Famed Animal Expert Jack Hanna Diagnosed With Dementia

Jack Hanna, the director emeritus of Ohio’s Columbus Zoo and Aquarium known for his many TV appearances, has been diagnosed with dementia, his family announced Wednesday in a post on Twitter.

His condition is now believed to be Alzheimer’s disease, the family wrote. Hanna, 74, announced his retirement last year.

“His condition has progressed much faster in the last few months than any of us could have anticipated,” his daughters Kathaleen, Suzanne and Julie Hanna wrote in the letter.

“Sadly, Dad is no longer able to participate in public life as he used to, where people all over the world watched, learned and laughed alongside him,” they wrote.

Jack Hanna

Hanna often appeared on “Good Morning America,” “The Tonight Show,” “Late Show,” “Late Late Show,” “Larry King Live,” “The Ellen DeGeneres Show” and “Maury.” He also hosted his own weekly TV programs, including “Jack Hanna’s Animal Adventures,” “Jack Hanna’s Into the Wild,” and “Jack Hanna’s Wild Countdown.”

Hanna joined the Columbus Zoo in 1978. He is credited with transforming the zoo from an “aging collection of pens and buildings” into what it is today — often listed as one of the best zoos in the U.S., according to NBC News.

“While Jack retired from his official role at the end of 2020, his legacy will be ever-present in our work as we continue to fulfill our organization’s mission to lead and inspire by connecting people and wildlife,” the Columbus Zoo and Aquarium told CBS News.

The family said that Hanna spent his life connecting with wildlife and people because he believed that seeing and experiencing animals was the “key to engaging them in more impactful conservation efforts.” The media appearances allowed him to bring awareness to global conservation and the natural environment, they wrote.

Hanna is no longer able to travel and work in the same way as before, the family added, but they hope his enthusiasm will continue a legacy. At the Columbus Zoo, Hanna advocated for improved wildlife habitats and connection between animals and humans. After he left the role of executive director in 1992, he continued to be a spokesman for the zoo until retirement.

His wife, Suzi, has been by his side for 53 years and continues to be the family’s “rock,” his daughters wrote in the letter. They asked for privacy during this time, especially due to safety concerns during the COVID-19 pandemic, and thanked readers and viewers for their ongoing support.

“While Dad’s health has deteriorated quickly, we can assure you that his great sense of humor continues to shine through,” they wrote. “And yes — he still wears his khakis at home.”

Sources:

Jack Hanna, “Twitter post at 12:59 p.m. on April 7, 2021: A Letter from the Hanna Family.”

NBC News, “Beloved animal expert Jack Hanna has dementia, steps away from public life.”

CBS News, “Celebrity zookeeper Jack Hanna diagnosed with dementia, family says.”

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South Korea Pays Price for Reliance on COVAX, Scrambles for Vaccines

SEOUL (Reuters) – South Korean authorities are facing a backlash for relying on global vaccine-sharing scheme COVAX for a bulk of its COVID-19 shots as shipment delays threaten to slow the country’s inoculation programme.

Once praised by the World Health Organization for its decision to procure vaccines through the global scheme, South Korea is now facing criticism at home as the government scrambles to meet the supply shortfall.

South Korea, Indonesia, the Philippines and Vietnam are among countries to be hit by shipment delays to vaccines they have been promised following export curbs by manufacturer India.

In February, South Korea slashed its first quarter vaccination target from 1.3 million people to just 750,000 due to adjustments in the supply timetable of the 2.6 million doses of AstraZeneca’s coronavirus vaccine from COVAX.

The latest COVAX shipment disruption announced earlier this week – that it would only receive 432,000 doses instead of 690,000 and delivery would be delayed to around the third week of April – is the second time that South Korea’s vaccine rollout has been hit by delayed supply from the scheme.

“The government should no longer cause public anxiety with the vaccines,” Lee Yong-ho, an independent lawmaker who sits on parliament’s health and welfare committee, said.

“It should either impose export curbs on the locally produced vaccines until the supply uncertainties are resolved, or come up with a special vaccine procurement strategy and bring the originally contracted quantity as planned.”

South Korean health authorities said they were not considering restricting exports of locally produced vaccines, but instead, holding talks with vaccine makers and distributors to advance delivery timelines.

The efforts appear to be bearing fruit with the government announcing on Thursday that delivery of the 432,000 doses of the AstraZeneca vaccines from COVAX would be brought forward to Saturday from the third week of April.

“(We) have accelerated administrative process and were able to bring forward the schedule from what COVAX had initially informed us,” the Korea Disease Control and Prevention Agency said.

The fluctuating shipment schedules have raised concerns about the country’s aim to immunise 12 million people by June, reaching herd immunity by November, but government officials have assured the goal is achievable.

“This is a very achievable target as we have factored supply schedule and our inoculation capability into the calculation,” Prime Minister Chung Sye-kyun told a news conference on Thursday.

Assuming no further delays, South Korea is scheduled to receive 13.7 million doses in the second quarter — 6 million from Pfizer Inc, 7 million from AstraZeneca and 729,000 from COVAX.

Oh Se-hoon, opposition candidate for Seoul’s mayoral by-election, attacked the government this week for its slow vaccine rollout, which he said was the world’s 105th to kick off.

The slow rollout was partly due to the country’s early strategy to focus more on containing the virus through aggressive testing and contact tracing than striking bilateral vaccine deals.

While most wealthy nations had shunned joint purchases through COVAX, raising concerns over vaccine inequity, South Korea committed to procure vaccines from the scheme which earned praise from the WHO.

