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‘I’m not an anti-vaxxer, but…’ US health workers’ vaccine hesitancy raises alarm

Coronavirus

With up to 40% of frontline workers in LA county refusing Covid-19 inoculation experts warn that understanding and persuasion are needed

Amanda Holpuch

Amanda Holpuch in New York @holpuch
Sun 10 Jan 2021 03.00 EST
Last modified on Sun 10 Jan 2021 10.07 EST
Source: The Guardian

Registered nurse Valerie Massaro administers the second dose of the Pfizer/BioNTech vaccine to health care workers at the Hartford HealthCare at the Hartford Convention Center in Hartford, Connecticut on January 4, 2021.
 Registered nurse Valerie Massaro administers the second dose of the Pfizer/BioNTech vaccine to health care workers at the Hartford Convention Center in Hartford, Connecticut, this week. Photograph: Joseph Prezioso/AFP/Getty Images
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Susan, a critical care nurse based in Alaska, has been exposed to Covid-19 multiple times and has watched scores of people die from the illness. But she did not want to get the vaccination when she learned it would soon be available.

“I am not an anti-vaxxer, I have every vaccine known to man, my flu shot, I always sign up right there, October 1, jab me,” said Susan, who didn’t want to give her last name for fear of retaliation. “But for this one, why do I have to be a guinea pig?”

The two authorized vaccines, made by Moderna and Pfizer-BioNTech, are safe according to leading expertsand clinical trials – for one thing they contain no live virus and so cannot give a person Covid – and with tens of thousands of patients, they have had about 95% efficacy. But across the country, health workers with the first access to the vaccine are turning it down.

Misinformation ‘superspreaders’: Covid vaccine falsehoods still thriving on Facebook and Instagram

The rates of refusal – up to 40% of frontline workers in Los Angeles county, 60% of care home workers in Ohio – have prompted concern and in some cases, shaming. But the ultimate failure could be dismissing these numbers at a critical moment in the US vaccination campaign.

Dr Whitney Robinson, an epidemiologist at the University of North Carolina, told the Guardian if these early figures coming from healthcare workers are not addressed: “It could mean after all this work, after all this sacrifice, we could still be seeing outbreaks for years, not just 2021, maybe 2022, maybe 2023.”

Vaccine hesitancy is common – 29% of healthcare workers said they were vaccine-hesitant, according to a survey by the Kaiser Family Foundation published last month. And it’s not exclusive to the US – up to 40% of care workers in the UK might refuse to have the vaccine, the National Care Association said in mid-December.

The numbers coming from hospital and care homes are unique in that they give a more specific picture of who is refusing the vaccine and why. Once vaccines are available to the general public, patterns will be more difficult to identify because the US does not have a centralized system to track vaccinations.

“If we don’t understand the patterns of who is not vaccinated, it will be hard to predict where outbreaks might spring from and how far they might spread,” Robinson said.

It will also leave underfunded public health agencies scrambling to identify and respond to hesitancy in the community.

“We can’t just write off somebody’s decisions and say, well that’s their personal decision,” Robinson said. “Because it’s not just their personal decision, it’s an infectious disease. As long as we have pockets of coronavirus anywhere in the world, until we have mass global vaccination, it’s a threat.”

Some employers and unions are seeing the numbers for what they are: an alarm in need of a response.

In New York City, the firefighters union found last month that 55% of 2,000 firefighter members surveyed said they would not get the vaccine.

But Covid cases are climbing at the FDNY. Twelve members have died and more than 600 were on medical leave in late December.

So, the Uniformed Firefighters Association (UFA) president, Andrew Ansbro, collected questions from some of the roughly 8,200 firefighters his union represents. A virologist friend had been helping Ansbro shape the union’s response to Covid-19 and answered their questions in a recorded video. The 50-minute video has now been viewed about 2,000 times.

“I actually received a couple dozen phone calls and messages from members that said it changed their mind,” said Ansbro, who was vaccinated on 29 December. “I think the vaccination numbers are definitely going to be higher than 45%.”Advertisement

He said people were concerned about how new the vaccine was, had read misinformation online and were worried about long-term effects. In other workplace surveys, people have shared concerns about how it could affect fertility or pregnant women. Some healthcare workers infected with Covid don’t think it’s necessary while they still have antibodies.

Each of these questions can be answered. And national surveys have shown that in general, vaccine hesitancy is decreasing.

