Covid-19 may cause prolonged gut infection, scientists say #ศาสตร์เกษตรดินปุ๋ย

#ศาสตร์เกษตรดินปุ๋ย : ขอบคุณแหล่งข้อมูล : หนังสือพิมพ์ The Nation.

Covid-19 may cause prolonged gut infection, scientists say

Health & BeautySep 08. 2020

By Syndication Washington Post, Bloomberg · Jason Gale · NATIONAL, HEALTH, SCIENCE-ENVIRONMENT, HEALTH-NEWS 
Covid-19 patients have active and prolonged gut viral infection, even in the absence of gastrointestinal symptoms, scientists found.

The coronavirus may continue to infect and replicate in the digestive tract after clearing in the airways, researchers at the Chinese University of Hong Kong said in a statement Monday. The findings, published in the medical journal GUT, have implications for identifying and treating cases, they said.

SARS-CoV-2 spreads mainly through respiratory droplets — spatters of virus-laden discharge from the mouth and nose, according to the World Health Organization. Since the first weeks of the pandemic, however, scientists have said infectious virus in the stool of patients may also play a role in transmission.

A February study of 73 patients hospitalized with the coronavirus in China’s Guangdong province found more than half tested positive for the virus in their stool.

“We used to think of SARS-CoV-2 as just a pulmonary or respiratory disease,” said Siew Chien Ng, assistant dean of medicine and associate director of the university’s Centre for Gut Microbiota Research, in an interview Tuesday. “But over the last couple months, a lot of evidence has emerged that SARS-CoV-2 also affects the intestinal tract.”

Ng and colleagues scientists studied stool samples from 15 patients to better understand the virus’s activity in the gastrointestinal tract. They found active gut infection in seven of them, some of whom had no nausea, diarrhea or other digestive symptoms. Patients’ stool continued to test positive about a week after their respiratory samples were negative, Ng said. One patient was still positive after 30 days, she said.

Ng and colleagues plan to conduct further tests to demonstrate virus particles from stool are capable of causing disease after finding surrogate biomarkers that indicate they are infectious.

It’s not yet known how SARS-CoV-2 makes its way to the gastrointestinal tract to cause an infection there, according to Ng. It’s possible some infectious particles survive the stomach’s acidic environment.

Treatments that modulate the gut microbiome should be explored, Ng said. The gut bacteria of patients with a gastrointestinal coronavirus infection showed a loss of protective microbes and a proliferation of disease-causing ones. The effects were worsened in the covid-19 cases treated with antibiotics, she said.

The Chinese University has offered free screening stool tests to travelers arriving at the airport since late March, and identified six infected children among more than 2,000 samples tested. From Monday, up to 2,000 covid-19 tests will be done daily as part of targeted detection of asymptomatic people.

More than one patient tested positive even though their respiratory samples were negative, said Francis K.L. Chan, the university’s dean of medicine and director of the Centre for Gut Microbiota Research.

“Stool test is accurate and safe, making it suitable and more effective for Covid-19 screening for specific groups of people,” Chan said in the statement. Some regulators including the U.S. Food and Drug Administration have reached out about stool tests.

Vaccine CEOs issue safety pledge amid Trump’s quest for pre-election approval #ศาสตร์เกษตรดินปุ๋ย

#ศาสตร์เกษตรดินปุ๋ย : ขอบคุณแหล่งข้อมูล : หนังสือพิมพ์ The Nation.

Vaccine CEOs issue safety pledge amid Trump’s quest for pre-election approval

Health & BeautySep 08. 2020

By The Washington Post · Christopher Rowland · NATIONAL, BUSINESS, HEALTH, HEALTH-NEWS 
The chief executives of nine drug companies pledged Tuesday not to seek regulatory approval before the safety and efficacy of their experimental coronavirus vaccines has been established in Phase 3 clinical trials, an extraordinary effort to bolster public faith in a vaccine amid President Donald Trump’s public rush to introduce a vaccine before Election Day.

“We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which covid-19 vaccines are evaluated and may ultimately be approved,” the executives wrote in their joint statement. The Wall Street Journal first reported Friday that a statement from the companies would be forthcoming.

The statement included a vow that the companies would “only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.”

They also vowed to “always make the safety and well-being of vaccinated individuals our top priority.”

The statement left open the door for partial data from the massive Phase 3 vaccine trials – which require the participation of at least 30,000 test subjects – being used to seek emergency-use authorization. Such trials typically take years to complete and require lengthy follow-up to see how long protection from a vaccine may last.

The executives signing the pledge included the leaders of AstraZeneca, Johnson & Johnson, Merck, Moderna, and Novavax, as well as those heading two joint vaccine projects, Pfizer and BioNTech, and Sanofi and GlaxoSmithKline.

In most contexts, pledges by drug companies that they will adhere to safety and efficacy standards would be unremarkable. But their joint resolve in the current political environment – and the headline pasted on their statement: “BIOPHARMA LEADERS UNITE TO STAND WITH SCIENCE” – make clear their intent to ease growing worries about the race for a vaccine amid intense White House pressure.

The companies issued their statement as Trump has increasingly tied his reelection hopes to introduction of a vaccine before Nov. 3. The White House said in a statement Monday that Trump has no intention of cutting corners.

“The American people can rest assured that any approval will maintain the FDA’s gold standard for safety and testing to ensure a vaccine or therapeutic is effective,” said White House spokesman Judd Deere, in an email. “This false narrative that the media and now the Democratic nominee for vice president (Sen. Kamala Harris) are suggesting that politics is influencing approvals is not only false but is a danger to the American public.”

Harris, D-Calif., said on CNN’s “State of the Union” Sunday that she would “not take his word for it” and would “not trust” Trump’s declarations about the safety of a vaccine.

Vaccine manufacturers want to bolster public faith in the safety and efficacy of a vaccine to counter perceptions that the Food and Drug Administration will cave to political pressure, said Amesh Adalja, senior scholar at the Johns Hopkins University Center for Health Security.

“It just reflects the fact that we have seen political meddling from the start in this pandemic response,” Adalja said.

He cited the FDA’s hasty emergency-use authorization of hydroxychloroquine to treat the novel coronavirus. That authorization was withdrawn in June after clinical trials showed hydroxychloroquine provided no benefit while potentially increasing risks of fatal heart arrhythmia, as well as the botched rollout of last month’s emergency-use authorization for convalescent plasma, when FDA Commissioner Stephen Hahn overstated potential benefits of the transfusions.

Convincing the public that a vaccine is safe and effective will be vital to making sure enough of the population gets immunized against SARS-CoV-2 to stem the tide of the pandemic, Adalja added.

“There is a thriving anti-vaccine movement that will use any kind of misstep when it comes to vaccine safety to undermine confidence in all vaccines,” he said.

The drug executives’ statement Tuesday emphasized that the FDA has established a rigorous set of rules for evaluating vaccines.

