The US should expect 20,000 more coronavirus deaths by the end of the month, former CDC director says – CNN

The US should expect 20,000 more coronavirus deaths by the end of the month, former CDC director says – CNN

More Companies Are Using Technology To Monitor For Coronavirus In The Workplace – NPR

More Companies Are Using Technology To Monitor For Coronavirus In The Workplace – NPR

October 14, 2020

Flight crew members walk past thermal cameras that check passengers' body temperatures at Los Angeles International Airport on June 23. As businesses look to reopen, technology firms are offering an array of monitoring systems to try to control the coronavirus. Frederic J. Brown/AFP via Getty Images hide caption

Flight crew members walk past thermal cameras that check passengers' body temperatures at Los Angeles International Airport on June 23. As businesses look to reopen, technology firms are offering an array of monitoring systems to try to control the coronavirus.

In March, Dr. Achintya Moulick found himself at the epicenter of the U.S. coronavirus pandemic.

He oversees three CarePoint Health hospitals in northern New Jersey and in the early days of the pandemic, they were swamped. "We had no idea what this infection was all about," he says.

One of the first challenges was screening patients for COVID-19 even before they entered the hospital.

"One day I saw a big line outside the entrance of the hospital," he says. "And they were manually checking everybody's temperature."

Moulick thought this was illogical. "The lines were all the way out to the garage," he says.

The process was diverting his front-line staff, burning through precious personal protective equipment and creating a bottleneck of potentially infectious patients outside his door.

So he hired a company that uses thermal scanners to take the temperature of up to 20 people at a time as they approach the front entrance.

The scanners allowed patients to flow more smoothly into the building, but the system also could alert nursing staff automatically if a patient needed immediate attention.

The thermal scanners are made by a company called Zyter. The readings can be used simply to let people in the door or for the company to keep a continuous record of employees' temperatures.

Zyter is just one of dozens of companies offering systems to help employers confront the new challenges of COVID-19.

As more and more businesses look to reopen, technology firms have an array of monitoring systems to try to keep the coronavirus out of office buildings, medical facilities and industrial plants.

This sector could be a multibillion-dollar business in the coming year, analysts say.

Some of the system are as simple as an app for employees to report any COVID-19 symptoms. Others use Bluetooth devices connected to company ID badges to make sure workers are staying at least 6 feet apart.

If someone comes down with COVID-19, the company has a record of exactly who that person had contact with, for how long, and even when exactly their temperature started to rise.

"All of that data can be tracked through a cloud-based portal on an ongoing basis," says Harish Pai, the chief technology officer at Zyter.

"So you have a complete snapshot of your organization across facilities, across locations, and what is your risk of exposure," he says.

Zyter has even more sophisticated monitoring systems that don't require any tracking devices on workers. One such system uses facial recognition linked to a network of digital cameras.

"It can track a person all through the facility and be able to identify that person," Pai says. So any potential coronavirus exposure can be identified. Rather than shutting down an entire unit of a factory if one worker gets sick, the system can identify who actually was close to the person who tested positive. Those employees can be quarantined and tested. The rest of the unit can keep working.

These COVID-19 monitoring systems raise obvious privacy concerns. Some employees will find it creepy if their every movement and even their body temperature is being tracked by their boss. Should human resources know exactly how long you spent in the bathroom?

But in the midst of the pandemic, a company may want to know if too many people are congregating in a break room or if certain units are regularly violating social distancing rules.

Employees give up many rights to privacy when they arrive at work, and courts have ruled that private companies have broad rights to monitor what happens on their premises.

Amazon is using a camera-based AI system it calls "distance assistant" to keep people spaced out in its warehouses.

Pai from Zyter says industrial plants where work from home isn't possible are some of his company's biggest customers.

"For example, we are deploying the entire contact tracing, the service and the cameras-based solution for a large manufacturing customer out of Malaysia as we speak," he says.

Some companies are adopting the bare minimum, doing just enough so the health department allows them to operate. Others like the manufacturing plant in Malaysia are monitoring every interaction at their workplace.

Kristin Baker Spohn, a partner with the tech venture capital firm CRV, says employers need to be very clear about the purpose of the new technologies they're using.

"If that purpose is the collective health of your company population, I think that's something that we'll see a lot of people be excited and eager to adapt to," she says. "But how you frame and how you protect that information is paramount to making sure that there is adoption and success."

And until there's a vaccine, the successful monitoring and suppression of the virus will be key to whether businesses can stay open.


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More Companies Are Using Technology To Monitor For Coronavirus In The Workplace - NPR
Nancy Pelosi’s ridiculously over-the-top response to questions about the coronavirus stimulus – CNN

Nancy Pelosi’s ridiculously over-the-top response to questions about the coronavirus stimulus – CNN

October 14, 2020

Blitzer: Even members of your own caucus, Madam Speaker, want to accept this deal, $1.8 trillion, Congressman Ro Khanna for example. But let met just quote Ro Khanna, a man you know well. I assume you admire him. He's a Democrat.