“The Republic of Korea despite being a high-income country that could easily afford to buy vaccines through bilateral deals has waited its turn for vaccines through COVAX,” WHO Director-General Tedros Adhanom Ghebreyesus said on March 22.

Mike Ryan, WHO’s top emergency expert, also lauded South Korea’s overall efforts to contain the COVID-19 disease.

He said the country not only developed a very successful surveillance and testing regime but exported those tests around the world, kept the disease under control in a very significant way, and have numbers of disease that are “the envy of the world.”

South Korea reported 551 new cases on Wednesday, bringing the country’s total infections to 103,639, with 1,735 deaths.

Despite international plaudits, some like lawmaker Lee said the slow rollout raises doubts about the government’s plan to reach herd immunity this year.

“With just 1.5% of the total 52 million population vaccinated, it is questionable with current supply when we will ever reach the herd immunity.”

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Rapid COVID Tests Are Coming to Stores Near You

 

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

Scientists and lawmakers agree that over-the-counter covid tests could allow desk workers to settle back into their cubicles and make it easier to reopen schools and travel.

But even as entrepreneurs race their products to market, armed with millions of dollars in venture capital and government investment, the demand for covid testing has waned. Manufacturing and bureaucratic delays have also kept rapid tests from hitting store shelves in large numbers, though the industry was energized by the Food and Drug Administration’s greenlighting of two more over-the-counter tests Wednesday.

Corporate giants and startups alike plan to offer a dizzying array of test options, most costing between $10 and $110. Their screening accuracy varies, as does the way consumers get results: collection kits mailed back to a lab, devices synced with artificial intelligence-enabled apps on a smartphone that spit out results within 15 minutes, and credit card-sized tests with strips of paper that must be dipped into a chemical substance.

“At-home tests are one of the key steps to getting back to normal life,” said Andy Slavitt, a member of the White House COVID-19 Response Team, during a February briefing.

The Biden administration announced in March it will allocate $10 billion from the recently passed stimulus package for covid testing to expedite school reopenings, and earlier said it would invoke the Defense Production Act to manufacture more at-home tests. Separately, the federal government has already sent millions of Abbott Laboratories’ BinaxNOW rapid tests to states, and California, for instance, is giving 3 million of them to its most disadvantaged school districts for free.

Large employers, like Google, sports leagues and the federal government, have already shelled out millions to regularly test their workers. Amazon just received emergency use authorization from the FDA for its own covid test and home collection kit, which it intends to use for its employee screening program.

Individuals who want to buy over-the-counter tests can bill their health insurance plans, which are required by the federal government in most cases to fully cover covid tests that have been authorized by the FDA.

Everlywell, based in Austin, Texas, is an at-home diagnostic company that already sells its collection kit to consumers through its website and Walgreens, and will soon offer same-day delivery via DoorDash in a dozen cities. Dr. Marisa Cruz, Everlywell’s executive vice president of regulatory and clinical affairs, said buyers can seek reimbursement from their insurance plans for the kit’s $109 cost. The tests are also eligible for purchase with pretax dollars from health savings or flexible spending accounts, she said.

Even with vaccines, epidemiologists say, rapid tests are desperately needed because more testing, along with mask-wearing and physical distancing, will get people back in offices and classrooms and help catch cases that go undetected. A report by the Centers for Disease Control and Prevention found that, of people with active infections, 44% reported no symptoms.

But the market for over-the-counter tests is risky. Demand for testing has plunged dramatically since the height of the winter surge and may not rebound as more people are vaccinated.

“You clearly are at risk of missing the market,” said Michael Greeley, co-founder and general partner at Flare Capital Partners, a venture capital firm focused on health care technology.

But Douglas Bryant, president and CEO of Quidel Corp., remains unfazed, even after the diagnostics manufacturer’s testing demand dropped by about one-third in the past two months.

“The level of testing for people with symptoms and the ‘worried well,’ who see others getting tested and think they should, too, is subsiding,” Bryant said. “But once we start to get more people vaccinated, the government will move from campaigning to get people vaccinated to saying, ‘Please test yourself regularly so we can get back to work.'”

Quidel, headquartered in San Diego, recently unveiled its latest test, the QuickVue  A t-Home COVID-19 Test, which takes 10 minutes to detect the coronavirus by homing in on specific proteins, called antigens. The FDA authorized the test for over-the-counter use Wednesday, and Quidel plans to announce retail partners in the coming weeks.

The FDA said in mid-March it would speed the pipeline for “screening testing,” including at-home covid tests that don’t require consumers to have symptoms or a prescription.

In February, the Biden administration cut a $232 million deal with Ellume, whose rapid antigen test was authorized by the FDA in December. Paired with an app, the test takes 15 minutes to analyze after a nose swab.

The Australian company currently ships hundreds of thousands of test kits a week to the U.S. from its factory in Brisbane to large companies and the Department of Defense. It plans to be on the shelves of multiple pharmacies by the second half of the year and in one major retailer in April, said Dr. Sean Parsons, the company’s founder and CEO.

“We are going as fast as we can possibly go,” he said.

The main holdup for Ellume has been getting enough swabs for its production line. The company is building a factory in the U.S. to reduce international shipping costs and increase production.

Abbott, which dominates the rapid-test market, said in January it expects to sell 120 million BinaxNOW antigen tests to consumers in the first half of the year. People who take the test now must do so under observation by telemedicine platform eMed. But Abbott received authorization from the FDA this week for an over-the-counter version that won’t require remote observation or a prescription. The test will be available in U.S. stores in the coming weeks, the company said.

