Indian-US firms working together on atleast 3 COVID-19 vaccines: Ambassador Sandhu Economic Times
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Indian-US firms working together on atleast 3 COVID-19 vaccines: Ambassador Sandhu - Economic Times
A main coronavirus vaccine trial a joint venture between an American and a German company got underway this week in the United States. Some participants are U.S. medical students. This trial joins others around the world, as pharmaceutical companies compete to discover the breakthrough for COVID-19. VOA's Carolyn Presutti takes us through whats being done and how.
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60-70% of human population will get COVID-19 if vaccine is not developed: Expert | Photo Credit: iStock Images
Jaipur: Health is one of the most important pillars of sustainable development, and India needs to spend more on healthcare infrastructure as the coronavirus crisis will have a major impact, public health strategist, Dr. David Bishai has said.
In his address at the webinar organised by Indian Institute of Health Management and Research (IIHMR), Jaipur on "Effect of COVID-19 on Indian Economy: Policy and Programmatic Implications" and attended by 722 participants, Bishai, a professor at the Bloomberg School of Public Health, Johns Hopkins University, suggested focusing on the health needs for poor.
He also raised the concern that the Covid-19 outbreak won't end until 60-70 per cent of the human population is immune to the virus, as it may take between 18 and 24 months to develop a vaccine for it.
If a vaccine is developed in next two years, it will impact Indian economy dramatically, particularly the health sector because there will be less money and the human resource available to run the existing programs will not be enough, Bishai said.
"The immediate need is to recover small business post Covid-19 by ensuring that the credit should reach them regularly from banks so that employment can be created," he said.
Dr. Narain Sinha, Professor, University of Botswana, talked about the Indian economy before Covid-19, the present situation, and the economy after Covid-19. His absolute focus was on the issue of migrant labors as they are most important for Indian economy.
"During lockdown, 92.5 per cent of labourers have lost 1 to 4 weeks of their work. Therefore Government should make immediate policies according to local demographic, social and economic fabric," he said.
Ujwal Thakar, ex-top banker, ex-CEO, Pratham India, and Board Member, Educate India, said that Covid-19 has forced the entire system to think about the biggest disaster i.e poverty.
"The tragedy that has made us realise that a very large section of daily wage earners in the country became very vulnerable in the wake of the pandemic. We need to focus on migrant labourers that they get immediate employment in their own villages which could help in boosting rural economy and sustainable livelihoods for poor," he said.
Author Tamal Bandyopadyay, Chartered Accountant, MSMEs consultant and IIM visiting faculty, Hema Krishnamurthy, IIHMR's Pro President, and Dean P. R Sodani, and IIHMR University's Faculty- Health Economics & Financing, Monika Chaudhary were others who participated in the webinar.
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60-70% of human population will get COVID-19 if vaccine is not developed: Expert - Times Now
Americas vocal ensembles,one of the soundtracks ofthis country, may notbe making musicuntil theres a COVID-19 vaccine. The same might also be true ofchurch choirs or church congregations. Operas and musicals, where performers sometimes sing directly into another's face,mighthave to be restaged to placesingers much farther apart.
The silencing of choral groupscould hit hard since an estimated 54 million people or 1 in 8 Americans sing in some type of choir, according to a 2019 study made for the group Chorus America.
The National Association of Teachers of Singing lastweek brought togetheran online panel discussion of scientistsand medical professionals to assess how the coronavirus will affect choirs.The discussion shared on YouTubesentshock waves through the singing world.
There is no safe way for singers to rehearse together until there is a COVID-19 vaccine and a 95% effective treatment in place, said Dr. Lucinda Halstead, president of the Performing Arts Medical Association, and the medical director of the Department of Otolaryngology at the University of South Carolina.
Earl Rivers, director of the Knox Church Choir reacts to his piano player as he directs during practice at the Knox Presbyterian Church in Hyde Park in 2011. The choir has a reputation for being one of the finest in Cincinnati.(Photo: Enquirer file)
Its culturally devastating, Ive never faced anything like this. Choir directors all over the country are asking what we can do safely (and) how were going to conquer this, said Earl Rivers, director of music at Knox Presbyterian Church in Hyde Park.
I share their concerns, but we also know the evidence is not clear yet as to what we can and can not do, said Rivers, who isthe outgoing director of choral studies and professor of music at the University of Cincinnati College-Conservatory of Music, as well as the former music director of the Vocal Arts Ensemble, Cincinnati's professional chamber choir.