“FDA’s guidance and criteria are based on the scientific and medical principles necessary to clearly demonstrate the safety and efficacy of potential covid-19 vaccines,” they said. “More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.”

The companies also stated they collectively have previous experience creating 70 successful vaccines “that have helped to eradicate some of the world’s most complex and deadly public health threats.”

Trump’s own top vaccine adviser, Operation Warp Speed co-chief Moncef Slaoui, said in an interview on NPR last week that it is “very unlikely” a vaccine would be authorized before Election Day. Slaoui was responding to reports that the Trump administration had told states to prepare to distribute vaccine by Nov. 1, two days before the election.

“There is a very, very low chance that the trials that are running as we speak could [be completed] before the end of October and therefore there could be – if all other conditions required for an Emergency Use Authorization are met – an approval,” Slaoui told NPR. “I think it’s extremely unlikely but not impossible, and therefore it’s the right thing to do to be prepared, in case.”

Slaoui said in a separate interview with the news site Science that he would not remain in the administration if he detected “undue” political pressure in vaccine approval.

“I would immediately resign if there is undue interference in this process,” he said, adding: “I have to say there has been absolutely no interference.”

For pediatricians, coronavirus raises a thorny problem #ศาสตร์เกษตรดินปุ๋ย

#ศาสตร์เกษตรดินปุ๋ย : ขอบคุณแหล่งข้อมูล : หนังสือพิมพ์ The Nation.

For pediatricians, coronavirus raises a thorny problem

Health & BeautySep 06. 2020File photoFile photo 

By The Washington Post · Marlene Cimons · HEALTH, HEALTH-FEATURES
Joanna Dolgoff, a pediatrician in Paulding County, Ga., cringed when she saw the photo on Facebook: a crowded high school hallway full of maskless students, an image that quickly went viral. “I was shocked at how closely the kids were packed together and that they weren’t wearing masks,” she says.

Then it got worse. “I didn’t know where the photo was from,” she says. The moment she learned these students were from North Paulding High School, where some of her patients attend classes, “I got a sinking feeling in my stomach,” she says. “These are my kids. These are the patients I take care of.”

As classes resume in person in some parts of the country, pediatricians – like parents, children and teachers – also are feeling the strain of the ongoing pandemic. They must not only provide a safe space to see patients, who range from newborns to 18-year-olds, and ensure a supply of personal protective equipment, but also determine whether that coughing child with a sore throat and fever has a common cold, the flu – or covid-19. 

“We are facing unprecedented challenges as the school year opens, and we’re scrambling to figure out how to handle everything,” Dolgoff says.

Six students and three staff members from North Paulding High tested positive in the days following widespread circulation of the photo. (For privacy reasons, Dolgoff won’t disclose whether any of her patients were among them.) She is angry that young people risk exposure when school districts such as hers fail to follow established public health measures.

“The rule in the county is that you don’t have to wear a mask,” she says. In addition, she says, the schools are saying they can’t social distance because the buildings aren’t big enough. “It’s not safe to go back to school if they aren’t requiring masks, or enforcing social distancing. It’s just not safe for the kids, their teachers or the staff.”

Parents are in a terrible bind because “they had no choice but to send their kids back to school,” she adds. “Most of them had to go back to work and couldn’t stay home.”

The school year has started in various formats in many parts of the country, making it difficult to protect kids, especially those attending in person. 

“I’ve been practicing for over 30 years and this spring, summer and fall are not like anything I’ve ever seen before,” says Sara “Sally” Goza, president of the American Academy of Pediatrics, whose website has posted a covid-19 resource page for pediatricians. “We’ve seen this all across the country. All practices are a little anxious about what will happen in the fall.”

Katie Lockwood, a pediatrician with Children’s Hospital of Philadelphia, agrees. “Everything has changed,” she says. “There’s a higher stress level that seems universal and . . . the effects of it are visible. My patients are dealing with food insecurity, job furloughs, challenges of distance learning, loss of family members, missing life events, social isolation and more, which impacts their physical and mental health. This fall, we are facing more unknowns as we enter a new season with covid and the added issue of influenza and other viral illnesses.”

Pediatricians are girding for an increase in respiratory illnesses once colder weather sets in. 

“Kids will come in with symptoms – sniffles, a fever, sore throat and cough – that a year ago we would have dismissed as a common cold or flu,” Dolgoff says. “Now we have to take it much more seriously. There’s no way to tell the difference based on symptoms alone. The only way to know is to test.”

When test supplies are limited, “the sickest children will get a test, as well as those who might have been exposed . . . If we don’t have enough tests, we treat all possible covid patients as if they have covid,” she says.

In the absence of a test, “we have to err on the side of caution and quarantine for 10 days from the onset of symptoms, until the symptoms decrease and there is no fever for 24 hours,” she adds, citing guidelines from the Centers for Disease Control and Prevention. “Only patients whose symptoms are not consistent with covid may return to school.”

Elizabeth Murray, who practices emergency pediatric medicine at the University of Rochester Medical Center’s Golisano Children’s Hospital, predicts that local public health officials will be watching disease transmission rates of all common respiratory illnesses closely once all schools open, and likely will advise providers about testing. 

“As pediatricians, we know we will be facing covid-19 in some shape or form, although we don’t know how severe it’s going to be,” she says. “The only certainty is that we are full of uncertainty.”

Children represent 9.5% of all cases, with more than 476,439 cases reported since the onset of the epidemic, according to the pediatrics academy. Between July 9 and Aug. 6, pediatric cases rose by 179,000, a 90% increase from the previous total that “caught everyone’s eye,” Goza says. 

Although most pediatric cases are not severe, and do not require hospitalization, recent research suggests children play a much larger role in community transmission than previously thought, shedding virus for weeks as asymptomatic spreaders. 

“There is risk of infection not just from the symptomatic child, but from asymptomatic children,” says Michael Martin, a Vienna, Va., pediatrician and president of the Academy’s Virginia chapter. “That is the big unknown.”

Moreover, physical symptoms are not the only health issues related to covid-19 that worry pediatricians. Many say they are seeing more mental health problems among their young patients, requiring the intervention of pediatric psychologists. 

“It’s rampant around the country,” says Dolgoff, a member of the academy’s covid-19 task force. “We see anxiety, depression, developmental regression, acting out. They’re scared about dying of covid. They’re scared about their family dying of covid. They’re depressed because they aren’t seeing their friends. Younger kids are wetting the bed. Not having a social structure is leading to depression in children.”

Martin agrees, noting that typical childhood stresses usually ease in the summer “as kids are able to unwind at camps and during family trips,” he says. “This did not happen this year.”

Still, after a drop in the spring, children are returning to pediatric offices for checkups, immunizations and sports physicals. At the start of the pandemic, when many people shunned doctor visits, some offices were forced to furlough staff members they couldn’t pay. Visits still may decrease in areas with virtual learning, since children isolated at home are less likely to get sick – a good thing for public health, although less so for pediatric business.

