Tuesday, September 01, 2020

Researchers propose new reforms to improve transparency of drug authorizations

On March 28, the Food and Drug Administration (FDA) exercised its Emergency Use Authorization (EUA) authority to allow the use of hydroxychloroquine for the treatment of COVID-19. On June 15, after a number of studies failed to find positive effects, the agency revoked this authorization.
This chain of events raises questions about the speed, rigor and potential politicization of the authorization process. These actions also may have hurt the FDA's credibility and the public's trust in the agency, which could decrease the public's confidence in and adoption of eventual COVID-19 vaccines.
In a Viewpoint piece published in JAMA: The Journal of the American Medical Association, a research team proposes reforms that the FDA could implement to improve the emergency use authorization process and drug approvals during public health crises, which could increase the FDA's credibility and the public's trust in it.
The recommendations are especially timely given that FDA Commissioner Stephen Hahn has stated that the agency will consider using the EUA process to authorize a COVID-19 vaccine, as well as the potential for full approval of COVID-19 vaccines in late 2020.
The FDA is "responsible for protecting public health," which includes ensuring that drugs are safe and effective.
The FDA entered highly unchartered territory when it came to the approval and revocation of hydroxychloroquine for COVID-19, as emergency use authorizations have typically been used for diagnostics and only rarely for therapeutics."
Herschel Nachlis, Study Co-author, Nelson A. Rockefeller Center for Public Policy and the Social Sciences, Dartmouth College
Nachlis is also a research assistant professor of government and policy fellow
"Through this piece in JAMA, we provide recommendations to help the agency make the authorization process more robust, rigorous and transparent in this pandemic environment," he added.

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To improve the accountability and transparency of drug authorizations and approvals, the researchers propose four reforms:
  • The FDA could clarify evidentiary standards for EUAs and could create higher standards for widely used products like vaccines.
  • The FDA could consult with the external experts on its Advisory Committees before issuing EUAs. The committee meetings could be live-streamed and more opportunities for public input could be established.
  • Once COVID-19 vaccines are granted marketing authorization, the FDA could establish extensive adverse event reporting systems, facilitate phase 4 trials to monitor post-approval safety and efficacy, and engage the National Vaccine Injury Compensation Program.
  • As part of the FDA's ongoing efforts to enhance public communication about COVID-19 diagnostics, therapeutics and vaccines, the FDA could launch public education campaigns and utilize communication tools like drug facts boxes to help explain regulatory decisions.
     
"The FDA's regulatory processes are often considered the gold standard for the approval of drugs, and are fundamental to American and global public health," said Nachlis.
"Our entire pharmaceutical and healthcare system depends on this standard. Maintaining credibility and public trust is integral to the FDA's ability to fulfill its mission. Now is the time for the FDA to consider ways to enhance its public support, as our nation and the world waits for effective vaccines to be quickly and safely developed, approved and deployed," he added.
Source:
Journal reference:
Thomson, K & Nachlis, H (2020) Emergency Use Authorizations During the COVID-19 Pandemic. JAMA. doi.org/10.1001/jama.2020.16253
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The 13 Most Outrageous Covid-19 Myths and Misconceptions

No, viruses can’t travel on 5G networks, and herd immunity is not a good option

Robert Roy Britt
Only a highly politicized, historically deadly pandemic could generate this number of outlandish and sometimes deadly myths, conspiracies, hoaxes, and misconceptions. There are so many false Covid-19 claims floating around — more than 2,000, according to a recent study — that even the sharpest minds can be excused for a little coronavirus confusion amid this great global infodemic, fueled by hucksters and pranksters and facilitated by social media.

“The stuff that gets shared by people makes people walk away thinking this is no big deal, that the virus is as trivial, and most people do fine, and for 99% of people it’s harmless,” says Ashish Jha, MD, a practicing internist and professor of medicine at Harvard Medical School.

While some of the fabrications might do little more than make your head spin, others are downright dangerous, and collectively, they fuel distrust in science, in media, and in the governments and institutions that are, or at least should be, trying to protect public health.

Here’s a reality check on a dozen or so of the more inaccurate, outrageous, and sometimes dangerous Covid-19 falsehoods.
1. The coronavirus spreads on 5G networks

This would be fascinating were it true… or even possible! Star Trek fans would recognize the stunning breakthrough as the first instance of biological teleportation. The myth, spread in part by a handful of celebrities, holds that cell towers broadcast Covid-19 over 5G frequencies or that the electromagnetic fields (EMFs) generated by 5G smartphones somehow cause the disease or make it worse. For the record, 5G is nothing more than radio waves at higher frequencies than 4G.