And he just said this. He said "People in need can't wait until February, $1.8 trillion is significant and more than twice the Obama stimulus. Make a deal, put the ball in McConnell court."

Pelosi: What I say to you is, I don't know why you're always an apologist. And many of your colleagues, apologists for the Republican position. Ro Khanna, that's nice. That isn't what we're going to do and nobody's waiting till February.

It went downhill from there. Asked if she had spoken to President Donald Trump about the possibility of a coronavirus stimulus deal, Pelosi said she doesn't "speak to the President." Pressed on why not -- given the suffering of people in desperate need of a stimulus deal to keep their business open or pay their bills -- Pelosi responded this way: "What makes me amused if it weren't so sad, is how you all think that you know more about the suffering of the American people than those of us who are elected by them to represent them at that table."

Uh, OK.

Pelosi wasn't done. "Let me say this with all due respect, with all due respect, and you know we've known each other a long time, you really don't know what you're talking about," she said as Blitzer continued to ask why the $1.8 trillion deal proposed by the White House wasn't good enough.

And she ended the interview with snark -- telling Blitzer ,"Thank you for sensitivity to our constituents' needs" and then when he responded that he was aware of their needs because 'I see them on the street begging for food, begging for money," the Speaker of the House said this: "Have you fed them? We feed them, we feed them."

On the whole, it was a decidedly embarrassing performance by the Speaker of the House. And I'll note here that I believe Pelosi to be the best congressional strategist of her generation -- bar none.

But this was a disaster.

Pelosi's position in the interview appeared to be that Blitzer wasn't allowed to ask her any questions about her unwillingness to accept the White House's latest stimulus deal because, uh, he wasn't the one negotiating it? And that by asking basic questions -- like why she continues to hold out for what she believes to be a better deal and whether she has spoken with Trump -- that Blitzer was an "apologist" for Republicans. Say what?

What about the prominent Democrats Blitzer cited who have been pushing -- publicly and privately -- Pelosi to make a deal? Well, according to Pelosi they don't matter either because they aren't the ones negotiating it. (Sidebar: I am sure Pelosi's California colleague -- Ro Khanna -- appreciated her condescending "that's nice" comment about his support for a deal.)

But the point is this: If you are the Speaker of the House and agree to an interview in the midst of a contentious debate over a coronavirus stimulus package three weeks before a presidential election, you can't act surprised -- or outraged -- when you get asked about the coronavirus stimulus package and whether or not you've spoken to the President of the United States about it.

Those are not Republican apologist questions. They are fair ones. And ones that Pelosi should have been prepared to answer rather than snark at Blitzer and act as though he was doing something untoward.


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Nancy Pelosi's ridiculously over-the-top response to questions about the coronavirus stimulus - CNN
University of Washington coronavirus outbreak reaches 242 positive cases – KING5.com

University of Washington coronavirus outbreak reaches 242 positive cases – KING5.com

October 14, 2020

Between Oct. 6 and 13, there were 63 new coronavirus cases connected to an outbreak on UW's Greek Row.

SEATTLE A COVID-19 outbreak involving students at the University of Washington's fraternities and sororities continues to grow with 242 positive cases as of Tuesday afternoon.

The cases were spread among 17 sororities and fraternities in the 45-chapter system, which is north of the university campus in Seattle, according to the university.

The numbers are up from 179 cases as of Tuesday last week, and 227 cases on Friday.

Students who have tested positive or have COVID-like symptoms are being told to isolate themselves, according to the university.

The university has given over 2,600 coronavirus tests in the last seven days, with a positivity rate of 1.6%.

At a press conference last week, Gov. Jay Inslee expressed frustration about the behavior on Greek Row that is exposing all of us to great risk.

As of Tuesday, a total of 619 UW students, faculty and staff have tested positive for COVID-19 since February, according to the university coronavirus case tracker.

Correction: A previous version of this story misstated that there were 619 cases connected to the outbreak at the University of Washington.


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One client in one spin studio that followed all the rules triggers a coronavirus outbreak with at least 61 cases – CNN

One client in one spin studio that followed all the rules triggers a coronavirus outbreak with at least 61 cases – CNN

October 14, 2020

SPINCO, in Hamilton, Ontario, just reopened in July and had all of the right protocols in place, including screening of staff and attendees, tracking all those in attendance at each class, masking before and after classes, laundering towels and cleaning the rooms within 30 minutes of a complete class, said Dr. Elizabeth Richardson, Hamilton's medical officer of health, in a statement.

Public health officials are very concerned about the number of cases and the size of the outbreak, especially because the city is not currently a hotspot and the facility was not ignoring health protocols, they said in a statement to CNN.