“No one wants children getting ill with ear infections, colds or the flu, so fewer sick children would be great,” says Gary Bergman, a pediatrician who practices in Alexandria and Fairfax, Va. “But as a business owner, I also have a responsibility to my staff – and their families – to keep them employed.”

When the pandemic began, Bergman says, visits to his office dropped by half. Now they are rising again. 

“Our numbers have rebounded, but not all the way to pre-pandemic numbers,” he says. “It appears parents are finally starting to feel more comfortable coming into a medical office, especially for delayed checkups and overdue vaccinations.”

When patients and children return, they will find waiting rooms looking very different. Children no longer sprawl on the floor, playing with toys or with each other. Parents no longer sit and chat. Instead, they sit in their cars and wait for a call telling them a room is available. Once inside, there is little, if any, wait time. Everyone must wear a mask. Chairs are stacked, or stored. There are no toys, books or magazines. Practices clean and disinfect each room between patients. Doctors and staff all wear PPE, a sight increasingly familiar to young patients.

“Children have been very tolerant of my PPE,” Lockwood says. “Sometimes I don’t recognize my colleagues under our PPE, but the children don’t seem fazed. If a patient does look hesitant, I try to make a joke about my ‘superhero mask’ or ‘bug-eyed goggles.’ “

While protecting patients, pediatricians also must remember to protect themselves, Martin says. “We have experience mitigating this risk,” he says. “Many of us have continued to practice throughout the pandemic without getting ill. We have learned that the risk of infection stems from letting our guard down with each other, and taking masks off in lunchrooms and common areas, and not social distancing with peers when we should.”

To be sure, the pressures are great, but pediatricians are adjusting, Goza says. “It’s amazing how practices are adapting,” she says. “They are making it work.”

Laguna Phuket holds health fair for guests #ศาสตร์เกษตรดินปุ๋ย

#ศาสตร์เกษตรดินปุ๋ย : ขอบคุณแหล่งข้อมูล : หนังสือพิมพ์ The Nation.

Laguna Phuket holds health fair for guests

Sep 05. 2020

 Laguna Phuket resort complex joined hands with Bangkok Hospital Phuket to host a health fair.

The Laguna Phuket Health Fair featured free consultations and health screening by specialists in dental, eye, heart, sports medicine and well being, for the residents and guests of Laguna Phuket.

The event was its latest initiative for its #StaySafeWithLagunaPhuket campaign, following the announcement of all its seven deluxe hotels being awarded Amazing Thailand Safety and Health Administration Certification and Laguna Phuket hosting the industry awards ceremony in July 2020.

The managing director of Laguna Phuket, Ravi Chandran, said: “For more than 25 years, Bangkok Hospital Phuket has provided on-site medical services from its clinic, located at the heart of Laguna Phuket. This facility is an integral part of our commitment to the health and well being of our Laguna Phuket community. We are delighted to deepen our partnership, as we heighten our practices to safeguard against the current public health situation.”

Assistant director of Bangkok Hospital Phuket, Dr Antika Jacqueline Klein, “Recognised with the industry JCI-accreditation, Bangkok Hospital Phuket is known for its uncompromising medical care. We are honoured to have worked with Laguna Phuket for many years and are pleased to partner Laguna Phuket in extending high-quality medical care and services in consumers’ quest for a healthier lifestyle.”

Laguna Phuket’s other destination facilities, such as residential services, spas, golf, tours, transportation and retail, have also enhanced safety measures to ensure residents, guests and associates can stay safe.

Eat a variety of food for best nutrition, advises expert #ศาสตร์เกษตรดินปุ๋ย

#ศาสตร์เกษตรดินปุ๋ย : ขอบคุณแหล่งข้อมูล : หนังสือพิมพ์ The Nation.

Eat a variety of food for best nutrition, advises expert

Sep 01. 2020

By THE NATION

A nutrition expert has advised people against eating the same thing over and over again, as the body will not be able to absorb enough nutrients.

Dr Adune Ratanavichitrasin, the deputy dean of the Faculty of Medicine at Siriraj Hospital, Mahidol University, said in a Facebook post on Tuesday (September 1) that eating the same food every day is not beneficial to the human body.

He said people should consume a variety of foods because not only is it less boring, but also because human beings need a variety of nutrients.

The doctor also said that consuming the same items, especially vegetables, will increase the risk of toxicity, especially from pesticide, and explained that the human body requires low amounts of salt, minerals and vitamins.

Months into the pandemic, still no easy answers on coronavirus testing #ศาสตร์เกษตรดินปุ๋ย

#ศาสตร์เกษตรดินปุ๋ย : ขอบคุณแหล่งข้อมูล : หนังสือพิมพ์ The Nation.

Months into the pandemic, still no easy answers on coronavirus testing

Health & BeautyAug 30. 2020Technicians process coronavirus saliva tests at the Waksman Institute of Microbiology in Piscataway, N.J. CREDIT: photo for The Washington Post by Bryan Anselm.Technicians process coronavirus saliva tests at the Waksman Institute of Microbiology in Piscataway, N.J. CREDIT: photo for The Washington Post by Bryan Anselm. 

By The Washington Post · Rachel Weiner, Steven Mufson, Laurie McGinley · NATIONAL, HEALTH, HEALTH-NEWS 
As a new school year dawns, the demand for cheaper, faster and more accessible coronavirus testing is growing. But slow and sometimes erroneous test results and confusion over when and how to get tested continue to plague Americans as they wrestle with decisions about resuming their lives.

An abrupt government recommendation this week that fewer people get tested – while at the same time the Trump administration moved to purchase 150 million rapid tests – has made a disorganized testing regime even murkier.

Saliva tests are prepared for processing at the Waksman Institute in Piscataway., N.J. CREDIT: photo for The Washington Post by Bryan Anselm.

Saliva tests are prepared for processing at the Waksman Institute in Piscataway., N.J. CREDIT: photo for The Washington Post by Bryan Anselm.

The controversy sparked by the revised standards and, separately, the fraught decisions about testing that confront local school officials and university administrators open a window onto the persistent problems dogging testing in the United States.

“I started to talk to colleagues nationally, and I was taken aback that most [public school] districts and most charter networks really had thrown in the towel quickly and said testing was too expensive and too complicated,” said Laura Clancy, chief talent officer for a nonprofit charter school network in Philadelphia and Camden, N.J., that plans to open its 24 schools on a limited basis by Oct. 1 pending community transmission rates and local guidance.

Some universities are already closing their campuses because they can’t keep up with outbreaks. A growing chorus of scientists say occasional screening, or surveillance, is not enough; they say students and others need be able to screen themselves at least twice a week.

While President Donald Trump has declared that we have enough or even too much testing, Democratic presidential nominee Joe Biden promised in his convention speech that “if I’m president . . . we’ll develop and deploy rapid tests with results available immediately.”