“EMF exposure from 5G devices does not cause Covid-19, nor does it have any effect on the disease process or health outcomes of those who are infected by the new coronavirus,” states the International Commission on Non-ionizing Radiation Protection.

The Mayo Clinic puts it bluntly: “Viruses can’t travel on radio waves.” (Well, some viruses can, but they’re not the biological variety.)
2. The virus was made in a laboratory

By mid-March, 23% of Americans were convinced Covid-19 was developed intentionally in a laboratory, and another 6% thought it was accidentally made in a lab, a Pew Research Center poll found. The percentage of infectious-disease experts who agree is roughly 0%.

There are variations on this conspiracy theory, as Yasmin Tayag reports in Elemental, including that it’s a scheme for population control or that Bill Gates is behind it as a way to boost vaccine sales. Or that either China or the U.S. developed it as a bioweapon.

In fact, the novel coronavirus, like many viruses before it, originated in animals and hopped to humans. Numerous scientists have analyzed the genome of the virus and come to the same conclusion. A July 28 study in the journal Nature Microbiology confirmed what many others have indicated: The virus came from bats.
3. It’s not that bad

This is just total B S— a product of political efforts to detract from the seriousness of the pandemic or outright denial of facts.

Sure, early on we didn’t have a clear picture of the full extent of the ravages of Covid-19. But scientists now say it’s about five times as deadly as the flu. The pandemic has already killed more Americans in a few months than any disease outbreak has in an entire year since 1918 (and no, the death toll is not inflated — in fact, it’s thought to be well below the real total). In addition, the notion that only old people suffer is bunk. More than 12,000 Americans under age 55 have died of Covid-19, according to the CDC.

Meanwhile, thousands of American at various ages are dealing with dozens of crippling long-haul symptoms, ranging from exhaustion to confusion to pain — weeks and months after their supposed recoveries.
4. The coronavirus is mutating into something more (or less) dangerous

Yes, the virus has mutated, surprising exactly zero virologists. No it hasn’t changed in any way important to our understanding of its seriousness.

“Viruses mutate all the time,” says Jha, the Harvard doctor. “Most of them have no clinical biological significance,” adding: “I haven’t seen any data at least that I’m aware of that compels me to think that the virus has become any more or any less lethal.”

A review of the existing research in Science magazine, citing several experts, concludes there is no firm evidence that the mutations have had any effect — positive or negative — on how infectious or deadly the virus is.
5. Drinking alcohol can protect you from the coronavirus

Unlike 5G networks, alcohol does have an effect on Covid-19: It raises your risk. “Alcohol use, especially heavy use, weakens the immune system and thus reduces the ability to cope with infectious diseases,” the World Health Organization states. And for the record, drinking alcohol-based hand sanitizer won’t help, either. In fact it could kill you straight away, as it has a few folks already.
6. Ingesting garlic, bleach, or hot peppers will kill coronavirus

Let’s take these one by one. Drinking bleach can destroy your organs and kill you. Spraying it on your body will irritate your skin. Neither is effective against any virus that’s inside you.

Garlic? Save it for the vampires.


Drinking bleach can destroy your organs and kill you. Spraying it on your body will irritate your skin. Neither is effective against any virus that’s inside you.

It’s a healthy food, but “there is no evidence from the current outbreak that eating garlic has protected people from the new coronavirus,” according to the World Health Organization (WHO).

Hot peppers? If they’re super hot, you might feel the pain, but the coronavirus won’t.
7. Hydroxychloroquine might work. Who knows?

No matter how many times someone with a big audience says this, it continues to be a fantasy, scientists know. The Food & Drug Administration says “recent results from a large, randomized clinical trial in hospitalized patients” found hydroxychloroquine and chloroquine phosphate (the stuff of fish-tank cleaners that an Arizona man fatally drank) “showed no benefit for decreasing the likelihood of death or speeding recovery.” That study was in line with other research, the FDA says. What does it have? A long list of side effects.


“This is already being presented as serious science on FOX News.”

The hydroxychloroquine ruse has, of course, been pitched by the U.S. president. It’s also promoted by professional-looking websites riddled with plausible-sounding disinformation about supposed supporting scientific evidence. “This is an infuriating new frontier in Covid-19 disinformation,” says Carl Bergstrom, PhD, a professor of Biology at the University of Washington and author of the new book Calling Bullshit: The Art of Skepticism in a Data-Driven World.