"They have also supported public health services in our investigation by sharing the messaging with all their members," said Richardson.

There are currently 44 confirmed positive primary cases associated with SPINCO and 17 confirmed secondary cases. Exposure was linked to several classes held from September 28 to October 4.

The studio's co-owners, Naz Zarezadegan and Ira Price, told The Hamilton Spectator on Monday that public health officials told them "patient zero displayed no symptoms."

SPINCO said it will stay closed pending further investigation by health officials.

City officials say SPINCO was operating at 50% capacity, with a 6-foot radius around each bike, and that this might raise questions about the safety of gyms and fitness studios during the pandemic.

"We continue to look at what does it mean, what do we need to understand about exercises classes," Richardson said in a media briefing Tuesday.

Canada is reckoning with a second wave of the coronavirus which has been marked by a doubling of new, daily positive cases of Covid-19 within the past month. Targeted restrictions and closures are in place in many urban centers including Toronto and Montreal, but not in Hamilton.


Original post: One client in one spin studio that followed all the rules triggers a coronavirus outbreak with at least 61 cases - CNN
Hundreds of potential coronavirus quarantines around Alaska in the wake of youth hockey tournament – Anchorage Daily News

Hundreds of potential coronavirus quarantines around Alaska in the wake of youth hockey tournament – Anchorage Daily News

October 14, 2020

Its still not clear how many people have tested positive for COVID-19 following an Anchorage youth hockey tournament in early October that led to what officials described as a cluster of infections.

But the Termination Dust Invitational is already having far-reaching consequences due to public health recommendations that attendees go into a 14-day quarantine to make sure they dont spread the virus thats surging in Anchorage and other communities through pathways including social gatherings and sports.

If followed, that recommendation could add up to one of the states largest quarantines since summer outbreaks in the seafood industry confined hundreds of workers to remote plants or hotel rooms in Anchorage.

Over three days between Oct. 2 and Oct. 4, more than 300 people students, coaches, staff, family members from Anchorage, Eagle River, Chugiak, Wasilla, Palmer, Kenai, Soldotna, Fairbanks and Juneau attended the event at the Ben Boeke and Dempsey Anderson arenas in Anchorage.

The president of the Anchorage Hockey Association, which held the tournament, didnt respond to a request for comment Monday. The organization maintains it followed all the proper protocols, though social distancing was difficult to enforce.

The Anchorage Health Department on Friday issued a warning: anyone testing positive for the virus should isolate away from family members for 10 days.

A department spokesman on Monday said a specific count on the number of confirmed positives in people attending the tournament wasnt available.

More broadly, however, the municipality recommended anyone else who attended should quarantine for two weeks.

That means no school until next Monday for school districts with students or staff who participated in the tournament if they follow the quarantine recommendations.

Mat-Su, which considers itself one of the largest school districts on the West Coast to offer in-person learning, sent out a letter Sunday warning students and teachers to quarantine if they attended so schools can remain open.

District officials on Monday couldnt say exactly how many, but some staff and students at multiple schools have voluntarily self-isolated.

The district had building closures last week that were directly connected to people attending the tournament, according to district spokeswoman Jillian Morrissey. Colony High School near Palmer closed briefly last week.

A Fairbanks district spokesperson didnt respond to a request for comment about tournament-related quarantines.

Catholic Schools of Fairbanks had several players from different teams who played in the tournament, according to safety liaison Lorna Illingworth. They will return to school next Monday. No staff members were involved.

A Juneau team participated that included high school players, according to Kristin Bartlett, spokeswoman for the Juneau School District. It appears that only a small number of students were involved. The Juneau Douglas Ice Association temporarily suspended activities last weekend.

Friday, Saturday and Sunday there was no hockey in Juneau, Bartlett said, adding the association is working with public-health officials on a reopening schedule. We do have a pretty tight hockey community here in Juneau. Even though it was just one team that traveled, the coaches, staff and players do have family members. A lot play hockey."

Statewide, the Alaska State Activities Association has decided to delay the start of high school hockey until Oct. 26. The season was supposed to start Wednesday.

The recommendation is rippling across not only sports and schools but jobs for adults who attended or participated, officials say.

School officials on the Kenai Peninsula received some pushback after posting a statement Friday on social media that anyone who participated in the tournament would need to quarantine.

District spokeswoman Pegge Erkeneff described the response as people asking, How come youre making this rash decision?"

Part of the communication I gave back was this isnt a decision the district is making," Erkeneff said Monday. "Were following the guidelines from public health. That helped a little bit.

The Alaska Department of Health and Social Services is assisting with contact tracing. A department spokesman referred any questions about the quarantine recommendation to the Anchorage Health Department.

The health department provided no additional information Monday.

The tournament cluster is rippling into teams already struggling with numerous COVID-19 delays including one in Homer where the entire football program is in quarantine after two coaches tested positive, according to Erkeneff.