Political rhetoric aside, testing companies and policy advocates face regulatory, scientific, logistical and ethical hurdles more than half a year after the virus appeared in the United States.

Turnaround times for most tests have improved in recent weeks, in part because of a substantial drop in the number of tests administered. Still, the Trump administration estimates that over the past month, 1 in 5 tests took more than three days to come back – rendering results largely useless. The equipment needed at the nation’s biggest private lab companies is expensive and on back order.

Many companies have developed faster, cheaper tests, but there is a trade-off: Such tests are not nearly as sensitive as the standard coronavirus tests that can take days or weeks to process. The Food and Drug Administration is opposed to letting people take these tests at home unless they meet higher senstivity standards, fearing they would create a false sense of security. And public health experts remain deeply divided.

Testing serves two purposes. One is diagnostic, in which it is used to confirm the presence of the virus in people who have symptoms or a known exposure to someone who is already sick. The other is to detect people who are infected but don’t know it. That second purpose is especially important for screening asymptomatic people out of large groups, at schools and elsewhere.

Two kinds of tests exist to look for active infections. Molecular tests search for the virus’s genetic material. Antigen tests look for spiky proteins on the surface of the virus.

The gold-standard test is molecular – a polymerase chain reaction (PCR) test performed with a long nasal swab, known to be highly sensitive because of an expensive and time-consuming amplification process that finds even a small bit of infectious material.

Antigen tests are simpler and cheaper but less sensitive; they need more virus in the body to generate a positive result.

The White House just announced a deal to produce 150 million new rapid tests that yield results in 15 minutes, without added equipment. But these tests still must be analyzed by a medical professional. Technically they are approved for use only on people with symptoms, although the White House is touting them as a potential solution for schools and businesses.

That announcement came days after the introduction of new guidance on testing from the administration. It replaces advice that everyone who has been in close contact with an infected person should get tested to find out whether they had contracted the virus. Instead, the updated guidance says those without symptoms “do not necessarily need a test.”

Some experts argue the only way out of our current morass is testing that is even cheaper and simpler, performed entirely at home – even if it is not as sensitive.

“This can work better than a vaccine if it could just be produced at scale,” said Michael Mina, a Harvard University epidemiologist who has become a vocal advocate for rapid at-home testing. The tests “are not going to tell you if you definitely do or do not have any virus in you. And that’s not their role. They’re going to tell you if on a given day when you wake up and use this test inside of your house, you are at risk of transmitting the virus to other people.”

– – – 

The novel coronavirus is particularly difficult to contain because it has a long incubation period and often leaves no symptoms behind. A test could be taken too early to catch the virus, or the results could come too late, when a person is already infecting others.

That’s why some public health experts argue in favor of rapid tests: If they’re cheap and convenient enough, they could be taken repeatedly by the same person, something unlikely to happen with more expensive PCR testing.

While the rapid tests might not catch every infection, experts say they should detect the most contagious cases.

“The notion of what a ‘junk test’ is has to be adapted for the role it’s playing,” said Carl Bergstrom, a biologist at the University of Washington and another proponent of rapid at-home testing. “It’s a substantial shift in what you’re looking for.”

Bergstrom suggests the FDA develop a separate track for approving such tests, with lower standards and appropriate warnings. People who are sick and need the right treatment, or who know they were exposed to the coronavirus, could get highly accurate PCR tests. Everyone else would proactively take rapid tests, using them as a potential indicator of infection.

An FDA official speaking on the condition of anonymity to explain the administration’s thinking said the agency is willing to approve less-sensitive rapid tests that are performed at point-of-care sites, such as a clinic or pharmacy, where a medical professional can offer advice on how to interpret the results. But the agency is loath to open the floodgates to rapid tests performed completely at home.

“Random testing of healthy people just all over the country is not what we’re advocating,” Adm. Brett Giroir, who leads the White House testing efforts, told reporters recently.

Some critics view even the few antigen tests that have met the FDA’s standards as suspect.

“It is better to not test at all and practice social distancing than to deliver a high number of false-negative results, since negative results often lead individuals to engage in risky behaviors that could increase virus spread,” said Bob Terbrueggen, president of a Los Angeles genomics company called DxTerity.

Public health experts express concerns that tests taken at home will go unreported, undermining efforts to measure the scope of the pandemic. Already, some states don’t report positive antigen test results, resulting in an incomplete portrait of the disease’s spread.

With no clear standards, average Americans may be on their own in understanding how best to use these tests.

“You’re potentially making consequential decisions, on the individual level, based on test results that are going to be harder to interpret,” Jennifer Nuzzo, an epidemiologist at the Johns Hopkins Center for Health Security, told reporters recently.

– – –

There are already more than 150 coronavirus tests approved for use by the FDA, with little explanation for consumers about what differentiates them.

One school district in Florida’s Lake County, for example, decided to screen all teachers and students before the school year began, partnering with a clinic that ended up choosing a rapid antibody test because other options were unreliable or not feasible.

“If you were to see my office . . . there’s boxes of rapid tests that we chose not to use,” said Matt Cady, practice administrator at Adult Medicine of Lake County. Some antibody tests were recalled by the FDA before they even arrived, while other options gave negative results in people known to be infected.

To cut down on lab time and boost capacity at the nation’s big labs, the FDA has approved efforts to pool samples and test groups of them at once, something the administration says at least half of states are doing. But pooling samples works only if most samples test as negative; a positive result means the whole batch needs to be tested again.

Peter Iwen, director of the Nebraska Public Health Laboratory, was one of the first scientists in the country to start pooling samples. Now, he says it’s pointless in his state: “The positivity rate in Nebraska is much too high,” he said.

The laboratory testing world is dominated by big companies – including Abbott Laboratories, Quest Diagnostics and Laboratory Corp. of America – that carry out about half of U.S. testing. Each machine is costly and processes as many as 2,000 tests a day. The American Clinical Laboratory Association, a trade group, says its members need Congress to establish a federal fund to pay for machines and tests not covered by insurance.

The rest of the testing world is full of small companies.

One called E25Bio in Cambridge, Mass., while still hoping to see its cheap at-home test hit the market, is now aiming for approval with a more sensitive version that requires a lab step.

“These type of antigen tests, while they will never be as accurate and sensitive as PCR, what they are very good at is detecting high viral loads early in infection,” E25Bio spokesman Carlos Henri-Ferré said. “What we’re talking about is a contagion tracker, a contagion stopper.”

Other companies are trying to bypass the debate with affordable, at-home saliva tests that can meet the FDA’s standards.

One is an antigen test being developed by a company in Hawaii named Oceanit, currently in clinical trials at The Queen’s Medical Center in Honolulu. Oceanit chief executive Patrick Sullivan said that by designing a molecule specifically for the coronavirus antigens, the test achieves greater sensitivity. The current model costs $20, but broader manufacturing could bring it down to $4 or $5, he said.

