Taking Two Different Vaccines?

By Derek Lowe

 We seem to be heading for a world with multiple coronavirus vaccines in it, and right off, I have to say that that this is a very good situation. But it has its complications, and one that I know many people have been wondering about is, what if you get two different ones? That could happen in several ways, of course, with the different vaccines themselves, the order in which a person is exposed to them, the total number of vaccinations involved, etc. And honestly, it’s not possible to be completely sure about the answer until this is actually tried (immunology!) But we can look back over previous vaccines and made some educated guesses.

The best outcome is that you get even stronger immunity. That seems to be what happens when people who received the oral (Sabin) polio vaccine were then given the injectable (Salk) form. The first is an attenuated live virus, and the second is a completely inactivated one. The Salk vaccine is better at producing humoral immunity (antibody and T-cell response), and the Sabin vaccine needs multiple doses to be effective. But it is better at producing mucosal immunity in the gut, which has a better chance of interrupting the spread of the disease in children. The choice about which one to use has always been a matter of argument. But the study linked above showed that in children who had already had the oral Sabin vaccine, that an injection of the Salk vaccine boosted their intestinal immunity better than another round of the oral vaccine. Again, you wouldn’t necessarily have predicted that – if it had come out that the injected dose didn’t seem to do much for mucosal immunity, it would have been easy to rationalize that as well.

There are other cases where multiple vaccines are available for the same pathogen, and where a mix-and-match approach doesn’t seem to make a difference either way. An example is hepatitis A, where there are several inactivated-virus options. In that case, it appears that the vaccines are basically interchangeable: the booster-shot schedule can be completed any way you like. The same goes for the two monovalent vaccines for hepatitis B, and for the three vaccines that target meningococcus group A, C, W, and Y. (Here’s an overview of vaccine interchangeability).

That said, all of those vaccines in each of those cases are rather similar to each other, and we now have the unusual – very, very unusual – situation of several different vaccine platforms coming into potential use against the same virus at almost the same time. By the spring we may well have two mRNA vaccines (Pfizer/BioNTech and Moderna), two different adenovirus vaccines (Oxford/AZ and J&J), and a recombinant protein vaccine (Novavax). We don’t have efficacy data on the J&J and Novavax candidates yet (numbers are on the way), and we can argue about the data for Oxford/AZ, but it’s certainly possible that all of them will be out there simultaneously. Putting one of these on top of the other is a step into the unknown.

And there are examples of vaccines for the same pathogen having some interference. Several vaccines for bacterial diseases are in the “conjugate vaccine” category: they have a bacterial polysaccharide fused to a carrier protein, which can give a more useful immune response than just dosing the polysaccharide by itself. But for pneumococcal vaccines, both types are given (with a different range of immune response to cover a variety of bacterial serotypes). It’s been found that if you give a pneumococcal polysaccharide vaccine (PPSV) followed by a pneumococcal polysaccharide conjugate vaccine (PCV), there’s a lower antibody responses for some serotypes targeted by the conjugate vaccine than there is if you give them in the opposite order. So the rule in this area is to give both for maximum protection, but to always give the conjugate vaccine first. Another tricky part is that the use of the same sorts of carrier proteins in different vaccines – you could imagine a situation where an immune response against the carrier protein causes a later vaccine to be less effective.

That last problem is similar to what we’re talking about with the immune response to adenovirus vectors and booster-shot dosing regimens with the same vaccine. But the Oxford/AZ vaccine is a chimpanzee adenovirus and the J&J one is Ad26, so that’s a different situation, and I have no idea of what would happen if you mixed those two. (The Russian vaccine is, in fact, a mixture of two different adenovirus vectors, one in the original shot and one in the booster). I also don’t know what happens if you take both an mRNA vaccine and one of the other types.