Throughout the pandemic, the government has depended heavily on medical device behemoth Abbott’s testing options. The company’s rapid-diagnostics arm alone has snared $673 million in federal contracts to combat the coronavirus, according to a ProPublica database. This includes bulk purchases made by the Defense Department, the national prison system, Immigration and Customs Enforcement, the State Department and former President Donald Trump’s office.

But antigen tests sometimes report false negatives, particularly among people without symptoms, noted Dr. Jac Dinnes, who co-authored a review of 64 covid test studies. By comparison, polymerase chain reaction (PCR) tests — generally employed by commercial labs — are more sensitive. PCR tests search for the virus’s genetic material over multiple testing cycles, which magnifies what’s in the swab sample, requiring a much smaller viral load for detection.

Antigen tests are the basis for most at-home screening, but the FDA has also authorized two at-home options — made by Lucira Health and Cue Health — that use molecular processes similar to a PCR test.

Still, many experts support the widespread distribution of cheap, rapid tests, even if they aren’t as sensitive as lab-run alternatives, and see a demand. In Germany, the supermarket chain Aldi began selling rapid tests in early March, roughly $30 for a five-pack, and sold out within hours. One recent study found that if a pack of tests was mailed to every household in the U.S. — even assuming that up to 75% would go into the garbage — they would save thousands of lives and avert millions of infections.

“Don’t let perfect be the enemy of good,” said study co-author and Yale University professor A. David Paltiel. “This doesn’t have to work perfectly to make a huge difference.”

Some companies are working on rapid-testing options that more precisely read samples, such as Gauss.

The Menlo Park, California, health tech company, which before the pandemic created an artificial intelligence-based app to measure surgical blood loss in real time, aims to harness its expertise to improve on the basic antigen test. It took about a week for CEO Siddarth Satish to raise $30 million of venture capital last October.

Its covid-testing app uses facial recognition software to confirm that test-takers correctly swab their noses. The app provides step-by-step instructions and timers. After 15 minutes, an algorithm based on thousands of sample tests interprets the result — which displays as a colored line, as with a pregnancy test — using the phone’s camera.

Gauss and Cellex, which manufactures the Gauss tests, await FDA authorization. In the meantime, they have produced more than 1.5 million kits and struck deals with supermarket chain Kroger and e-pharmacy site Truepill to sell them for about $30.

“A huge part of the accuracy issue with rapid tests is that you have to visually interpret them,” Satish said. “Sometimes you get really faint lines, just like with a pregnancy strip, and there’s some guesswork.”

Lucira Health, based in Emeryville, California, uses something called loop-mediated isothermal amplification technology, which is similar to PCR tests in precision. In February, the company went public, raising $153 million largely to fund the manufacturing of its all-in-one testing kit, currently prescribed by doctors across the country. The kit comes with a nose swab and a vial of chemicals analyzed by a hand-held device — taking up to 30 minutes for results.

Kelly Lewis Brezoczky, Lucira’s executive vice president, envisions the test kit on the shelf in local pharmacies, perched next to the NyQuil. “I always like to tell people that it is as easy to use as toothpaste,” she said.

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Feds Still Expecting Updated Data on AstraZeneca COVID Vaccine

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

March 24, 2021 — White House officials said at a briefing Wednesday they are still anticipating updated vaccine data from AstraZeneca, after federal officials called Tuesday’s release of interim phase 3 data from the company “outdated information.”

“Right now, AstraZeneca is getting back with the Data and Safety Monitoring Board and will likely come out with an updated statement,” said Anthony Fauci, MD, a top COVID-19 official and chief of the National Institute of Allergy and Infectious Diseases, the agency that complained to the pharmaceutical company that their current information was “incomplete.”

Andy Slavitt, senior White House adviser for COVID-19 response, added: “Our takeaway is the importance of transparency and trust…. I would urge us not to focus on the process of the last couple days, but instead to focus on what really matters, which is what happens when these applications for these candidates are submitted to the FDA.”

AstraZeneca has said it plans to submit data to the US Food and Drug Administration next month in pursuit of an emergency use authorization for its vaccine.

Officials at the briefing also announced that President Joe Biden will authorize the government to spend $81 billion to help schools get back to in-person learning — a step toward his stated goal of reopening schools within the first 100 days of his presidency.

“Today, at the Department of Education’s National Safe School Reopening Summit, President Biden will announce $81 billion in American Rescue Plan funds will be made available to all 50 states, DC, and Puerto Rico to support their efforts to safely return to in-person instruction as expeditiously as possible this spring and meet the needs of all students,” said Slavitt.

The recent coronavirus relief bill that Biden signed into law earmarks $122 billion for K-12 schools. The $81 billion announced Wednesday will be available right away.

Slavitt also reported that 70% of Americans ages 65 and older have now received at least one vaccine dose — up from 8% at the beginning of February.

“In the 62 days since taking office, we’ve more than tripled vaccine output from 8.6 million doses to 27 million doses per week,” he said. “We intend to keep up this progress until all Americans are vaccinated.”

Fauci also outlined data published Tuesday in The New England Journal of Medicine highlighting how well COVID-19 vaccines work in the real world, which mirrors findings from clinical trials. One study, published Tuesday, found that just four out of 8121 fully vaccinated employees at the University of Texas Southwestern Medical Center in Dallas were infected with the virus.

Another study found that seven out of 14,990 workers at UC San Diego Health and the David Geffen School of Medicine at the University of California, Los Angeles, produced positive COVID-19 tests after receiving a second dose of vaccine from either Pfizer or Moderna.

“Every day, we get closer and closer to that extraordinary degree of effectiveness, which we’re seeing at the community level,” Fauci said. “And at the end of the day, that’s what it is that’s going to end this pandemic in this country.”