The company designed the test to be simple enough for 8-year-olds to take before school, but the first clients would be a different unruly bunch: mainland tourists.

“The restaurants, the hotels, the airlines – everybody wants a tool like this,” Sullivan said.

The FDA this month granted emergency use authorization for two saliva-based tests that don’t require swabs or the chemical testing agents that have been in short supply. The administration is encouraging schools to look into using both. While saliva tests are less common, researchers have found they can be as sensitive as nasal swabs.

SalivaDirect, developed at the Yale School of Public Health with funding from the National Basketball Association, cuts costs down to the level of a cup of coffee – $1 to $4 a test in part by avoiding costly preservatives and using a cheap container. The school is making its test available to any company or laboratory interested in using it.

“Its novelty is its simplicity,” said Anne Wyllie, a Yale epidemiologist. “We saw the need for cheap testing because it needs to be accessible around the country. And colleges and schools need frequent testing.”

But materials are not the only reason coronavirus tests are hard to come by. Andrew Brooks, a geneticist who runs a Rutgers University lab that in April got the first FDA emergency clearance for a saliva test, said even cheap and fast tests involve staffing and packaging costs. Tests need to be logged, billed and reported to public health authorities.

“What people don’t understand is there are other operational issues that impact the ability for the lab to do this, not just reagents,” said Brooks, whose lab has analyzed some Major League Baseball tests. “We can’t hire people fast enough.”

Back in Cambridge, not far from E25, a company called Sherlock Biosciences is developing a paper strip test that offers “lab quality molecular diagnostics in the palm of your hand,” in the words of chief executive Rahul Dhanda. Rather than searching for a protein, the test uses the virus itself to create a signal detectable without amplification or special instruments. By next year, Dhanda said, the company could produce a test with “as good or better sensitivity than exists with PCR today.”

But he said Sherlock Biosciences was wrestling with the value of holding out for perfection in the middle of a crisis. At the same time, he worries that sacrificing accuracy, even if allowed by the FDA, would make the test harder for people to use, understand and trust.

“We wonder whether we should be making some trade-offs on performance to get the products out faster,” he said. “We’re torn as to what the right answer is. And I think we’re all collectively as a sort of society trying to get to that.”

Amazon’s creepy new health wearable analyzes your voice and body #ศาสตร์เกษตรดินปุ๋ย

#ศาสตร์เกษตรดินปุ๋ย : ขอบคุณแหล่งข้อมูล : หนังสือพิมพ์ The Nation.

Amazon’s creepy new health wearable analyzes your voice and body

Health & BeautyAug 28. 2020The Halo app uses photos you take of your body in minimal, tight clothing to estimate your body fat composition. CREDIT: AmazonThe Halo app uses photos you take of your body in minimal, tight clothing to estimate your body fat composition. CREDIT: Amazon 

By The Washington Post · Geoffrey A. Fowler · NATIONAL, BUSINESS, TECHNOLOGY, FEATURES, HEALTH, HEALTH-FEATURES 

I couldn’t pick just one crazy thing to say about the Halo, Amazon’s new wearable health gadget. So here are three:

1. Mirror, mirror on the wall, Amazon thinks you’re fat.

2. The artificial intelligence would like you to stop sounding overwhelmed now.

3. That nagging voice inside your head is now on your wrist.

Amazon's Halo Band and app track the wearer's fitness, health and even emotional state. MUST CREDIT: Amazon

Amazon’s Halo Band and app track the wearer’s fitness, health and even emotional state. MUST CREDIT: Amazon

The Halo is a $100 wrist-worn device that, among other functions, listens to your conversations so you can understand how you sound to others. And it comes with a companion app that 3D-scans your body to track your progress at gaining your quarantine-15.

Amazon is upfront about these invasive functions, which users of the Halo have to opt into using. What’s revealing is that one of tech’s biggest companies thinks consumers in 2020 might want them.

The Halo uses microphones on its band to listen to snippets of conversation and analyze how it thinks you come across to others.  CREDIT: Amazon

The Halo uses microphones on its band to listen to snippets of conversation and analyze how it thinks you come across to others. CREDIT: Amazon

Amazon CEO Jeff Bezos owns The Washington Post, but I review all tech with the same critical eye. Amazon declined to let me speak with an executive about the product, nor did it offer me the chance to get my hands on one for first impressions. (Anyone can sign up for the product’s waiting list, and I did. Hope they pick me!)

It makes sense that Amazon wants to push into health. This year in particular, tech companies are trying to transition their body-worn devices from fitness trackers into health and wellness assistants. Earlier this week, Fitbit launched a new $330 smartwatch called the Sense that includes a temperature sensor, an electrocardiogram app and an electrodermal activity sensor to detect the body’s response to stress. In September, Apple is expected to unveil a new version of its Watch with more health bells and whistles.

The makers of Fitbits, Oura rings and other wearables have also been participating in clinical studies to see if the data they gather can be used to predict the onset of covid-19 symptoms before patients even realize they’re sick.

In some ways, Amazon’s Halo is a me-too health tracker. There’s no screen, but like Fitbits it has sensors that collect data about your activity, sleep, temperature and heart activity. Covered in fabric or silicone, the water-resistant Halo Band looks like a style of bracelet that might have been popular in high school in the 1980s. Its accompanying app and paid service nudge you to healthier habits with content from companies including Headspace and Orangetheory Fitness.

Unlike the Apple Watch and other devices, Amazon’s Halo hasn’t received Food and Drug Administration clearance for any of its functions. It doesn’t count as a medical device.

But the Halo and Amazon’s $4-per month service attempt to use AI to be a more “comprehensive” wellness guide – and that’s where things get weird. The Halo can’t track your weight on its own, but it asks you to take photos of your body (wearing minimal, tight clothing) with its app so it can estimate your body fat percentage. A motivational slider in the app shows you what you would look like if you lost weight.

And then there’s the tone-monitoring. Amazon says understanding emotion is key to overall health, so it uses AI to analyze “energy and positivity” in a customer’s voice recorded from microphones on the band. (It knows your voice, as opposed to those around you, by making a profile of you speaking.) Amazon says tone results may, for example, “reveal that a difficult work call leads to less positivity in communication with a customer’s family, an indication of the impact of stress on emotional well-being.” 

Say what? Why would you want to know what an AI thinks about your tone? Are you supposed to make behavior changes – or seek counseling? Amazon says you could use it for feedback on public speaking, or to understand how sleep impacts your tone.

Amazon spokeswoman Molly Wade said its tech does not make “judgments” about tone, but determinations such as “friendly,” “hesitant,” and “overwhelmed” sure sound like judgments to me.

Also, why should we trust what AI has to say about this? The whole idea of “tone” is fraught with ideas about gender, ethnicity and class. Will it judge women more harshly than men? Amazon’s Wade says the company trained its system with data from “all demographic groups.” 