Worse, the false claims get picked up by popular media outlets and relayed as factual or possible. “This is already being presented as serious science on Fox News,” Bergstrom says of one of the bogus sites.
8. Kids aren’t contagious

First there was the false notion that kids didn’t catch Covid-19. As of late May, nearly 10% of American believed that one, according to an Ipsos poll. The Coronavirus in Kids project, which draws on state and federal data and does its own research to find cases not in the official numbers, estimates that about 3 million American children 17 and younger have been infected.

Talk shifted to “Well, yeah, but kids don’t pass it on.” And, lo and behold, they do. Kids 10 and older are thought to be as contagious as adults. Younger children can pack a boatload of coronavirus in their snot, and one study estimated they are about half as contagious as adults, though subsequent research has suggested the rate may be lower.

Still, there’s this myth…
9. Kids don’t get sick with Covid-19

It’s true that children and also young adults seem less likely to become seriously ill or die from the disease, but less risk is clearly not no risk. The CDC data is not thought to paint a complete picture of childhood Covid-19 deaths, given poor reporting by some states and reporting lags, but here are the agency’s numbers as of Aug. 22:

17 infants

12 kids ages 1–4

28 kids ages 5–14

The Coronavirus in Kids project paints a fuller picture. As of Aug. 27, the project counts 1,240 pediatric intensive care admissions and 118 deaths of children and teens 19 and younger, with only 27 states reporting such data.

Some people are quick to note how low these numbers are, to which others might respond: They are not low if your child is among them. And the picture is changing: The CDC recently said cases among kids are rising — perhaps a reflection of lockdowns being lifted — as is the rate of hospitalization among children. We’ve only begun to experience, let alone analyze, what happens in communities where classrooms open and children are reintroduced into society after being largely locked down since the early days of the pandemic.

Recent data from the American Academy of Pediatrics actually finds Covid-19 hospitalizations and deaths are now rising at a faster rate in children and teens than among the general public, The New York Times reports Aug. 31.
10. Six feet is the golden rule

It would be nifty if the coronavirus, when emitted by coughing, sneezing, or just breathing, always fell to the ground within 6 feet. While it makes really good sense to stay six feet away from other people to reduce the risk of infection, this guideline is rooted in data from the 1930s.

Scientists have since learned that while large respiratory droplets do fall within a few feet, smaller droplets called aerosols can go farther.

Scientists and health organizations like the WHO now agree that the coronavirus can become airborne and travel throughout a room. This is why experts say six feet is great, 10 feet is better, and neither are fully effective in crowded rooms with poor ventilation.
11. Masks don’t help

Well, um, how do we say this? Masks work. Admittedly, public health officials messed up the messaging on this big time. But the basic science is settled: Properly worn, masks provide some protection to the wearer, and they are even more effective at protecting others. While not a silver bullet (see the six-foot rule above), masks are a key tactic in layers of mitigation needed to get the pandemic under control.
12. Neck gaiters may actually spread the virus

If you heard neck gaiters are worse than nothing, that’s wrong, too. Unfortunately, several media outlets misinterpreted a recent study and fueled this misconception. Any cloth face covering is better than nothing at reducing the amount of coronavirus an infected person releases, research shows.

And no, wearing a mask “does not lead to CO2 intoxication nor oxygen deficiency,” WHO says. We know this from the millions of doctors, nurses, and other health care professionals who wear them constantly.
13. Herd immunity can end the pandemic

There could be some truth to this one, but before you follow the herd of disingenuous proponents of the idea, you might want to know the “ifs” and “buts.”

If a successful vaccine is developed, and most people get the vaccine, the virus finds fewer people to infect and eventually goes sub-pandemic. Yet, we don’t know for sure that a safe and successful vaccine will emerge, nor when, nor just how effective it will be. But herd immunity can also occur naturally. If no vaccine is developed, and sans serious prevention efforts, the idea is that enough people would catch the coronavirus, creating sufficient population-level immunity to significantly slow or stop the spread. But we don’t yet know how much immunity develops from a Covid-19 infection, nor how long it lasts. Regardless, at least 40–50% of people would have to develop immunity for the herd effect to work, experts say, maybe as many as 70% (it depends on just how effective the immunity actually is).

But that level of natural immunity would result in at least 1 million U.S. deaths. That’s a “but” with six zeroes.