Overall, though, I would tend to think that it would work out. All of the coronavirus vaccines we’re talking about target the Spike protein, after all, and they are, by different means, presumably raising a pretty similar suite of antibodies (with perhaps more differences in T-cell response, which remains to be seen in detail). So the chances are that the immune response will be similar (as with the hepatitis vaccines) or perhaps even a bit better (as with mixing the polio vaccines), rather than worse. But we haven’t proven anything like that in the clinic yet, and educated guesses will only take you so far. I would assume that there will be people who end up taking both types, for all sorts of reasons, and I hope that we collect as much data from those cases as we can.

https://blogs.sciencemag.org/pipeline/archives/2020/12/02/taking-two-different-vaccines

Building better vaccines for the elderly

 As human lifespans have gotten longer, certain proteins in our bodies are increasingly prone to take on alternative shapes. These misfolded proteins can ultimately trigger neurodegenerative diseases such as Alzheimer's, Parkinson's and Lou Gehrig's disease, formally known as amyotrophic lateral sclerosis (ALS).

Meredith Jackrel, assistant professor of chemistry in Arts & Sciences at Washington University in St. Louis, and her lab group study protein misfolding disorders. They are especially interested in how protein misfolding occurs, how it leads to disease and how scientists might be able to prevent or even reverse protein misfolding. Their work promises applications in flu vaccines as well as in the current coronavirus pandemic.

In this Q&A, Jackrel describes how her lab's expertise in protein misfolding and neurodegenerative diseases has made them uniquely qualified to work on developing new amyloid-inspired vaccine technologies aimed at elderly populations.

How does your research relate to the current pandemic?

We are working on the development of new vaccine technologies specifically tailored to elderly populations. We originally initiated this project to evaluate new flu vaccine technologies, but this approach could also be relevant to COVID-19 since seniors are particularly susceptible to its severe complications.

A general problem with vaccination of elderly individuals is immuosenescence, or age-related dysfunction of the immune system. Immunosenescence is typically overcome by the addition of adjuvants to improve immune response and efficacy. However, adjuvants create local inflammation, which obstructs the immune system and makes vaccines less effective.

A colleague at WashU in biomedical engineering, Jai Rudra, studies self-assembling peptides as materials for developing novel vaccines that do not require the use of adjuvants. These self-adjuvanting peptide nanofibers are hypothesized to trigger the autophagy pathway, a kind of cellular recycling that can also promote good immunological functions, which has emerged as a potential vaccine target. Administration of these peptide nanofibers leads to robust, high-affinity, and neutralizing antibody responses without local reactions, making them attractive for vaccine delivery in the elderly.

To further pursue application of these nanofibers, we must now investigate the toxicity and clearance mechanism of these materials.

How are you using your expertise in protein folding/misfolding in your work on vaccine technology?

Peptide nanofiber materials rapidly assemble into configurations that closely resemble the underlying causes of neurodegenerative disorders. These amyloids are recognized as clumps of proteins that accumulate in patients with Alzheimer's, Huntington's and Parkinson's disease.

While there are key differences that we anticipate will not make use of these materials problematic, it is nonetheless essential that the safety and clearance mechanism of the peptide nanofiber vaccines be thoroughly tested. My lab's expertise in the development of model systems to study the toxicity and mechanism of disease-associated amyloid proteins is therefore highly relevant to this project.

Furthermore, due to the complexities of studying the peptide nanofibers in mammalian cells, my lab's expertise in the use of Baker's yeast as a model system is proving highly relevant for studying the mechanism of clearance of these new materials.

What are your specific goals in this project?

The primary goals for my lab are to determine the toxicity and mechanism of clearance of the peptide nanofiber vaccines in a yeast model system. We aim to compare the toxicity of the nanofibers to the toxicity of disease-associated proteins. We will also employ autophagy-deficient yeast models to establish the mechanism of clearance of the nanofibers. The Rudra lab then aims to assess the efficacy of the nanofiber-based vaccines in aged mice.

Where does the project stand now? What are the next steps?