But these surveys also suggest action is still needed to address populations more likely to be distrustful because of the country’s history of medical abuse.

Recent surveys show that Black people are the most vaccine-hesitant. In mid-November, 83% of Asian Americans said they would get the vaccine if it was made available to them that day. That sentiment was shared by 63% of Hispanic people, 61% of white people but just 42% of Black people, according to a Pew Research report.

Dr Nikhila Juvvadi, the chief clinical officer at Loretto hospital in Chicago, told NPR that conversations with vaccine-hesitant staff revealed mistrust was an issue among African American and Latino workers.

She said people specifically mentioned the Tuskegee Study, when federal health officials allowed hundreds of Black men with sexually transmitted diseases to go untreated to study disease progression. The study lasted from 1932 to 1972.

“I’ve heard Tuskegee more times than I can count in the past month – and, you know, it’s a valid, valid concern,” Juvvadi said.

Juvvadi, who administered vaccines at the hospital, said one-on-one conversations validating these concerns and answering questions had helped people be more comfortable with the vaccine.

Vaccine hesitancy in healthcare workers has also put pressure on health systems intent on getting doses to as many people as possible, as quickly as possible.

Georgia’s public health commissioner, Kathleen Toomey, announced last week that the state would expand vaccine access to adults 65 and older and first responders because healthcare workers were declining to take it.

Dr Toomey said that while hundreds of healthcare workers were on waiting lists to get the vaccine in the state’s urban center, Atlanta, in rural areas the vaccine was “literally sitting in freezers” because healthcare workers there did not want to take it.

At one of the Texas hospitals hardest hit by the virus, Doctors Hospital at Renaissance in the Rio GrandeValley, workers contacted local EMTs, paramedics and medical workers from outside the hospital to distribute their remaining vaccines because of their limited shelf-life.

Susan, the nurse in Alaska, said her preference would be for her parents to get the vaccine first because they are more vulnerable.

She has made peace with the vaccine and plans to get it the next time it is offered. She said she was ultimately convinced to get it after speaking to other health professionals who did not dismiss her concerns and listened to her questions.

Now, however, there is another hurdle. Susan has declined the vaccine twice because of logistics. She is currently on a temporary crisis assignment in rural Texas and the travel meant both times she was offered the vaccine, she would be in a different state when it was time to take the second dose. Susan said: “I feel terrible I’ve said no.”

Why do you think medical professionals are hesitant to take the vaccine? Shouldn’t one lead by example? If they are unwilling to do it, why should you be willing? Will you take the COVID 19 vaccine?

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Why Elon Musk’s pigs are a legal headache

Elon Musk (credit: Duncan.Hull via Wikimedia Commons) and Gertrude
Source: Legal Cheek
Shidonna Raven Garden and Cook
William Holmes, Legal Cheeck
Shidonna Raven Garden and Cook

By William Holmes
on Dec 16 2020 9:18am
Source: Legal Cheek

Bristol University student and future trainee William Holmes explores the challenges ahead for brain-computer interface (BCI) systems

Elon Musk’s pig, Gertrude, looks like any other pig. But the coin-sized chip Musk’s company Neuralink have placed in Gertrude’s brain makes her a key part of a ground-breaking experiment to discover if technology can enable us to do things with thoughts.

The chip is a brain-computer interface (BCI) which picks up neural activity. Musk hopes to decode this neural activity so that it can be understood as instructions for a computer, allowing BCI users to control a computer with their minds. In other words, BCIs can transform a thought into an act.

For many who have lost certain bodily functions, BCI technology is a scientific miracle. The technology has the potential to treat neurological conditions like dementia or Parkinson’s, restore paralysed individual’s ability to control their bodies and even allow the blind to see again. But for prosecutors, judges and policy makers, BCIs are a troubling legal headache.

Proving criminal responsibility for most crimes requires the prosecution to prove both a defendant’s criminal act (actus reus) and intention (mens rea). So, how would this work for a defendant who used a BCI to commit a crime? An act is defined in most legal systems as “a bodily movement” (the quote here is from the US Model Penal Code). But a crime committed using a BCI involves no bodily movement. Nevertheless, if we take a neuroscientific approach, this is not an insurmountable obstacle for a prosecutor.