Still, natural herd immunity — letting the virus spread rapidly while letting the nation get back to business as usual — is reportedly being promoted to the president by Scott Atlas, who joined the White House recently as a pandemic adviser, according to the Washington Post. Angela Rasmussen, PhD, a virologist at the Columbia University Mailman School of Public Health, reacted on Twitter to the news: “If herd immunity through natural infection is even achievable, it will result in thousands — if not millions — more deaths,” she said


WRITTEN BY
Robert Roy Britt
Explainer of things, science & health journalist, author, former editor-in-chief of LiveScience & Space dot com, seeker of a more just and equitable world.
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A Supercomputer Analyzed Covid-19 — and an Interesting New Theory Has Emerged
A closer look at the Bradykinin hypothesis


Thomas Smith

Photo: zhangshuang/Getty Images

Earlier this summer, the Summit supercomputer at Oak Ridge National Lab in Tennessee set about crunching data on more than 40,000 genes from 17,000 genetic samples in an effort to better understand Covid-19. Summit is the second-fastest computer in the world, but the process — which involved analyzing 2.5 billion genetic combinations — still took more than a week.

When Summit was done, researchers analyzed the results. It was, in the words of Dr. Daniel Jacobson, lead researcher and chief scientist for computational systems biology at Oak Ridge, a “eureka moment.” The computer had revealed a new theory about how Covid-19 impacts the body: the bradykinin hypothesis. The hypothesis provides a model that explains many aspects of Covid-19, including some of its most bizarre symptoms. It also suggests 10-plus potential treatments, many of which are already FDA approved. Jacobson’s group published their results in a paper in the journal eLife in early July.

According to the team’s findings, a Covid-19 infection generally begins when the virus enters the body through ACE2 receptors in the nose, (The receptors, which the virus is known to target, are abundant there.) The virus then proceeds through the body, entering cells in other places where ACE2 is also present: the intestines, kidneys, and heart. This likely accounts for at least some of the disease’s cardiac and GI symptoms.

9 Things Experts Have Learned About Covid-19 So Far

The disease has not changed, but scientific understanding has evolved dramatically

elemental.medium.com

But once Covid-19 has established itself in the body, things start to get really interesting. According to Jacobson’s group, the data Summit analyzed shows that Covid-19 isn’t content to simply infect cells that already express lots of ACE2 receptors. Instead, it actively hijacks the body’s own systems, tricking it into upregulating ACE2 receptors in places where they’re usually expressed at low or medium levels, including the lungs.

In this sense, Covid-19 is like a burglar who slips in your unlocked second-floor window and starts to ransack your house. Once inside, though, they don’t just take your stuff — they also throw open all your doors and windows so their accomplices can rush in and help pillage more efficiently.

The RAS controls many aspects of the circulatory system, including the body’s levels of a chemical called bradykinin, which normally helps to regulate blood pressure. According to the team’s analysis, when the virus tweaks the RAS, it causes the body’s mechanisms for regulating bradykinin to go haywire. Bradykinin receptors are resensitized, and the body also stops effectively breaking down bradykinin. (ACE normally degrades bradykinin, but when the virus downregulates it, it can’t do this as effectively.)

The end result, the researchers say, is to release a bradykinin storm — a massive, runaway buildup of bradykinin in the body. According to the bradykinin hypothesis, it’s this storm that is ultimately responsible for many of Covid-19’s deadly effects. Jacobson’s team says in their paper that “the pathology of Covid-19 is likely the result of Bradykinin Storms rather than cytokine storms,” which had been previously identified in Covid-19 patients, but that “the two may be intricately linked.” Other papers had previously identified bradykinin storms as a possible cause of Covid-19’s pathologies.


Covid-19 is like a burglar who slips in your unlocked second-floor window and starts to ransack your house.

As bradykinin builds up in the body, it dramatically increases vascular permeability. In short, it makes your blood vessels leaky. This aligns with recent clinical data, which increasingly views Covid-19 primarily as a vascular disease, rather than a respiratory one. But Covid-19 still has a massive effect on the lungs. As blood vessels start to leak due to a bradykinin storm, the researchers say, the lungs can fill with fluid. Immune cells also leak out into the lungs, Jacobson’s team found, causing inflammation.

Coronavirus May Be a Blood Vessel Disease, Which Explains Everything

Many of the infection’s bizarre symptoms have one thing in common

elemental.medium.com

And Covid-19 has another especially insidious trick. Through another pathway, the team’s data shows, it increases production of hyaluronic acid (HLA) in the lungs. HLA is often used in soaps and lotions for its ability to absorb more than 1,000 times its weight in fluid. When it combines with fluid leaking into the lungs, the results are disastrous: It forms a hydrogel, which can fill the lungs in some patients. According to Jacobson, once this happens, “it’s like trying to breathe through Jell-O.”