We have established a yeast model system of these peptide nanofibers and completed much of the preliminary work. Excitingly, we have confirmed that these peptide nanofibers are not toxic in yeast and have made some new insights into their mechanism of clearance. We aim to complete the early stage of this project shortly, and the Rudra lab has begun work in animal systems. Once we complete work with the nanofibers alone, we will begin to test conjugates to various vaccine targets, notably those that underpin COVID-19.

https://medicalxpress.com/news/2020-12-vaccines-elderly.html

How safe are the new COVID-19 vaccines?

 Two COVID-19 vaccines are on the verge of approval in the United States, with pharmaceutical companies promising that millions of doses will be available to the first wave of recipients within a matter of weeks.

Creating two vaccines in less than a year is an astonishing achievement, experts say, but the next task could prove even more difficult—convincing Americans that it's safe to take vaccines developed at such a breakneck pace.

Average folks can take comfort from the safety data that's already been gathered in clinical trials, and additional data expected to pour in from millions more people participating in the earliest waves of COVID-19 vaccine distribution, said Dr. Paul Offit. He's director of the Vaccine Education Center at the Children's Hospital of Philadelphia.

"For people who are worried about safety, we are essentially, by necessity, testing the water with one foot," Offit said. "We'll have tens of millions of people who will be getting this vaccine before the general population gets it, so you'll have a much bigger safety profile than you have when it initially rolls out."

Offit is a member of the U.S. Food and Drug Administration advisory board that will review the clinical trial data for both the Pfizer and Moderna vaccines within the next two weeks.

In fact, Offit has already started to go over the data on the Pfizer vaccine, which will be considered at the advisory board's Dec. 10 meeting.

'Very reassured'

Offit said skyscraper-high reams of documents tend to be generated during clinical trials, and the FDA advisory board painstakingly reviews all that data before recommending vaccine approval.

"You don't want us [only] to look at the press release and say these data look great and just say, 'Let's go,'" Offit said. "You've seen the tip of the iceberg. We're going to look at the base of the iceberg and make sure there's nothing at the base that's cracking, that makes us wonder about whether the tip is really true."

Vaccine makers are not involved at all in this review process, Dr. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, stressed last week during an HD Live! interview.

"You separate them so that the Data and Safety Monitoring Board does [its review] independently," Fauci explained.

Only after committees from both the FDA and the U.S. Centers for Disease Control and Prevention agree on the data would FDA officials decide that "'we're going to do an EUA'—we are going to have an Emergency Use Authorization," he said.

Offit and other infectious disease experts said they do have early confidence in the safety of the two COVID-19 vaccines, given what's been reported so far.

"We really see vaccine side effects in the first week after vaccine, and sometimes in the first month to two months of the vaccine," said Dr. Buddy Creech, director of the Vanderbilt Vaccine Research Program, in Nashville, Tenn. "We've been very reassured that we haven't seen a number of cases of things that we would not expect."

Offit added, "What you're going to be able to say now, when these vaccines roll out, is you're going to be able to say that, at least in tens of thousands of people, there were no uncommon serious side effects that were seen within two months of getting a dose."

Long-term tracking

Rare side effects remain a concern, however, and the limited number of people involved in a clinical trial means that these problems won't necessarily crop up in initial testing.

For example, polio-like Guillain-Barre syndrome is known to happen in about one out of every million people who get a flu shot, Offit noted. Researchers only learned of that after hundreds of millions of flu shots were handed out over the years.

"Usually if you have a serious side effect, you'll find it out quickly," Offit said. "That said, 20,000 people isn't 20 million people. You're only going to find a rare serious adverse event post-approval. That's always true."

That's why participants in the vaccine clinical trials will continue to be tracked for at least two years, serving as "canaries in the coal mine" for longer-term safety problems, the experts said.

According to Dr. Kathleen Neuzil, director of the Center for Vaccine Development and Global Health at the University of Maryland School of Medicine, in Baltimore, "If there is any safety signal in that gold-standard trial, those people will be five to six months ahead of where we are with vaccinating the public."