The chain of causation for a BCI user is as follows. First, the BCI user imagines an act that they want the computer to perform (I shall refer to this as a “mental act”). Second, neural activity is triggered by the mental act that is input for the BCI. Finally, the BCI interprets this neural activity and performs the act. Just as a finger pulls the trigger on a gun, neural activity triggers the BCI. Therefore, the neurons that fire and produce measurable neural activity could plausibly be considered the actus reus in cases involving the use of BCI technology. So, it appears that a legal loophole in prosecuting disembodied acts can be avoided. But at a price.

By finding actus reus in the activity of a defendant’s neurons, we have been forced to expand the law into the mental sphere. This is a sphere which, in keeping with the Roman law maxim that “nobody shall be punished for thoughts” (cogitationis poenam nemo patitur), is not regulated by the law. In the UK, this doctrine is a right enshrined in article 9 of the Human Rights Act 1998. Given the repercussions for our freedom of thought, is it acceptable to regulate BCIs? If not, can legal systems that only regulate outward behaviour properly maintain the rule of law in BCI cases?

The middle ground between a BCI Wild West and criminalising thoughts is granting BCI users the ability to waive their right to freedom of thought. For those that this technology offers the most, for example tetraplegics, this may well be a right they are happy to waive. Should an individual be allowed to take such a decision? Legislators would have to step in to clarify who can use BCIs and judges would have to recognise implied consent from BCI users to waive this right to freedom of thought.

When deciding this, we must not ignore how significant this expansion of government regulation would be. For the first time, certain thoughts or mental acts would be outlawed. As a result, law-abiding BCI users will be forced to think before they think, regulating themselves in an unprecedented way. This is the immediate ‘legal headache’: BCIs force us to consider the merits of breaking a human right that is fundamental to democratic society and individual liberty in order to avoid criminal loopholes.

There is, however, a second long-term ‘legal headache’. Using the brain’s neurons to establish responsibility forces us to reconsider how we determine responsibility more broadly. How we attribute responsibility is (and has always been) a social decision. In some societies in the past, if an act was compelled or inspired by a divine force, then the law did not deem the individual responsible. In societies where an artist considered the muses responsible for their work, an acceptable waiver of responsibility was the excuse that “God made me do it”.

Today, we consider acting people to be responsible. But this could change in the future, especially if BCIs help to promote neuroscience to the forefront of the legal system. A recent example that highlights the influence of neuroscience on policy is Holland’s adolescent criminal law that came into force in 2014. This law allows those aged between 16 and 22 to be tried as an adult or as a juvenile at the court’s discretion. The underlying rationale is based on neuroscience: Holland’s new system hopes to take into consideration the mental development of defendants when sentencing them. This represents a social shift that sees the brain as the responsible agent.

This shift, which was famously critiqued as “brain overclaim syndrome” by Stephen J. Morse, could have some troubling consequences. The data recorded by BCIs (especially from the amygdala which regulates emotion) offers temptingly persuasive evidence for a defendant’s mens rea and mental state. The question for judges is whether this data is admissible evidence.

A neurocentric legal culture would encourage a judge to admit such evidence. If admissible, a high level of cross-examination is vital to ensure that there is clarity around neuroscience’s technical and interpretive limits. For example, there is evidence that factors like parenting and socio-economic status change the way the amygdala and prefrontal cortex function. The fact that neuroscientific technology is overwhelmingly tested on students from Western Educated Industrialised Rich and Democratic (WEIRD) population means that there is a possible bias in interpreting neuroscientific information. Unquestioned, these limitations allow lawyers to cast uncertain aspersions based on competing expert testimony which could lead juries to jump to false conclusions.

Furthermore, if the brain is considered responsible for criminality, then a reform of the penal system is implicit. The chances of recidivism and the methods with which guilty prisoners are treated — be it regenerative or punitive — would no longer be based on human nature and character. Instead, neuroscience would nuance our understanding of criminality and how to treat it. And the result might not be dissimilar to the Ludovico Technique, a type of psychological treatment that Antony Burgess portrays in his dystopian novel A Clockwork Orange.

Gertrude the pig is just the start of a technology that could rewire the legal norms of responsibility and radically change the legal concept of action. In light of this, policy makers and judges must prepare the criminal justice system for advent of BCIs. There is currently no regulation that is specific to BCI technology in the UK, as the British government acknowledged in a report published in January 2020. That is because the technology is still being developed and there are no clear solutions yet. But one thing is for sure: Elon Musk’s pigs promise to be a complex legal headache for scholars, lawyers, judges and legislators for decades to come.