Eagle River High Schools football season ended Friday following a party Oct. 3 that resulted in positive cases. The district also stood down all sports programs at the high school through the weekend. On Monday, a letter that went out to Eagle River families announced riflery and swim/dive teams were to remain suspended pending further test results.

Allowed to return: C team football; flag football; debate, drama and forensics; bowling; and gymnastics.

The Anchorage School District last week reported that 14 teams were undergoing 14-day quarantine periods due to potential virus exposure from a teammate or coach. The district also issued a two-week stop to high school volleyball after multiple teams at a handful of schools reported COVID-19 illness, related symptoms or exposure.


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Hundreds of potential coronavirus quarantines around Alaska in the wake of youth hockey tournament - Anchorage Daily News
People Harmed by Coronavirus Vaccines Will Have Little Recourse – The Wall Street Journal

People Harmed by Coronavirus Vaccines Will Have Little Recourse – The Wall Street Journal

October 12, 2020

The U.S. government paid out $4.4 billion over more than 30 years covering injuries relating to a host of vaccinesfrom flu to poliobut payouts for potential injuries from Covid-19 vaccines will be covered by a far less-generous program.

Covid-19 vaccine injuries will be covered under a program known as the countermeasures injury compensation fund, which was set up in 2010 to cover harm resulting from vaccines for a flu pandemic, or drugs to treat an anthrax or Ebola outbreak, for example.

This...


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The Fringes of the Race for a COVID-19 Vaccine | Magazine – Harvard Crimson

The Fringes of the Race for a COVID-19 Vaccine | Magazine – Harvard Crimson

October 12, 2020

The vaccine came together in 10 minutes.

Alone in a private laboratory in Cambridge, Mass., Preston W. Estep poured five ingredients into a beaker salt, water, sodium triphosphate, the shrimp-based compound chitosan, and peptides from the novel coronavirus which together coalesced into gel nanoparticles the size of the SARS-CoV-2 virus.

He poured the mixture into a spray bottle, raised it to his nose, and breathed in the mist.

Estep, then the Director of Gerontology at Harvards Personal Genome Project, had long been skeptical of the DIY biology movement the push to bring biological experimentation outside of institutional settings. But in March, as he followed reports of elderly people dying unattended in nursing homes in Italy and Seattle, he decided not to wait 12 to 18 months more for a commercial vaccine. He believed his community of leading citizen scientists and edgy academic and company types could develop a superior product by the end of the year, without ever running a clinical trial or securing billions of dollars in funding: Instead, each member would test the vaccine on themselves.

Alongside three colleagues connected to Harvard Medical School, Estep launched the Rapid Deployment Vaccine Collaborative (RaDVaC) this spring to produce a vaccine based on an extremely promising but little-used technology he noticed again and again in research papers.

The team not only designed a novel vaccine they also released it to the public. In a 59-page report now signed by five Harvard affiliates and 34 anonymous authors, the group lays out the rationale and protocol for its vaccine, disclaiming any guarantees of safety or efficacy.

Their website calls it a necessary act of compassion.

For Estep, putting the information online democratized it. This kind of knowledge, this kind of privilege, is very restricted, he says. But if you work a little harder, you can give [people] access to privileges they normally dont have.

Two of the groups co-founders, Alexander Hoekstra and Ranjan Ahuja, worked with Estep on the Personal Genome Project, a Harvard-based study that seeks to sequence and create a public library of the genomes of 100,000 volunteers. HMS Professor George M. Church founded the PGP in 2005, envisioning an undertaking that could accelerate the pace of genetics research and bridge the gap between scientists and citizens.

Upon its founding, the PGP was criticized for posing an undue risk to its participants privacy; many doubted that non-scientists could make informed decisions about whether or not to enroll. Today, its model is accepted by many over 10,000 people have participated, and it has inspired offshoots in five separate countries.

Estep, Hoekstra, and Ahuja all drew parallels between the missions of RaDVaC and the PGP, arguing that both endeavors aim to bring science into the hands of regular people. Indeed, the questions the two projects ask are similar: What counts as a valid form of knowledge creation? How should scientists working within the walls of institutions relate to the people beyond it? And where is the line between accessibility and irresponsibility?

Estep hopes people will treat the RaDVaC report less as the textbook on DIY virology than as a launching pad for further experiments. He envisions amateur and professional scientists will soon get under the hood themselves, tinkering with the design to meet current needs as well as those presented by future pandemics.

The collaborative initially shared the vaccine with family members, professional connections, and groups of biohackers. In June, as reporters learned that Church somewhat of a mythic figure in the science world had also taken it, RaDVaC started receiving heightened attention. Hundreds of people contacted the group expressing interest in the vaccine. The team has since fielded their questions by email and coached some through the protocol by phone.

