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Medicine

Nobel Prize in Medicine Awarded To Scientists Who Discovered Hepatitis C Virus (nytimes.com) 17

Raisey-raison writes: The Nobel Prize in Physiology or Medicine was awarded jointly to Dr. Harvey J. Alter, Michael Houghton and Charles M. Rice on Monday for the discovery of the hepatitis C virus, a breakthrough the Nobel committee said had "made possible blood tests and new medicines that have saved millions of lives." "For the first time in history, the disease can now be cured, raising hopes of eradicating hepatitis C virus from the world population," the committee said in a statement. They announced the prize at the Karolinska Institute in Stockholm. About 71 million people worldwide live with a chronic infection of the hepatitis C virus, a blood-borne pathogen that can cause severe liver inflammation, or hepatitis, and is typically transmitted through shared or reused needles and syringes, infected blood transfusions and sexual practices that lead to blood exposure. Tests and treatments "all start with being able to recognize the virus exists," said Craig Cameron, chair of the department of microbiology and immunology at the University of North Carolina at Chapel Hill and a hepatitis C virus researcher.
Security

Some Coronavirus Vaccine Trials Resort To Pen and Paper After Ransomware Hits Software (nytimes.com) 81

A software company supporting hundreds of clinical trials — including coronavirus vaccine trials — has been hit by a ransomware attack that "has slowed some of those trials over the past two weeks," reports the New York Times.

Employees "discovered that they were locked out of their data by ransomware..." eResearchTechnology (ERT) said clinical trial patients were never at risk, but customers said the attack forced trial researchers to track their patients with pen and paper. Among those hit were IQVIA, the contract research organization helping manage AstraZeneca's Covid vaccine trial, and Bristol Myers Squibb, the drugmaker leading a consortium of companies to develop a quick test for the virus. ERT has not said how many clinical trials were affected, but its software is used in drug trials across Europe, Asia and North America. It was used in three-quarters of trials that led to drug approvals by the Food and Drug Administration last year, according to its website.

On Friday, Drew Bustos, ERT's vice president of marketing, confirmed that ransomware had seized its systems on September 20. As a precaution, Mr. Bustos said, the company took its systems offline that day, called in outside cybersecurity experts and notified the Federal Bureau of Investigation. "Nobody feels great about these experiences, but this has been contained," Mr. Bustos said. He added that ERT was starting to bring its systems back online on Friday and planned to bring remaining systems online over the coming days...

One of ERT's clients, IQVIA, said it had been able to limit problems because it had backed up its data. Bristol Myers Squibb also said the impact of the attack had been limited, but other ERT customers had to move their clinical trials to move to pen and paper.

The Times notes it's just one of "more than a thousand ransomware attacks on American cities, counties and hospitals over the past 18 months." Other interesting details from the article:
  • Two companies working on a coronavirus vaccine — Pfizer and Johnson & Johnson — emphasized to the Times that they weren't affected by ERT's issues, with a Pfizer spokesperson stressing they're not even using ERT's software.

Medicine

Hydroxychloroquine Advocate Angry Donald Trump Took 'Experimental Antibody Stupidness' (newsweek.com) 287

"A doctor notorious for claiming hydroxychloroquine is a 'cure' for COVID-19 has denounced White House doctors for not giving President Donald Trump the drug to treat his infection..." reports Newsweek.

"Other unsubstantiated claims from Immanuel include declarations that fasting can cure those affected by 'witchcraft,' that having sex with demons while dreaming can cause gynecological problems and that certain medications contain the DNA of extraterrestrial aliens." Dr. Stella Immanuel, who gained fame in July after Trump retweeted a video showing her touting the malaria drug, expressed outrage in a series of tweets on Friday, condemning the medical decisions of "bozo doctors" who surrounded the president after he tested positive for COVID-19. "Instead of giving the president of the United States a known safe drug," Immanuel tweeted. "They gave him some experimental antibody stupidness. This is so dumb. Please potus family you guys wake up. Give him HCQ, Zpack & zinc asap." "Whoever told the president to stop taking HCQ should be punched in the face," she said in an earlier tweet. "This did not have to happened. I am so upset. This is our president for crying out loud. No one need to get sick or pcr positive."

