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Global report: Germany may extend lockdown as Covid cases in Italy soar

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Record daily infections in Germany; Naples hospitals at risk of being overwhelmed; France reports slowdown in rate of new cases

Jon HenleyKate Connolly in Berlin and Angela Giuffrida in Rome

Fri 13 Nov 2020 12.14 ESTLast modified on Fri 13 Nov 2020 23.36 EST
Source: The Guardian

  • Germany’s partial lockdown could be extended beyond the end of the month and hospitals in parts of Italy are near breaking point as Covid-19 cases continued to surge in both countries, despite positive signs elsewhere in Europe.

New daily coronavirus cases in Germany hit a record of 23,542 on Friday, the Robert Koch Institute for infectious diseases reported, prompting government spokesman Stefan Seibert to say measures “were not expected to be relaxed” by next week.

Federal and regional leaders are due to meet on Monday to discuss whether the country’s closure of all gyms and entertainment venues has slowed the disease’s spread, but the health minister, Jens Spahn, said it was too early to say.Advertisement

“We will see in the next few days whether they are making a difference,” Spahn said. Winter gatherings and festivities such as office Christmas parties were in any event unlikely to go ahead.

Christmas markets, traditional St Martin’s Day parades and Germany’s carnival season, which should have started this week, have all been cancelled, while more than 300,000 school pupils are in quarantine along with about 30,000 teachers.

The southern Italian city of Naples, meanwhile, was braced for further restrictions as hospitals risked becoming overwhelmed by new cases, with medics forced to bring oxygen tanks outside to treat desperate patients waiting in their cars.

“The situation in Campania is out of control,” the Italian foreign minister, Luigi Di Maio, said after a video emerged showing an 84-year-old man dead in a hospital bathroom where he had been waiting for a Covid test. “We need urgent restrictions… people are dying.”

Hundreds of people from Campania have been travelling to neighbouring Lazio in search of urgent medical help as political wrangling continues over whether to impose a total lockdown in the region.Advertisement

Campania is expected to be upgraded to the “red zone” from Sunday, meaning people will have to stay home unless going out for work, shopping or medical reasons, and bars, restaurants and most shops will close.

Italy’s alternative approach to the crippling nationwide lockdown it imposed during the first wave this spring has had little apparent success so far, with total infections passing the million mark this week and cases rising at more than 30,000 a day.

Confirmed cases in Portugal pushed past 200,000 with new daily infections reaching a record high of 6,653 and a new record of 2,799 Covid patients in hospital. A state of emergency due to last until 23 November is likely to be extended.

“When we reach the peak of the disease, it will still take weeks to see a drop in demand for hospitals and even more weeks to reduce the fatality count,” the health minister, Marta Temido, told a news conference.

The French prime minister, Jean Castex, on Friday said upcoming regional elections due in March should be delayed until June, a day after confirming the country’s two week-old lockdown would not be eased for at least another fortnight.

While the rate of increase continues to slow significantly, France has the fourth highest number of confirmed cases in the world, at almost 1.9 million, and the number of people in hospital with the coronavirus has reached a new all-time high of 32,638.

Castex said France could start to loosen restrictions from 1 December providing case numbers continue to fall, first by allowing non-essential shops to re-open. But bars and restaurants would not be permitted to resume operating until later still, he said.

Several European countries including France, Belgium, the Netherlands, the Czech Republic and Ireland have reported a slowdown in new infections since introducing strict new measures last month, but hospital services remain under severe pressure.

Ireland’s prime minister, Micheál Martin, said on Friday the country may embark on a staged approach after 1 December, with the aim of having restrictions eased by the run-up to Christmas “because I do get that people will want to meet with family”.Advertisement

Elsewhere, however, infections continue to soar. Sweden recorded a record 5,990 new cases on Friday, its highest since the start of the pandemic, the national health agency said, as well as 42 new deaths taking its overall toll to 6,164.

The Scandinavian country, which has a Covid death tally per million inhabitants many times higher than its Nordic neighbours, is battling a second wave that health officials had hoped its light-touch, anti-lockdown approach would mitigate.

Russia, which has the world’s fifth largest number of cases, also reported a record 21,983 infections as Moscow prepared to close restaurants, bars and nightclubs on Friday between 11pm and 6am until mid-January in an effort to contain the pandemic.

Officials warned of raids and fines for establishments that do not comply. The capital has also moved university and college students to online learning and recommended that school children, already learning from home, keep travel to a minimum.

Beyond Europe, the virus is returning to New York City after it was in effect banished over the summer, with the city’s seven-day average of positive Covid-19 tests climbing to 2.6% on 11 November.

The governor, Andrew Cuomo, urged New Yorkers to “do their part” and “take this seriously” as officials started rolling back some reopenings, prompting fears of more dramatic lockdowns loom and possibly schools closures.

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Many health care professionals warned about a second wave. We can now see that numbers are on the rise any many parts of the world and even here in Virginia. Where are you? Have the number of COVID 19 cases risen in your area? Why?

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As virus cases rise, Navy limits sailors’ travel, activity

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By BEN FINLEY, November 17, 2020
Source: AP News

NORFOLK, Va. (AP) — U.S. Navy bases and personnel in Virginia’s Hampton Roads region were ordered Tuesday to limit travel and other activities as coronavirus cases rise.

The Navy said in a statement that the order was issued by Rear Adm. Charles W. Rock of Navy Region Mid-Atlantic. It impacts the world’s largest Navy base in Norfolk and several other installations throughout the region, including a large air station in Virginia Beach.

Sailors’ travel will be restricted to commuting from home to work, with stops only for essential goods and services such as food, medicine and child care. Dining inside restaurants is not allowed. Neither is using off-base gyms and barber shops.

The order also prohibits participation in team sports and bans social gatherings in sailors’ homes that have more than 10 guests who don’t live there.

“The health and safety of our Navy family is our number one priority,” Rock said in a statement. “We’ve been fighting this virus for a long time, but we’ve still got some more work to do and can’t give in to fatigue.”

The region’s Navy installations were operating at a less restrictive level since Sept. 23.

The Navy’s order follows one by Virginia Gov. Ralph Northam that took effect Sunday at midnight and implemented new restrictions across the state. They include reducing the cap on gatherings from 250 people to 25 people and prohibiting alcohol sales at dining and drinking establishments after 10 p.m.

“COVID-19 is surging across the country, and while cases are not rising in Virginia as rapidly as in some other states, I do not intend to wait until they are. We are acting now to prevent this health crisis from getting worse,” Northam, who is a physician, said on Friday.

Over the past two weeks, the rolling average number of daily new cases in Virginia has increased by more than 20%, according to an Associated Press analysis of data from the COVID Tracking Project.

There also were nearly 250 new cases per 100,000 people in Virginia, which ranks 46th in the country for new cases per capita, according to AP’s analysis. One in every 763 people in Virginia tested positive for the virus in the past week.

Where are you located? Where does your state rank with regard to COVID 19 cases? Why?

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Opinion: For now, it’s unethical to use human challenge studies for SARS-CoV-2 vaccine development

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Source: Proceedings of the National Academy of Sciences of the USA

 View ORCID ProfileJeffrey P. Kahn,  View ORCID ProfileLeslie Meltzer Henry,  View ORCID ProfileAnna C. Mastroianni,  View ORCID ProfileWilbur H. Chen, and  View ORCID ProfileRuth MacklinPNAS November 17, 2020 117 (46) 28538-28542; first published October 29, 2020;

The prospect of a widely available severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine is an increasingly high priority for an effective response to the coronavirus disease 2019 (COVID-19) pandemic and an area of intense interest and attention for professionals, politicians, and the public alike. The understandable desire for such a vaccine has led to significant discussion and even some planning for the possibility of human challenge studies (HCS) as a tool for accelerating the process for identifying, testing, and developing an effective vaccine (13).

Typically, undertaking HCS in vaccine development requires that the disease for which a challenge would be introduced either has an available rescue therapy to treat those who become infected or the disease is known to be self-limiting. There is no rescue therapy for SARS-CoV-2 infection, and proponents of HCS have claimed that the infection is likely to be self-limiting and mild in young, healthy volunteers based on current understanding of the infection. If accurate, the basic requirements for undertaking an HCS could be met if conducted with that population. Proponents further argue that such HCS are ethically acceptable in the current pandemic. Most critically, they contend that these studies are likely to speed the development of effective vaccines.