So far, around 50 people have taken at least one dose of the vaccine, with few reporting any symptoms aside from nasal congestion. Most are scientists and physicians, some of whom are at an elevated risk for COVID-19. One department head at a major U.S. hospital had previously considered designing his own vaccine, but found the task daunting. He now plans to modify the RaDVaC vaccine for himself and his wife.

While the group maintains it has a duty to mitigate the suffering caused by the pandemic, many in the scientific community believe its efforts are equal parts futile and irresponsible. Barry R. Bloom, an immunologist at the T.H. Chan School of Public Health, suspects the project will be absolutely useless due to its small sample size. More importantly, he fears it will exacerbate the publics distrust of vaccines. Jacob S. Sherkow, a professor of law at the University of Illinois, says the potential harms are both easily articulable and substantial, ranging from health complications to false senses of security.

In part due to the outrage, Estep elected to take a leave from the Harvard-affiliated PGP. He remains steadfast in his position, though, and regularly shares a motto with the team: Dont be afraid of being controversial. Be afraid of being wrong. He draws inspiration from Church, his former Ph.D. advisor and long-time mentor, who has routinely ruffled feathers while pushing the boundaries of genetic engineering.

RaDVaC stands out even among other citizen science projects for its ambition (and risk and prestige). At its core, however, it is driven by the same belief that governs efforts to produce cheap insulin and imagine new models of research like the Personal Genome Projects: that our scientific institutions are not only slow-moving but dangerously insular.

On March 9, Estep sent a mass email to a list of associates he believed might be interested in working on a DIY vaccine. US government estimates that a therapy would take over a year to develop seemed painfully slow. There is already sufficient information [online] to guide the development of a safe and likely effective vaccine, he wrote.

Many responded, Estep remembers, along the lines of, This sounds crazy, I dont think I can be involved with it.

But a few others adopted a different tack: This sounds crazy; lets definitely do it.

Hoekstra, a former project manager at the PGP, read the message while attending what was to be his last in-person scientific conference. At first, he kept picturing the challenges theyd face producing a vaccine. But the more he thought about it, the more he was drawn to the idea. By mid-March, the pandemic had already spun out of control. Hoekstra felt that even if the project failed, it was irresponsible not to act.

Hoekstra decided to join Estep and two others Ahuja, Director of Community at the PGP and Don Z. Wang, an HMS-trained immunologist in co-founding RaDVaC. The four soon began their project in a rented laboratory unaffiliated with Harvard, working with commercially available reagents.

Within three weeks, the team had settled on an initial version of the vaccine.

Estep administered it to himself on March 28. He was skeptical, but says he had no reason not to take it he didnt believe it was dangerous. And as soon as he inhaled the solution, he felt he had taken a big first step towards something important. I had this incredible psychological lift, he recounted. Every time I take it, I have that feeling.

When he developed a stuffy nose later that afternoon, he took it as a promising sign.

The other three followed suit in April and June, taking one dose of vaccine every two weeks. When I spoke to Hoekstra, he said he was already looking forward to his next one. Its got some good CD4 T-cell epitopes in there, he added, smiling.

In early July, the group published a white paper on its website detailing the specifications of its vaccine so others could make it themselves. Estep, Ahuja, Hoekstra, and Wang signed on as co-authors; a dozen other initial participants elected to remain anonymous.

According to Estep, it typically takes lay people around 25 minutes to make the vaccine. The recipe requires little lab equipment, and one can procure both the ingredients and materials required to make it from biotech sites and Amazon for less than $200 in total.

Reading the protocol, I was surprised to see that it was simpler than some of the procedures Id worked on in freshman year biology courses.

Soon after the publication of the white paper, Church enlisted as a guinea pig. For many observers, his choice brought increased attention, and scrutiny, to the projects methods.

Onlookers have criticized RaDVaC for forgoing the typical model of a clinical trial, which usually consists of four stages that take place over the span of several years, with different stages testing for safety, efficacy, and rare side effects.

Estep and Ahuja claim this system is ill-suited to adapt to emerging pandemics, and that there are several reasons their model is superior to that of a clinical trial.

For one, they argue clinical trials dont allow for vaccines to adapt to new research findings. Many of the vaccine designs currently in clinical trials were locked in when we knew less about COVID-19. Most of those vaccine candidates rely on similar strategies delivery via injection and targeting of the spike protein, the receptor the novel coronavirus uses to enter our cells risking mass failure. RaDVaCs vaccines, by contrast, are delivered via nasal spray and include other peptides that might elicit an additional form of immunity; Estep and his team also adapt the RaDVaC vaccine as new information about the coronavirus emerges.

Churchs justification of RaDVaC is a bit more cautious. He says he believes the pandemic has opened the opportunity to try to answer the question of how to rapidly deploy a vaccine in times of crisis. Though he emphasizes the importance of clinical trials, he nonetheless believes the RaDVaC vaccine is safe in small numbers and will be taken largely by people who understand its risks.