Halstead noted that somesevere COVID-19 infections had started in churches. Examples include two congregations in Hopkins County, Kentucky that had a combined total of50 COVID-19 cases and four deaths after revivals in March.
The debate about the safety ofsinging in the age of COVID-19 comes days ahead of when the May Festival Chorus should have been taking the stage at Music Hall to begin its annual two-week run, starting this year with Beethoven's Ninth Symphony on May 22. The chorus runs the oldest continuous choral festival in the Western Hemisphere.
Soloists Michelle DeYoung and Anthony Dean Griffey in the foreground, while projections played across a large screen behind the May Festival Chorus and Cincinnati Symphony, led by Michael Francis in the May Festival's "Dream of Gerontius."(Photo: Provided/Lee Snow)
"As far as when we return to singing in groups and when that is safe nobody can say definitively when that is going to be,it is a long way off," said Matthew Swanson, the festival's associated director of choruses. "But its going to be different depending on what part of the country youre in and what your singing circumstances are."
A vaccine is 18 to 24 months away, Halsteadestimated during the panel discussion, which also included representatives of the American Choral Directors Association, Chorus America andthe Barbershop Harmony Society. Other estimatesincluding one by Dr. Anthony Fauci, the government's top infectious disease expert say a vaccine will be available sooner.
As of 5 p.m. Sunday, there hadbeen 1.3million COVID-19 in the United States resulting in more than 79,000 deaths, according to the Johns Hopkins University Coronavirus Resource Center.
The concern of scientists is what's put into the air when somebody sings and how that's magnified when a group of people sings.
Since early in the coronavirus epidemic, scientists have been focusing on aerosol transmission of the virus where the coronavirus in droplets goes directly into the respiratory system or ends up there after somebody touchesa surface contaminated with droplets and then touchestheir "T-zone" in and aroundtheir mouths, noses or eyes.
Aerosolized particles of the virus are about five microns in size (for reference, a human hair is 100 microns) and can survive in aerosol form for about three hours, a recent New England Journal of Medicine article concluded.
"Ordinary breathing and speech both emit large quantities of aerosol particles," noted an April 4 article published in the journal Aerosol Science and Technology.
San Francisco Gay Mens Chorus conductor Tim Seelig in a scene from "Gay Chorus Deep South."(Photo: Courtesy of Adam Hobbs and Thorsten Thielow)
But the volume of airborne droplet nuclei generated by singing issix times more than those emitted during normal talking, according toTim Seelig, director of the San Francisco Gay Men's Chorus, who talked to doctors in his chorus and researchedscientific papers about singing and aerosolized particles.
Singing is equal to coughing in the number of particles emitted, he wrote in a set of guidelines for choruses. Unlike coughing, "singing ... is sustained," Seelig addedin his guideposted on the Chorus America website.
He concluded: "Should we be so fortunate as to perform in the fall/winter, not only will audiences most likely be required to adhere to physical distancing, but the performers will as well."
In addition to cases at churches, an outbreak among dozens of choir members at a Washington state church drew attention in March. The Los Angeles Times reported that at least two singers died.
In Germany, 59 of 78 singers in Berlin's Protestant cathedral caught the virus, according to the Guardian newspaper. When the countryreopened its churches on May 3, there was no singing, reported the public broadcaster Deutsche Welle.
Officials at the Archdiocese of Cincinnati Friday announced that in-person services would resume May 25 six days before Pentecost Sunday, commemorating the date that the Christian church began its mission to the world with the descent of the Holy Spirit converting Christ's disciples into apostles.
In addition to limiting the number of parishioners and observing social distancing, guidelinesfor the 211 parishes in the 19-county archdiocese includethis: "Consideration should be given to reducing the role of choirs and ensembles in light of social distancing and public health regulations."
Sunday, Indiana reopened churches in 91 of its 92 counties for in-person services with no health restrictions on singing. Churches in Marion County (Indianapolis) remained closed.
Gov. Eric Holcomb said officials will be able to learn from places of worship, depending on what happens over the next 14 to 21 days as in-person services resume."If we can manage this, it gives us a lot of confidence in some other arenas as well," he said.
The May Festival Chorus(Photo: Provided)
Donald Milton, an infectious bio-aerosol specialist at the University of Maryland School of Medicine in Baltimore, said during last week's conference call there are multiple challenges keeping singers from safely coming together.