Leonard Schleifer, CEO of Regeneron Pharmaceuticals, insisted that taking his company's experimental treatment, made of potentially virus-neutralizing antibodies, could see the president's condition improve within one week. Although the treatment is widely viewed as having potential, some medical experts have expressed less confidence in its effectiveness. Conley issued a second memorandum late Friday night, revealing that "in consultation with specialists, we have decided to initiate Remdesivir therapy" for Trump, referring to the antiviral drug that gained an emergency use authorization from the Food and Drug Administration (FDA) over the summer after studies showed it could reduce the length of time a person is ill with COVID-19.

Newsweek reminds its readers that early in the pandemic Trump did take a two-week course of hydroxychloroquine "as a preventative measure, hoping it would prevent his infection..."
Medicine

The Apple Watch Heart Monitor Sends Too Many People To the Doctor 43

The heart monitoring feature on the Apple Watch may lead to unnecessary health care visits, according to a new study published this week. The Verge reports: Only around 10 percent of people who saw a doctor at the Mayo Clinic after noticing an abnormal pulse reading on their watch were eventually diagnosed with a cardiac condition. The finding shows that at-home health monitoring devices can lead to over-utilization of the health care system, said study author Heather Heaton, an assistant professor of emergency medicine at the Mayo Clinic College of Medicine, in an email to The Verge. That may be expensive for patients and for the system as a whole, and it may take up doctor and patient time unnecessarily.

Heaton and the study team scanned patient health records at every Mayo Clinic site, including offices in Arizona, Florida, Wisconsin, and Iowa, for mentions of the term "Apple Watch" over a six-month period from December 2018 to April 2019. The window came just after Apple introduced a feature to detect abnormal heart rhythms and after publication of a study tracking how well the watches could detect atrial fibrillation. They found records of 264 patients who said their Apple Watches flagged a concerning heart rhythm. Of that group, 41 explicitly mentioned getting an alert from their watch (others may have had an alert, but it wasn't mentioned specifically in their health record). Half of the patients already had a cardiac diagnosis, including 58 who'd been previously diagnosed with atrial fibrillation. About two-thirds had symptoms, including lightheadedness or chest pain. Only 30 patients in the study got a cardiac diagnosis after their doctors visit. Most of the concerning heart monitor data, then, were probably false positives, the study concluded.
Government

Trump Goes To Hospital After Testing Positive For COVID-19 (bbc.com) 279

President Donald Trump has been flown to the hospital less than 24 hours after testing positive for COVID-19. The BBC reports: The White House said the decision to transport him to Walter Reed National Military Medical Center was taken "out of an abundance of caution." Mr Trump began exhibiting "mild symptoms" of Covid-19 on Thursday. He said early on Friday he and First Lady Melania Trump had tested positive. The White House said he was feeling "fatigued but in good spirits."

Wearing a mask and suit, Mr Trump walked out across the White House lawn on Friday afternoon to his helicopter, Marine One, for the short trip to hospital. He waved and gave a thumbs-up to reporters but said nothing before boarding the aircraft. In a video posted to Twitter, Mr Trump said: "I want to thank everybody for the tremendous support. I'm going to Walter Reed hospital. I think I'm doing very well. But we're going to make sure that things work out. The first lady is doing very well. So thank you very much, I appreciate it, I will never forget it -- thank you."