This may explain why ventilators have proven less effective in treating advanced Covid-19 than doctors originally expected, based on experiences with other viruses. “It reaches a point where regardless of how much oxygen you pump in, it doesn’t matter, because the alveoli in the lungs are filled with this hydrogel,” Jacobson says. “The lungs become like a water balloon.” Patients can suffocate even while receiving full breathing support.

The bradykinin hypothesis also extends to many of Covid-19’s effects on the heart. About one in five hospitalized Covid-19 patients have damage to their hearts, even if they never had cardiac issues before. Some of this is likely due to the virus infecting the heart directly through its ACE2 receptors. But the RAS also controls aspects of cardiac contractions and blood pressure. According to the researchers, bradykinin storms could create arrhythmias and low blood pressure, which are often seen in Covid-19 patients.

The bradykinin hypothesis also accounts for Covid-19’s neurological effects, which are some of the most surprising and concerning elements of the disease. These symptoms (which include dizziness, seizures, delirium, and stroke) are present in as many as half of hospitalized Covid-19 patients. According to Jacobson and his team, MRI studies in France revealed that many Covid-19 patients have evidence of leaky blood vessels in their brains.

Bradykinin — especially at high doses — can also lead to a breakdown of the blood-brain barrier. Under normal circumstances, this barrier acts as a filter between your brain and the rest of your circulatory system. It lets in the nutrients and small molecules that the brain needs to function, while keeping out toxins and pathogens and keeping the brain’s internal environment tightly regulated.

If bradykinin storms cause the blood-brain barrier to break down, this could allow harmful cells and compounds into the brain, leading to inflammation, potential brain damage, and many of the neurological symptoms Covid-19 patients experience. Jacobson told me, “It is a reasonable hypothesis that many of the neurological symptoms in Covid-19 could be due to an excess of bradykinin. It has been reported that bradykinin would indeed be likely to increase the permeability of the blood-brain barrier. In addition, similar neurological symptoms have been observed in other diseases that result from an excess of bradykinin.”

Increased bradykinin levels could also account for other common Covid-19 symptoms. ACE inhibitors — a class of drugs used to treat high blood pressure — have a similar effect on the RAS system as Covid-19, increasing bradykinin levels. In fact, Jacobson and his team note in their paper that “the virus… acts pharmacologically as an ACE inhibitor” — almost directly mirroring the actions of these drugs.

By acting like a natural ACE inhibitor, Covid-19 may be causing the same effects that hypertensive patients sometimes get when they take blood pressure–lowering drugs. ACE inhibitors are known to cause a dry cough and fatigue, two textbook symptoms of Covid-19. And they can potentially increase blood potassium levels, which has also been observed in Covid-19 patients. The similarities between ACE inhibitor side effects and Covid-19 symptoms strengthen the bradykinin hypothesis, the researchers say.

ACE inhibitors are also known to cause a loss of taste and smell. Jacobson stresses, though, that this symptom is more likely due to the virus “affecting the cells surrounding olfactory nerve cells” than the direct effects of bradykinin.

Though still an emerging theory, the bradykinin hypothesis explains several other of Covid-19’s seemingly bizarre symptoms. Jacobson and his team speculate that leaky vasculature caused by bradykinin storms could be responsible for “Covid toes,” a condition involving swollen, bruised toes that some Covid-19 patients experience. Bradykinin can also mess with the thyroid gland, which could produce the thyroid symptoms recently observed in some patients.

The bradykinin hypothesis could also explain some of the broader demographic patterns of the disease’s spread. The researchers note that some aspects of the RAS system are sex-linked, with proteins for several receptors (such as one called TMSB4X) located on the X chromosome. This means that “women… would have twice the levels of this protein than men,” a result borne out by the researchers’ data. In their paper, Jacobson’s team concludes that this “could explain the lower incidence of Covid-19 induced mortality in women.” A genetic quirk of the RAS could be giving women extra protection against the disease.

The bradykinin hypothesis provides a model that “contributes to a better understanding of Covid-19” and “adds novelty to the existing literature,” according to scientists Frank van de Veerdonk, Jos WM van der Meer, and Roger Little, who peer-reviewed the team’s paper. It predicts nearly all the disease’s symptoms, even ones (like bruises on the toes) that at first appear random, and further suggests new treatments for the disease.