There are no barriers currently safe for singing. An N95 mask may provide some measure of safety if fit-tested, but it would be difficult to breathe (and) decrease the levels of oxygen with rebreathing, Milton said, adding, the masks could cause headaches and injure people with asthma.
A particular concern about rehearsal spaces is that they are smaller than performance halls, making it hard to space the singers at least six apart. In addition, indoor spaces have air that's potentially more likely to be saturated with aerosolized particles emitted from singing.
The spacing issues also will apply to performances, Halstead said.
"Think about the Westminster Choir spacingsix feet apart," she said talking about an acclaimed 50-voiceensemble from New Jersey's Rider Universitythat is the chorus-in-residenceat the Spoleto Festival USA in Charleston, South Carolina. "You would need a football field."
Seelig has an array of ideas he's considering for his nearly 300-voice chorus, which has made more than 30 recordings and toured across America and numerous foreign countries. They include:
Rivers said his church will have three Zoom meetings thisweek to discuss solo, choir and congregational singing.
Were waiting to find out the best practices and what might we safely do to protect the singers or one attending a choir concert, he said. We arent going to do anything until safe.
The May Festival's Swanson said smaller groups of singers may be able to get together sooner than a 120-member chorus.
Theres still a lot to be found out in terms of science. Hopefully, we wont have to wait 18 months, Swanson said.
Singing in Cincinnati itself is not going to stop, he added.
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Right now, the best bridge to a new normal is a successful vaccine against Covid-19. Scientists are racing to develop one on an unprecedented timeline, but it could still take a year to 18 monthspossibly longer.
Vaccines are harder to make than ordinary pharmaceuticals. Typical drugs carry out a specific process in the body, and they only have to work only until the kidneys and liver filter them out. Vaccines, though, have to do a bit of biological catfishing: They dupe certain cells in our blood, called B-cells, into responding to a pathogenic threat that doesnt actually exist.
Tricking those cells into producing antibodies against a disease it hasnt yet faced is a difficult process. Scientists need help from benign viruses and bacteria, gene editing tools, and even copies of the infectious pathogen itselfand sometimes combinations of all three. And right now, scientists are throwing all of these strategies at Covid-19 to see what sticks.
At the time of writing, there are 123 vaccine candidates in various stages in the research pipeline. In a best-case scenario, multiple kinds of vaccines would be found safe and effective, so there would be several options for drug manufacturers and distributers to make and ship across the globe. Heres your guide to understanding the different approaches.
The most effective way (pdf) to generate antibodies against an infection is to actually get sick. The next best option? Show your B-cells a copy of the same pathogenbut genetically modified or kneecapped with a chemical like formaldehyde so it cant cause an infection. These vaccines cancause a minor infection if the virus is merely weakened and still capable of replicating, but its not nearly as dangerous as if it were at full-strength.
Scientists have developed inactivated or weakened vaccines for illnesses like measles, chicken pox, and polio. These vaccines are tried and true, but finding a new one requires a delicate balance: It has to be as close to the actual virus as possible, but not capable of replicating like it normally would.
If for some reason, the virus does start replicating, a perfectly healthy person would become sick. This is why safety testing is so critical for these vaccines. Currently, only two vaccine candidates in this category are in early clinical trials: one being developed by the Wuhan Institute of Biological Products, and one by Sinovac Biotech, which is also based in China.
Instead of showing B-cells the entire pathogen, protein subunit vaccines only show the body partsof the virus. For Covid-19, most developers are going after the spike protein that SARS-CoV-2 uses to enter our cells. The hope is that by showing B-cells that characteristic protein, theyll be able to recognize it on the pathogen itself, too. Itd be like showing your B-cells a novelty bedazzled bowling hat, and telling them to watch out for any invader wearing it in the future.
Protein subunits arent able to turn into a full-blown infection. But the immune responses they produce get weaker over time, which means that a person may require boosters throughout their life. Some annual flu vaccines take the form of protein subunits, as does the HPV vaccine. So far, none of the protein subunit vaccines have made it to testing in humans.
Protein subunit vaccines require manufacturers to genetically modify a microbe, like the bacteria E. coli, to produce the desired protein. Then these proteins have to be purified and mixed with adjuvants, which signal to B-cells to pay attention to them. So to speed up the process, scientists have worked out a way to get the body to produce these desired subunit proteins themselves.