Privacy is also clearly a stumbling block. Many owners of Amazon’s popular Echo speakers are, rightly, concerned the Alexa assistant is eavesdropping on their conversations. (Police are increasingly turning to those recordings for evidence.) Unlike Echo speakers, the Halo doesn’t send Amazon the words you say – instead, it listens on the band itself, where it runs an analysis of your tone and then deletes the files. (You can press a button on the band to deactivate its microphone.) Amazon says body scan images are sent to its cloud but are deleted from its computers after processing.

But using the Halo does mean Amazon is going to learn even more about you. Amazon says no one can view your health data without your explicit permission, and it won’t sell it. The giant retailer also says it won’t use the data gathered by the Halo to sell you things. But it has already announced a partnership with health insurance company John Hancock to share your data for savings.

Amazon has a long history of being the try-anything company in consumer tech. It doesn’t have its own smartphone on the market, so it has to think outside the box. Over the years, I’ve reviewed Amazon products including a closet camera that judges your fashion sense (the now defunct Echo Look), a TV streaming box you operate via voice (the FireTV Cube), and most recently glasses that let you have private conversations with Alexa everywhere you go (the Echo Frames).

Like many of those other Amazon product launches, you can’t just buy the Halo directly – at least not yet. Customers in the U.S. can sign up on Amazon’s website to request “early access” that includes the device and six months of service for an introductory price of $65.

Virus’s retreat in Brazilian Amazon upends notions of herd immunity #ศาสตร์เกษตรดินปุ๋ย

#ศาสตร์เกษตรดินปุ๋ย : ขอบคุณแหล่งข้อมูล : หนังสือพิมพ์ The Nation.

Virus’s retreat in Brazilian Amazon upends notions of herd immunity

Health & BeautyAug 25. 2020Alessandra Said and her team take a 78-year-old covid-19 patient to an ambulance in the Coroado neighborhood of Manaus, Brazil, in May. CREDIT: photo for The Washington Post by Raphael Alves.Alessandra Said and her team take a 78-year-old covid-19 patient to an ambulance in the Coroado neighborhood of Manaus, Brazil, in May. CREDIT: photo for The Washington Post by Raphael Alves.

By The Washington Post · Terrence McCoy, Heloísa Traiano · WORLD, THE-AMERICAS 
The hospital system was coming apart. Coronavirus patients were being turned away. Basic necessities – beds, stretchers, oxygen – had run out. Ambulances had nowhere to take patients. People were dying at home. Gravediggers couldn’t keep up.

The human destruction in the Brazilian city of Manaus would be “catastrophic,” physician Geraldo Felipe Barbosa feared.

But then, unexpectedly, it started to let up – without the interventions seen elsewhere.

Photo by: The Washington Post — The Washington Post

Photo by: The Washington Post — The Washington Post

Hospitalizations of coronavirus patients plummeted in the state from a peak of more than 1,300 in May to fewer than 300 in August. Excess deaths in Manaus fell from around 120 per day to practically zero. The city closed its field hospital.

In a country devastated by the novel coronavirus, where more than 3.2 million people have been infected and over 105,000 killed, the reversal has stunned front-line doctors. Manaus never imposed a lockdown or other strict containment measures employed successfully in Asia and Europe. And what policies did exist, many people ignored. 

In the spring, the Amazonian city became a global symbol of the devastation the disease can wreak in the developing world. But now it has returned to near normalcy – far sooner than many expected – and scientists and public health officials are asking why. The question is part of a broader debate among scientists and public health officials over the mechanics of herd immunity and the level of transmission that must be crossed before the disease starts to recede.

European cities that were pummeled by the disease have begun to reopen without crippling second waves. In Guayaquil, the Ecuadoran metropolis where bodies were left on the streets, scientists have cautiously speculated that collective immunity has been reached. Some researchers are now suggesting the same about New York City.

The factors that are helping to keep the virus at bay in Manaus and other cities remain unclear. Changed behaviors and individual community characteristics surely play a role. Manaus is testing far more than it once did. But whatever the dynamic, scientists and health officials are starting to wonder whether early prognostications about herd immunity overshot the mark.

It was initially believed that between 60 and 70% of the population needed to develop antibodies to reach collective immunity. But Guayaquil never broke 33%. Manaus, the capital of Amazonas state, never got past 20.

“Manaus is an interesting case, indeed,” said Jarbas Barbosa da Silva, assistant director of the Pan American Health Organization. “The hypothesis – and this is just a hypothesis – is that the peak we had in Manaus was very strong, and there was such widespread community transmission that it may have produced some kind of collective immunity.”

Draconian restrictive measures reduce the disease sharply, Barbosa said. But in Manaus, the reduction has been gradual, with a steady progression of new cases still arriving every day. That curve suggests the disease followed a “natural dynamic,” Barbosa said.

Manaus, he said, “paid a very large price” to get there. During the spring, it suffered three times as many deaths as normal. In all, the city of 2 million along the Amazon River buried some 3,300 people more than usual.

“This was not a strategy,” Barbosa said. “It was a tragedy.”

– – – 

The idea of herd immunity has long been used to justify and explain the purpose of mass vaccination campaigns. Scientists would plug the disease transmission rate – or how many people one sick person infects – into a calculation to determine the percentage of people who should be inoculated. For particularly infectious diseases, such as measles, that’s as high as 95%. For others, it’s lower.

But researchers say collective immunity works differently in a live outbreak. The disease doesn’t simply vanish when a magic number is crossed. Instead, as the pool of potential victims shrinks, transmission decelerates until it’s gone. Containment policies can lower transmission further. But regardless of whether they’re adopted, once the pool of potential victims reaches a critical mass, an explosive resurgence is unlikely. Too many people would have already contracted the disease.

“In Italy, it struck the Milan region very badly,” said Tom Britton, a mathematician at Stockholm University. “But not Rome very much. If I had to bet money that there was a second wave, I would bet all of my money on Rome, rather than Milan.”

Britton and other researchers have been studying what’s known as “heterogeneity in susceptibility.” Early herd immunity models – and vaccination campaigns – have operated from the assumption that everyone’s the same. But individuals vary: Some people are more socially active, others are more physically vulnerable. Heterogeneity, researchers say, reduces the percentage of infection at which herd immunity may be achieved. The people most likely to get the disease and pass it on – the most socially active, the most susceptible – catch it first. But once they’re out of the pool of potential victims, the risk is less for everyone else.

“The effect of their immunity will be bigger,” Britton said. 

In a paper published in Science in June, he and other researchers estimated that population heterogeneity shaves the coronavirus herd immunity rate to 43%. Others say it might be lower.

Gabriela Gomes, a mathematician at the University of Strathclyde in Glasgow, has scrutinized European cities overwhelmed by the disease. In a paper she wrote with nine other researchers, which hasn’t yet been peer-reviewed, she arrived at a striking conclusion: Herd immunity could be lower than 20%. 