China

550 Million Chinese Traveling In Biggest Holiday Since COVID-19 48

hackingbear shares a report from CNN: As October 1 arrives, hundreds of millions of people in China are expected to pack highways, trains and planes for the National Day holiday, one of the busiest times for travel in the world's most populous country. In a sign of the government's confidence in keeping the virus under control, the Chinese Center for Disease Control and Prevention said last week that domestic travels can be arranged "as normal" for the upcoming holiday, given all cities in mainland China are marked as low risk for the coronavirus. The expected 550 million trips during the 8-day holiday will be a much-awaited boost to Chinese economic recovery. "I think China has (the virus) under pretty good control," said a 29-year-old traveler flew from Guangzhou to Shanghai. "I'm wearing masks and bringing alcohol wipes with me to clean my hands, especially before eating -- although in Shanghai, few people wear masks now." More than eight months on, China's restrictions on domestic movement have all been lifted. Officially, some cities still require passengers to produce a green health code on their smartphones at train stations and airports to show they're safe to travel, but implementation can be lax in practice. China has not reported any locally transmitted symptomatic case since mid-August, and is rigorously screening overseas arrivals and workers at risk of exposure to the virus. In other coronavirus-related news, vaccine trial participants are reporting day-long exhaustion, fever and headaches -- but say it's worth it. Slashdot reader gollum123 shares a report from CNBC: Luke Hutchison woke up in the middle of the night with chills and a fever after taking the Covid-19 booster shot in Moderna's vaccine trial. Another coronavirus vaccine trial participant, testing Pfizer's candidate, similarly woke up with chills, shaking so hard he cracked a tooth after taking the second dose. High fever, body aches, bad headaches and exhaustion are just some of the symptoms five participants in two of the leading coronavirus vaccine trials say they felt after receiving the shots. While the symptoms were uncomfortable, and at times intense, they often went away after a day, sometimes sooner, according to three participants in the Moderna trial and one in Pfizer's as well as a person close to another participant in Moderna's trial. Hutchison said he's concerned that the pharmaceutical manufacturers have not sufficiently informed the public about potential side effects. If the vaccines are approved, he fears, it might cause a widespread backlash if word spreads, which is why he decided to go public now.
Medicine

Great North Air Ambulance Trials Paramedic Jet Suit (bbc.com) 53

A jet suit for paramedics which would see patients reached in minutes by a "flying" medic has been tested by the Great North Air Ambulance Service. The BBC reports: After a year of talks between GNAAS and Gravity Industries, a first test flight was carried out in the Lake District. Andy Mawson, director of operations at GNAAS, came up with the idea and described seeing it as "awesome." He said it meant a paramedic could "fly" to a fell top in 90 seconds rather than taking 30 minutes on foot.

The test flight was carried out by Richard Browning, founder of Gravity Industries. He said the suits had two mini engines on each arm and one on the back allowing the paramedic to control their movement just by moving their hands. "The biggest advantage is its speed," Mr Mawson said. "If the idea takes off, the flying paramedic will be armed with a medical kit, with strong pain relief for walkers who may have suffered fractures, and a defibrillator for those who may have suffered a heart attack. In a jet pack, what might have taken up to an hour to reach the patient may only take a few minutes, and that could mean the difference between life and death."

Medicine

In Brazil's Amazon a COVID-19 Resurgence Dashes Herd Immunity Hopes (reuters.com) 134

Anthony Boadle, reporting for Reuters: [...] In April and May, so many Manaus residents were dying from COVID-19 that its hospitals collapsed and cemeteries could not dig graves fast enough. The city never imposed a full lockdown. Non-essential businesses were closed but many simply ignored social distancing guidelines. Then in June, deaths unexpectedly plummeted. Public health experts wondered whether so many residents had caught the virus that it had run out of new people to infect. Research posted last week to medRxiv, a website distributing unpublished papers on health science, estimated that 44% to 66% of the Manaus population was infected between the peak in mid-May and August.

The study by the University of Sao Paulo's Institute of Tropical Medicine tested newly donated banked blood for antibodies to the virus and used a mathematical model to estimate contagion levels. The high infection rate suggested that herd immunity led to the dramatic drop in cases and deaths, the study said. Scientists estimate that up to 70 pct of the population may need to be protected against coronavirus to reach herd immunity. In Manaus, daily burials and cremations fell from a peak of 277 on May 1 to just 45 in mid-September, the mayor's office said. The COVID-19 death toll that officially peaked at 60 on April 30 dropped to just two or three a day by late August. Now the numbers are on the rise again.