Nucleic acid vaccines use either double-stranded DNA (the same genetic material stored in each of our cells nuclei), or messenger RNA (mRNA). These forms of genetic material contain the recipe for the desired proteins, just like our DNA does (mRNA is genetic material that is just a little farther along in the process). Cells within the body translate this foreign genetic material into target proteins, which B-cells then create antibodies against.
The advantage of this approach is that its relatively fast; once scientists have genetically sequenced a novel pathogen, they can isolate target proteins for the body to recreate. The challenge, though, is getting the body to actually respond to them.
Nucleic acid vaccines made with DNA have to get through the cell membrane and the cells nucleic membrane, which protects your DNA.Those with mRNA only have to get through the cell membrane, but theres still an additional hurdle: Even if the cells make the desired protein, they have to fold it into a shape that resembles the actual viral protein. Its like the difference between using a boxed cake mix to make 12 cupcakes versus two round cakes.
A nucleic acid vaccine has never been approved for use. But one of the leading vaccine candidates for Covid-19 uses this approach. Its an mRNA vaccine created by the Cambridge-based company Moderna, and the US government has already invested millions in it, even though its still in early clinical testing.
Another way to get around B-cells failure to respond to subunit vaccines or nucleic acid vaccinesis to try a hybrid approach: using otherweakened or inoculated viruses to transport genetic material that codes for bits of SARS-CoV-2, the coronavirus that causes Covid-19. The carrier virus can make its way into our cells like other infectious diseases wouldbut once it gets there, it produces SARS-CoV-2 proteins that generate the correct antibody response.
Some of these carrier viruses, called viral vectors, are capable of reproducing to a small degree, while others dont at all. Either way, they shouldnt cause an actual illness. The only reason these vaccines would be ineffective is if the recipient already has some form of immunity against the knocked-out vectormaking it impossible for the virus to enter our cells. One virus that scientists like to use is an adenovirus, for example, which often causes the common cold.
The newly-minted Ebola vaccine, which the US Food and Drug Administration approved in December 2019, is a viral vector vaccine. There are two promising vaccine approaches for Covid-19 using this platform, one by researchers at Oxford University, and one from the drug company Johnson and Johnson.
The last main tactic that developers are exploring is another variation of subunit vaccines. Instead of getting B-cells to recognize only certain viral proteins, virus-like particle vaccines introduce all the proteins on the outer shell of SARS-CoV-2. Its like showing B-cells only the menacing trench coat of a potential pathogen. Underneath the trench coat, though, theres nothingno genetic machinery to reproduce and destroy cells.
Currently, there are no virus-like particle vaccines in human trialsbut Medicago Inc., a company based in Quebec City in Canada, is hoping to start theirs in July.
Excerpt from:
A brief overview of all the Covid-19 vaccines in the pipeline - Quartz
Similarities, differences between 1918 and 2020 pandemics
In many ways, 2020 is looking like 1918, the year the great influenza pandemic raged. Like then, science is unable to crush an insidious yet avoidable infectious disease before hundreds of thousands die from it.
The availability of a vaccine for the novel coronavirus willlikely playakey rolein determining when Americans can return to life as usual. Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, on April 30 announced that a vaccine could even beavailable by January 2021.
Whether a vaccine can end this pandemic successfully, however, depends on more than its effectiveness at providing immunity against the virus, or how quickly it can be produced in mass quantities. Americans also must choose to receive the vaccine.
RELATED: CoronavirusNOW.com, FOX launches national hub for COVID-19 news and updates
According tosomeestimates, 50% to 70% of Americans would need to develop immunity to COVID-19 either naturally, or via a vaccine in order to thwart the spread of the virus. If these estimates are correct, that could mean that nearly twice as many Americans would need to elect to receive a COVID-19 vaccine than those who currently opt to be vaccinated against seasonal influenza.Just 37%of American adults did so in 2017-2018, even in the midst of ahistorically severeflu season.
Making matters more complicated is the possibility that people who hold skeptical views about vaccine safety sometimes referred to as anti-vaxxers will not opt to receive the coronavirus vaccine. According to some estimates, aboutone-fifthtotwo-fifthsof Americans express reservations about vaccine safety. If most of these individuals forego receiving a COVID-19 vaccine, they could potentially jeopardize the recovery process.
RELATED:COVID-19 shutdowns are clearing the air, but pollution will return as economies reopen
One of us is adoctoral candidate, and the other is aprofessor, who both study vaccine resistance. We conducted a study, which is currently undergoing peer review, where we estimate the number of Americans who report being willing to receive a COVID-19 vaccine, once it becomes available. We also investigate the reasons some Americans might refuse the vaccine.