He anticipates the vaccine will soon move to a study, where it will be regulated by conventional standards. He sees this informal experiment as a means to bring the teams design into the running, since clinical trials often require billions of dollars.

Church isnt taking the vaccine out of fear that he will contract the virus he hasnt left his home in five months. He is a true believer in RaDVaCs mission. He thinks the project may demystify vaccines for those who are wary of them; he also believes the model of open access will get people excited about and engaged with science and realize facts dont just come from the sky.

So far, Estep claims, the RaDVaC model has been safe. Church says that its riskier to go to a supermarket than to take a few peptides by the nose. Of the about 50 people who have taken the vaccine, Estep says, the worst symptom participants have exhibited is nasal congestion which, again, the RaDVaC team takes as a positive sign, Estep explains, apologizing to me for sniffling as we speak.

It remains unclear, though, whether the RaDVaC team can generate meaningful conclusions from self-experimentation. Bloom argues that their studies will not be able to give them any conclusive results, since rare side effects only emerge in larger sample sizes.

But regardless of whether or not their data is meaningful, many critique how they obtain it.

The white paper detailing the instructions for making the RaDVaC vaccine is available to anyone on the internet. Estep claims that, because they outline the potential risks in the same report, anyone who takes the vaccine is participating in a model of informed consent they have the information they need to make an informed decision about whether to participate.

But others, like Sherkow, question whether an average person, desperate for a cure and trusting of the Harvard name, can be expected to give informed consent. And even if they can, what happens if they make a mistake in assembling the vaccine? What happens if, as a result of taking the vaccine, they change their behavior in regards to social distancing? What if they decide not to sign up for clinical trials or take a commercial vaccine later?

Responses to questions of what exactly constitutes informed consent in this context vary. Hoekstra believes the specialized language in the white paper will limit the population of people who engage with the vaccine instructions to those who are scientifically literate.

Church puts it differently: We discussed the possibility of publishing a little piece of it just as if it were a cookbook, he says. Like, This is how you make brownies. And this is how you make RaDVaC. And oh, by the way, the RaDVaC recipe is a little bit easier. No, that's not the way we did it. We actually want people to, if they want it badly enough, they will read about it.

Estep seems more optimistic about the idea of non-scientists benefiting from RaDVaC he claims that the jargon in the report is not an insurmountable barrier, but simply a hurdle for those interested. We all start off as non-scientists, he says.

The group also rejects the notion they are recruiting participants or providing advice; they believe they are simply putting information online and allowing people to respond as they will.

The issues of informed consent, of bridging the gap between the general public and the ivory tower of scientific research, have their roots in the Personal Genome Project. Three of the four RaDVaC co-founders were members of the PGP, and several of them drew analogies between their work at the PGP and their work at RaDVaC.

Hoekstra called the PGP an act of re-empowering people to contribute their data to something much larger than a single project, and claimed that the philosophies of the PGP translated very easily and really helped empower or shape what RaDVaC became.

Estep said that the motivations behind the PGP and his participation in science in general are rooted in increasing citizens engagement in real-world science. He says, This is something that George Church and I have always sort of been aligned on, and that hes really pioneered: creating infrastructures for people to contribute scientifically outside of the normal channels. In Esteps eyes, RaDVaC is another one of those infrastructures.

Estep also says the PGP has helped him to think about how to responsibly operate RaDVaC. PGP has given us a unique perspective and the deep understanding of how to conduct citizen science, he says. We know the complexities of the kind of open and informed consent that weve employed at RaDVaC.

So who is science for, really?

In 1993, time was running out for Estep to settle on a laboratory for his Ph.D. thesis. He had found his past two rotations unfulfilling, and hoped, with the third, to finally find a place where he could combine his interests in biology and computer science cutting-edge stuff for the time.

His advisor said one man might fit the bill: a young assistant professor named George Church. If hes not weird enough for you, then theres nothing for you at Harvard, Estep remembers her saying. This is the most out-there stuff that weve got.

The first time he heard Church speak, Estep was in heaven.

It was the most mind-blowing stuff Id ever heard, he recounts. Within five minutes of meeting Church, he knew he wanted to work with him. He thought, my life is changing; my life has just changed. Church has had a profound influence on him as a scientist and as a person. I dont remember the old me anymore, he says.

Church is something of a celebrity in the world of genetics. The details of his biography paint a picture of a man who has never followed the rules after graduating from Duke in two years, he flunked out of a graduate program for spending too much time in the lab and forgoing his coursework. But he was later accepted to Harvards graduate school, where, in 1984, he devised the first-ever direct DNA sequencing technology.