But based on our assessment of these arguments, we disagree. We believe it is unethical to move forward with such trials at the current time. Whereas proponents of these studies suggest that such studies will accelerate the time to approved vaccines, the facts fail to support these claims. HCS to address SARS-CoV-2 face unacceptable ethics challenges, and, further, undertaking them would do a disservice to the public by undermining already strained confidence in the vaccine development process.

Accelerating Vaccine Approval

There is general consensus among researchers, ethicists, and oversight bodies that HCS can be ethical, provided certain conditions are satisfied (46). Key among those criteria is the requirement that HCS generate sufficient social value to justify exposing healthy volunteers to uncertain risks with no prospect of direct benefit. Proponents of SARS-COV-2 HCS, notably a nonprofit called 1DaySooner started in April to advocate for such trials (7), contend that such studies will provide “enormous social value” by accelerating the timeframe for vaccine development and distribution, thereby saving thousands of lives (8).

The acceleration argument relies on several interconnected assumptions that prove problematic under deeper scrutiny. The first is that SARS-CoV-2 HCS can provide vaccine efficacy data faster than the standard vaccine pathway. Although comparative speed is an accepted scientific justification for conducting HCS, its conventional application is to circumstances in which conducting field studies would be prohibitively difficult because the target pathogen is rarely transmitted in the natural local environment (9). The opposite is true of conducting HCS in a pandemic environment. During the Zika pandemic, for instance, the ability to conduct field trials played a prominent role in a federal ethics committee determination that it was premature to proceed with Zika virus HCS (10). Widespread transmission of SARS-CoV-2 is already facilitating close to 10 active Phase III trials of SARS-CoV-2 vaccine candidates (11). With more field studies likely to follow, the necessity and relative speed of HCS becomes even less compelling.

Technical and logistical aspects of developing and implementing HCS further undercut the assumption that SARS-CoV-2 HCS would result in a viable vaccine faster than the traditional vaccine pathway. Before initiating definitive SARS-CoV-2 efficacy HCS, researchers must develop a suitable challenge model. This requires carefully selecting the challenge strain, manufacturing it in a BSL-3 laboratory that adheres to current Good Manufacturing Practice (cGMP), receiving regulatory approval from the Food and Drug Administration (FDA) or other regulator to administer it to human volunteers, and conducting dose-escalation studies to determine the target dose of the challenge agent that will elicit the level of illness necessary for determining the primary outcome of the efficacy studies. Vaccine experts estimate that in the context of SARS-CoV-2 HCS those steps will collectively take one to two years to complete, leading them to conclude that such studies are “unlikely to accelerate the establishment of vaccine efficacy” (12).

Ultimately, the social value of SARS-CoV-2 HCS (in terms of deaths averted) hinges on the premise that people at greatest risk of COVID-19–related mortality will receive a safe and efficacious vaccine sooner than they would without HCS.

Even if SARS-CoV-2 HCS were to accelerate vaccine development, it is unclear that the FDA will consider data from HCS in its licensing decision. Although the FDA’s recent approval of a cholera vaccine based on efficacy data from HCS might signal the agency’s willingness to make similar determinations in the future (13), the agency is not likely to do so in the context of SARS-CoV-2. The FDA’s latest Guidance for Industry on developing SARS-CoV-2 vaccines not only omits HCS from its discussion of expedited trial designs but also states that to meet vaccine approval standards, “late phase clinical trials…will likely need to enroll many thousands of participants,” including “adequate representation of elderly individuals and individuals with medical comorbidities” (14). Although it is conceivable that HCS initiated 12–24 months from now could generate efficacy data to support the necessary Phase III results for licensing (12), those HCS would not accelerate the current pathway, in which multiple Phase III trials are underway and a licensed vaccine is possible within 6 months.

Ultimately, the social value of SARS-CoV-2 HCS (in terms of deaths averted) hinges on the premise that people at greatest risk of COVID-19–related mortality will receive a safe and efficacious vaccine sooner than they would without HCS. Those high-risk groups include older adults and people who are immunocompromised or have comorbidities, as well as members of Black, Latinx, and Native American communities—groups who are, as emerging evidence demonstrates, at disproportionate risk of serious COVID-19–related outcomes (15). Current proposals and guidelines for conducting SARS-CoV-2 HCS, however, recommend only enrolling young, healthy adults (781617). Although that strategy arguably reduces the risks associated with HCS, it jeopardizes the generalizability of trial results (1819).

Because the safety and efficacy of vaccine formulations and dosing may differ between populations (e.g., based on age), the social value of HCS—in terms of reducing mortality among those at greatest risk—is likely limited. Moreover, the social value of vaccines depends in large part on whether people get vaccinated (20). Ongoing, standard SARS-CoV-2 vaccine trials, however, are currently struggling to recruit participants from some communities of color, and in recent polls respondents who self-identified as Black were more than twice as likely as white respondents to be leery of taking a SARS-CoV-2 vaccine (21). Well-intentioned recruitment from communities of color into HCS may nevertheless evoke historical mistrust over discrimination in research and elicit concerns of exploitation, either of which could detrimentally impact vaccine uptake in at-risk communities.

Acceptable Risk–Benefit

For research to be ethically sound, the relationship between risks and potential benefits must be reasonable. IRBs are charged with making that assessment, but in the case of human challenge studies, knowledge about infection with SARS-CoV-2 and potential resulting COVID-19 illness continues to evolve; many unknowns remain. Despite the earlier belief that young, healthy adults (the proposed subjects) experience a mild form of COVID-19 and recover quickly, recent data have revealed that this population can experience significant adverse effects when they become infected (2224). An additional shortcoming of HCS is that some risks of the vaccine itself may emerge only when a larger number of individuals have been vaccinated.

Because the proposed HCS will enroll only young adults, the result is a much narrower potential benefit than proponents have assumed. Vaccine trials using the standard methodology would still be needed to ensure safety and efficacy for the vast numbers of people who do not fit the narrow inclusion criteria of HCS.

Taken together, these considerations make it virtually impossible for IRBs to make an appropriate assessment of the risk–benefit balance. If the potential benefit is low because Phase III field efficacy studies would still be necessary, and larger numbers of participants would be needed to obtain adequate safety data, this would call into question an acceptable balance of benefits over the risks to participants in HCS.

The uncertainty of information about risks to participants from both the infection and the vaccine makes adequate disclosure next to impossible in the informed consent process. Along with the unknown potential benefits to groups other than the age cohort in the study, accurate, detailed information in informed consent documents is bound to be limited. Despite acknowledgment in consent forms that participants may not experience direct benefits from the experimental intervention, it is entirely possible that volunteers may labor under a “preventive misconception” that they will receive some protection from infection by their participation. This is analogous to the so-called “therapeutic misconception” in research on experimental therapies, in which research subjects agree to participate in part based on the misconception that they are likely to gain some therapeutic benefit as a result.

Very little has been said so far in the literature about payment or other incentives to potential HCS volunteers (2526). A misconception about immunological protection is only one of several such incentives, which could include monetary payments, a common inducement in HCS for other diseases. More information is needed about such incentives or misconceptions before IRBs can meaningfully assess the ethical acceptability of proposed HCS for COVID-19.

Resources Required

Current arguments in favor of SARS-CoV-2 HCS fail to account for the pandemic realities of global, national, and local resource constraints and the extent to which diversion of scarce health care resources could compromise local pandemic response.

We find such HCS proposals to be flawed in their core claim about speeding vaccine development, and we believe that the risk–benefit balance for such HCS is both too uncertain and likely to be unacceptable, even with greater information.

Any proposed SARS-CoV-2 HCS would necessarily provide all medical care for study participants who become infected during the trial. Some have even advocated that participants receive “priority” access to critical care resources (clinical support, ventilators, drugs, and other interventions) “notwithstanding the possibility of severe shortages” (16). Others who have closely examined the ethical requirements for these trials, in contrast, argue convincingly that HCS sponsors should be required to show that HCS do not “unduly compete for scarce resources” that affect local pandemic response (5).