As Jacobson and team point out, several drugs target aspects of the RAS and are already FDA approved to treat other conditions. They could arguably be applied to treating Covid-19 as well. Several, like danazol, stanozolol, and ecallantide, reduce bradykinin production and could potentially stop a deadly bradykinin storm. Others, like icatibant, reduce bradykinin signaling and could blunt its effects once it’s already in the body.

Interestingly, Jacobson’s team also suggests vitamin D as a potentially useful Covid-19 drug. The vitamin is involved in the RAS system and could prove helpful by reducing levels of another compound, known as REN. Again, this could stop potentially deadly bradykinin storms from forming. The researchers note that vitamin D has already been shown to help those with Covid-19. The vitamin is readily available over the counter, and around 20% of the population is deficient. If indeed the vitamin proves effective at reducing the severity of bradykinin storms, it could be an easy, relatively safe way to reduce the severity of the virus.

Other compounds could treat symptoms associated with bradykinin storms. Hymecromone, for example, could reduce hyaluronic acid levels, potentially stopping deadly hydrogels from forming in the lungs. And timbetasin could mimic the mechanism that the researchers believe protects women from more severe Covid-19 infections. All of these potential treatments are speculative, of course, and would need to be studied in a rigorous, controlled environment before their effectiveness could be determined and they could be used more broadly.

Covid-19 stands out for both the scale of its global impact and the apparent randomness of its many symptoms. Physicians have struggled to understand the disease and come up with a unified theory for how it works. Though as of yet unproven, the bradykinin hypothesis provides such a theory. And like all good hypotheses, it also provides specific, testable predictions — in this case, actual drugs that could provide relief to real patients.

The researchers are quick to point out that “the testing of any of these pharmaceutical interventions should be done in well-designed clinical trials.” As to the next step in the process, Jacobson is clear: “We have to get this message out.” His team’s finding won’t cure Covid-19. But if the treatments it points to pan out in the clinic, interventions guided by the bradykinin hypothesis could greatly reduce patients’ suffering — and potentially save lives.


WRITTEN BY
Thomas Smith
Co-Founder & CEO of Gado Images. I write, speak and consult about AI, privacy, photography, tech and the Bay Area. Send any inquiries to tom@gadoimages.com.
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Co-Founder & CEO of Gado Images. I write, speak and consult about AI, privacy, photography, tech and the Bay Area. Send any inquiries to tom@gadoimages.com.
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Coronavirus can spread through drain pipes in bathrooms, study suggests



As the coronavirus pandemic evolves, more information emerges on how the virus spreads in the community. Recently, the World Health Organization (WHO) recognized that the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes the coronavirus disease (COVID-19), spreads through aerosols, which are small droplets that remain suspended in the air.
Now, a new study reveals that the virus may spread via aerosols through drain pipes in bathrooms, after scientists examined an abandoned apartment in Guangzhou, China. The findings add to the body of evidence suggesting the virus is transmissible via aerosols.
Study: Aerosol transmission of SARS-CoV-2? Evidence, prevention and control.
 Image Credit: Kateryna Kon / Shutterstock

Airborne transmission

Several studies have revealed that COVID-19 can spread through aerosols in the hospital setting.
Airborne transmission is defined as the spread of an infectious agent through the dissemination of droplet nuclei (aerosols) that remain infectious when suspended in the air for long distances and time, the WHO reports.
Initially, the WHO said that the airborne transmission of SARS-CoV-2 could occur during medical procedures that produce aerosols, such as nebulization. However, recent evidence has shown that airborne transmission can also spread in enclosed areas where there is poor ventilation, such as offices.
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Spread in bathrooms

A team of researchers from the China Center for Disease Control and Prevention (CCDC), the University of Utah, and the Nanjing Medical University aimed to review the evidence of aerosol transmission of SARS-CoV-2.
To arrive at the study findings, the scientists conducted an “on-site tracer simulation experiment” to evaluate if the virus could spread through waste pipes through tiny airborne particles, which are generated by the force of a toilet flush.
The team noted an incident in February, when SARS-CoV-2 RNA on surface samples, such as those from the shower handle, faucet, and sink, was found in a bathroom of an unoccupied apartment. The bathroom is located on the 16th floor, which was right above the apartment of five people with COVID-19, which were diagnosed between Jan. 16 and Jan. 30.
The team said that an on-site trace simulation experiment also confirmed the possibility of aerosol transport through drainage pipes after flushing the toilet on the 15th floor. The team showed that aerosols were found in the restrooms of apartments on the 25th floor and the 27th floor of the building.
“Although transmission via the shared elevator cannot be excluded, this event is consistent with the findings of the Amoy Gardens SARS outbreak in Hong Kong in 2003,” the authors wrote in the paper, citing unpublished data from the CCDC.