Medicine

'Why Modeling the Spread of COVID-19 Is So Damn Hard' (ieee.org) 117

Slashdot reader the_newsbeagle writes: At the beginning of the pandemic, modelers pulled out everything they had to predict the spread of the virus. This article explains the three main types of models used: 1) compartmental models that sort people into categories of exposure and recovery, 2) data-driven models that often use neural networks to make predictions, and 3) agent-based models that are something like a Sim Pandemic.
"Researchers say they've learned a lot of lessons modeling this pandemic, lessons that will carry over to the next..." the article points out: Finally, researchers emphasize the need for agility. Jarad Niemi, an associate professor of statistics at Iowa State University who helps run the forecast hub used by the CDC, says software packages have made it easier to build models quickly, and the code-sharing site GitHub lets people share and compare their models. COVID-19 is giving modelers a chance to try out all their newest tools, says biologist Lauren Ancel Meyers, the head of the COVID-19 Modeling Consortium at the University of Texas at Austin. "The pace of innovation, the pace of development, is unlike ever before," she says. "There are new statistical methods, new kinds of data, new model structures."

"If we want to beat this virus," says Mikhail Prokopenko, a computer scientist at the University of Sydney, "we have to be as adaptive as it is."

Medicine

Johnson & Johnson's Covid-19 Vaccine Produces Strong Immune Response in Early Trial (newsweek.com) 48

Newsweek reports: Pharmaceutical manufacturer Johnson & Johnson announced Friday that early trials of a COVID-19 vaccine showed a 98 percent success rate in showing a boost in the immune system. According to research from Johnson & Johnson, the vaccine enabled 98 percent of those who took it to create antibodies that fight off the coronavirus infection. Those neutralizing antibodies were present 29 days after receiving the vaccination...

Currently, four U.S. vaccines are in the final trial stages. Vaccines from other pharmaceutical companies such as Pfizer and Moderna are administered in two doses while the Johnson & Johnson vaccine only requires one.

"Based on the current results, Johnson & Johnson on Wednesday kicked off a final 60,000-person trial," reports Reuters, "which could pave the way for an application for regulatory approval. The company said it expects results of that so-called Phase 3 trial by the end of the year or early next year."
Medicine

Vaccine Maker Novavax Enters Final Large-Scale Testing of Its Covid-19 Vaccine (deccanherald.com) 57

The New York Times reports: Vaccine maker Novavax said Thursday that it would begin the final stages of testing its coronavirus vaccine in the United Kingdom and that another large trial was scheduled to begin next month in the United States. It is the fifth late-stage trial from a company supported by Operation Warp Speed, the federal effort to speed a coronavirus vaccine to market, and one of 11 worldwide to reach this pivotal stage.

Novavax, a Maryland company that has never brought a vaccine to market, reached a $1.6 billion deal with the federal government in July to develop and manufacture its experimental vaccine, which has shown robust results in early clinical trials. The new study, known as a Phase 3 trial, is expected to enroll up to 10,000 people in the United Kingdom. Half of the volunteers will receive two doses of the experimental vaccine, 21 days apart, and the others will receive a placebo.

Although Novavax is months behind the front-runners in the vaccine race, independent experts are excited about its vaccine because its early studies delivered particularly promising results. Monkeys that were vaccinated got strong protection against the coronavirus. And in early safety trials, published early this month in The New England Journal of Medicine, volunteers produced strikingly high levels of antibodies against the virus. It is not possible to make a precise comparison between early clinical studies of different vaccines, but John Moore, a virologist at Weill Cornell Medicine, said that the antibodies from Novavax were markedly higher than any other vaccine with published results. "You just can't explain that away," he said. The Phase 3 trials will determine if Novavax can live up to that promise.