We found that about one-fifth of Americans, and more than half of people who hold skeptical views toward vaccine safety, may be unwilling to pursue vaccination. Although most Americans do plan to get vaccinated, noncompliance rates may be high enough to pose a threat to collective immunity.
Is coronavirus changing minds about vaccine safety?
On the one hand, a pandemic may be encouraging anti-vaxxers tochange their minds. One reason so many Americans doubt vaccine safety is due tocomplacency the idea that, because high rates of vaccine compliance have kept us safe from diseases thatonce reachedepidemic proportions in the U.S., segments of the population can hold anti-vaccine views without endangering public health.
Consistent with this view, research finds that when people are concerned that once nearly eradicated diseases might reemerge to reach epidemic levels, people aremore likely to trust recommendationsfrom public health experts. Additionally,cross-national survey researchsuggests that people who live in parts of the world where the threat of epidemics is more likely tend to hold more positive views toward vaccines than the rest of the world.
Studies based on in-depth interviews with parents further suggest that parents who chose not to vaccinate their children are often willing to accept treatments for children withlife-threatening illnesses.
On the other hand, however, it could be the case that anti-vaxxers remain suspicious of a COVID-19 vaccine, when it becomes available.Prominent anti-vaccine websiteshave already begun circulating misinformation about the COVID-19 vaccine such as the idea that a vaccine has existed for years and has been kept from public consumption. Additionally, recent research suggests that anti-vaccine views are tied to deeply heldpsychological and moral aversionsto inoculation, implying that attitudes may be difficult to change.
Exercising and eating right are vital.
What do anti-vaxxers say now?
We set out to investigate this important question. In a demographically representative survey of 493 U.S. adults conducted on April 15, 2020, we investigated whether people who hold skeptical views toward vaccine safety plan to receive a vaccine against COVID-19.
Specifically, we asked respondents whether they would be willing to get vaccinated against COVID-19 once a vaccine becomes available. Nearly a quarter (23%) of respondents said that they would not.
Additionally, and consistent with the view that even a global pandemic may not persuade anti-vaxxers to get vaccinated, we find that 62% of people who are skeptical of vaccines said that they will forego COVID-19 vaccination.
To assess this, we measured vaccine skepticism by asking respondents three questions about whether they find vaccines to be safe, effective and/or important which is how vaccine skepticism istypically measured. Respondents indicated whether they thought each characteristic described vaccines quite a bit, a moderate amount, a little bit or not at all. We then averaged the score across the three to create a scale of vaccine skepticism.
Nearly one-fifth (19%) of respondents were more vaccine skeptical than not. Among vaccine skeptics, 62% stated that they would not get vaccinated against COVID-19. By contrast, just 15% of those more supportive of vaccines than skeptical said that they would not get the COVID-19 vaccine.
We also asked respondents if they self-identified as anti-vaxxers, and nearly 16% said they did. For those that identified as anti-vaxxers, 44% said they would not vaccinate against COVID-19, compared to 19% of people who did not identify as anti-vaxxers.
RELATED:Rare inflammatory condition affects some kids with COVID-19
A threat to collective immunity?
We believe that these findings, although preliminary, suggest that many people who hold anti-vaccine beliefs may jeopardize the effectiveness of a COVID-19 vaccine once its available, due to issues of noncompliance. Furthermore, it appears that anti-vaccine sentiment is at least as widespread as it was before the pandemic began.
We caution that a drawback of this study is that it doesnt directly measure changes in vaccine sentiment over time. However, the levels of anti-vaccine sentiment found in this data are comparable to similar levels of anti-vaccine sentiment in the American public before the pandemic, according topreviousstudies. Tracking public attitudes toward a COVID-19 vaccine can help public health agencies better understand who plans to receive the vaccine, and why some people might choose to refuse it.
This article is republished from The Conversation under a Creative Commons license. Read the original article here:https://theconversation.com/a-majority-of-vaccine-skeptics-plan-to-refuse-a-covid-19-vaccine-a-study-suggests-and-that-could-be-a-big-problem-137559.