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IDSA Updates COVID-19 Treatment Guidelines: Monoclonals and More

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

While there is still no “game-changer” for treating COVID-19, the Infectious Diseases Society of America (IDSA) continues to examine available and potential treatments as new evidence emerges.

Use of the combination of monoclonal antibodies bamlanivimab and etesevimab to treat outpatients with mild-to-moderate disease at risk of progressing to severe COVID-19, for example, is a new recommendation in IDSA guidelines released March 5.

The society also updated its guidance on use of tocilizumab, pointed to less evidence on bamlanivimab monotherapy, and recommended against use of ivermectin outside of clinical trials.

“I would say to all the patients and everyone in the country who gets COVID-19 is check in with your clinician about what options there are for treatment because this is a rapidly evolving field,” said Rajesh T. Gandhi, MD, cochair of the expert panel that updated the IDSA Guidelines on the Treatment and Management of COVID-19 and an IDSA Fellow, during a media briefing March 18.

“What may have been the case 6 months ago has changed,” said Gandhi, director of HIV Clinical Services and Education at Massachusetts General Hospital in Boston.

The expert panel also aims to help physicians and patients make sense of the large amount of COVID-19 research coming out on a continuous basis.

“We still have an overwhelming avalanche of COVID-19 studies of varying quality of evidence. We still have misinformation about COVID-19 therapies that are influencing patients, policies, and healthcare providers,” said Adarsh Bhimraj, MD, cochair of the IDSA COVID-19 treatment panel, during the briefing.

“It starts with messaging to our clinical colleagues. One thing we do know is that most patients do have a close relationship with their physician,” Gandhi said. “We try to synthesize information in the way that presents what does work and what doesn’t work…and then I think from there it gets out to patients,” said Bhimraj, who is head of the Neurologic Infectious Diseases Section in the Department of Infectious Diseases at Cleveland Clinic and an IDSA Fellow.

New Recommended Combination

The recommendation for bamlanivimab and etesevimab in certain outpatients stems from a clinical trial with more than 1000 participants. This research revealed a significantly lower rate of hospitalization and death among people who received the monoclonal antibody cocktail, Gandhi said.

The FDA granted emergency use authorization (EUA) to bamlanivimab plus etesevimab on February 10. The agency also granted EUAs to bamlanivimab monotherapy and the combination of casirivimab and imdevimab in November to treat outpatients with mild-to-moderate COVID-19.

The IDSA panel reviewed evidence for these two authorized therapies but noted that data come from smaller studies. “It is possible that bamlanivimab by itself or the casirivimab and imdevimab cocktail may have a similar clinical benefit, but the data thus far are more limited,” Gandhi said.

“We expect there will be more data coming,” he added.

Monoclonals and Virus Variants

Similar to evidence for varying effectiveness of the COVID-19 vaccines against variants, the effectiveness of monoclonal antibodies might change.

“I know this is on all of our minds right now,” Gandhi said. Evidence suggests that the B.1.1.7 variant first identified in the United Kingdom may be susceptible to monoclonal antibody treatment, he said. In contrast, these agents might be less effective against variants recently identified in South Africa, California, and New York City, at least in laboratory experiments.

More research is needed, Gandhi added. Public health officials throughout the United States continue to track local variant data, and the IDSA “will modify recommendations as we get more information.”

Better Clarity 1 Year Out

The IDSA first released treatment guidelines in April 2020, a time in the pandemic when there was insufficient evidence for all potential treatments. “Clinicians, including ourselves, were using the ‘kitchen sink’ approach because we didn’t yet know how to treat COVID-19,” Gandhi said.

“Now, about a year later, we do have sufficient data to support several effective treatments,” he added. “And equally importantly we also know about what doesn’t really work.”

In addition to some monoclonal antibodies, scientific evidence suggests the steroid dexamethasone, the anti-inflammatory baricitinib, and the antiviral remdesivir have efficacy as COVID-19 treatments, he said.

“What doesn’t work? We know now that hydroxychloroquine does not work. Ritonavir, an HIV medicine, does not work. Azithromycin, an antibacterial, does not work.”

“So we have made real progress,” Gandhi said.

A New Take on Tocilizumab

Based on some landmark studies, including REMAP-CAP and the RECOVERY trial, the IDSA updated its recommendation for the monoclonal antibody tocilizumab

The open label trials linked tocilizumab with a decrease in mortality and improvement in other clinical outcomes, Bhimraj said. Some limitations in the evidence didn’t allow the panel to determine which people with COVID-19 are most likely to benefit, although “it did show some benefit in patients who are already receiving steroids who are still sick.”

The guidelines suggest use of tocilizumab in hospitalized patients who continue to have elevated blood markers even after receiving steroids and are therefore at risk for progression to severe COVID-19.
 

A Limited Recommendation on Ivermectin

The antiparasitic ivermectin “has been gaining popularity as an off-label treatment for COVID-19,” both in the United States and globally, Bhimraj said. So the IDSA reviewed the evidence and identified five randomized controlled trials and two non-randomized studies robust enough to consider for the guideline update.

However, the certainly of evidence was low for any effect on outcomes including mortality, and there was a high likelihood of bias in some of these studies, Bhimraj added.

“This led the guideline panel to suggest against ivermectin use outside the context of the clinical trial for both hospitalized patients and outpatients,” he said. “I know there’s a lot of enthusiasm about this, but I really think we need more data.”

In addition to addressing treatment and management, the IDSA periodically updates three other related COVID-19 guidelines on infection prevention, diagnostics, and serology.