Medicine

MS Treatment a Step Closer After Drug Shown To Repair Nerve Coating (theguardian.com) 20

An anonymous reader quotes a report from The Guardian: Doctors believe they are closer to a treatment for multiple sclerosis after discovering a drug that repairs the coatings around nerves that are damaged by the disease. A clinical trial of the cancer drug bexarotene showed that it repaired the protective myelin sheaths that MS destroys. The loss of myelin causes a range of neurological problems including balance, vision and muscle disorders, and ultimately, disability.

While bexarotene cannot be used as a treatment, because the side-effects are too serious, doctors behind the trial said the results showed "remyelination" was possible in humans, suggesting other drugs or drug combinations will halt MS. "It's disappointing that this is not the drug we'll use, but it's exciting that repair is achievable and it gives us great hope for another trial we hope to start this year," said Prof Alasdair Coles, who led the research at the University of Cambridge. The drug had some serious side-effects, from thyroid disease to raised levels of fats in the blood, which can lead to dangerous inflammation of the pancreas. But brain scans revealed that neurons had regrown their myelin sheaths, a finding confirmed by tests that showed signals sent from the retina to the visual cortex at the back of the brain had quickened. "That can only be achieved through remyelination," said Coles.

Medicine

'Extremely Brilliant Source' X-Rays Set To Revolutionize Science (gizmodo.com) 77

Rose Pastore reporting via Gizmodo: A new way of producing powerful X-ray beams -- the brightest on Earth -- is now making it possible to create 3D images of matter at astounding resolutions. This "Extremely Brilliant Source" officially opened last month at the European Synchrotron Radiation Facility in France, and scientists are already using it to study the coronavirus behind covid-19. These X-ray beams will image the interiors of fossils, brains, batteries, and countless other interesting items down to the atomic scale, revealing unprecedented information and supercharging scientific research.

A typical medical X-ray, like you would get for a broken bone, can show doctors details about your particular fracture and the tissue around it. X-rays penetrate the body and are absorbed at different rates by different tissue; once they've passed through you, they hit a detector, creating the familiar black-and-white X-ray image. The Extremely Brilliant Source produces X-rays 10 trillion times more powerful than those used in hospitals. With such a beam, scientists could create a 3D image of your broken bone so detailed that they could see the individual atoms in the blood cells surrounding your fracture. Of course, you wouldn't want to be hit with this particular beam -- the dose of radiation would be fatal.

The possibilities that the Extremely Brilliant Source opens up feel endless. One area that particularly excites Francesco Sette, director general of the ESRF, is research into the structure and functioning of brains, which could eventually enable brain-like electronics. "It would be a major revolution, not only for neuroscience, but also for all those applications that are coming up to use possibly the human brain architecture for a new generation of devices," he said.

Medicine

3D Printing Inside the Body Could Patch Stomach Ulcers (scientificamerican.com) 34

An anonymous reader quotes a report from Scientific American: Stomach ulcers and other gastric wounds afflict one in eight people worldwide, but common conventional therapies have drawbacks. Now scientists aim to treat such problems by exploring a new frontier in 3-D printing: depositing living cells directly inside the human body. [...] In their effort to treat stomach lesions less invasively, scientists in China wanted to develop a miniature bioprinting robot that could enter the human body with relative ease. The researchers used existing techniques for creating dexterous electronic devices, such as mechanical bees and cockroach-inspired robots, says the study's senior author Tao Xu, a bioengineer at Tsinghua University in Beijing.

The resulting micro robot is just 30 millimeters wide -- less than half the width of a credit card -- and can fold to a length of 43 millimeters. Once inside a patient's body, it unfolds to become 59 millimeters long and can start bioprinting. "The team has constructed clever mechanisms that make the system compact when entering the body yet unfurl to provide a large working area once past the tight constrictions at entry," says David Hoelzle, a mechanical engineer at the Ohio State University, who did not take part in the study. In their experiments, the researchers in China fitted the micro robot onto an endoscope (a long tube that can be inserted through bodily openings) and successfully snaked it through a curved pipe into a transparent plastic model of a stomach. There, they used it to print gels loaded with human stomach lining and stomach muscle cells (which were grown in culture by a commercial laboratory) onto a lab dish. The printed cells remained viable and steadily proliferated over the course of 10 days. "This study is the first attempt to combine micro robots and bioprinting together," Xu says.
The study has been published in the journal Biofabrication.
Medicine