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Its been four months since researchers in China sequenced the novel coronavirus now known as SARS-CoV-2. In those four months, at least 3.8 million people around the world have been diagnosed with Covid-19, the deadly respiratory disease it causes. As of Friday morning, more than 267,000 people have died. Doctors have been trying lots of existing drugsfrom malaria medications to anti-influenza pills to Ebola treatmentsin an effort to save patients from the ravages of the disease, which can damage the heart, kidneys, brain, and lungs. But so far, no blockbusters have emerged. Researchers are still testing hundreds of potential candidates in search of a cure.
Here's all the WIRED coverage in one place, from how to keep your children entertained to how this outbreak is affecting the economy.
A vaccine, which would teach peoples immune systems to recognize and fend off the virus before an infection can take hold, would be even better. An inoculated public could get back to work, stop sheltering in place, resume normal life. Developing a safe, effective vaccine against a new pathogen typically takes years, if not decades. Thats because, unlike with experimental treatments, its impossible to know right away if a vaccine has worked. During testing, researchers have to wait for participants to encounter the real virus in the wild, which if people are sheltering in place or an outbreak has ended, can take a very long time.
Clinical testing generally has three stages: Phase I involves a few dozen healthy volunteers, Phase II expands to several hundred in an outbreak area, and Phase III repeats the experiment with several thousand. Then US Food and Drug Administration officials must review the data and decide if the shot is safe and effective enough to approve.
But in the face of the current global pandemic, scientists, pharmaceutical companies, and regulators are sprinting at record-shattering speeds to test hundreds of vaccine candidates. Without clinical trial data, its impossible to predict which contenders will emerge from the onslaught of experiments as the most successful. For the front-runners, that information could arrive as early as this fall. Heres what you need to know:
Phase II candidates: Moderna gets the green light, joining Oxford group and CanSino Biologics
On Thursday, Boston biopharma company Moderna announced that its vaccine candidate, mRNA-1273, had been cleared by the FDA to move into a Phase II trial. The study, which will begin enrolling 600 participants in the coming weeks, is designed to begin assessing whether or not the potential vaccine can induce a persons immune system to produce antibodies that recognize SARS-CoV-2.
With the news, Moderna pulls neck and neck with the current coronavirus vaccine leader: Oxford Universitys Jenner Institute. Scientists there had a head start, as The New York Times reported last month. Having already acquired safety data from human trials of similar vaccines for the related coronavirus that causes MERS, Oxford researchers convinced British regulators to push forward with a large Phase II study involving 6,000 people while the outbreak in the UK is still raging. The vaccine is based on a technology that involves genetically modifying a harmless virus to create a SARS-CoV-2 look-alike that doesnt cause disease but does trigger an immune response.
Modernas vaccine candidate, which was developed in collaboration with scientists at the National Institutes of Allergy and Infectious Disease, is made out of messenger RNA, hence the phrase mRNA in the vaccines name. This molecule is responsible for carrying the genetic recipes for making different proteins to a cells protein production factories. The version inside Modernas vaccine carries the instructions for making a little bit of the spike protein that SARS-CoV-2 uses to infect human tissues. The idea is that a vaccine recipients cells will produce this partial spike protein, which will train their bodies immune systems to recognize the virus and attack it the next time it shows up.
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Front-Runners Emerge in the Race for a Covid-19 Vaccine - WIRED
This is an excerpt fromSecond Opinion, aweeklyroundup of eclectic and under-the-radar health and medical science news emailed to subscribers every Saturday morning.If you haven't subscribed yet, you can do that byclicking here.
As researchers around the world race under immense pressure to develop a COVID-19 vaccine, a controversial approach could potentially help get them there faster but it's incredibly risky.
The process is known as a human challenge study, and it involves intentionally infecting willing volunteers with the coronavirus that causes COVID-19 in order to test the effectiveness of potential vaccines and treatments against it.
"These are very powerful studies that could make a difference, especially since we don't know a lot about the novel coronavirus," said Seema Shah, a medical ethicist at Northwestern University and Lurie Children's Hospital of Chicago.
"They could clarify what's happening in infections with people who are not symptomatic and people who have more severe disease even if they don't have underlying conditions that put them at higher risk."
Shah said COVID-19 human challenge studies could also help identify people who have developed immunity to the coronavirus, while also helping to narrow down the growing list of potential vaccines and treatments for patients.
"If there were a couple of vaccine candidates that had gotten through safety testing and there was a question about which one of those vaccines was more likely to work, a human challenge study could be a quick way to pick the best vaccine of the candidates," she said.