“Without immunity, you would have expected the cases to start growing very soon after interventions were lifted,” she said. “That’s what we were saying at the time: ‘It’s premature to lift interventions. Cases will start going up.’ But they didn’t. And in most cases, they continued going down. It was quite unexpected.”

But with the stakes so high – more than 770,000 dead worldwide and so much about the virus still unknown – many researchers have been reluctant to say whether they believe the worst in some of the hardest-hit cities has already passed. No one knows how long immunity lasts. The virus could mutate.

“In Manaus, maybe we’re done with it, and that’s it,” said Jeffrey Shaman, an environmental health scientist at Columbia University. “I would love that as well. But the reality is that it’s wishful thinking. It’s confirmation bias. We can’t pick evidence we hope is true. We have to be very careful about this because it could blow up in your face very quickly.”

– – – 

Pietro Pinheiro Alves, a physician in Manaus, knows how quickly that can happen. Despite its physical remoteness in the rainforest, Manaus is one of Brazil’s most international cities. Drawn by a free-trade zone, companies from all over the world have put down roots in the Amazon. As the coronavirus spread worldwide, strains from China, Europe and the United States were soon circulating, unseen. 

It didn’t take long for the patient surge to overwhelm the hospital system. 

“People are dying in their houses,” Pinheiro Alves wept into the phone in early May, when things were at their worst. “They can’t get any help in the hospitals.”

He felt hopeless. People were still crowding the streets. Officials weren’t willing to impose a lockdown. In impoverished Manaus, where many already live on the brink, the mayor said it would lead to social chaos and violence. So Pinheiro Alves spent his off hours trying to jury-rig ventilators.

Manaus Mayor Arthur Virgílio Neto said he “fought for social isolation.”

“The attempt failed,” he said. “There wasn’t real social isolation. People still went out, and it wasn’t understood why. In the most difficult hours, I’d go to the field hospital, get stuck in a traffic jam and think, ‘Why aren’t people home? What are they doing out?’ “

Physician Uildéia Galvão saw the result: Every day, there would be a line of ambulances outside her hospital in central Manaus, each holding a patient in need of a bed. Sometimes they sat for hours, waiting for someone to die and relinquish their bed.

At the height of the city’s outbreak, there would be three or four lined up. Then one day, it was two. Then one.

“It was the first sign that the number of emergency calls were dropping,” Galvão said.

Intensive care units started to clear. Emergency coronavirus calls slowed, dropping from 2,410 in April to fewer than 180 in July. The wail of ambulances quieted. Some scientists said victory was in sight.

“Why Manaus will be the first Brazilian city to defeat the Covid-19 pandemic,” wrote a group of researchers from the Federal University of Amazonas. 

Street activity returned to pre-pandemic levels. People flocked to the river to swim and party. Appeals to wear masks: widely ignored. Private schools opened up. Then public. Cases continued to number in the hundreds every day, but far fewer were serious enough to warrant hospitalizations.

“There isn’t a concrete explanation,” said Henrique dos Santos Pereira, a scientist at the Federal University of Amazonas. Maybe there’s an unseen biological immunity in the population. Or the city’s relative youth staved off the worst.

“The problem is that we don’t know how many people are susceptible,” dos Santos Pereira said. “In the beginning, we were thinking it was everywhere, but it doesn’t seem like the whole world is susceptible. . . . It is causing us to reconsider the theory of herd immunity.”

Virgílio, the mayor, hopes the scientists are right. The medical system in Manaus has failed once. If a second wave does come, he has little doubt what would happen.

“Our capacities would be overwhelmed.”

Coronavirus update: Infections are trending upward in the Midwest #ศาสตร์เกษตรดินปุ๋ย

#ศาสตร์เกษตรดินปุ๋ย : ขอบคุณแหล่งข้อมูล : หนังสือพิมพ์ The Nation.

Coronavirus update: Infections are trending upward in the Midwest

Health & BeautyAug 23. 2020

By The Washington Post · Derek Hawkins, Marisa Iati · NATIONAL, HEALTH 
Coronavirus infections are trending upward across the Midwest, raising concerns that those states are struggling to contain their outbreaks even as the nation’s total daily caseload continues to decline. 

Seven-day averages for new cases rose over the past week in the Dakotas, Illinois, Minnesota, Kansas and Iowa, according to tracking by The Washington Post. North and South Dakota experienced the biggest jumps, with average daily caseloads up 23 percent and 34 percent, respectively.

Other states reported progress against the virus, though it appeared to be marginal in some places. Daily case averages declined by about 6 percent over the previous week in Wisconsin and fell by 10 to 20 percent in several other Midwestern states, according to The Post’s tracking.

Spikes in cases across the Midwest come as other regions of the country have reported gains against the virus after seeing infections surge over the summer. Nationwide, the seven-day average for new cases has steadily trended downward after peaking in late July.

Several cases in South Dakota have been linked to a motorcycle rally that drew hundreds of thousands of people to the city of Sturgis this month. Health officials there said Thursday that they were aware of fewer than 25 infections among attendees, but acknowledged that they could not identify every case that exists because of the event.

Three neighboring states have also announced infections among rally attendees, according to local news outlets: seven cases in Nebraska, 15 in Minnesota and “a few” in Wyoming.

CDC Director Robert Redfield warned of a “third wave in the heartland” if Midwestern states don’t follow guidance from health officials to slow the virus spread.

“Middle America right now is getting stuck,” he said in an interview this week with the Journal of the American Medical Association. “That is why it’s so important for Middle America to recognize the mitigation that we talked about.” 

As cases have surged, President Donald Trump has taken aim at the pandemic response within his own administration.

On Saturday, he escalated his attacks on the Food and Drug Administration, tweeting a conspiracy theory about coronavirus treatments and stoking doubts about the agency’s decision to pull its emergency approval of the drug hydroxychloroquine.

In an early morning tweet, Trump made the baseless claim that “the deep state, or whoever” in the FDA was “making it very difficult for drug companies to get people in order to test vaccines and therapeutics.” He tagged FDA Commissioner Stephen Hahn, who was appointed by Trump last year, saying “they are hoping to delay the answer” until after the November election.

Trump also misleadingly claimed that “many doctors and studies disagree” with the FDA’s decision to revoke an emergency use authorization for hydroxychloroquine for treating covid-19, the disease caused by the coronavirus. The FDA said in June that the drug was ineffective and that potential benefits were outweighed by safety risks. Other research by the federal government and private institutions has found that hydroxychloroquine performs no better than a placebo in virus patients.

The president’s criticisms reflect a deepening politicization of federal health agencies and public health science as the virus rages around the country and the administration faces pressure to boost testing and develop a vaccine.

“This is really taking it to an unprecedented level,” Eric Topol, a cardiologist and director of the Scripps Research Translational Institute, said of Trump’s statements Saturday. “Every aspect of covid-19 – whether it’s diagnostic, therapeutic – every single aspect, through and through, is being overtaken by Trump.