Could Open Source Licensing Stop Big Pharma Profiteering On Taxpayer-Funded Covid-19 Vaccines? (theconversation.com) 81

Two professors at the University of Massachusetts have co-authored a new essay explaining how open source licensing "could keep Big Pharma from making huge profits off taxpayer-funded research" in the international, multi-billion-dollar race for a Covid-19 vaccine: The invention of the "General Public License," sometimes referred to as a viral or reciprocal license, meant that should an improvement be made, the new software version automatically inherits the same license as its parent. We believe that in a time of a global pandemic, a safe and effective COVID-19 vaccine should be licensed with General Public License-like properties...

Fortunately, some pharmaceutical companies, national governments, nonprofits like the Bill & Melinda Gates Foundation and international organizations like the Coalition for Epidemic Preparedness Initiatives — which supports vaccine development — are putting policies in place that embrace openness and sharing rather than intellectual property protection. Coalition for Epidemic Preparedness Initiatives officials have stated that all of their funding agreements require that "appropriate vaccines are first available to populations when and where they are needed to end an outbreak or curtail an epidemic, regardless of ability to pay." That's an important start.

However, when there is a safe, effective COVID-19 vaccine, the U.S. and other national governments need to create contractual agreements with firms that provide fair and reasonable funding to cover their costs or even some reasonable profit margin while still mandating the open sharing of the processes for vaccine production, quality assurance and rapid global distribution.

Medicine

AstraZeneca Resumes Coronavirus Vaccine Study (usnews.com) 85

"Oxford University announced Saturday it was resuming a trial for a coronavirus vaccine it is developing with pharmaceutical company AstraZeneca, a move that comes days after the study was suspended following a reported side-effect in a U.K. patient," reports the Associated Press: In a statement, the university confirmed the restart across all of its U.K. clinical trial sites after regulators gave the go-ahead following the pause on Sunday. "The independent review process has concluded and following the recommendations of both the independent safety review committee and the U.K. regulator, the MHRA, the trials will recommence in the U.K.," it said.

The vaccine being developed by Oxford and AstraZeneca is widely perceived to be one of the strongest contenders among the dozens of coronavirus vaccines in various stages of testing around the world...

The university said in large trials such as this "it is expected that some participants will become unwell and every case must be carefully evaluated to ensure careful assessment of safety." It said globally some 18,000 people have received its vaccine so far. Volunteers from some of the worst affected countries — Britain, Brazil, South Africa and the U.S. — are taking part in the trial... Brazil's health regulator Anvisa on Saturday said it had approved the resumption of tests of the "Oxford vaccine" in the South American country after receiving official information from AstraZeneca... The university insisted that it is "committed to the safety of our participants and the highest standards of conduct in our studies and will continue to monitor safety closely."

Pauses in drug trials are commonplace... The Oxford-AstraZeneca study had been previously stopped in July for several days after a participant developed neurological symptoms that turned out to be an undiagnosed case of multiple sclerosis that researchers said was unrelated to the vaccine.

Medicine

CDC Report Links Dining Out To Increased COVID-19 Risk (cnbc.com) 129

gollum123 shares a report from CNBC: Dining out raises the risk of contracting Covid-19 more than other activities, such as shopping or going to a salon, according to a report published Thursday by the Centers for Disease Control and Prevention. The findings come as many states consider the safest ways to reopen businesses, especially restaurants. Those who tested positive for SARS-CoV-2, the virus that causes Covid-19, "were approximately twice as likely to have reported dining at a restaurant than were those with negative SARS-CoV-2 test results," the study authors wrote. And those who were diagnosed without any known exposure to the virus were more likely to report having visited a bar or coffee shop in the previous two weeks. The increased risk makes sense; it's easy to wear a mask in stores or in places of worship, but it's nearly impossible to do so while eating and drinking. In addition to being maskless, individuals are often close together when eating at a restaurant, sitting across the table from one another.
Medicine