Researchers will also be tracking safety data from the first waves of people who get the vaccine, starting with about 21 million people in the health care industry and 3 million folks living or working at long-term care facilities.

Ongoing tracking data will also assess how long the vaccines will protect against COVID-19, Offit added.

As a general rule, he noted, coronaviruses induce immunity that is short-lived and incomplete.

"By short-lived, I mean years, not decades," Offit said. "By incomplete, I mean not sterilizing immunity—protection against moderate to severe disease, but not necessarily mild disease or asymptomatic infection."

Reducing hospitalizations

But even immunity that is temporary and incomplete will help during this pandemic, Offit explained.

"All you want to do is keep people out of the hospital and keep them out of the morgue, and I think this vaccine certainly can do that," he said.

But the fact that these are the first two broadly available vaccines based on bits of genetic material called messenger RNA will prompt additional scrutiny regarding long-term effects, experts added.

The vaccines work by delivering mRNA into a person's cells, supplying genetic instructions that prompt the cells to produce the specific "spike" protein that the novel coronavirus uses to bind with and enter cells. The immune system recognizes the protein as a potential threat and stimulates a response, creating antibodies that would ward off any subsequent attack by the actual coronavirus.

"What turns it off? What makes it so it is no longer making coronavirus spike protein anymore?" Offit said. "If you look at the animal model studies, mice for example, you would assume that goes on for about 10 days. But what happens in humans, I don't know. We will find that out, I think, over time."

Neuzil noted that RNA is very unstable, which is why these vaccines need to be kept frozen during distribution. But with that cold storage in place, she's confident the vaccine will do its job and then flush from the body.

"We can be assured that they don't integrate into our cells," Neuzil said. "They share that code, they do their job and then they are naturally taken away by enzymes in our bodies. We wouldn't expect any prolonged side effects from these mRNA vaccines."

https://medicalxpress.com/news/2020-12-safe-covid-vaccines.html

New CRISPR-based test for COVID-19 uses smartphone camera

 Imagine swabbing your nostrils, putting the swab in a device, and getting a read-out on your phone in 15 to 30 minutes that tells you if you are infected with the COVID-19 virus. This has been the vision for a team of scientists at Gladstone Institutes, University of California, Berkeley (UC Berkeley), and University of California, San Francisco (UCSF). And now, they report a scientific breakthrough that brings them closer to making this vision a reality.

One of the major hurdles to combating the COVID-19 pandemic and fully reopening communities across the country is the availability of mass rapid testing. Knowing who is infected would provide valuable insights about the potential spread and threat of the virus for policymakers and citizens alike.

Yet, people must often wait several days for their results, or even longer when there is a backlog in processing lab tests. And, the situation is worsened by the fact that most infected people have mild or no symptoms, yet still carry and spread the virus.

In a new study published in the scientific journal Cell, the team from Gladstone, UC Berkeley, and UCSF has outlined the technology for a CRISPR-based test for COVID-19 that uses a smartphone camera to provide accurate results in under 30 minutes.

"It has been an urgent task for the scientific community to not only increase testing, but also to provide new testing options," says Melanie Ott, MD, Ph.D., director of the Gladstone Institute of Virology and one of the leaders of the study. "The assay we developed could provide rapid, low-cost testing to help control the spread of COVID-19."

The technique was designed in collaboration with UC Berkeley bioengineer Daniel Fletcher, Ph.D., as well as Jennifer Doudna, Ph.D., who is a senior investigator at Gladstone, a professor at UC Berkeley, president of the Innovative Genomics Institute, and an investigator of the Howard Hughes Medical Institute. Doudna recently won the 2020 Nobel Prize in Chemistry for co-discovering CRISPR-Cas genome editing, the technology that underlies this work.

Not only can their new diagnostic test generate a positive or negative result, it also measures the viral load (or the concentration of SARS-CoV-2, the virus that causes COVID-19) in a given sample.