As part of a risk minimization strategy, trial sites should be geographically located in high prevalence areas to reduce the risk associated with intentional infection [i.e., recruiting those who have an otherwise high baseline risk of exposure (16)]. Unfortunately, these are areas with the most demands on essential public health resources.

The reality is that essential supplies for conducting SARS-CoV-2 HCS are already limited because of the pandemic (18), with communities, states, and even national governments competing for access (e.g., personal protective equipment, ventilators, oxygen, supportive care, treatments such as remdesivir and convalescent plasma, and even testing). Human resources are similarly strained by the pandemic, and HCS may remove critical trained personnel from provision of urgent health care: Highly sought-after health care workers on the study team must have training in biocontainment and infection control, and planning must further account for worker quarantine and medical treatment if they test positive.

We believe that the unique impact that a SARS-CoV-2 HCS places on scarce and already strained resources during a pandemic must be given considerable weight in any justification of these trials. In contrast to community-based field studies, which are effectively outpatient rather than inpatient trials, a SARS-CoV-2 HCS will place greater demands on medical resources, including specially trained personnel, biocontainment units, and dedicated hospital rooms. Decisions to further burden an already battered public health system with intentional infection—including the potential for unintentional release—will involve hard choices and consultation with, and buy-in from, affected stakeholders, including public health authorities, regulators, regional and local institutions, health care providers, and communities already hard hit by infection. Coordination is essential to ensure that decisions are not made unilaterally (27). These efforts will take time, further slowing any hoped for promise of acceleration.

HCS and Public Mistrust

Undertaking an HCS in the context of this pandemic risks fueling and potentially worsening levels of public mistrust. All aspects of the public health response to the pandemic have been politicized, feeding concerns across a wide spectrum of the population (20). This includes those traditionally skeptical about vaccine policy (so-called anti-vaxxers) as well as proponents of vaccine development and drug discovery who fear that approval will be hasty in response to intense political pressures, a concern only reinforced by both Russian and Chinese “approval” of candidate vaccines that had not gone through a phase III trial. Concerns within the science community have prompted hundreds of medical and public health experts to issue an open letter to the FDA calling for assurances that full and transparent review of vaccine candidates will be undertaken, and nine pharmaceutical companies have felt the need to make a collective pledge “to uphold the integrity of the scientific process” (2829). Introducing HCS that do not meet basic principles of research ethics and vaccine development are likely to play into concerns that shortcuts are being taken and that science is being politicized, further undermining public trust (19).

In sum, the severity of COVID-19, and the lack of a cure or effective treatment, make it unethical, at this point in time, to institute HCS for the development of a SARS-CoV-2 vaccine. We think proponents’ core claim about speeding vaccine development is flawed, and we believe that the risk–benefit balance for such HCS is both too uncertain and likely to be unacceptable, even with greater information. In addition, issues of resource allocation are critically important and difficult to justify. Vaccine trials aiming to undertake risky and uncertain steps in human subject research—particularly those that depart from standard approaches to protection of subjects in HCS—risk further exacerbating increasing levels of public mistrust related to SARS-CoV-2 vaccine development. Taken together, we believe that these arguments make undertaking SARS-CoV-2 HCS both unwarranted and unethical. At this critical moment in the response to the pandemic, it would do more harm than good.


  • The authors declare no competing interest.
  • Any opinions, findings, conclusions, or recommendations expressed in this work are those of the authors and have not been endorsed by the National Academy of Sciences.

Published under the PNAS license.


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View Abstract

Like many things, there are different opinions regarding COVID 19 trails and the vaccines that are produced from them even within the medical and science communities. Will you take the vaccine? Why? Why not?

Share your comments with the community by posting them below. Share the wealth of health with your friends and family by sharing this article with 3 people today. As always you are the best part of what we do. Keep sharing!

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The End of the Pandemic Is Now in Sight

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A year of scientific uncertainty is over. Two vaccines look like they will work, and more should follow.
Source: The Atlantic

Editor’s Note: The Atlantic is making vital coverage of the coronavirus available to all readers. Find the collection here.

For all that scientists have done to tame the biological world, there are still things that lie outside the realm of human knowledge. The coronavirus was one such alarming reminder, when it emerged with murky origins in late 2019 and found naive, unwitting hosts in the human body. Even as science began to unravel many of the virus’s mysteries—how it spreads, how it tricks its way into cells, how it kills—a fundamental unknown about vaccines hung over the pandemic and our collective human fate: Vaccines can stop many, but not all, viruses. Could they stop this one?

The answer, we now know, is yes. A resounding yes. Pfizer and Moderna have separately released preliminary data that suggest their vaccines are both more than 90 percent effective, far more than many scientists expected. Neither company has publicly shared the full scope of their data, but independent clinical-trial monitoring boards have reviewed the results, and the FDA will soon scrutinize the vaccines for emergency use authorization. Unless the data take an unexpected turn, initial doses should be available in December.

The tasks that lie ahead—manufacturing vaccines at scale, distributing them via a cold or even ultracold chain, and persuading wary Americans to take them—are not trivial, but they are all within the realm of human knowledge. The most tenuous moment is over: The scientific uncertainty at the heart of COVID-19 vaccines is resolved. Vaccines work. And for that, we can breathe a collective sigh of relief. “It makes it now clear that vaccines will be our way out of this pandemic,” says Kanta Subbarao, a virologist at the Doherty Institute, who has studied emerging viruses.

The invention of vaccines against a virus identified only 10 months ago is an extraordinary scientific achievement. They are the fastest vaccines ever developed, by a margin of years. From virtually the day Chinese scientists shared the genetic sequence of a new coronavirus in January, researchers began designing vaccines that might train the immune system to recognize the still-unnamed virus. They needed to identify a suitable piece of the virus to turn into a vaccine, and one promising target was the spike-shaped proteins that decorate the new virus’s outer shell. Pfizer and Moderna’s vaccines both rely on the spike protein, as do many vaccine candidates still in development. These initial successes suggest this strategy works; several more COVID-19 vaccines may soon cross the finish line. To vaccinate billions of people across the globe and bring the pandemic to a timely end, we will need all the vaccines we can get.

But it is no accident or surprise that Moderna and Pfizer are first out of the gate. They both bet on a new and hitherto unproven idea of using mRNA, which has the long-promised advantage of speed. This idea has now survived a trial by pandemic and emerged likely triumphant. If mRNA vaccines help end the pandemic and restore normal life, they may also usher in a new era for vaccine development.

The human immune system is awesome in its power, but an untrained one does not know how to aim its fire. That’s where vaccines come in. They present a harmless snapshot of a pathogen, a “wanted” poster, if you will, that primes the immune system to recognize the real virus when it comes along. Traditionally, this snapshot could be in the form of a weakened virus or an inactivated virus or a particularly distinctive viral molecule. But those approaches require vaccine makers to manufacture viruses and their molecules, which takes time and expertise. Both are lacking during a pandemic caused by a novel virus.

mRNA vaccines offer a clever shortcut. We humans don’t need to intellectually work out how to make viruses; our bodies are already very, very good at incubating them. When the coronavirus infects us, it hijacks our cellular machinery, turning our cells into miniature factories that churn out infectious viruses. The mRNA vaccine makes this vulnerability into a strength. What if we can trick our own cells into making just one individually harmless, though very recognizable, viral protein? The coronavirus’s spike protein fits this description, and the instructions for making it can be encoded into genetic material called mRNA.

Both vaccines, from Moderna and from Pfizer’s collaboration with the smaller German company BioNTech, package slightly modified spike-protein mRNA inside a tiny protective bubble of fat. Human cells take up this bubble and simply follow the directions to make spike protein. The cells then display these spike proteins, presenting them as strange baubles to the immune system. Recognizing these viral proteins as foreign, the immune system begins building an arsenal to prepare for the moment a virus bearing this spike protein appears.