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In the Amoy Gardens case in 2003, warm and moist air from the bathroom of a severe acute respiratory syndrome (SARS) patient excreting high concentrations of the virus in feces and urine has established a plume in the air shaft that spread the pathogen to other apartments.

Other sources of airborne transmission

Aside from bathrooms through sewage pipes, the team also cited other instances that airborne spread of the SARS-CoV-2 is more likely. For instance, a choir rehearsal in Washington in the United States has led to the infection of 53 out of the 61 attendees, while two of these patients had died. The rehearsal imposed adequate precautions for droplet transmission, and none of the attendees had symptoms.
Health experts suspect that the virus may have spread through singing, wherein the forceful inhalation and exhalation may have aerosolized the virus, leading to high levels of disease transmission.
“This indoor transmission risk may have been increased because of high occupancy, long duration, loud vocalization, and poor ventilation. A recent study addressed the potential long distances covered by SARS-CoV-2 through cough and sneeze and revealed that small droplets emitted during a sneeze, could reach distances of 7–8 meters,” the authors noted.
Other reports of airborne transmission have been mentioned, such as outbreaks involving cases in relatively confined or crowded environments, including hospitals, public vehicles, offices, shopping malls, and prisons.
“Poor ventilation for a relatively long time and lack of mask use may have increased the risk of aerosolized infection. Taken together, this suggests the possibility of aerosol transmission, especially in confined settings after exposure to high concentrations of viral aerosols for a long time,” the researchers said.
The team urges governments and healthcare settings to impose precautionary control strategies that are essential for the protection of public health. They should inform the general public, particularly the vulnerable groups, about avoiding crowded and poorly ventilated environments.
Since there is a risk of airborne transmission in closed spaces, providing adequate natural ventilation, increasing air exchange rates, and reducing the use of central air conditioning, are all critical. Public transport vehicles should be disinfected regularly, and restrooms should also be thoroughly cleaned regularly.
Most importantly, wearing masks, avoiding crowded places, physical distancing, and proper hand hygiene are still the best ways to prevent infection and spread of COVID-19.
The study is published in the journal Environmental International.
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Newly approved drugs in Canada lack key pediatric drug information

Newly approved drugs in Canada lack important pediatric drug information in their product monograph, according to an analysis led by McMaster University and McMaster Children's Hospital.
This absence of pediatric information perpetuates "off-label" drug use which could be dangerous for this vulnerable population, say the authors. They add that Canadian regulatory mechanisms are needed to ensure submission of pediatric data by manufacturers when use in children is anticipated.
The findings were published today in Canadian Medical Association Journal (CMAJ) Open.
Less than one-third of new Canadian drugs are approved for pediatric patients. Dosing information was missing for the majority of pediatric age groups, but most concerningly for newborns. In addition, we found that many important drugs that treat critical diseases are not approved for use in newborns or children."
Samira Samiee-Zafarghandy, Study Senior and Corresponding Author and Assistant Professor of Pediatrics, McMaster University
Samiee-Zafarghandy is also a neonatologist and pediatric clinical pharmacologist at Hamilton Health Sciences' McMaster Children's Hospital.
Diseases with no new drug development approved for children include, among others, inflammatory bowel disease, diabetes, human immunodeficiency virus (HIV), seizure, depression and severe pain.
The detailed analysis was conducted of product monographs, which are intended to provide the necessary information, especially for health professionals, for the safe and effective use of a new drug.
The research team manually reviewed monographs of all new drugs approved by Health Canada between 2007 and 2016. During this time, Health Canada approved 281 drugs, 270 of which had clear benefit for children.

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However, only 75 (28 per cent) of the drug monographs were approved for children and there were only 10 (4 per cent) drugs approved for use in newborns.
For a few oral drugs with approval in children (15), only nine (60 per cent) were available in child-friendly, age-appropriate dosage forms.
"Although we were aware that information present in the drug labels are usually more focused on adult patients, the extent of the absence of prescribing information available for children was much, much greater than we anticipated," said Samiee-Zafarghandy.
"We were also confounded by how many drugs used in critical conditions for pediatric and newborn patients did not have any information for their proper use in these children. Many of these drugs are being prescribed to children anyway, and the lack of pediatric data in their monograph can make it difficult for physicians and pharmacists to optimize treatment. The result may be inadequate treatment or increased side effects."
Samiee-Zafarghandy said regulatory mechanisms to require the submission of pediatric data by manufacturers to Health Canada are urgently needed to promote both neonatal and pediatric drug development.
"Our study is the first to report this severe lack of necessary information in labeling of Canadian drugs for pediatric patients," she said.
"The results of this study will serve as a foundation for future comparisons of pediatric drug information availability between Canadian drug labels, and drug labels of medications approved in other advanced countries."
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Scientists say insect repellent kills the SARS-CoV-2 coronavirus on surfaces