“The whole idea is to promote human health and safety,” Topol added, “and this is all steps to compromise that.” 

House Speaker Nancy Pelosi, D-Calif., also pushed back on Trump’s allegations, saying the FDA must ignore his political pressure and approve only treatments or vaccines that are safe and effective.

“The President’s dangerous attempt to inject himself into the scientific decisions of @US_FDA jeopardizes the health & well-being of all Americans,” she wrote on Twitter.

Trump’s remarks came just days after the administration barred the FDA from regulating a range of laboratory tests, including tests for the coronavirus. The move stunned public health experts, who warned that the shift could result in unreliable coronavirus tests coming to market and worsening the crisis if people get erroneous results.

The president also recently blamed the FDA for not yet authorizing the emergency use of convalescent plasma, a promising but unproven treatment. “You have lot of people over there that don’t want to rush things. They want to do it after November 3,” he said in a White House news briefing this week.

The decision to block the FDA from overseeing lab-developed tests drew a rare public rebuke from former FDA commissioner Scott Gottlieb, who suggested that the move could open the door for substandard tests.

Gottlieb, who served in the Trump administration from 2017 to 2019, noted in a widely circulated Twitter thread Saturday that the FDA had spent the past six months working with labs to develop hundreds of coronavirus tests. The new policy from the Department of Health and Human Services “could put this work at risk,” he said.

“Now, FDA’s ability to protect public health could be challenged. FDA might not be able to provide critical advice to test developers or take needed enforcement actions against bad tests,” Gottlieb wrote. “After all, how can FDA take action over something HHS says it doesn’t regulate?” 

Gottlieb said a “plethora” of tests could enter the market and go directly to consumers without being vetted by the FDA for clinical accuracy first.

“Policies issued in the middle of this pandemic should be carefully considered for their impact on the crisis,” he said. “First do no harm.” 

Administration officials told The Post this week that the policy, announced Wednesday on the HHS website, was made for legal reasons and that the FDA lacks the authority to regulate lab-developed tests.

The Trump administration has also sought to diminish the role of the Centers for Disease Control and Prevention in responding to the pandemic. Last month, the administration ordered hospitals to bypass the CDC in reporting data on covid-19 patients, causing the information to briefly disappear from the agency’s website. Officials reversed the decision after outcry from state governors and health experts who said they worried that the administration was manipulating the data for political purposes.

J&J plans huge vaccine study while Pfizer cites rapid enrollment #ศาสตร์เกษตรดินปุ๋ย

#ศาสตร์เกษตรดินปุ๋ย : ขอบคุณแหล่งข้อมูล : หนังสือพิมพ์ The Nation.

J&J plans huge vaccine study while Pfizer cites rapid enrollment

Health & BeautyAug 21. 2020The Johnson & Johnson logo is displayed outside the company's headquarters in New Brunswick, N.J., on Aug. 1, 2020. MUST CREDIT: Bloomberg photo by Mark Kauzlarich.
The Johnson & Johnson logo is displayed outside the company’s headquarters in New Brunswick, N.J., on Aug. 1, 2020. MUST CREDIT: Bloomberg photo by Mark Kauzlarich.

By Syndication Washington Post, Bloomberg · Robert Langreth, Cristin Flanagan · BUSINESS, US-GLOBAL-MARKETS
As the race for a covid-19 vaccine gets closer to the finish line, investors are parsing details of trial designs like never before as they handicap which is most likely to succeed.

Johnson & Johnson confirmed in an email Thursday that it plans to test its covid-19 vaccine in as many as 60,000 people, twice the number of other big trials being conducted in the U.S. The company first posted the design for the trial on Aug. 10, and it is set to begin in late September.

Meanwhile, Pfizer Inc. released favorable safety data from a Phase 1 trial of its vaccine. The New York-based company, which is developing its product with German partner BioNTech, hadn’t previously released safety data on the shot it will move into a final-stage trial.

“Investors are trying to decipher who’s going to be the winner and who might be left behind,” said Yaron Werber, a Cowen analyst, in an interview.

The Pfizer data support the company’s “slight lead” in the race, according to Werber. J&J researchers, meanwhile, “are buying themselves a lot of insurance” with an extra big trial aimed, he said, at making “sure they are coming out with positive data.”

Shares of both Pfizer and New Brunswick, New Jersey-based J&J gained on Thursday, rising 1.2% and 0.7%, respectively, in New York trading after the announcements.

There are more than 160 covid-19 vaccines being developed worldwide, and about 30 have entered human trials, according to the World Health Organization. Even before scientists know whether the inoculations will work, many of the furthest-along companies are already starting to produce the products and cutting deals to supply shots to governments worldwide.

In the U.S., two messenger RNA vaccines have entered final-stage trials, including Pfizer’s vaccine and a competing shot from the biotech company Moderna Inc.

“We can confirm that planning and recruitment is underway” for J&J’s Phase 3 trial, company spokesman Jake Sargent said in an email. The trial plan “is intended to be as robust as possible,” he said, and will be conducted in places with high rates of Covid-19, based on epidemiology and modeling data.

On the surface, the J&J trial will be about twice as big as the final-stage vaccine trial underway at Pfizer. In an interview, Philip Dormitzer, Pfizer’s vice president of viral vaccine research, said the the nation’s high infection rates means the company expects to hit the needed number of Covid-19 cases with 30,000 people or less.

If the incidence rate suddenly drops, the trial size could be increased, he said. The trial is enrolling rapidly and had more than 9,000 volunteers as of August 19th, he said in an interview.

“Things are going very quickly,” Dormitzer said. “We remain on target” to have results ready to submit to regulators in October.

The Food and Drug Administration is tentatively planning to hold an advisory panel meeting on October 22 to discuss covid-19 vaccines, according to Anand Shah, the agency’s deputy commissioner for medical and scientific affairs. Pfizer’s Dormitzer said he couldn’t say whether Pfizer would have results in time to present at this meeting.

Pfizer and BioNTech also posted Phase 1 data from its vaccine candidate on medRxiv.org, a preprint site for research results that haven’t yet been published.

The company has tested several messenger RNA vaccines in its phase 1 trial, and previously released safety results for one of them. But when it began large scale trials in late July, it used another RNA vaccine candidate that it hadn’t yet revealed early results from.

There was nothing mysterious about the switch, Dormitzer said. Pfizer got the safety data from the second vaccine candidate shortly before it began larger scale trials at the end of July. It appeared to be equally good at generating antibodies against the coronavirus as the first vaccine, but with fewer side effects.

That made the second vaccine the obvious choice to move into final-stage trials, he said. But because results were flowing in so fast and decisions were being made quickly, Dormitzer said there wasn’t time to compile and release the safety data for the second vaccine until now.

“It was a surprise,” that the second vaccine had fewer side effects, he said, calling the result a “bit of a vindication” of their strategy of testing multiple RNA vaccine candidates in Phase 1 trials, before selecting the best one for large-scale trials.