Room for More Advance

“We have made a lot of progress,” Bhimraj said, but none of the treatments so far are “a game-changer…like penicillin was for streptococcus.”

In addition to the incremental progress made so far on COVID-19 therapies, there are additional monoclonal antibodies and antiviral agents in development that look promising, but Bhimraj said he will remain cautiously optimistic until data from Phase 3 trials emerges. 

Gandhi added that an oral monoclonal antibody therapy would be a welcome advance because, for now, the treatments are given via intravenous infusion.

Similar to the evolution of HIV treatment, Gandhi predicted incremental progress in COVID-19 therapies will likely continue “until you get to the point when either you combine things or you get a really effective drug, and then you can really change the direction” of the disease course.

Gandhi also emphasized that as more effective therapies emerge, systems must be in place to ensure they are available widely and equitably.

“We should continue to do what we are doing — masking, social distancing, the surveillance and research as it impacts not just this pandemic but also future pandemics and future epidemics,” Bhimraj said.

“We hope to continue vigilantly and diligently monitoring for new studies and to keep updating the guidelines until the pandemic actually disappears.”

Based on a March 18 media briefing by IDSA.

Damian McNamara is a staff journalist based in Miami. He covers a wide range of medical specialties, including infectious diseases, gastroenterology, and critical care. Follow Damian on Twitter:  @MedReporter.

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US COVID Infections ‘More Widespread’ Than Thought?

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

A study evaluating asymptomatic adults for COVID-19 would add another 16 million to the total number of SARS-CoV-2 infections in the United States, at least up to September 2020.

Investigators assessed 61,910 adults who reported feeling well when they applied for life insurance. A total of 4094, or 6.6%, had a positive serum or plasma antibody test for SARS-CoV-2 infection.

The finding would “double the number who have been infected with COVID-19 compared to the number of clinically diagnosed cases,” lead author Robert L. Stout, PhD, chief scientific officer at Clinical Reference Laboratory, Inc in Lenexa, Kansas, told Medscape Medical News .

“As of September, the scope of the pandemic was about double the number of reported cases,” Stout added. “It is not like measles, where it is easily identified. Quite simply, for the asymptomatic patient they think that everything is fine and continue to go about their normal activities. Some practice recommended CDC guidelines in public places, while some may not.”

The Research Letter was published online March 16, 2021, in JAMA Network Open.

Once investigators evaluated the national convenience sample in September 2020, they extrapolated to the number of US adults, based on census data.

Sex, Age, and State-by-State Comparison

The cross-sectional study included age, sex, state of residence, and antibody status. The mean age of people in the study was 39 years. Of the 4094 positive cases, 54% were men.

The seroprevalence rate was slightly higher among women, 6.9%, compared with 6.4% among men.

The lowest SARS-CoV-2 seroprevalence rate was 2.8% among asymptomatic people older than 70. In contrast, the youngest cohort up to age 30 years had the highest rate, at 9.8%.

“The seroprevalence rates varied widely by state,” noted Stout and coauthor Steven Rigatti, MD, from MassMutual.

The highest SARS-CoV-2 seroprevalence rate in September 2020 was 14.4% in New York, followed by 12% in Louisiana, and 10% in Nevada. States with the lowest rates included Oregon with 1.5%, Maine with 0.6%, and Alaska with 0%.

Implications and Skepticism

“Our estimate implied more than twice the number of infections than cases reported to the Centers for Disease Control and Prevention,” the researchers note, “suggesting a more widespread pandemic.”

Potential limitations of the study include self-reporting of health — all people reported feeling well — and evaluation of blood tests submitted for clinical evaluation vs a random sample of the overall population.

“Overall, it is difficult to interpret the findings, as the sample for the study was a convenience sample of individuals applying for life insurance,” Neeraj Sood, PhD, told Medscape Medical News when asked to comment.

Dr Neeraj Sood

The numbers might even be higher. “People applying for life insurance tend to be more educated, richer, and probably more risk-averse. So the findings from this study do not generalize to the general population and probably represent a lower bound of true seroprevalence in the general population,” said Sood, director of the COVID Initiative at the University of Southern California Schaeffer Center in Los Angeles.

Sood was the lead author of a JAMA Research Letter published in May 2020 evaluating the seroprevalence of SARS-CoV-2 among adults in Los Angeles County.

JAMA Netw Open. Published online March 16, 2021. Full text

The Clinical Reference Laboratory (CRL) in Lenexa, Kansas, provided funding for this study. Stout is an employee and Rigatti received consultant fees from CRL. Sood disclosed no relevant financial relationships. 

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Antibiotics Aimed at COVID-19 Are Escalating Another Threat

In the midst of the COVID-19 pandemic, a twin threat looms, affecting someone in the United States every 11 seconds and leading to a death every 15 minutes, according to the Centers for Disease Control and Prevention (CDC).

Antibiotic-resistant infections are on the rise, although they pale in comparison to COVID-19 deaths, which have now hit 535,000 in the United States. But the fear is that what has, in some cases, been overtreatment of COVID-19 might make the problem of antibiotic resistance even worse.

Public awareness of the urgency of the antibiotic-resistance threat is low, says Paul Auwaerter, MD, clinical director of the division of infectious diseases at Johns Hopkins School of Medicine in Baltimore.

Although a large number of Americans have experienced a COVID-19 death in their circle of family and friends or have seen reports of suffering in the media, few have witnessed a death that happened because there was no drug to treat someone’s infection.

Paul Auwaerter

“What we most fear is that routine things that we take for granted now — giving chemotherapy to cancer patients, replacing knee joints, having a cesarean section, and not having that complicated by infection — will become much harder or perhaps impossible to manage,” Auwaerter says.