William Holmes is a penultimate year student at the University of Bristol studying French, Spanish and Italian. He has a training contract offer with a magic circle law firm.

BCI is cutting edge and so are the criminals who use it to commit crimes. The health care industry is not stranger to crime such as sexual assault, fraud and stalking all in the name of health and science. How do parents protect their children from criminals? How does society protect women? How do you protect intellectual rights? How do you prevent hacking? Will humanity always prevail or how can this technology be used to put technology over people in the hands of criminals?

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Ethical or exploitative—should prisoners participate in COVID-19 vaccine trials?

Source: Science Mag
Photos Source: Science Mag
By Eli Cahan Sep. 14, 2020 , 1:50 PM

Science’s COVID-19 reporting is supported by the Pulitzer Center and the Heising-Simons Foundation.

As 38 clinical trials seek tens of thousands of volunteers to receive doses of experimental vaccines, researchers are discussing how to find and recruit participants effectively and ethically. Some people who are especially vulnerable to COVID-19 have not been well represented in studies—or represented at all. Prisoners, for instance, have borne a heavy burden of COVID-19, with more than 125,000 U.S. prisoners infected, and more than 1000 dead. But prisoners have also been excluded from the trials out of concern that they might be coerced into participating or exploited if they do.

Now, some researchers argue that including prisoners in studies could offer outsize health benefits. Correctional facilities have experienced many COVID-19 outbreaks and are structurally unsuited to social distancing (among other precautions). And so, the researchers argue, like other people at high risk of catching the disease, prisoners should be allowed to participate in clinical trials. 

ScienceInsider spoke with George Annas, a lawyer and bioethicist at Boston University, whose research addresses ethics and human rights in clinical trials, and Lauren Brinkley-Rubinstein, a sociologist and epidemiologist at the University of North Carolina, Chapel Hill, who studies management of infectious disease and substance abuse in incarcerated people. Both have published about health and ethics in holding facilities during the pandemic: In July, Annas wrote in The New England Journal of Medicine about inhumane medical practices in immigrant detention centers and, and in August, Brinkley-Rubinstein and colleagues argued in JAMA that prisoners should be included in vaccine trials.

This interview has been edited for brevity and clarity.

Q: What clinical research has been done historically in correctional facilities? Has it been done well?

George Annas: The history is pretty dark. It’s a history of research done without consent, without oversight, and without consequences. It starts in some respects with the Nazis, since Holocaust research—or pretend research, really—was done in prisoners to get scientific information for the German state. Another famous experience was John Charles Cutler’s 1940s experiments in Guatemalan prisons. In those experiments, prisoners were deliberately infected with gonorrhea, syphilis, and chancroid.

Lauren Brinkley-Rubinstein: There are lots of instances of prisoners being intentionally infected with diseases in order to develop new drugs, including malaria and hepatitis C. Horrible things happened at San Quentin [State Prison], including giving prisoners experimental testicular transplants. I think dark is the right word.

Q: Is any COVID-19 vaccine research taking place in correctional facilities? Has anyone put forward serious proposals to do such research?

L.B.R.: There was some conversation at the federal level at the initiation of large vaccine trials to include people involved in some way with the criminal justice system. My colleagues and I had a couple of phone calls with people involved in running those trials to see if it was something they’d entertain. There was some openness to it. But ultimately, including incarcerated populations felt too cumbersome. Between the ethical risks and the operational obstacles to actually get the sites up and running, it would have required a lot of extra effort.

G.A.: Up until recently, there’s really been no excuse to do research in these settings. But it’s a strange and perhaps intriguing group to study, because they’re almost definitely going to be exposed to the virus. So, it could give you answers you may not get if you trial the general population—who may not ever be exposed. That’s why we’re looking again. I’m not a big fan of prison research, but I am a big fan of science, so I think we should look at all these things again.

L.B.R.: Still, I think part of this conversation should be focused on people on probation or parole—the high-risk population that is criminal justice involved, but not presently incarcerated.

G.A.: Yeah. I’d be much more amenable to efforts to bring people on probation or parole into trials. They would be unshackled, literally, from some of the risks of exploitation we think about for prisoners who receive perks for “good” behavior and punishment for “bad” behavior.