"When coupled with repeated testing, measuring viral load could help determine whether an infection is increasing or decreasing," says Fletcher, who is also a Chan Zuckerberg Biohub Investigator. "Monitoring the course of a patient's infection could help health care professionals estimate the stage of infection and predict, in real time, how long is likely needed for recovery."

A photo of a device attached to an ordinary smartphone that can detect the presence of SARS-CoV-2 in a nasal swab. Credit: Daniel Fletcher and Melanie Ott

A Simpler Test through Direct Detection

Current COVID-19 tests use a method called quantitative PCR—the gold standard of testing. However, one of the issues with using this technique to test for SARS-CoV-2 is that it requires DNA. Coronavirus is an RNA virus, which means that to use the PCR approach, the viral RNA must first be converted to DNA. In addition, this technique relies on a two-step chemical reaction, including an amplification step to provide enough of the DNA to make it detectable. So, current tests typically need trained users, specialized reagents, and cumbersome lab equipment, which severely limits where testing can occur and causes delays in receiving results.

As an alternative to PCR, scientists are developing testing strategies based on the gene-editing technology CRISPR, which excels at specifically identifying genetic material.

All CRISPR diagnostics to date have required that the viral RNA be converted to DNA and amplified before it can be detected, adding time and complexity. In contrast, the novel approach described in this recent study skips all the conversion and amplification steps, using CRISPR to directly detect the viral RNA.

"One reason we're excited about CRISPR-based diagnostics is the potential for quick, accurate results at the point of need," says Doudna. "This is especially helpful in places with limited access to testing, or when frequent, rapid testing is needed. It could eliminate a lot of the bottlenecks we've seen with COVID-19."

Parinaz Fozouni, a UCSF graduate student working in Ott's lab at Gladstone, had been working on an RNA detection system for HIV for the past few years. But in January 2020, when it became clear that the coronavirus was becoming a bigger issue globally and that testing was a potential pitfall, she and her colleagues decided to shift their focus to COVID-19.

"We knew the assay we were developing would be a logical fit to help the crisis by allowing rapid testing with minimal resources," says Fozouni, who is co-first author of the paper, along with Sungmin Son and María Díaz de León Derby from Fletcher's team at UC Berkeley. "Instead of the well-known CRISPR protein called Cas9, which recognizes and cleaves DNA, we used Cas13, which cleaves RNA."

In the new test, the Cas13 protein is combined with a reporter molecule that becomes fluorescent when cut, and then mixed with a patient sample from a nasal swab. The sample is placed in a device that attaches to a smartphone. If the sample contains RNA from SARS-CoV-2, Cas13 will be activated and will cut the reporter molecule, causing the emission of a fluorescent signal. Then, the smartphone camera, essentially converted into a microscope, can detect the fluorescence and report that a swab tested positive for the virus.

"What really makes this test unique is that it uses a one-step reaction to directly test the viral RNA, as opposed to the two-step process in traditional PCR tests," says Ott, who is also a professor in the Department of Medicine at UCSF. "The simpler chemistry, paired with the smartphone camera, cuts down detection time and doesn't require complex lab equipment. It also allows the test to yield quantitative measurements rather than simply a positive or negative result."

The researchers also say that their assay could be adapted to a variety of mobile phones, making the technology easily accessible.

"We chose to use mobile phones as the basis for our detection device since they have intuitive user interfaces and highly sensitive cameras that we can use to detect fluorescence," explains Fletcher. "Mobile phones are also mass-produced and cost-effective, demonstrating that specialized lab instruments aren't necessary for this assay."

Accurate and Quick Results to Limit the Pandemic

When the scientists tested their device using patient samples, they confirmed that it could provide a very fast turnaround time of results for samples with clinically relevant viral loads. In fact, the device accurately detected a set of positive samples in under 5 minutes. For samples with a low viral load, the device required up to 30 minutes to distinguish it from a negative test.