Worldwide, superbugs could kill 10 million people annually by 2050 if better treatments aren’t developed, according to a United Nations report. The World Health Organization has declared antimicrobial resistance to be among the 10 top threats facing humanity.

The pandemic came on top of an already troubling trend. Even before case counts started to rise, one in three antibiotic prescriptions was found to be unnecessary, according to the CDC.

And then COVID-19 created the “perfect storm” for antibiotic-resistant infections in healthcare settings, another CDC report shows, with prolonged hospital stays, increased antibiotic use, crowding, and severe sickness.

In the early days of the pandemic, amid symptom confusion and desperation with mounting deaths, clinicians were prescribing broad-spectrum antibiotics at unnecessarily high rates, according to Christine Kubin, PharmD, clinical pharmacy manager and lead for infectious diseases and antimicrobial stewardship at NewYork-Presbyterian Hospital, and her colleagues.

When cases surged in New York City in late March and early April last year, about 1700 people were hospitalized each day and approximately 70% of patients with COVID-19 received an antibiotic, the team writes in their recent report, published in the American Journal of Health-System Pharmacy

Christine Kubin

However, patients with COVID-19 had low rates of bacterial coinfection — only about 3% to 8% at the time of admission — they note. That was different from people admitted for influenza, who had bacterial coinfection rates of 11% to 35%.

“This hit us hard and hit us fast,” says Kubin.

At the height of the pandemic, “it was really difficult, with the paucity of information, for us to curb antibiotic use from the perspective of these patients, who were critically ill,” she explains. “They had a lot of inflammatory markers that we’re used to correlating with infection, but in reality, it was part of COVID and part of the hyperinflammatory syndrome, so it was difficult for us to differentiate bacterial and viral infections.”

Problems distinguishing illnesses during the pandemic have also been an issue across the nation, including at the University of Wisconsin in Madison, where David Andes, MD, is head of the Department of Infectious Diseases.

David Andes

The problem is that our diagnostic capabilities to detect these nosocomial bacterial and fungal infections have their own limitations, and with these patients being so ill, even despite negative microbiologic tests, it’s not uncommon for clinicians to err on the side of overtreatment,” he tells Medscape Medical News.

“We’re still learning how to manage these patients who are coming in, from an antimicrobial-stewardship standpoint,” he says. “It’s been quite challenging.”

In addition, resources during the pandemic have been funneled to the prevention and treatment of daily cases of COVID-19, pausing some antimicrobial-stewardship programs.

COVID-19 is such an acute scenario it is impossible to ignore, whereas antimicrobial resistance is a slow and steady, yet progressive, phenomenon.

Complications from COVID are coupled with a decades-long development drought for new antibiotics and a dysfunctional market that discourages the production of new antibiotics.

Development Roadblocks

Experts agree that overprescription is only part of the problem, and that pipeline and market issues must be resolved to stave off antibiotic resistance.

David Hyun

“We haven’t had a truly new class of antibiotics developed and brought to market in 35 years now,” says David Hyun, MD, director of the antibiotic-resistance project at Pew Charitable Trusts.

The last nine antibiotics were approved — three each year — in 2017, 2018, and 2019, according to a spokesperson for the US Food and Drug Administration (FDA).

But recently approved drugs are hybrids from scientific discoveries made before 1984, Hyun tells Medscape Medical News. And mixing and matching opens the door for cross-resistance, which is another reason brand new antibiotic classes are needed, he explains.

Big pharmaceutical companies have pulled out of antibiotic development, leaving the job to small biotech companies. But the current model is not sustainable and many have declared bankruptcy.

From 2014 to 2020, the number of large pharmaceutical companies developing new antibiotics fell from eight to two, according to a report from Pew Charitable Trusts.

“They’re not able to recoup the investment in costs,” Hyun says. Much of that has to do with the short duration of use for the inexpensive drugs — usually less than 2 weeks — as opposed to that for cancer or chronic diseases, such as diabetes, which are much more lucrative. Also, physicians try to use antibiotics as a last resort, for stewardship purposes, which runs against market goals.

In 2019, $9.7 billion in private investment went into oncology research, compared with just $132 million for antibiotics research, Pew reports.

According to a new report from Pew, as of December 2020, 43 antibiotics were in development: 15 in phase 1 clinical trials, 13 in phase 2 trials, 13 in phase 3 trials, and two awaiting word from the FDA on New Drug Application status.

“Historically, about 60% of drugs that enter phase 3 will be approved,” the Pew report says.

A pharmaceutical collaboration — the AMR Action Fund, announced in July 2020 — is among the new approaches to speed development. More than 20 pharmaceutical giants have pledged to invest more than $1 billion in smaller biotech companies to bring two to four new antibiotics to patients by 2030.

Although this is a welcome development, even the stakeholders acknowledge that it is a temporary solution, says Hyun.

Meanwhile, the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance, or PASTEUR Act, supported by Pew, is awaiting reintroduction in the new Congress.

It would allow the federal government to contract with antibiotic innovators in a “Netflix-type” subscription model. Under that model, financial stability for innovators would no longer be based on use or sales of the individual drugs. Instead, a subscription model would provide a predictable return on investment for new antibiotics.

The PASTEUR legislation remains a high priority for the Infectious Disease Society of America (IDSA), and “we are eager for its reintroduction this year,” says Amanda Jezek, senior vice president for public policy and government relations at IDSA.

“The COVID-19 pandemic has demonstrated the importance of preparedness, and an arsenal of safe and effective antibiotics is a critical tool in responding to public health emergencies, many of which can be complicated by secondary resistant infections,” she tells Medscape Medical News.