Q: Could this kind of research actually benefit incarcerated people if they participate?

L.B.R.: It definitely could, assuming the vaccine works. Incarcerated people do have different risks, in terms of the barriers they face to getting certain elements of routine health care along with their potential to be exploited. But they also potentially would gain more from vaccination, given these settings are extreme amplifiers of infection.

G.A.: But the risk if an experimental vaccine doesn’t work is that these individuals won’t only be disappointed, but they’ll feel they were lied to or exploited.

L.B.R.: Another big part about why understanding these contexts is important is that we do eventually want vaccines to be made available to these populations. But there are lots of implementation issues that are very particular to jails and prisons. How do we store the vaccines under potentially very specific conditions? How do we monitor patients for side effects after injections? How we manage any needed follow-up, like a booster shot? We need to get expertise to optimize these programs when vaccines are eventually deployed. I don’t think that alone is justification to do a trial, but it is such a big part of vaccines being effective once they are approved. It’s something we’ll have to figure out.

Q: Could there be broader public health advantages for doing COVID-19 vaccine research in correctional facilities? Would experimental use of vaccines in correctional facilities benefit staff, neighboring communities, and more distant ones?

L.B.R.: If the experimental vaccines work, then the public health benefit of focusing vaccine resources—even during trials—on correctional facilities cannot be overemphasized. We’ve already seen that jail churn plays a tremendous role in community transmission.

G.A.: To me, it’s a different experiment. You can’t use community results to justify research on individuals. The risk-benefit analysis needs to come out right for the individual before they can consent to being in the trial.

Q: If such research is undertaken, how will we know whether ethical safeguards did enough to protect participants’ rights?

George Annas (left) and Lauren Brinkley-Rubinstein (right) GEORGE ANNAS AND LAUREN BRINKLEY-RUBINSTEIN

G.A.: There probably is no replacement for asking the participants themselves. Did they feel exploited? Did they feel used? Did they feel fulfilled? Did they feel part of something bigger?

L.B.R.: This is really at the crux of the issue. We’d have to ask, but also to appoint oversight boards that have prisoner representation. And we’d have to adopt other safeguards to ensure we are doing things ethically.

Q: Would giving prisoners the option to participate in a vaccine trial set a precedent for future research? What about continuing to withhold access?

G.A.: I think the question of “if not now, when?” is a very good one. We have a worldwide pandemic with a giant prisoner population that’s very susceptible to the disease and is dying from it. If we’re not going to permit research in that circumstance, we’re never going to permit it.

L.B.R.: Also, if we can figure out how to do this right—given the stakes right now—that could give back some element of power or respect that is otherwise not present in these places.

G.A.: It’s a question of whether we treat prisoners as human beings with agency, who are allowed to participate in something for the public good.

L.B.R.: Our approach to experimentation in prisons has been very binary: a history of serious abuses of power when we have run trials, versus the decision to completely avoid including prisoners in trials. We have to ask ourselves whether there’s a middle path.

G.A.: And considering a middle path, but then deciding it’s too much work—that would be an extreme position, too.

Q: As the prospect of an approved vaccine nears, fierce debate surrounds who should receive it first. According to current Centers for Disease Control and Prevention guidance, prisoners are not considered separate from the general population, putting them last in line. In contrast, a draft proposal released this month by the National Academies of Sciences, Engineering, and Medicine said prisoners should get vaccinated after health care workers, but before the general population. Where do you think incarcerated people belong on the priority list?

L.B.R.: Based on the evidence have about outbreaks, incarcerated people should be at the top tier. There’s a clear connection between what happens in these institutions and what happens in the community. When we have infections that spread in jails or prisons like wildfire, and staff going in and out and in and out, we’re making COVID infection more likely everywhere. If the only thing you cared about was your own health, you would still make the decision to prioritize them.

G.A.: People at the highest risk should receive the treatment first. That includes prisoners. It’s that simple, really. 

doi:10.1126/science.abe7861

As we are in the midst of the only Pandemic in recent history desperately in search of a vaccine, one must question the ethics employed in medical trails and the medical industries murky and dark history with experimentation not to mention fraud and scams. Without a current doubt those who find an effective vaccine will reap financial benefit. Every country on the globe is interested. Are you willing to take a vaccine? A health professional once stated, there is no profit in health. The profit is in disease. As many are trying to decided who should have the vaccine first and reporting in those population most affected by the corona virus, one must ask if these populations should also bare the brunt of clinical trials as well. Are clinical trials on unknowing and those not asked ever ethical and permissible?