This overall process mimics the steps of infection better than some traditional vaccines, which suggests that mRNA vaccines may provoke a better immune response for certain diseases. When you inject vaccines made of inactivated viruses or viral pieces, they can’t get inside the cell, and the cell can’t present those viral pieces to the immune system. Those vaccines can still elicit proteins called antibodies, which neutralize the virus, but they have a harder time stimulating T cells, which make up another important part of the immune response. (Weakened viruses used in vaccines can get inside cells, but risk causing an actual infection if something goes awry. mRNA vaccines cannot cause infection because they do not contain the whole virus.) Moreover, inactivated viruses or viral pieces tend to disappear from the body within a day, but mRNA vaccines can continue to produce spike protein for two weeks, says Drew Weissman, an immunologist at the University of Pennsylvania, whose mRNA vaccine research has been licensed by both BioNTech and Moderna. The longer the spike protein is around, the better for an immune response.

All of this is how mRNA vaccines should work in theory. But no one on Earth, until last week, knew whether mRNA vaccines actually do work in humans for COVID-19. Although scientists had prototyped other mRNA vaccines before the pandemic, the technology was still new. None had been put through the paces of a large clinical trial. And the human immune system is notoriously complicated and unpredictable. Immunology is, as my colleague Ed Yong has written, where intuition goes to die. Vaccines can even make diseases more severe, rather than less. The data from these large clinical trials from Pfizer/BioNTech and Moderna are the first, real-world proof that mRNA vaccines protect against disease as expected. The hope, in the many years when mRNA vaccine research flew under the radar, was that the technology would deliver results quickly in a pandemic. And now it has.

“What a relief,” says Barney Graham, a virologist at the National Institutes of Health, who helped design the spike protein for the Moderna vaccine. “You can make thousands of decisions, and thousands of things have to go right for this to actually come out and work. You’re just worried that you have made some wrong turns along the way.” For Graham, this vaccine is a culmination of years of such decisions, long predating the discovery of the coronavirus that causes COVID-19. He and his collaborators had homed in on the importance of spike protein in another virus, called respiratory syncytial virus, and figured out how to make the protein more stable and thus suitable for vaccines. This modification appears in both Pfizer/BioNTech’s and Moderna’s vaccines, as well as other leading vaccine candidates.

The spectacular efficacy of these vaccines, should the preliminary data hold, likely also has to do with the choice of spike protein as vaccine target. On one hand, scientists were prepared for the spike protein, thanks to research like Graham’s. On the other hand, the coronavirus’s spike protein offered an opening. Three separate components of the immune system—antibodies, helper cells, and killer T cells—all respond to the spike protein, which isn’t the case with most viruses.

In this, we were lucky. “It’s the three punches,” says Alessandro Sette. Working with Shane Crotty, his fellow immunologist at the La Jolla Institute, Sette found that COVID-19 patients whose immune systems can marshal all three responses against the spike protein tend to fare the best. The fact that most people can recover from COVID-19 was always encouraging news; it meant a vaccine simply needed to jump-start the immune system, which could then take on the virus itself. But no definitive piece of evidence existed that proved COVID-19 vaccines would be a slam dunk. “There’s nothing like a Phase 3 clinical trial,” Crotty says. “You don’t know what’s gonna happen with a vaccine until it happens, because the virus is complicated and the immune system is complicated.”

Experts anticipate that the ongoing trials will clarify still-unanswered questions about the COVID-19 vaccines. For example, Ruth Karron, the director of the Center for Immunization Research at Johns Hopkins University, asks, does the vaccine prevent only a patient’s symptoms? Or does it keep them from spreading the virus? How long will immunity last? How well does it protect the elderly, many of whom have a weaker response to the flu vaccine? So far, Pfizer has noted that its vaccine seems to protect the elderly just as well, which is good news because they are especially vulnerable to COVID-19.

Several more vaccines using the spike protein are in clinical trials too. They rely on a suite of different vaccine technologies, including weakened viruses, inactivated viruses, viral proteins, and another fairly new concept called DNA vaccines. Never before have companies tested so many different types of vaccines against the same virus, which might end up revealing something new about vaccines in general. You now have the same spike protein delivered in many different ways, Sette points out. How will the vaccines behave differently? Will they each stimulate different parts of the immune system? And which parts are best for protecting against the coronavirus? The pandemic is an opportunity to compare different types of vaccines head-on.

If the two mRNA vaccines continue to be as good as they initially seem, their success will likely crack open a whole new world of mRNA vaccines. Scientists are already testing them against currently un-vaccinable viruses such as Zika and cytomegalovirus and trying to make improved versions of existing vaccines, such as for the flu. Another possibility lies in personalized mRNA vaccines that can stimulate the immune system to fight cancer.

But the next few months will be a test of one potential downside of mRNA vaccines: their extreme fragility. mRNA is an inherently unstable molecule, which is why it needs that protective bubble of fat, called a lipid nanoparticle. But the lipid nanoparticle itself is exquisitely sensitive to temperature. For longer-term storage, Pfizer/BioNTech’s vaccine has to be stored at –70 degrees Celsius and Moderna’s at –20 Celsius, though they can be kept at higher temperatures for a shorter amount of time. Pfizer/BioNTech and Moderna have said they can collectively supply enough doses for 22.5 million people in the United States by the end of the year.

Distributing the limited vaccines fairly and smoothly will be a massive political and logistical challenge, especially as it begins during a bitter transition of power in Washington. The vaccine is a scientific triumph, but the past eight months have made clear how much pandemic preparedness is not only about scientific research. Ensuring adequate supplies of tests and personal protective equipment, providing economic relief, and communicating the known risks of COVID-19 transmission are all well within the realm of human knowledge, yet the U.S. government has failed at all of that.

The vaccine by itself cannot slow the dangerous trajectory of COVID-19 hospitalizations this fall or save the many people who may die by Christmas. But it can give us hope that the pandemic will end. Every infection we prevent now—through masking and social distancing—is an infection that can, eventually, be prevented forever through vaccines.

Will you take the vaccine? How do you think the vaccine will impact the pandemic? How has the pandemic impacted you and yours?

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The Long, Strange History of Bill Gates Population Control Conspiracy Theories

Source: Type Investigation
How the billionaire philanthropist displaced George Soros as the chief bogeyman of the right.

PHOTO BY WILLIAM WEST/AFP VIA GETTY IMAGESAnti-vaccine protesters in Melbourne, Australia on May 10, 2020.

Three months into the global pandemic, Bill Gates has displaced George Soros as the chief bogeyman of the right.


In April, dozens of Texans crowded around Infowars host Alex Jones at an anti-shutdown demonstration in Austin, Texas, chanting “arrest Bill Gates.” A New York-based tech nonprofit falsely rumored to be working with the Bill and Melinda Gates Foundation to implant vaccine microchips in people received so many death threats that it contacted the FBI. And a White House petition demanding the billionaire’s foundation be investigated for “medical malpractice and crimes against humanity” amassed half-a-million signatures in three weeks.

Gates, who has announced that his $40 billion-foundation will shift its “total attention” to fighting COVID-19, has been accused of a range of misdeeds, from scheming to profit off a vaccine to creating the virus itself. On April 8, Fox News host Laura Ingraham and Attorney General Bill Barr speculated about whether Gates would use digital certificates to monitor anyone who got vaccinated.


  • Accusations that Bill Gates has sinister plans to control or experiment on the public under the guise of medical charity date back at least a decade, in part to an obscure political fight in Ghana. 

A Christian Right broadcaster, Brannon Howse of “Worldview Watch,” warned that Gates and the “medical globalist deep state” were using the crisis to regulate people’s fertility depending on their worldview, through “procreation tickets” and microchips. On Instagram, anti-vaccination activist Robert F. Kennedy, Jr., posted a video featuring a “1984”-style audience listening to Gates, with text declaring that the Microsoft Corp. co-founder “is conducting global social and medical experimentation,” via the World Health Organization. The New York Times noted that misinformation about Gates has become “the most widespread of all coronavirus falsehoods” trending online.ARINDAM SHIVAANI/NURPHOTO VIA GETTY IMAGES

An anti-lockdown rally in Toronto, Canada, on April 25, 2020.

But while these themes have fed the imagination of QAnonPizzagate and anti-vaccination proponents since January, conspiracy theories involving Gates actually have a much longer history. Accusations that he has sinister plans to control or experiment on the public under the guise of medical charity date back at least a decade, including to an obscure and different political fight in Ghana.