In the meantime, the healthcare system has to remain vigilant about antimicrobial stewardship.

Lessons From New York City

In their analysis of data from New York City, Kubin and her colleagues describe how their antimicrobial-stewardship program overcame obstacles.

Pharmacists were embedded in front-line units to disseminate information. With the COVID-19 crisis, “no one’s reading their emails, so as much face time as possible” is necessary, Kubin explains.

In addition, multidisciplinary teams should “find a time to meet on a daily or weekly basis to share the most pertinent information,” she advises.

Kubin’s team had a few people dedicated to combing through the literature and sharing information with a multidisciplinary group so that they could develop hospital guidelines “almost weekly.”

Plus, experience and education have given prescribers confidence over the past year. “We’re definitely much more comfortable withholding antibiotics for bacterial infection in these patients without the evidence of a bacterial infection going on,” Kubin says.

Marcia Frellick is a freelance journalist based in Chicago . She has previously written for the Chicago Tribune and Nurse.com and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud ( Minnesota ) Times. Follow her on Twitter at @mfrellick.

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Don’t Stop Osteoporosis Meds for COVID-19 Vaccines, Say Experts

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

COVID-19 vaccines are safe and effective for patients taking osteoporosis medications, according to joint guidance from six endocrine and osteoporosis societies and foundations.

They noted, though, that some timing modifications with certain medications should be considered to help distinguish between adverse events from the medication versus the vaccine.

The American Society for Bone and Mineral Research “is an international organization, so we brought together our sister societies that have a vested interested in bone health. Vaccination is happening worldwide, and we wanted to present a united front and united recommendations about how to handle osteoporosis medications appropriately during vaccination,” said Suzanne Jan De Beur, MD, who is president of ASBMR and an associate professor of medicine at Johns Hopkins University, Baltimore.

There has been quite a lot of concern from the community about vaccine and medications, from both physicians and patients wondering whether treatments and vaccines should occur in a certain order, and whether there should be a time gap between the two, said Jan De Beur. “There was a dearth of information about the best practices for osteoporosis treatment management during vaccination, and we didn’t want people missing their opportunity for a vaccine, and we also didn’t want them unnecessarily delaying their osteoporosis treatment.”

There is no evidence that osteoporosis therapies affect the risk or severity of COVID-19 disease, nor do they appear to change the disease course. Osteoporosis itself does not appear associated with increased risk of infection or severe outcomes, so patients with osteoporosis do not need to be prioritized for vaccination based on that condition alone.

There is no evidence that osteoporosis therapies affect the safety or efficacy of vaccination, but given that vaccine availability is currently inconsistent, patients may need to make temporary changes to their osteoporosis regimens to ensure they can receive vaccine when it is available, such as ensuring a delay between medication and vaccination injections.

A key reason for a delay between injectable or infusion medications and a vaccine is to distinguish between adverse events that could occur, so that an adverse reaction to vaccine isn’t mistaken for an adverse reaction to a drug. Nevertheless, the real world is messy. Jan De Beur noted a recent patient who arrived at her clinic for an injectable treatment who had just received a COVID-19 vaccination that morning. “We decided to put the injection in the other arm, rather than reschedule the person and put them through the risk of coming back. We could distinguish between injection-site reactions, at least,” she said.

No changes should be made to general bone health therapies, such as calcium and vitamin D supplementation, weight-bearing exercises, and maintenance of a balanced diet.

The guidance includes some recommendations for specific osteoporosis medications.

  • Oral bisphosphonates: Alendronate, risedronate, and ibandronate should be continued.

  • Intravenous bisphosphonates: a 7-day interval (4-day minimum) is recommended between intravenous bisphosphonate (zoledronic acid and ibandronate) infusion and COVID-19 vaccination in order to distinguish potential autoimmune or inflammatory reactions that could be attributable to either intravenous bisphosphonate or the vaccine.

  • Denosumab: There should be a 4- to 7-day delay between denosumab infusion and COVID-19 vaccination to account for injection-site reactions. Another option is to have denosumab injected into the contralateral arm or another site like the abdomen or upper thigh, if spacing the injections is not possible. In any case, denosumab injections should be performed within 7 months of the previous dose.

  • Teriparatide and abaloparatide should be continued.

  • Romosozumab: There should be a 4- to 7-day delay between a romosozumab injection and COVID-19 vaccine, or romosozumab can be injected in the abdomen (with the exception of a 2-inch area around the naval) or thigh if spacing is not possible.

  • Raloxifene should be continued in patients receiving COVID-19 vaccination.

Guidance signatories include ASBMR, the American Association of Clinical Endocrinology, the Endocrine Society, the European Calcified Tissue Society, the National Osteoporosis Foundation, and the International Osteoporosis Foundation.

Jan De Beur has no relevant financial disclosures.

This article originally appeared on MDedge.com, part of the Medscape Professional Network.

 

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Guilt, Envy, Distrust: Vaccine Rollout Breeds Mixed Emotions

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

This image shows part of an Instagram post by Jeff Klein holding his COVID-19 vaccination card. The 44-year-old musician notes he was given a shot as a volunteer at a mass vaccination hub.

NEW YORK (AP) — Before posting a selfie with her COVID-19 vaccination card on Twitter, Aditi Juneja debated whether to include an explanation for why she was eligible for a shot.

“The first draft of the tweet had an explanation,” says Juneja, a 30-year-old lawyer in New York City.

After some thought, she decided to leave out out that her body mass index is considered obese, putting her at higher risk of serious illness if infected. A friend who disclosed the same reason on social media was greeted with hateful comments, and Juneja wanted to avoid that.