In 2005, when Church had been a professor at Harvard for 19 years, he had the idea to sequence the genomes of 100,000 strangers. At the time, the ethical standard for genomic research was to recruit a cohort of people to study one condition, get them to sign a consent form, promise not to use their data for anything else, and then never contact them again. Because researchers needed to protect the privacy of their participants, they couldnt ask for too much information and they couldnt share data sets. If they learned anything that could be of use to the participant (such as a genetic risk), they werent allowed to communicate it.

Church felt this was absurdly inefficient and pointless, especially because many scientists knew they could not truly protect the privacy of their study participants the information they gave was enough to be identifying and yet relied on boilerplate consent forms anyway. Having participated in many psychological studies himself as an undergraduate, he felt transparency would breed trust.

He imagined researchers could upload participants genomes and medical records for wide public use. Instead of one research team keeping the data to themselves, they could share it in the hope that others would use the data to study all sorts of conditions. Breaking down the barrier between researcher and participant could be a win-win situation: In exchange for sending their biological samples and health records to various scientists, participants could then learn of any genetic risks they might have.

Church received a $10 million grant from the National Institute of Health to move his experiment forward but when Harvard Medical Schools Institutional Review Board looked over his project, they paused it out of concern. The board feared that few participants would enroll in the study, which would open up the possibility of genetic discrimination by empoyers or insurance companies. Church says this worry has proven to be unfounded; such discrimination is not only now illegal but quite rare.

Church believes people were so hesitant to adopt his model for two main reasons: first, because Harvard feared the liability that might come from disclosing (incorrectly or correctly) someones risk factors, and second, because there was inertia among researchers who he claims had their own fiefdoms they had worked hard to acquire their own data sets and didnt want to share them.

Alongside an ethicist and a lawyer, Church created a new, open model of consent for this project, which became the Personal Genome Project a model that is widely-accepted today. Participants have to receive a perfect score on a thorough assessment that tests whether they understand the potential risks of putting such information online.

Estep says it was only later that he fully realized the benefits of the open-consent model it allows people to engage with the research, he claims, which not only makes them more effective research subjects, but also more educated citizens.

In describing the difference between the model of open consent and more traditional research models, Estep draws a comparison with RaDVaC, which similarly seeks to empower people with information, rather than the very conservative and patriarchal biomedical practice people usually engage in where theyre like, Okay, Im going to stick this needle here and inject you with something. Trust me, Its good for you.

It took a year for HMSs Institutional Review Board to approve the project. It rolled out in phases, with the first volunteers being Church and other medical experts the Board believed could make informed decisions. In an interview conducted at the time, Church said the project could be something very big once people tune in; not many people know about it so far.

Today, more than 10,000 volunteers have joined the project, and it has inspired offshoots in five countries. Church and his family even did a road trip across Canada to meet participants who wrote to him about joining the study.

In 2005, Hoekstra was a graduate student at Michigan State University who had recently become so disillusioned with conventional scientific research what he saw as a toxic relationship between scientists, their institutions, journals, and funders that he considered dropping out of graduate school.

But then he learned of the PGP then described as a zany project going on in Cambridge in a footnote in a lecture on genomics. He was so captivated by it that he decided on a whim to come up to Boston and attend a PGP conference.

At the conference, he met Church and expressed his concerns about the scientific establishment.

George pulled on his beard for a moment and said, If thats how you feel, you shouldn't continue, you should do something different. And if you'd like, you should come out and work on the Personal Genome Project, Hoekstra recalls. That changed my life, changed my whole trajectory.

It was so life-changing, Hoekstra says, because he finally found people who were willing to challenge the status quo. He believed he was among people who embraced the idea of doing things differently, doing things that seemed radical, and to many people seem[ed] incredibly risky, but that had the power to change the way science is done and change the way we understand ourselves and the world.

Ahuja describes meeting Estep and Hoekstra as a blessing. He felt an instant connection to them, which he says is very rare given his eccentric outlook. Working with them, he feels he can implement ideas that have a chain reaction, ideas that change not just one thing but change the conditions going forward.

Estep says that the spirit of the PGP its commitment to engaging citizens in science and disrupting traditional models of science persists in RaDVaC. One reason he decided to post the vaccine design online was that doing otherwise would be completely contradictory to [his], and George Churchs, commitment to intellectual sharing and open science.

Sherkow, the bioethicist, finds this comparison between the PGP and RaDVaC incomprehensible. He calls the PGP the mirror image, the opposite, of RaDVaC. Whereas the PGP requires a high standard of consent for a low risk project that is low risk, Sherkow says, RaDVaC sets a low standard for a high risk project. If people can mess up baking bread, he argues, they can certainly mess up manufacturing this vaccine.

And where the PGP, to some, met a real need, Bloom, the HSPH immunologist, believes scientists are already deploying a vaccine as fast as they safely can.