A New War Over Birth Control In Africa

In 2010, a former staffer with a government health initiative in Ghana made a shocking claim: a project partially funded by the Gates Foundation had tested the contraceptive Depo-Provera on unsuspecting villagers in the remote region of Navrongo, as part of an illicit “population experiment.” The woman making the charge was the Ghanian-born, U.S.-educated communications officer for another Gates-funded initiative by the Ghanaian government and Columbia University to use mobile phones to improve health care access for rural women and children. She had previously attempted to sue her employer for a multi-million dollar settlement when, after repeated clashes with her boss, her contract wasn’t renewed.

The lawsuit fizzled, but with help from a small U.S. nonprofit called the Rebecca Project for Human Rights, she shopped a series of stories to Ghana’s tabloid press. The Depo-Provera story caused a national scandal. Although it was denounced by Ghanaian health professionals and traditional leaders as libelous—the Navrongo project hadn’t tested any medications— so many death threats were directed at the project that some staff had to be evacuated across the Burkina Faso border.

  • The new narrative was that Gates was waging “chemical warfare on poor women” in a neocolonial effort to suppress African births. 

The episode would mark the opening shot in a new war over birth control in Africa. It also reflected an evolution in the U.S. anti-abortion movement’s strategy in which it started to co-opt the language of women’s and civil rights used by progressives. There were fewer bloody fetus posters and more talk about how abortion and contraception violated women’s safety and impeded racial justice.

Anti-abortion groups hired black activists and highlighted uglier aspects of the history of reproductive health care — in particular, the courting of the eugenics movement by Planned Parenthood founder Margaret Sanger in the early part of the 20th century. A right-wing documentary, Maafa 21: Black Genocide in 21st Century America, used a Swahili word that refers to the holocaust of African enslavement to denounce Planned Parenthood as racist. Billboards in Atlanta and Manhattan carried messages like, “The most dangerous place for an African American is in the womb.” And federal and state legislators proposed a series of bills banning race- and sex-selective abortions in order to insinuate that abortion providers deliberately target communities of color.


  • Thinly sourced research from a small nonprofit, The Rebecca Project, suggested a massive international conspiracy, led by the Gates Foundation, to push dangerous contraceptives on poor black women as a means of decreasing African births. 

As black feminists pointed out, these groups cared little for women’s or civil rights in general, or black women’s well-being in particular. (A 2009 U.S. House bill titled the “Susan B. Anthony and Frederick Douglass Prenatal Nondiscrimination Act” was co-sponsored by a champion of the Confederate flag.)

But the strategy exploited the real and painful history of medical abuses against people of color in the U.S., from compulsory or coercive sterilization campaigns from the 1910s to ’60s (including the sterilization of a third of all Puerto Rican mothers between 20 and 49 years old by 1965) to unsafe contraceptives marketed to poor women of color from the 1970s to ’90s. And the legacy of those abuses could be profound. One 2016 study found that the notorious Tuskegee Study, wherein hundreds of black men were left with untreated syphilis so U.S. government researchers could track the progress of the disease, led to such mistrust of the medical establishment that it reduced the life expectancy of a generation of black men by more than a year.

The Rebecca Project, a small, Washington-based nonprofit focused on issues disproportionately affecting women of color, hadn’t been involved on either side of the abortion fight. But in 2011, the group released a thinly-sourced report titled “Non-Consensual Research in Africa: The Outsourcing of Tuskegee,” outlining what it claimed was a series of unethical U.S.-backed medical experiments in Africa.

Some of the examples were documented stories of legitimate concern — for instance, HIV-positive women in southern Africa had been pressured into sterilization procedures by local health care entities. The report attempted to link them to shakier allegations of USAID funding being used for coercive sterilization campaigns in other countries. But the report’s real target, it seemed, was the Gates-backed health initiative in Navrongo. Later, the report’s lead author would suggest that people involved with the project should be charged with attempted genocide.

The report had numerous factual problems. Its author ― the Rebecca Project’s chief financial officer, Kwame Fosu ― also hadn’t disclosed a significant conflict of interest: The employee who’d leveled the charges against the Ghana project was the mother of his child. The fallout wound up splitting the organization, as one of its founders and several staff departed, taking with them all the Rebecca Project’s funding. Left with the group’s name, Fosu doubled down on his conspiratorial claims.

In 2013, Fosu published another report, “Depo-Provera: Deadly Reproductive Violence Against Women.” Drawing heavily on unnamed sources, paranoid accusations and the rhetoric of right-wing anti-abortion groups, this report used the Ghana story to anchor claims of a massive international conspiracy, led by the Gates Foundation, to push dangerous contraceptives on poor black women as a means of decreasing African births and advancing “population control ideology.” Fosu brought the Rebecca Project into alliance with a network of conservative Catholic nonprofits, like C-Fam and the Population Research Institute (PRI), that had long focused on fighting reproductive rights in developing nations or at the United Nations.REBECCA PROJECT FOR JUSTICE

A portion of the title page from The Rebecca Project for Justice’s 2013 report.

His new allies began publicizing Fosu’s claims to a large audience of conservative activists, arguing that he had uncovered the smoking gun confirming their long-held suspicions. As the head of PRI put it, “The population controllers will stop at nothing to stop African women from having children.” By 2014, the Rebecca Project was focusing full-time on the scourge of Depo-Provera. At the same time, the Gates Foundation was undertaking a new mission to radically expand contraceptive access to women in Africa, including with a new, low-dose adaptation of Depo-Provera.

The foundation’s family planning campaign had already drawn predictable backlash from religious groups. But as U.S. anti-abortion groups and websites circulated the Rebecca Project’s allegations, the opposition was no longer dominated by complaints that Gates was tempting African women to defy their faith. The new narrative was that Gates was waging “chemical warfare on poor women” in a neocolonial effort to suppress African births.

Soon, powerful figures across Africa were making similar claims, undermining vital public health projects in the process. In 2014, Zimbabwe’s Registrar General, Tobaiwa Mudede — the official responsible for overseeing the country’s dubious elections — warned women to avoid modern contraceptives because they caused cancer and were a Western ploy to limit African population growth. In 2015, Mudede told parliamentarians, “Western countries are bent on curtailing the population of the darker races of the world.” According to a parliamentary committee, Mudede’s campaign panicked Zimbabwean women, who flooded into clinics to have contraceptive implants removed.


  • Recently, these claims have grown to suggest that a Gates-backed vaccine against COVID-19 — in which the foundation has invested $300 million — could be a stealth attack on African populations. 

In Kenya, all 27 members of the nation’s Conference of Catholic Bishops declared that a WHO/UNICEF campaign to administer neonatal tetanus vaccines to women of childbearing age was really “a disguised population control programme.” According to the bishops, the vaccines were laced with a hormone that would cause repeated miscarriages and eventual sterility.

The same conservative Catholic network the Rebecca Project had allied itself with published numerous stories amplifying the bishops’ accusations and casting doubt on the government’s response. The Kenyan Parliament was forced to have the vaccine tested repeatedly. But by the time the claims were debunked, priests around Kenya had already instructed their congregants to refuse the vaccine.

Back in the U.S., Fosu also worked with C-Fam to lobby delegates from African nations, with some success. After a meeting of the Commission on the Status of Women, a regional grouping of African countries released an unprecedented statement expressing concerns over “harmful contraceptives,” echoing specific claims by Fosu and his allies. The next month, at the Commission on Population and Development, delegates couldn’t agree on an outcome document for the first time in the commission’s 48 years — the result, conservative advocates claimed, of African and other developing nations’ frustration with “the profusion of references to population control, adolescent sexual activity, abortion, and comprehensive sexuality education.”

Undermining Confidence In A Coronavirus Vaccine

The Rebecca Project has long since faded into obscurity. But the current attacks on Gates and his foundation are now broadcasting the same themes to a massive global audience.

In April, Trump boosters Diamond & Silk vowed they would never take a vaccine created by Gates because he’d sought to make Africans “guinea pigs.” (This claim was helped along by erroneous media reporting that falsely suggested Gates planned to test his vaccine in South Africa.) “I have a problem receiving any vaccine from any entity, especially anybody like Bill Gates who pushed for population control. The same thing that Margaret Sanger pushed for,” Diamond said. “Abortions! Genocide!” Silk explained.