The rollout of COVID-19 vaccines in the U.S. is offering hope that the pandemic that has upended life around the world will finally draw to an end. But as distribution widens in the U.S., varying eligibility rules and unequal access to the coveted doses are also breeding guilt, envy and judgment among those who’ve had their doses — particularly the seemingly young and healthy — and the millions still anxiously awaiting their turn.

Adding to the second-guessing about who should be getting shots is the scattershot feel of the rollout, and the sense that some might be gaming the system. Faced with a patchwork of confusing scheduling systems, many who aren’t as technically savvy or socially connected have been left waiting even as new swaths of people become eligible.

The envy and moral judgments about whether others deserve to be prioritized are understandable and could reflect anxieties about being able to get vaccines for ourselves or our loved ones, says Nancy Berlinger, a bioethicist with the Hastings Center.

“There’s the fear of missing out, or fear of missing out on behalf of your parents,” she says.

Stereotypes about what illness looks are also feeding into doubts about people’s eligibility, even though the reason a person got a shot won’t always be obvious. In other cases, Berlinger says judgments could reflect entrenched biases about smoking and obesity, compared with conditions that society might deem more “virtuous,” such as cancer.

Yet even though a mass vaccination campaign is bound to have imperfections, Berlinger noted the goal is to prioritize people based on medical evidence on who’s most at risk if infected.

Nevertheless, the uneven rollout and varying rules across the country have some questioning decisions by local officials.

In New Jersey, 58-year-old software developer Mike Lyncheski was surprised when he learned in January that smokers of any age were eligible, since he knew older people at the time who were still waiting for shots.

“It didn’t seem like there was medical rationale for it,” says Lyncheski, who isn’t yet eligible for the vaccines. He also noted there’s no way to confirm that people are smokers, leaving the door open for cheating.

The suspicions are being fueled by reports of line jumpers or those stretching the definitions for eligibility. In New York, a Soul Cycle instructor got vaccinated after teachers became eligible in January, the Daily Beast reported, and later apologized for her “terrible error” in judgment. In Florida, two women wore bonnets and glasses to disguise themselves as elderly in hopes of scoring shots. Hospital board members, trustees and donors have also gotten shots early on, raising complaints about unfair access.

It’s why some feel obligated to explain why they were able to get the vaccine. In an Instagram post, Jeff Klein held up his vaccination card and noted he was given a shot as a volunteer at a mass vaccination hub.

“I definitely mentioned it on purpose, because I didn’t want people to get the wrong idea,” says Klein, a 44-year-old musician in Austin, Texas.

As she waited for a shot in Jacksonville, Florida, 33-year-old Amanda Billy said it could be frustrating seeing people her age in other states posting about getting vaccinated. She understood that state rollouts vary, but felt anxious because she has a medical condition that makes COVID-19 “very real and scary.”

“I’m just happy for them that they got it. But also, I want it,” she said in an interview before getting her first shot.

Others are finding they are opening themselves up to criticism when sharing news that they got a shot. Public figures in particular might become targets of second-guessing by strangers.

In New York, local TV news co-host Jamie Stelter posted a photo of herself after getting the first shot earlier this month. Many replies were positive, but others noted that she didn’t look old enough or that she must “have connections.”

Afterward, Stelter’s co-host Pat Kiernan weighed in and tweeted that the “you don’t look that sick to me” commentary she received was “evidence of the hell that COVID has placed us in.”

For Juneja, the decision to get a shot after becoming eligible wasn’t easy, given the struggles she knew others were having securing appointments because of technology, language or other barriers. But she realized it wouldn’t help for her to refrain from getting vaccinated.

“It’s not like with other types of things where I could give my spot to someone else who I think is more in need,” she says. “We are sort of all in this situation where we can only really decide for ourselves.”

Candice Choi, a reporter on The Associated Press’ Health & Science team, has been covering the pandemic and vaccine rollout in the United States.

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World No Closer to Answer on COVID Origins Despite WHO Probe: Expert

SHANGHAI (Reuters) – Despite a high-profile visit to China by a team of international experts in January, the world is no closer to knowing the origins of COVID-19, according to one of the authors of an open letter calling for a new investigation into the pandemic.

“At this point we are no further advanced than we were a year ago,” said Nikolai Petrovsky, an expert in vaccines at Flinders University in Adelaide, Australia, and one of 26 global experts who signed the open letter (https://on.wsj.com/3bdg11w), published on Thursday by the Wall Street Journal.

In January, a team of scientists picked by the World Health Organization (WHO) visited hospitals and research institutes in Wuhan, the central Chinese city where the coronavirus was identified, in search of clues about the origins of COVID-19.

But the mission has come under fire, with critics accusing the WHO of relying too much on politically compromised Chinese fieldwork and data.

Team members also said China was reluctant to share vital data that could show COVID-19 was circulating months earlier than first recognised.

The open letter said the WHO mission “did not have the mandate, the independence, or the necessary accesses to carry out a full and unrestricted investigation” into all theories about the origins of COVID-19.

“All possibilities remain on the table and I have yet to see a single piece of independent scientific data that rules out any of them,” said Petrovsky.

At a press briefing to mark the end of the WHO visit to Wuhan, mission head Peter Ben Embarek appeared to rule out the possibility that the virus leaked from a laboratory in Wuhan.

But Petrovsky said it “doesn’t make any sense” to rule any possibility out, and said the aim of the open letter was “to get an acknowledgement globally that no one has yet identified the source of the virus and we need to keep searching.”

“We need an open mind and if we close down some avenues because they are considered too sensitive, that is not how science operates,” he said.

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