Whereas Church finds the analogy between the PGP and RaDVaC somewhat apt, others at the PGP have distanced themselves from the vaccine and declined to comment for this article. Jeantine E. Lunshof, the ethicist that helped Church conceive of the open consent model has called RaDVaC an ego trip.

And while Churchs lab has passed scrupulous institutional review, RaDVaC does not report to any regulatory body, and it does not yet require self-experimenters to report symptoms. All such steps in the protocol outlined in the white paper are labeled as optional. While the team does plan on creating a platform for people to discuss their experiences with variations of the vaccine, it is unclear what this might look like and when it will be open to the public.

Bloom also suspects few people will self-administer the RaDVaC vaccine, given that several commercial vaccines are likely to hit the markets by early next year.

The project exists in a murky legal space. The team could be subject to FDA crackdown if the FDA determines they are distributing the vaccine or its ingredients across state lines, though Sherkow says he believes this is unlikely, since the FDA so far has not taken any action against DIY COVID vaccines. Sherkow adds that because DIY biology has never been so common or so sophisticated, there arent many laws regulating it.

Scientific institutions have long struggled to balance profit and progress. Even today, Jones points out, people struggle to access the medications they need because pharmaceutical companies abide by commercial incentives, monopolizing certain drugs and not working on rare diseases. Some people who are drawn to DIY bio are simply desperate for another way out. By extending the same logic to COVID-19 vaccines, this team of Harvard scientists seems to suggest its time to work outside the constraints of the pharmaceutical and research landscape, and in the process are raising the question of what risk and responsibility mean in these circumstances.

Whether the RaDVaC team succeeds in their effort or not, they have at the very least attracted the interest of two major pharmaceutical companies. While they have yet to sign any contracts, they are in advanced talks about moving a vaccine based on their original design, backed by a small amount of evidence, into a clinical trial.

Still, Estep and Ahuja stress that the initial goal of RaDVaC was not commercialization. Instead, Estep says, the project was borne out of the groups commitment to take science out of its walled garden, to make its findings accessible to the public, to engage as many people as possible in the process of scientific discovery despite the torrent of criticism.

Ahuja remembers that as he first prepared the vaccine, many thoughts rushed through his head. He thought about how his actions reflected a commitment to participate in a certain path of inquiry and to push the bounds of scientific understanding. He imagined what their effort represented for science itself as an enterprise. He felt a sharp sense of duty and privilege to [help] move the practice of science forward.

Then, he took a deep breath in.

Staff writer Saima S. Iqbal can be reached at saima.iqbal@thecrimson.com.


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Resettlement Officials: Refugees Should Be Among The First To Receive COVID-19 Vaccine – WKU Public Radio

Resettlement Officials: Refugees Should Be Among The First To Receive COVID-19 Vaccine – WKU Public Radio

October 12, 2020

Refugee resettlement officials in Bowling Green believe the international community should be among the first to have access to a COVID-19 vaccine once its available.

Executive director of the International Center of Kentucky in Bowling Green, Albert Mbanfu, said the refugee community is at high risk because of their living arrangements and because many are essential workers. Most refugees that the International Center has helped place in jobs were working in processing plants where COVID-19 outbreaks have occurred.

Hear the audio version of Alana's story.

Kentuckys 2nd District Congressman wants any COVID-19 vaccine to be immediately available to vulnerable populations, including refugees.

Ultimately, it will be a vaccine that offers us the best chance to finally end this pandemic, allowing our nation to fully reopen, Congressman Brett Guthrie of Bowling Green said during a recent hearing.

Guthrie is the top Republican on the House Energy and Commerce Committees Oversight and Investigations Subcommittee. Hes helping oversee the development of the COVID-19 vaccine.

His Bowling Green district director, Mark Lord, said during a quarterly international community meeting last week that Guthrie wants the vaccine to be available to populations that are more susceptible to the virus.

Lord said Guthrie recognizes there are challenges for people who have to commute together and live together in close proximity.

That inherently leads to more vulnerable population regardless of the health conditions of those residents and commuters, Lord said.

Mbanfu said new requirements are in place for refugees arriving in the area.

Any refugee that arrived in the United States in August, they had to stay in their homes for two weeks before they go about their business. We serve them where they are, Mbanfu said.

WKU Public Radio previously reported that the international center placed 162 refugees during the federal fiscal year that ended Sept. 30. Mbanfu said that all refugees are also encouraged to get tested for coronavirus when they arrive.

Any COVID-19 vaccine has to be approved by the Food and Drug Administration.

Guthrie said during a hearing that after the vaccine is approved, there will need to be widespread acceptance, distribution, and immunization to help fight the virus.


Here is the original post: Resettlement Officials: Refugees Should Be Among The First To Receive COVID-19 Vaccine - WKU Public Radio
Cameron County officials discuss plans for a COVID-19 vaccine that’s set to arrive by the end of 2020 – KRGV