"It could also be useful to study whether the vaccine itself causes different kinds of harm."
The WHOsays any potential vaccine is still at least a year away, but human challenge trials could accelerate theprocess because of the time they save in the clinical trial phase.
Typically, researchers inject thousands of study participants with a vaccine or placebo and wait for symptoms to develop an approach that can take months or years after vaccine development.
Human challenge studies instead vaccinatea small group of people and then intentionally infectthem with the virus, saving critical research time, especially during a global pandemic.
But despite the potential benefits of a controlled human challenge study on COVID-19 patients, experts say the controversial approach is an ethical minefield that could have disastrous consequences if not handled carefully.
Human challenge studies typically recruit young, healthy volunteers in an effort to keep the risk of severe medical complications low.
Thousands of potential volunteers have already pledged to participate in human challenge trials on a website called 1DaySooner, but no such studies are yet underway.
Yet given what we know and don't know about the different ways in which COVID-19 attacks the human body even in young, healthy people, how do we effectively inform participants who may be unknowingly putting themselves at severe risk?
"We know that younger people tend to tolerate COVID-19 as an illness better, but what would worry me about that is there's a lot that is still unknown," said Kerry Bowman, a bioethicist and professor of global health at the University of Toronto.
He said the potential for COVID-19 patients of all ages to face long-term health implications and even death from a virus we still know so little aboutcalls into question how truly informed participants could be on the risks of a human challenge study.
"Do you truly have an informed decision?" he said. "You have consent, but is itreally well-informed? Do people fully understand? Because if we don't understand the virus itself, I wonder about the quality of informed consent that you can ask of people."
In a new paper published in the journal Science Thursday, Shah and a team of international researchers outline an ethical framework for how human challenge studies could be effectively used to combat COVID-19.
The researchers supportdeveloping a "challenge strain" of the coronavirus a stabilizedversion of the one thatis circulating worldwide to potentially infect participants, but stopped short of advocating for the work to proceed.
"The pandemic has affected just about everyone in the world in various ways, so the potential amount of social value is unprecedented here," Shah said.
"That's why our group concluded it's really important to give challenge studies a hard look and potentially invest in laying the groundwork for doing them.
"But then make that judgment call about whether and how to do them at a later date when they're ready to go."
The World Health Organization released specific criteria this week outlining its recommended approach to conducting human challenge studies, without advocating for or against them.
Among those recommendations is a need for "strong scientific justification" for the studies, ensuring that the potential benefits outweigh risksand that the selection of participants should be done with "rigorous" informed consent.
"The overarching, really important one is to minimize risk to participants as much as possible," said bioethicist Dr. Ross Upshur, of the University of Toronto's Dalla Lana School of Public Health, who helped work on the WHO guidelines.
"You need to make sure that people understand what's being proposed:what they're going to be doing;how they're going to be managed in this situation;how their safety and their well-being is going to be protected.
"But it's also incumbent on the researchers to outline all of the uncertainties,because we may not be able to actually quantify some of those risks."
Timothy Caulfield, a Canada Research Chair in health law and policy at the University of Alberta who has researched human challenge studies, said those ethical dilemmas have historically plagued this approach.
"I understand the desire to use human challenge trials, especially in this context, because people are desperate to get a vaccine quickly, not just for clinical reasons, but also for economic and social reasons," he said.
"So the pressure is intense, but the exact reason that we have research ethics guidelines is to protect research participants."
Caulfield said the damage that could be done if a human challenge trial were to go awry would be devastating.
He points to the ethics scandal involvingJesse Gelsinger, a teenager who died in a clinical trial for gene therapy in 1999, as an example of a failed human study that set the research ethics field back immensely.
Gelsingerhad a genetic disease called ornithine transcarbamylase (OTC) that he controlled through diet and medication, but after enrolling in the trialhe was injected with an experimental therapy and died a few days later.
"Just imagine the impact that it could have on vaccine research, especially in this environment where there's so much uncertainty," Caulfieldsaid.
"If it doesn't go well and if we cut corners on research ethics standards, it could end up backfiring and being really problematic."
To read the entireSecond Opinionnewsletter every Saturday morning, subscribe byclicking here.
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Could intentionally infecting volunteers with COVID-19 help find a cure sooner? - CBC.ca
Donald Trump has said coronavirus will go away without a vaccine and is expecting 95,000 or more deaths in the US, as Mike Pences press secretary tested positive for coronavirus.