Apple Design Teams Develop Special Face Masks for Employees 42

Apple has developed two types of masks that the company is beginning to distribute to corporate and retail employees to limit the spread of Covid-19. From a report: The masks -- called the Apple Face Mask and Apple ClearMask -- are the first developed in-house by the Cupertino, California-technology giant for its staff. The company previously created a different face shield for medical workers and distributed millions of other masks across the health-care sector. Apple told staff members that the masks were developed by the Engineering and Industrial Design teams, the same groups that work on devices such as the iPhone and iPad. The Apple Face Mask is made up of three layers to filter incoming and outgoing particles. It can be washed and reused as many as five times, the company told employees. In typical Apple style, the mask looks unique with large coverings on the top and bottom for the wearer's nose and chin. It also has adjustable strings to fit around a person's ears. Apple told staff that the masks were designed and manufactured completely by Apple. The company, which confirmed the news, said it conducted careful research and testing to find the right materials to filter the air properly while not disrupting the supply of medical personal protective equipment.
Medicine

AstraZeneca Covid-19 Vaccine Study Put on Hold (statnews.com) 123

phalse phace writes: A large, Phase 3 study testing a Covid-19 vaccine being developed by AstraZeneca and the University of Oxford at dozens of sites across the U.S. has been put on hold due to a suspected serious adverse reaction in a participant in the United Kingdom. A spokesperson for AstraZeneca, a frontrunner in the race for a Covid-19 vaccine, said in a statement that the company's "standard review process triggered a pause to vaccination to allow review of safety data." In a follow-up statement, AstraZeneca said it initiated the study hold. The nature of the adverse reaction and when it happened were not immediately known, though the participant is expected to recover, according to an individual familiar with the matter. The spokesperson described the pause as "a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials." The spokesperson also said that the company is "working to expedite the review of the single event to minimize any potential impact on the trial timeline." An individual familiar with the development said researchers had been told the hold was placed on the trial out of "an abundance of caution." A second individual familiar with the matter, who also spoke on condition of anonymity, said the finding is having an impact on other AstraZeneca vaccine trials underway -- as well as on the clinical trials being conducted by other vaccine manufacturers.
Medicine

A New Theory Asks: Could a Mask Be a Crude 'Vaccine'? (nytimes.com) 147

A reader shares a report from The New York Times: As the world awaits the arrival of a safe and effective coronavirus vaccine, a team of researchers has come forward with a provocative new theory: that masks might help to crudely immunize some people against the virus. The unproven idea, described in a commentary published Tuesday in the New England Journal of Medicine, is inspired by the age-old concept of variolation, the deliberate exposure to a pathogen to generate a protective immune response. First tried against smallpox, the risky practice eventually fell out of favor, but paved the way for the rise of modern vaccines.

Masked exposures are no substitute for a bona fide vaccine. But data from animals infected with the coronavirus, as well as insights gleaned from other diseases, suggest that masks, by cutting down on the number of viruses that encounter a person's airway, might reduce the wearer's chances of getting sick. And if a small number of pathogens still slip through, the researchers argue, these might prompt the body to produce immune cells that can remember the virus and stick around to fight it off again. "You can have this virus but be asymptomatic," said Dr. Monica Gandhi, an infectious disease physician at the University of California, San Francisco, and one of the commentary's authors. "So if you can drive up rates of asymptomatic infection with masks, maybe that becomes a way to variolate the population."

That does not mean people should don a mask to intentionally inoculate themselves with the virus. "This is not the recommendation at all," Dr. Gandhi said. "Neither are pox parties," she added, referring to social gatherings that mingle the healthy and the sick. The theory cannot be directly proven without clinical trials that compare the outcomes of people who are masked in the presence of the coronavirus with those who are unmasked -- an unethical experimental setup. And while outside experts were intrigued by the theory, they were reluctant to embrace it without more data, and advised careful interpretation.

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