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COVID 19 Cases on the Rise: Your States Stats

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Source: Wavy 10 – Norfolk, VA, USA
WASHINGTON (NEXSTAR) — As coronavirus cases in the United States climb towards another peak, new daily cases have reached their highest point yet in 17 states, according to the New York Times.

On Thursday, new confirmed cases climbed over the 65,000 mark — a total the country hasn’t seen since the end of July. Additionally, we’re seeing cases rise in more than 45 states, according to a Times tracking tool.

The U.S. leads the world with 7.9 million coronavirus cases and some 217,000 confirmed deaths. Globally, there have been 39 million reported cases and 1.09 million confirmed deaths.Pfizer coronavirus vaccine won’t be available before Election Day, CEO confirms.

As the nation experiences a 25% increase in confirmed cases, here’s a look at the states that are seeing the highest percentage increases in COVID-19 cases:

States seeing case increases (by percentages):

  • New Mexico – Average of 457 cases per day, an increase of 123 percent from the average two weeks earlier.
  • Vermont – Average of nine cases per day, an increase of 110 percent from the average two weeks earlier.
  • New Hampshire – Average of 78 cases per day, an increase of 101 percent from the average two weeks earlier.
  • Montana – Average of 611 cases per day, an increase of 91 percent from the average two weeks earlier.
  • Connecticut – Average of 326 cases per day, an increase of 80 percent from the average two weeks earlier.
  • Indiana – Average of 1,655 cases per day, an increase of 66 percent from the average two weeks earlier.
  • Wyoming – Average of 183 cases per day, an increase of 65 percent from the average two weeks earlier.
  • Alaska – Average of 193 cases per day, an increase of 64 percent from the average two weeks earlier.
  • Rhode Island – Average of 199 cases per day, an increase of 63 percent from the average two weeks earlier.
  • Arizona – Average of 763 cases per day, an increase of 59 percent from the average two weeks earlier.
  • Colorado – Average of 894 cases per day, an increase of 57 percent from the average two weeks earlier.
  • Michigan – Average of 1,483 cases per day, an increase of 56 percent from the average two weeks earlier.
  • Nebraska – Average of 767 cases per day, an increase of 55 percent from the average two weeks earlier.
  • North Dakota – Average of 610 cases per day, an increase of 54 percent from the average two weeks earlier.
  • Ohio – Average of 1,654 cases per day, an increase of 53 percent from the average two weeks earlier.
  • South Dakota – Average of 653 cases per day, an increase of 50 percent from the average two weeks earlier.
  • Mississippi – Average of 760 cases per day, an increase of 49 percent from the average two weeks earlier.
  • Illinois – Average of 3,069 cases per day, an increase of 48 percent from the average two weeks earlier.
  • Virginia – Average of 1,058 cases per day, an increase of 42 percent from the average two weeks earlier.
  • Pennsylvania – Average of 1,362 cases per day, an increase of 39 percent from the average two weeks earlier.
  • Tennessee – Average of 1,870 cases per day, an increase of 38 percent from the average two weeks earlier.
  • Idaho – Average of 660 cases per day, an increase of 37 percent from the average two weeks earlier.
  • North Carolina – Average of 1,943 cases per day, an increase of 36 percent from the average two weeks earlier.
  • New Jersey – Average of 835 cases per day, an increase of 35 percent from the average two weeks earlier.
  • West Virginia – Average of 251 cases per day, an increase of 33 percent from the average two weeks earlier.
  • Nevada – Average of 587 cases per day, an increase of 30 percent from the average two weeks earlier.
  • New York – Average of 1,329 cases per day, an increase of 29 percent from the average two weeks earlier.
  • Washington – Average of 659 cases per day, an increase of 29 percent from the average two weeks earlier.
  • Minnesota – Average of 1,312 cases per day, an increase of 28 percent from the average two weeks earlier.
  • Kentucky – Average of 980 cases per day, an increase of 27 percent from the average two weeks earlier.
  • Missouri – Average of 1,916 cases per day, an increase of 27 percent from the average two weeks earlier.
  • Wisconsin – Average of 3,124 cases per day, an increase of 25 percent from the average two weeks earlier.
  • Utah – Average of 1,216 cases per day, an increase of 23 percent from the average two weeks earlier.
  • Alabama – Average of 1,027 cases per day, an increase of 21 percent from the average two weeks earlier.
  • Oregon – Average of 345 cases per day, an increase of 21 percent from the average two weeks earlier.
  • Massachusetts – Average of 663 cases per day, an increase of 20 percent from the average two weeks earlier.
  • Kansas – Average of 788 cases per day, an increase of 19 percent from the average two weeks earlier.
  • Florida – Average of 2,711 cases per day, an increase of 18 percent from the average two weeks earlier.
  • Oklahoma – Average of 1,182 cases per day, an increase of 16 percent from the average two weeks earlier.
  • Georgia – Average of 1,409 cases per day, an increase of 14 percent from the average two weeks earlier.
  • Iowa – Average of 1,044 cases per day, an increase of 13 percent from the average two weeks earlier.
  • South Carolina – Average of 907 cases per day, an increase of 13 percent from the average two weeks earlier.
  • Arkansas – Average of 911 cases per day, an increase of 11 percent from the average two weeks earlier.
  • Maryland – Average of 589 cases per day, an increase of 11 percent from the average two weeks earlier.
  • Texas – Average of 4,587 cases per day, an increase of 8 percent from the average two weeks earlier.
  • Louisiana – Average of 543 cases per day, an increase of 7 percent from the average two weeks earlier.
  • Delaware – Average of 125 cases per day, an increase of 5 percent from the average two weeks earlier.
  • California – Average of 3,285 cases per day, an increase of 2 percent from the average two weeks earlier.