The coronavirus disease (COVID-19) pandemic is ravaging across the globe and has now infected more than 24.1 million people and claimed over 825,000 lives. There is no known vaccine or treatment for COVID-19, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), but physical distancing, proper hand hygiene, and wearing of masks are known ways to prevent infection.
Now, a team of scientists at Britain's Defence Science and Technology Laboratory (DSTL) has shared preliminary findings of their research, showing that a product in insect repellent can kill the SARS-CoV-2 virus.
Defense scientists conducted the study to see if insect repellents would provide a protective layer against COVID-19, which contains Citridiol, a clinically proven insect repellent that is naturally sourced and a flagship product of Citrefine International Ltd.

Insect repellent study

In the study, which has not yet been externally peer-reviewed, DSTL was tasked by MoD Surgeon General to examine the antiviral activity of Citriodiol, and Mosi-Guard Natural spray against SARS-CoV-2 virus. The team released two trials, which were performed by the United Kingdom government laboratory at Proton Down.
The team adopted two approaches of the antiviral activity of the product – when directly applied to the virus as a liquid drop and assessment of the product after application to latex synthetic skin.

The trials

In the standard assay or liquid contact, the team mixed a virus suspension with Mosi-guard Natural spray, or selected constituent components have reduced the SARS-CoV-2 strain, England-2, isolate titers after just one minute.
The first trial confirmed that the product, traditionally sold as in insect repellent containing 30 percent Citriodiol, has a significant effect on SARS-CoV-2. When the mixture was slightly diluted, the product still demonstrated at least 99.99 percent inactivation of the coronavirus within just one minute. In the test, there were 10,000 live virus particles, but in just ten minutes, the number went down to 10 active particles.
In the second test, the team studied the effect of Mosi-guard Natural on a surface. The researchers chose to dry off any alcohol in the product, which can interfere with the results of the experiment. They found that the product had reduced the viruses on the surface by up to 99 percent almost immediately and continuing to inactivate the remaining particles over the next four hours. After four hours, about 99.99 percent of the virus particles have been inactivated.
"We are very excited by these findings and have several new studies either already going through laboratories or planned," Jacqueline Watson, Managing Director of Citrefine, said.
The team said that the experiments used the SARS-CoV-2 England-2 isolate, which was isolated from a patient in the United Kingdom obtained from the Public Health England (PHE) Colindale.
"Although other isolates may behave differently within the experimental design described, it is assumed that all isolates and subsequent passages will behave similarly," the researchers said.

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Sky News reports that Military troops are being given the insect repellent that may provide a new layer of protection against the coronavirus disease.

What is Citriodiol?

Citriodiol® is a trading name for commercial preparation of Eucalyptus citriodora oil, which contains the major component, p-menthane-3,8-diol. Formulations containing Citriodiol® are widely used as mosquito repellents. A major component of Citriodiol® is p-menthane-3,8-diol (PMD).
The product is considered the most effective insect repellent and is a naturally sourced active ingredient against several biting insects. It is derived from the oil of the Eucalyptus cirtriodora tree, also called Corymbia citriodora.
Close-up of gum nuts and citrus scented eucalyptus leaves of the Lemon Scented Gum, Australia (Eucalyptus citriodora) or (Corymbia citriodora). Image Credit: Peter Krisch / Shutterstock
Close-up of gum nuts and citrus-scented eucalyptus leaves of the Lemon Scented Gum, Australia (Eucalyptus citriodora) or (Corymbia citriodora). Image Credit: Peter Krisch / Shutterstock

COVID-19 situation

The COVID-19 pandemic has now reached 188 countries and territories, wherein the United States and Brazil are the hardest-hit nations. The U.S. has seen over 5.82 million people infected with the coronavirus, while more than 179,000 people have died. In Brazil, there are at least 3.71 million confirmed cases and more than 117,000 deaths.
India and Russia follow with more than 3.3 million cases, and at least 968,000 people are infected, respectively.
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