25,251,614 tests.

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Alarming Spread of COVID-19 in South Asia, Home to a Quarter of Humanity

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uala Lumpur/Delhi/Islamabad/Dhaka/Geneva – South Asia is fast becoming the next COVID-19 epicenter as cases soar in India, Pakistan and Bangladesh, according to an official statement made in July by the International Federation of Red Cross and Red Crescent Societies (IFRC).

India alone was nearing 1 million infections in July, where the country joined Pakistan and Bangladesh in reaching a combined total of more than 1.35 million cases – over 10 per cent of the world’s total. An IFRC spokesperson said the mortality rate was expected to climb far beyond the reported 31,000 deaths across the three countries.

Referring to the latest projections from Massachusetts Institute of Technology (MIT) researchers, the IFRC post said that India risks having the largest number of COVID-19 cases in the coming months. The MIT report, yet to be peer reviewed as of July, predicts that by year end, 2020 India will be the worst affected country in the world, with up to 287,000 cases a day. Insufficient HES 1/2 Page Island responses to the pandemic may lead to hundreds of millions of COVID-19 cases in India, Bangladesh and5-7/16” Pakistan.x 7-1/8” According to figures from the John Hopkins Center that were collated by the University of Melbourne, active cases in India were expected to increase significantly in August.

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News Briefs

German Study Shows Low Coronavirus Infection Rate in Schools

Egyptian Health Ministry Reports Decline in COVID-19 Cases

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RESDEN, Germany – The COVID-19 infection rate in schools may be lower than thought, according to German study that analyzed blood samples from almost 1,500 children and 500 teachers, according to the Technische University of Dresden (TU).

The study was conducted in 13 Saxony schools by researchers from the Medical Faculty of the TU Dresden and University Hospital Carl Gustav Carus. In early July, researchers said that very few of the school children and teachers tested in the German state of Saxony showed antibodies to COVID-19. Schools had resumed classes in May and June after a COVID-19 lockdown this spring.

Three of the schools surveyed had confirmed corona cases. However, teachers and pupils there did not have more antibodies detected above average, suggesting that schools have not become hotspots.

The initial results gave no evidence that school children play a role in spreading the virus particularly quickly. Of the 2045 blood samples examined, 12 were found to have antibodies against the SARS-CoV-2 virus.

Five study participants stated that they had previously tested positive for the SARS-CoV-2 virus. In addition, there were 24 households where a family member had been tested positive in advance.

The study was representative for the state of Saxony, which has a relatively low rate of infection compared to other parts of Germany, noted lead researcher, Reinhard Berner, who is clinical director of the Clinic and Polyclinic for Pediatrics and Adolescent Medicine at the University Hospital Carl Gustav Carus.

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he Deputy head of the Scientific Committee to Combat Coronavirus at the Egyptian Health Ministry Gehan el-Assal says that the number of critical coronavirus cases in the country has decreased, and that most current cases are minor to moderate, requiring only home isolation treatment protocols, reports EgyptIndependent.com Egypt, which is not currently working on finding a treatment for coronavirus, has been conducting experiments on a series of vaccines that can hopefully be used against the coronavirus.

As of mid-July, Worldometer showed the country to have 84,843 coronavirus cases, 4,067 deaths, and 26,135 recovered. A temporary isolation hospital was set up in university dormitories in Alexandria last May and was dismantled in July when decreasing numbers of patients infected with coronavirus were being admitted.

The director of Abu Qir General Hospital said that the hospital’s remaining 30 patients were transferred to another temporary isolation hospital in Abu Qir Youth City. The coronavirus quarantine in Alexandria was limited to a temporary isolation hospital in Abu Qir Youth City.

Federal Court Strikes Down Baltimore City Air Quality Ordinance Baltimore Had Tried to Override Federal and State Law on Air Pollution Control for Waste Combustors

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HEALTHCARE ENVIRONMENTAL SOLUTIONS news

summer 2020

rlington, VA – Recently, the U.S. District Court for the District of Maryland struck down the Baltimore Clean Air Act. The Court ruled that the requirements in the ordinance were in conflict with existing federal and state laws and regulations.

Wheelabrator Baltimore, L.P., the only waste-to-energy facility located in the City of Baltimore, and Curtis Bay Energy, L.P., the only medical waste incinerator in Maryland, brought this action along with the National Waste & Recycling Association (“NWRA”), the Energy Recovery Council, and TMS Hauling, LLC to invalidate Baltimore’s attempt to force the closure of the Wheelabrator and Curtis Bay facilities through the imposition of extraordinary emission limits and operational requirements that Baltimore had no power to impose.

“NWRA is pleased with the Court’s decision. We agree with Judge Russell’s view that state and federal regulations already in place protect the public’s health and that allowing the Baltimore City Council to replace those state and federal regulations with its own ordinance is not in alignment with spirit of those existing state and federal regulations,” said NWRA President and CEO Darrell Smith.

“We thank Judge Russell for issuing his ruling on the key preemption issues in an expeditious manner given the September 2020 deadlines for implementation of the Baltimore Clean Air Act that would have forced the closure, at least temporarily, of the Wheelabrator Baltimore facility,” stated Jim Riley, NWRA’s Chief Counsel and Senior Vice President for Government Affairs. “Baltimore’s attempt to do this disregarded nearly fifty years of federal and state primacy in directing a uniform system to regulate air pollution and imposed unprecedented emission limits that lacked scientific, technical, or factual bases.”

The emission limits and other requirements of the Baltimore ordinance directly conflicted with the emission limits and provisions in the Federal Clean Air Act, EPA’s regulations, and the Title V operating permits granted to Wheelabrator and Curtis Bay. Additionally, the ordinance criminalized conduct allowed under federal law and, as the ordinance’s sponsor admitted, was passed with the intent to shut down these facilities under the guise of regulation.

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