The presidents comments, at an event with Republican lawmakers, capped a horror week in the US, in which it was revealed unemployment had risen to 14.7%, up from 3.5% in February, with 20 million people losing their jobs in April.
The news that Mike Pences press secretary Katie Miller had Covid-19, having recently tested negative, again brought the danger of the virus to the White House inner circle. Katie Miller is married to the White House immigration adviser and speech writer Stephen Miller. On Thursday one of Trumps personal valets tested positive to the virus.
The president again appeared to reset expectations for the final US death toll, saying he expected 95,000 or more to die. The current toll stands at just over 77,000, with nearly 1.3 million infections, including nearly 29,000 new infections added to the count on Friday.
The US state department on Friday accused China and Russia of stepping up cooperation to spread false narratives over the coronavirus pandemic, saying Beijing was increasingly adopting techniques honed by Moscow.
Even before the Covid-19 crisis we assessed a certain level of coordination between Russia and the PRC in the realm of propaganda, said Lea Gabrielle, coordinator of the state departments global engagement centre which tracks foreign propaganda.
But with this pandemic the cooperation has accelerated rapidly, she told reporters, in a continuing war of words between Washington and Beijing.
Leaders of the US congressional foreign affairs committees weighed in by writing to nearly 60 countries asking them to support Taiwans participation in the World Health Organization, citing the need for the broadest effort possible to fight the coronavirus pandemic. The move is likely to further inflame Sino-US relations as Taiwan is not a member of the United Nations, and has been excluded from the WHO, due to objections from China, which considers Taiwan to be part of its territory.
Taiwan has been seeking to join a ministerial meeting this month of the WHOs decision-making body, the World Health Assembly, with backing from Washington and several US allies. Taiwan has argued that its exclusion from the WHO has created a dangerous gap in the global fight against the coronavirus.
China reported one new coronavirus case on Saturday and 15 new asymptomatic cases. the countrys total number of infections stood at 82,887, with the death total unchanged at 4,633, the national health authority said.
In Italy, the head of the infectious diseases department at the renowned Sacco hospital in Milan, Massimo Galli, said the northern city was a bit of a bomb in terms of the virus spreading.
We have a very high number of infected people returning to circulation, he told La Repubblica, after photographs of people sitting along Milans canals enjoying aperitifs in the sunshine, many without wearing masks or respecting physical distancing rules, were splashed over the front pages of the countrys newspapers.
Milans mayor, Giuseppe Sala, said the behaviour was shameful and threatened to close the well-known aperitif area if people persisted in flouting the rules. Almost 40% of Italys infections are in the Lombardy region, of which Milan is the capital.
On Friday, Italy became the first country in the European Union to pass 30,000 deaths from the virus. Britain, which left the EU in January, passed that milestone on Wednesday, and deaths on Friday stood at more than 31,300.
Travellers into the UK will be quarantined for two weeks when they arrive as part of measures to prevent a second peak of the coronavirus pandemic, Boris Johnson is expected to say on Sunday when he lays out his roadmap out of the lockdown. He will announce the introduction of quarantine measures for people who arrive at airports, ports and Eurostar train stations, including for Britons returning from abroad.
People will be asked to provide the address at which they will self-isolate for two weeks on arrival by filling out a digital form, according to a report in the Times newspaper.
Russia on Friday registered more than 10,000 new coronavirus cases for the sixth day in a row, after emerging as a new hotspot of the pandemic. The total number of infections stood at nearly 188,000. The country also recorded 98 new deaths from the virus, for a total of 1,723, and while some officials were considering softening the current lockdown, the WHO warned Russia was going through a delayed epidemic.
WHO emergencies director Michael Ryan said in a virtual briefing must learn some of the lessons which came at great cost in other parts of the world.
In other coronavirus news:
Global infections stood at 3,937,813, with 276,863 deaths, according to the Johns Hopkins tracker.
Roy Horn, of the double act Siegfried and Roy, has died after contracting Covid-19, according to US media reports. He died in Las Vegas on Friday, aged 75.
The US issued a new rule on Friday tightening visa guidelines for Chinese journalists, saying it was in response to the treatment of US journalists in China.
Mexicos president Andres Manuel Lopez Obrador said on Friday that he aimed to present plans next week to reopen the economy, as key sectors like car-making look to begin business again after over a month of quarantine measures.
Argentina will extend a quarantine covering its capital Buenos Aires but relax restrictions in the rest of the country.
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