In response to these and other conspiracy theories, including their contention that the virus was a “plandemic,” Fox Nation reportedly cut ties with the pair. But Diamond and Silk weren’t alone.

Conservative commentator Candace Owens tweeted in April that “vaccine-criminal Bill Gates” had used “African & Indian tribal children to experiment w/ non-FDA approved drug vaccines.” Last week, she declared “that under no circumstances will I be getting any #coronavirus vaccine that becomes available. Ever. No matter what.”

  • In the U.S. alone, nearly a third of Americans say they’ll refuse a coronavirus vaccine. 

An Infowars video suggested that Gates was the successor of eugenicist population controllers from Sanger to Nazi collaborators, and asked whether viewers would “allow your government to impose forced vaccines.” In a viral sermon, Rev. Danny Jones, the pastor of a 250-member Georgia church, predicted that Gates would use vaccines to usher in a new world order under which Christians might be forced to accept biometric tattoos.

On Twitter, hundreds of posts claimed that the billionaire had publicly said that vaccines could be used to lower the population by 10% to 15%. This was an old misrepresentation of Gates’ suggestion that increasing vaccination rates in the developing world could slow population growth, since families in which more children survive to adulthood might have fewer children overall.

Doctored photographs falsely suggesting the Gates Foundation runs a “Center for Human Population Reduction” spread so widely that both Reuters and Snopes published articles debunking them. Anti-vaxxer and Pizzagate proponents began sharing old C-Fam articles as proof that Gates “Thinks There Are Too Many Africans.” And the White House petition resurrected the old Kenyan controversy, informing new believers that Gates has “already been credibly accused of intentionally sterilizing Kenyan children through the use of a hidden HCG antigen in tetanus vaccines.”

By Saturday, the Gates-population control narrative had made its way onto conservative network One American News, quoting an anti-social distancing protester who charged,“This is not about COVID or about a virus. This is about gaining control over the human race and limiting population.”

Anti-Gates theories have resurfaced in Africa, as well. Unfounded rumors that Gates had bribed Nigerian lawmakers to pass a compulsory vaccination bill sparked a legislative investigation there. African Twitter influencers posted threads linking him not just to population control but the entire history of colonialist medical violence. One described the foundation’s family planning work “as genocide in Sub-Saharan Africa.” Another suggested that Gates would turn to “toxic Covid-19 vaccines” to depopulate South Africa next, since it had become “clear that this Depo is not working fast enough.”

Nancy Rosenblum, author of “A Lot of People are Saying: The New Conspiracism and the Assault on Democracy,” said that some people may simply see the proliferation of these conspiracy narratives as a vehicle to advance their agenda, exploiting the swirling outrage around Gates to introduce fringe arguments to a much larger audience. To Quassim Cassam, author of the book “Conspiracy Theories,” the anti-Gates attacks reflect a larger global trend towards populism, characterized by profound distrust of the establishment and experts.

“If you say it’s Gates or big corporations who are responsible for developing coronavirus via 5G, these are all ways of expressing anti-elitist sentiment,” Cassam said. “They’re fantasies, but they’re fantasies that give expression to real things in their lives.”

The potential impact of such fantasies could be dire. The legacy of medical abuses against people of color helped give rise to HIV/AIDS conspiracy theories, Rosenblum noted, from claims that it was a government-crafted bioweapon to charges that life-saving medications were poison. After the latter theory was adopted by South Africa’s former president, Thabo Mbeki, Harvard University researchers found it was responsible for more than 330,000 unnecessary deaths.

The Gates Foundation has already committed $300 million to fighting the coronavirus and finding a vaccine. Tens of millions of that sum are dedicated to ensuring that vaccines are distributed in poor countries. Conspiracy theories suggesting an eventual vaccine is part of a nefarious plot could leave many of the world’s most vulnerable at greater risk; in the U.S. alone, a late April survey found, nearly a third of Americans say they’ll refuse a vaccine.

Of course, the same side that is accusing Gates of planning an imminent eugenicist attack is also loudly pushing to reopen the economy, even though this will almost undoubtedly come at the cost of thousands of lives, overwhelmingly people of color. Rather than reckon with that reality, Republican leaders have argued that “there are more important things than living” and the public will “have to accept” massive new casualties.

Wisconsin’s chief justice dismissed superclusters of infection in the minority-staffed meatpacking industry as distinct from the threat posed to “regular folks.” One local California official mused that allowing the virus to “run rampant” through the ranks of the homeless, the old, the sick and the poor, represents a “natural” process of culling the “herd” that could lighten Social Security and health care burdens and free up jobs and housing.

Against this backdrop, right-wing claims of eugenics or population control begin to seem not just disingenuous, but like the most amoral form of projection.

Unethical medical experiments are not new and without past apologies. What are your thoughts on the information in this article? Why? What are your thoughts on COVID 19? Why?

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Should COVID-19 vaccine testing be done on prisoners? Some researchers say we should ask them.

covid 19 shidonna raven garden and cook

September 4, 2020 by Hannah Critchfield
Source: North Carolina Health News

Is it time to reconsider restrictions on using prisoners in medical experiments? Some experts say we should ask incarcerated people themselves.

By Hannah Critchfield 

As the COVID-19 infection toll inside United States prisons and jails reaches 100,000, some researchers are wondering if it’s time to reconsider bans on using prisoners in medical trials, such as the vaccine trials currently underway across the country.

Though often in the center of the discussion of a contentious topic, prisoners have had little input into the conversation. The researchers say it’s time to ask prisoners what they might want.

In the past, prisoners were used as medical study subjects, sometimes against their will. Prisoners were paid hundreds of dollars — far more than what a person normally receives doing prison labor, even today — to undergo studies involving everything from the toxic substance in Agent Orange, dioxin, to Johnson & Johnson bubble bath products (which reportedly led one prisoner to break out in painful blisters) to skin viruses like herpes.

Since 1978, however, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research has heavily restricted most research involving incarcerated people. The regulations followed reports of widespread abuse in drug and vaccine testing on prisoners in places like Holmesburg Prison in Philadelphia, where inmates were exposed to radioactive, carcinogenic and hallucinogenic chemicals without independent oversight or obtaining informed consent.

“I was in prison with a low bail,” former Holmesburg prisoner Leodua Jones told Executive Intelligence Review in 1999. “I couldn’t afford the monies to pay for bail. I knew that I wasn’t guilty of what I was being held for. I was being coerced to plea bargain. So, I thought, if I can get out of this, get me enough money to get a lawyer, I can beat this. That was my first thought.”

An exposé of the prison experiments in 1974 came on the coattails of the public’s discovery and the subsequent shutdown of the Tuskegee Study of Untreated Syphilis in the Negro Male, a 40-year study commissioned by the U.S. Public Health Service in which researchers withheld and concealed the existence of widely available, effective treatment for syphilis from its all-Black participants in order to study the long-term effects of the disease.

“You can make a strong argument that Holmesburg was as bad, if not worse,” said Allen Hornblum, who worked as a literacy instructor at the prison at the time and later wrote the book Acres of Skin about the experiments. “Because it’s not happening in the backwoods of Alabama, it’s happening in the third-largest city in the nation. A city loaded with universities, and medical schools, and very sophisticated people. Yet nobody seemed bothered or perturbed by it.”

In the time of pandemic 

Today, research in correctional settings is only permitted in limited conditions. Two of the categories of potentially permissible research are “research on conditions particularly affecting prisoners as a class” and “research on practices intended and deemed likely to improve the health or well-being of participants.”

Federal law requires that the secretary of the U.S. Department of Health and Human Services must convene a panel of experts before any trial takes place, a barrier that drastically reduces the likelihood that studies of this kind would occur.

With present regulations, vaccine trials for COVID-19 will not include currently-incarcerated people. But the novel coronavirus has ravaged the very places where incarcerated people live, leading some researchers to ask if now is the time for convening a DHHS panel. Inmates are more likely to contract COVID-19 than the general population, and to have chronic conditions that increase risk of severe illness from the virus, such as diabetes and heart conditions.