States seeing case decreases (by percentages):

  • Hawaii – Average of 89 cases per day, a decrease of 17 percent from the average two weeks earlier.
  • Maine – Average of 28 cases per day, a decrease of 9 percent from the average two weeks earlier.

Just when we think we are coming out of this pandemic and we struggle to get back to normal after the economic crisis that came along with the pandemic, we see many states still struggling with COVID 19 cases Norfolk, VA, USA included. While our cases continue to fluctuate our state is not one of the states that was hit the hardest by COVID 19 cases. We took a cautious and measured approach and it paid dividends. In fact as factors, such as going back to school and mere weather change, now have to be factored in, some of the European countries that were fairing better in the crisis are now seeing new and emerging struggles with COVID 19. COVID 19 has definitely taken its place in history. What solutions have worked well for your state? How are people adjusting to having to spend more times in doors, which has lead to less social distancing, due primarily to weather change and an increase in COVID 19 cases across the globe? What are you winter plans and how do you plan to maintain social distancing measures and keep your immune system strong? Remember, healthy is the New Normal! States such as Hawaii and California may likely fair better than other states like New York and Vermont where citizens will be forced to spend more time indoors in the warmth bracing against the cold winter weather while Hawaii and California can still take advantage of the fresh circulating air outdoors and easier means of social distancing.

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Coronavirus clinical trials are pausing over safety concerns – here’s what that means

covid 19 shidonna raven garden and cook

Source: CNBC
PUBLISHED THU, OCT 15 2020 6:00 AM EDT UPDATED THU, OCT 15 20209:02 PM EDT
Berkeley Lovelace Jr.@BERKELEYJR

  • J&J said Monday it paused the late-stage trial of its coronavirus vaccine candidate after a participant reported an “adverse event.”
  • Less than 24 hours later, Eli Lilly said its late-stage trial of its leading monoclonal antibody treatment for the coronavirus had been paused by U.S. health regulators over potential safety concerns.
  • Pauses to clinical trials are not uncommon, and the delays should reassure the public that the systems in place intended to protect volunteers are working, medical experts say.

Coronavirus clinical trials from drug giants Johnson & Johnson and Eli Lilly hit a snag this week after safety monitors halted them over bad reactions from participants.

J&J said Monday it paused the late-stage trial of its coronavirus vaccine candidate after a participant reported an “adverse event.” Less than 24 hours later, Eli Lilly said its late-stage trial of its leading monoclonal antibody treatment for the coronavirus had been paused by U.S. health regulators over potential safety concerns. The pauses are likely to add to concerns about the safeness of potential Covid-19 vaccines or treatments.