Outbreaks have ravaged North Carolina prisons, infecting thousands and killing 10 in the state correctional system alone. The facilities have been likened to petri dishes for the virus, as incarcerated people are housed in close, crowded conditions that make it difficult to social distance.

In a report released earlier this month in the Journal of the American Medical Association, health experts from the schools of medicine at Yale, Johns Hopkins and the University of North Carolina asked DHHS to consider if a Phase 3 vaccine trial for COVID-19 might meet the criteria for study of a condition “particularly affecting” prisoners.

“We’re just calling into question whether we’re taking away the agency of people who are in these settings,” said Lauren Brinkley-Rubinstein, a public health researcher at UNC-Chapel Hill and co-author of the report. “A majority of cluster outbreaks in this country are happening in these settings, and so why wouldn’t you give people that live there the option of participating or not?”

Trial participation would need to be voluntary, according to the authors, and couldn’t be tied to any condition, such as release from incarceration or special treatment

It would also require approval from an Institutional Review Board, those bodies that oversee the ethics of drug trials, that would need to include a prisoner representative.

Prisoner participants shouldn’t make up more than 50 percent of the test subjects to avoid exploitation and would need to be adequately briefed on risks, including “potentially the unique risks in the correctional health system of obtaining aftercare.”

“What we tried to communicate in that article is not that we definitely should be doing [correctional testing],” said Brinkley-Rubinstein. “But we tried to create a framework that could be used, if we were to consider it, that tries to center the voice of people who have been incarcerated.”

Oversight and equitable access

Clinical vaccine trials involving incarcerated people must ensure their correctional facilities have the resources to provide adequate treatment for vaccine complications, as well as funding for an incarcerated person’s aftercare in a community setting upon release.

The report also emphasizes that clinical trials should guarantee that incarcerated people have universal access to vaccines once one is proven successful. They also call for the federal government to pass legislation guaranteeing this universal access.

“I think once vaccines are proven that they work, the first places they should be deployed are nursing homes, prisons and jails,” said Brinkley-Rubinstein. “So that’s a part of [considering research with incarcerated people] too — if we are to do that, we need to understand how best to implement vaccine programs in the settings.”

The authors emphasize the need for a Federal Oversight Board in addition to an IRB, regardless of whether the trials are funded by the U.S. government, to monitor any clinical COVID-19 trials in prisons and jails.

Is consent possible behind bars?

Still, some people like Hornblum, the former Holmesburg worker, remain skeptical about whether it’s possible to ethically implement any medical trial behind bars.

“A lot of people in high positions do not want to ruffle the feathers of the medical-industrial community,” he said. “Can you imagine what ‘federal oversight’ would be with the Trump administration?

“I see the argument that is being made, and there is merit to it,” Hornblum added. “But I’m not just an academic who has read this in a journal, I witnessed it. I saw the lies, I saw the deceit. I saw inmates trusting their doctors, who were from an Ivy League institution, yet people were being damaged on an industrial scale.

“When it can happen at prison in a major sophisticated city, just think what can happen in smaller-scale facilities.”

Central to this debate is the issue of free and informed consent.

Some researchers believe that a person who cannot leave their present environment due to incarceration cannot truly give “informed consent” — that incarceration itself is too great a power dynamic to surmount. Many cite the Nuremberg Code, a set of research ethics principles drafted in the aftermath of the Nuremberg Trials at the end of World War II.

“Prisoner testing flies in the face of the first principle of the Nuremberg Code, which argues that if you’re confined or in a facility that lacks freedom, if you can’t walk out, you should not be used as a test subject,” said Hornblum.

‘A million ethical landmines’

Brinkley-Rubinstein conceded that there would be “a million ethical landmines” to navigate in vaccine trials inside prisons and jails.

“I do think the entire critique of whether it should happen or not really rests on that power dynamic, and that can manifest in a million different ways,” she said. “It would take a lot of time to figure out how to do it well.”

But the authors of the JAMA report said a blanket bar on research involving prisoners lacks nuance — in this moment, researchers must ask if it’s also unethical to not allow incarcerated people to participate.

“While the history of clinical trials in US prisons suggests that there is potential and opportunity for coercion in correctional settings, research on this issue in the contemporary era is limited,” the report states, noting that while prisoners need protection from coercion and exploitation, respect for prisoners requires “recognition of their autonomy in decision-making.”

“An ethical position that could be considered is that because of the epidemiology of this disease, it may be unethical to not provide clinical trial opportunities to these groups,” it adds.

“There are definitely places in which I would be terrified if they tried to do something like this,” said Brinkley-Rubinstein, who researches addiction treatment for incarcerated people in North Carolina, Rhode Island and Pennsylvania facilities. “But I think there are some systems, like Rhode Island’s, that are primed for this and have demonstrated their ability to properly take care of people in their custody.

“It’s context dependent, and lots of different voices should be at the table,” she added.

Considering the inclusion of incarcerated people in vaccine testing, according to Brinkley-Rubinstein, would signal a shift away from what she called “patriarchal” ideas about prisoners in research.

“We [on the outside] may all agree that this could never ethically happen in these settings, but like it’s not for us to decide,” Brinkley-Rubinstein said. “There needs to be this paradigm shift where people who have lived in those settings, and experienced the risks to their health from COVID, get to decide if this is a prevention activity that they want to engage in.”

Is it ethical to include unknowing people in medical experiments in or out of jail? Informed consent is not always received by people not in prison. What is the difference? Would you recognize health care fraud when you see it?

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Gov. Northam announces new statewide COVID-19 restrictions as cases surge

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Source: 13 News Now
RICHMOND, Va. — Gov. Ralph Northam reinstated new COVID-19 restrictions statewide Friday.

The restrictions come as Virginia is seeing an increase in virus cases, especially in the southwest region of the state.

The new restrictions include:

  • Reduction in public and private social gatherings (indoor and outdoor) from 250 to 25.
  • The mask mandate will now include ages 5 and up. (It was previously ages 10 and up.)
  • Essential retail such as grocery stores and pharmacies will now have an enforceable penalty through the Virginia Department of Health. It will be a class 1 misdemeanor. (The penalty was previously only applied to non-essential retail.)
  • Alcohol sales must stop at 10 p.m. and bars and restaurants must close by midnight.

The restrictions will go into effect at 12:01 a.m. Monday, Nov. 16. 

The 25-person cap applies only to public and private social gatherings. It doesn’t apply to employment or instructional education settings (schools).

“COVID-19 is surging across the country, and while cases are not rising in Virginia as rapidly as in some other states, I do not intend to wait until they are. We are acting now to prevent this health crisis from getting worse,” Northam said in a release.

At a briefing on Tuesday, Northam said cases were trending in the wrong direction, especially in Southwestern Virginia, where percent positivity was about 9 percent. The rest of the state was slightly above 6 percent.

Northam said cases have been rising for about a month. A few weeks ago, Virginia’s positivity rate was about 5 percent.

“We are one state – one Commonwealth – and no region is an island,” Northam said at the briefing. 

“We all need to step up our vigilance and our precautions, especially as we head towards the Thanksgiving holiday.”

Virginia Beach, Norfolk and Hampton have seen slight upticks in cases. Virginia Beach reported 100 cases on Thursday.

At the onset of the pandemic masks were scare. Today masks appear to have become an extension of our wardrobe. Masks are one way to help prevent the spread of COVID. Social distancing is another means of preventing the spread. What measures do you take to prevent the spread of COVID 19? How have things changed for you and yours since the pandemic?

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COVID-19 vaccine could be ready for 20 million Americans by December

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By Melanie Gray
November 14, 2020 | 9:45am
Source: New York Post

Get ready to roll up your sleeve for a COVID-19 shot.

As many as 20 million Americans could be inoculated against the coronavirus before the end of the year — and the number jumps to 80 million by March — if the government hits the target deadlines of the vaccine campaign’s top scientist, Moncef Slaoui.

Slaoui’s schedule put the number of monthly vaccines at 25 million to 30 million a month, starting in January. At that pace, roughly a fourth of the population could be vaccinated before spring, Business Insider reported.

Earlier predictions by two other top government officials, Dr. Anthony Fauci and Health and Human Services Secretary Alex Azar, had set April as the rollout date.