But pauses to clinical trials are not uncommon, and the delays should reassure the public that the systems in place intended to protect volunteers are working, medical experts said in phone interviews with CNBC.WATCH NOWVIDEO04:02Jim Cramer: Eli Lilly pausing antibody trial isn’t a big setback

The data and safety monitoring board, an independent group of experts who oversee U.S. clinical trials to ensure the safety of participants, recommends a pause to a clinical trial any time there is an “adverse event,” said Isaac Bogoch, an infectious disease specialist and professor at the University of Toronto. The pause will take as long as needed to gather all information and does not necessarily mean there is a problem with the vaccine or treatment, he said.

“The DSMB will say let’s push pause on this,” said Bogoch, who is also a member of the group and is overseeing other clinical drug trials. “They will say, ‘we need more data and let’s see if this person was in the vaccine group or in a placebo group.’ They’ll say, ‘let’s see what the actual illness is and use all the data at our disposal to determine whether this was a true side effect from the vaccine and if so, decide if it is safe to proceed with this study.’”

Pauses happen all the time, especially in large clinical trials with older adults, according to Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

Offit, a past member of the CDC’s Advisory Committee on Immunization Practices, said “adults get sick” and sometimes “they are going to get sick in the same period of time” of getting a vaccine or treatment.

“Johnson & Johnson’s vaccine is designed to prevent Covid-19. It is not designed to prevent everything else that happens in life,” he said. “You’re always going to be sorting out those temporal associations. Strokes, heart attacks, neurological problems. Always. You always err on the side of caution and make sure that this isn’t a problem and then continue again.”

Bogoch echoed those remarks, adding, “no one before Covid-19 cared when there was a pause on a clinical trial for an antibiotic or heart medication.”

“Never have we been in a scenario where you truly have 7 billion people watching intently and following every single bit of progress under a microscope,” he said. “You know, it’s fascinating and it’s good. It creates a more health literate community. There is only good that can come of it.”

He added a pause isn’t the same as a regulatory hold, sometimes referred to as a “clinical hold.”  A clinical hold is imposed by a health authority, like the Food and Drug Administration, he said.

“It’s a little more serious when you get to a regulatory hold,” he said. “That’s actually when the FDA steps in and say we’re concerned about a particular event and we’re going to stop this trial because we don’t think it’s safe to proceed with the data that we have available at this point in time.”

The FDA still has a late-stage clinical trial from AstraZeneca, a front-runner in the Covid-19 vaccine race, on hold in the United States. That means the company is unable to administer second doses of its two-dose vaccine regimen to U.S. participants.

The company announced on Sept. 8 that its trial had been put on hold due to an unexplained illness in a patient in the United Kingdom. The patient is believed to have developed inflammation of the spinal cord, known as transverse myelitis. The trial has since resumed in the U.K. and other countries but is still on hold in the U.S.

It remains unknown what reactions the participants in J&J’s and Eli Lilly’s trials had.

Offit said companies will sometimes claim they are protecting the confidentiality of the patient, but he disagreed with the behavior. “As long as you can’t identify the person, they can give you a fair amount of information about the person, but they don’t,” he said.

Dr. Mathai Mammen, global head of research and development at J&J’s Janssen arm, told investors on a conference call Tuesday that the company still had “very little information” on the reason for the holdup, including if the patient received the vaccine or the placebo. “It’ll be a few days at minimum for the right information to be gathered,” he added.

Dr. Ezekiel Emanuel, a former health advisor in the Obama administration, said it would “raise serious questions” if the participant received the vaccine.

“One adverse event is serious, especially when you’re considering a vaccine that you’re going to roll out to tens, hundreds of millions of people, maybe even billions,” he said Tuesday on CNBC’s “Squawk Box.” “That’s the ultimate concern.”

Eli Lilly and the National Institutes of Health did not disclose what the “safety” concern was either, but Eli Lilly said it was “supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study.”

“Safety is of the utmost importance to Lilly. We are aware that, out of an abundance of caution, the ACTIV-3 independent data safety monitoring board (DSMB) has recommended a pause in enrollment,” spokeswoman Molly McCully told CNBC. 

Indeed, the whole world is on edge for the first time in “modern” history with over 1 Million dead global (as reported by Wikipedia) from COVID 19 and even more cases. People are waiting for a solution and the end of the pandemic. How important is a vaccine to you and yours? Is a safe and effective vaccine more important to you than simply a vaccine? Will you take the vaccine once it is here?

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