First in line will be healthcare workers and those highest at risk, such as seniors with pre-existing conditions. An advisory panel to the Centers for Disease Control and Prevention will determine the specifics of the allocation plan.

Hitting the target dates is only possible if regulators approve two vaccines in the works by pharmaceutical giants Pfizer and Moderna. Slaoui told reporters that he expected both companies to ask the Food and Drug Administration for emergency use authorization by early December.

What do you think of the COVID 19 vaccine? Will you take it? How do you think a vaccine was obtained quicker than officials anticipated?

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Sweden’s experiment with herd immunity is unethical and undemocratic — and reveals an underlying political pathology

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Sigurd Bergmann, Posted Wed 14 Oct 2020, 10:41am
Updated Wed 14 Oct 2020, 10:41am
Source: ABC New Australia

We speak of “herd immunity,” in the context of a life-threatening pandemic, as a way of providing protection for an entire population. It is a state that can be achieved either artificially, through a vaccine, or naturally, by a sufficiently large number of people (around 60-85 per cent) contracting the virus.

The leaders of Sweden’s Public Health Agency (Folkhälsomyndigheten) have repeatedly insisted that they are not actively pursuing “natural” herd immunity in response to the COVID-19 pandemic. And yet, they have repeatedly promised that “herd immunity” would soon become manifest, and have called it a beneficial by-product of their overall strategy.

After months of confusion, however, Johan Giesecke — the architect of the Swedish strategy and mentor of the Agency’s “chief epidemiologist” Anders Tegnell — has publicly promoted “Sweden’s herd immunity approach,” which entails a “controlled spread” of the virus “among the under-60s” and a “tolerable spread” of the virus “among the over-60s.” A number of leaked documents and public statements corroborate the widespread suspicion that this has long been the Agency’s strategy.

Demonstrably, Sweden’s incautious approach — which has been interpreted in other countries as a Sonderweg, “separate path” — was driven by pursuit of natural herd immunity in the population. Such an approach, which is the polar opposite of New Zealand’s elimination strategy, has recently attracted attention in the United States, where the death toll from COVID-19 has passed 220,000. President Donald Trump’s latest pandemic advisor, Scott Atlas, has caused considerable controversy by advocating the same method as Sweden — which was amusingly mischaracterised by Trump himself as “herd mentality.” This comes in the face of a warning given by some Swedish scientists in May, who warned the United States “not to do what we did.”

The question I would like to broach here is: Is natural herd immunity ethically responsible and politically acceptable?

But before diving into the ethical dimensions of this question, it is worth reminding ourselves of legal dimensions. In August, a campaign was initiated to scrutinise the British government’s initial decision to allow the virus to spread unchecked, and to investigate whether the state has acted criminally in its pursuit of herd immunity, in breach of Article 2 of the European Convention on Human Rights. A similar investigation — which is already underway in France — will probably also take place in Sweden sooner or later, and we can expect a large number of cases to come before the European Court of Human Rights next year.

Here, I want to lay out some of the reasons why the strategy of pursuing natural herd immunity is unethical, irresponsible, and morally unacceptable in democratic societies which have an obligation to uphold the equal value of all citizens. Such is the unanimous assessment in all other European countries — although three of them were tempted and considered pursing this strategy for a few short days, before abandoning it altogether.

Utilitarianism’s malfunction

The method of allowing a viral infection to spread — either freely or at a “reasonable rate” — is profoundly unethical because it exposes large groups of citizens to life-threatening risks. Senior citizens, those with severe illness, and those who due to low income, scant education, and limited job opportunities, are exposed to a significantly greater risk of mortality than rich, younger, healthy citizens. The method discriminates against the elderly, the sick, and the poor, and diminishes human dignity and equal rights of citizens. It thus violates fundamental principles in the Swedish democratic constitution.

Pursuing natural herd immunity fits well into the schema of ethical utilitarianism, where one is obliged to maximise happiness (or some cognate value) for the largest possible number of people by calculating and optimising the consequences of actions to achieve the desired goal — in our case, “public health.” In the context of a pandemic, the public health of a society is sought by quickly attaining a state where many healthy, young, highly productive citizens with immunity can keep the economic gears of society turning.

Some, however, necessarily must pay the “price” for this happiness when ethically weighing the short- and long-term consequences against each other. Selection, de-prioritisation, and palliative (instead of hospital) care are side-effects for the elderly. Medical staff in Sweden have reported many such situations of ethical stress, even as the authorities have assured that healthcare was not overburdened, despite the fact that it was being stretched to the breaking point and beyond. Herd immunity thus entails various forms of medical violence and, to some degree, even euthanasia — a question examined by the Christian Ecumenical Council. In addition, the lack of a rapid reduction of the infections (through an early lockdown) has led to a “medical care debt” (due to unexecuted treatments), taking the health system years to compensate. Applied utilitarianism in the context of a pandemic reveals its fatal malfunction.

Even so-called duty ethics obviously has its shortcomings, but given the traditional Western image of humanity it is not unreasonable that principles such as “Thou shalt not kill,” “All people have equal value,” and “Human rights apply equally to all citizens” should be applied without compromise. Herd immunity without doubt ignores these constitutionally protected rights and the associated understanding of what it means to be a human being; ultimately, it violates the commandment not to kill. Aptly, therefore, virologist Sandra Cieseck has remarked, “First and foremost this path [of natural herd immunity] is undesirable as the virus is causing so much damage that many people would die.”

What are your thoughts on herd immunity? What are your thoughts on a vaccine? Why?

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Pfizer’s CEO cashed out 60% of his stock on the same day the company unveiled the results of its COVID-19 vaccine trial

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Source: Business Insider
Shalini Nagarajan Nov. 11, 2020, 10:21 AM

  • Pfizer CEO Albert Bourla sold 62% of his stock in the company on the same day the drugmaker announced the results of its COVID-19 vaccine trial.
  • Bourla sold $5.6 million in stock on Monday as part of a predetermined trading plan adopted August 19.
  • His stock sale was carried out at $41.94 a share. The 52-week-high for Pfizer stock is $41.99, which means the CEO cashed out his shares at close to their highest price this year.
  • Pfizer and its German partner BioNTech on Monday became the first to post positive results from late-stage COVID-19 vaccine trials.

Pfizer CEO Albert Bourla sold 62% of his stock on the same day the company announced its experimental COVID-19 vaccine succeeded in clinical trials.

The vaccine announcement sent Pfizer’s shares soaring almost 15% on the day.

Bourla sold 132,508 shares in the company at an average price of $41.94 a share, or $5.6 million total, according to filings registered with the Securities and Exchange Commission. The 52-week high for Pfizer’s stock is $41.99, meaning Bourla sold his stock at almost its highest value in the past year. 

His stock sale was carried out through a routine Rule 10b5-1, a predetermined trading plan that allows company staff members to sell their stock in line with insider-trading laws. Bourla’s sale was part of a plan adopted August 19, the filing showed. He continues to own 81,812 Pfizer shares.

Pfizer confirmed that Bourla’s stock sales were part of a plan that allows major shareholders and insiders of exchange-listed corporations to trade a predetermined number of shares at an agreed time. 

“Through our stock plan administrator, Dr. Bourla authorized the sale of these shares on August 19, 2020, provided the stock was at least at a certain price,” a Pfizer spokesperson told Business Insider.

On Monday, Pfizer and its German partner BioNTech said their COVID-19 vaccine was found to be over 90% effective in preventing illness, based on 94 observed cases in a trial with thousands of participants. The pharma firms are the first to report positive results from late-stage COVID-19 vaccine trials.

Pfizer is already working on a workaround powder-form vaccine to address the current one’s biggest limitation: having to be stored at extremely low temperatures. 

The vaccine, which involves two doses administered three weeks apart, won’t be distributed immediately, as it still needs to be evaluated and approved by the US Food and Drug Administration.

Bourla is not the first pharmaceutical company executive to announce promising COVID 19 vaccine results and to dump his company stock. The question on many people’s minds is why? What do you think about taking the COVID 19 vaccine? What do you think of the ethics surrounding the COVID 19 vaccine trails? Why?

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