"Recent models of SARS-CoV-2 suggest that frequent testing with a fast turnaround time is what we need to overcome the current pandemic," says Ott. "We hope that with increased testing, we can avoid lockdowns and protect the most vulnerable populations."

Not only does the new CRISPR-based test offer a promising option for rapid testing, but by using a smartphone and avoiding the need for bulky lab equipment, it has the potential to become portable and eventually be made available for point-of-care or even at-home use. And, it could also be expanded to diagnose other respiratory viruses beyond SARS-CoV-2.

In addition, the high sensitivity of smartphone cameras, together with their connectivity, GPS, and data-processing capabilities, have made them attractive tools for diagnosing disease in low-resource regions.

"We hope to develop our test into a device that could instantly upload results into cloud-based systems while maintaining patient privacy, which would be important for contact tracing and epidemiologic studies," Ott says. "This type of smartphone-based diagnostic test could play a crucial role in controlling the current and future pandemics."

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Explore further

For quick COVID-19 testing, iSCAN can be adopted for airports and public transportation

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More information: Parinaz Fozouni et al, Amplification-free detection of SARS-CoV-2 with CRISPR-Cas13a and mobile phone microscopy, Cell (2020). DOI: 10.1016/j.cell.2020.12.001

https://medicalxpress.com/news/2020-12-cell-camera-sars-cov-.html

Older patients shrink from elective procedures as COVID-19 surges

 

• Older people appear less willing to undergo elective procedures as the number of U.S. COVID-19 cases has risen, according to a survey by analysts at investment firm Needham & Company.

• A November poll of 251 individuals with an average age of 61 years found 27% of respondents are willing to have elective procedures. That's down from a similar poll in September when 37% of respondents were willing.

• That deterioration in consumer readiness to seek and follow through with care comes as medtech companies including Hologic, Johnson & Johnson and Zimmer Biomet have run campaigns aimed at giving people the confidence to re-engage with the healthcare system.

The pandemic's impact on volume of elective procedures has changed since the virus first shut down economies early this year. After an initial wave of deferrals enforced by governments or individual hospital systems, a key factor in the recovery of medtech sales became the willingness of patients themselves to follow through on procedures amid concerns of being exposed to the virus.

Analysts at Needham began tracking the sentiments of older patients in May, at which time 13% of the surveyed individuals were willing to have an elective procedure. Willingness increased over the summer, culminating in 37% of people in September saying they would undergo surgery that month if needed.

Come the middle of September, the U.S. was typically reporting fewer than 40,000 COVID-19 cases a day. Now, about two months later, the U.S. began averaging more than 150,000 cases a day. The Needham survey contains evidence the surge has dented the confidence of patients in the safety of seeking elective surgeries.

In addition to the 10 percentage point drop in the proportion of people willing to immediately undergo surgery, the survey tracked a decline in the fraction of patients who plan to have an elective procedure by the end of the year. In the November survey, 53% of people who need an elective procedure said they plan to have the surgery this year, compared to 64% of respondents to the September poll.

The latest survey found most of the procedures are expected to take place before the second half of next year but it will be some time before all are completed. “We expect a meaningful portion of people will continue to act with an abundance of caution which could result in a recovery with a long tail,” the Needham analysts wrote.

If the analysts are right, medtech companies exposed to elective procedures face a long wait for the normalization of demand. The rollout of vaccines could accelerate the process, notably by reducing infection rates and thereby tackling the main factor in decisions about whether to undergo surgery. However, the survey suggests vaccine uptake may be gradual, with 43% of people saying they will wait for full FDA approval and 39% saying they do not know when, if ever, they will get the jab.

Medtech companies are proactively trying to get patients to undergo delayed procedures. Hologic in August offered women who completed a mammogram appointment the chance to win a private, virtual performance by Sheryl Crow. J&J kicked off an educational campaign in September, followed by Zimmer Biomet in November.

https://www.healthcaredive.com/news/older-patients-less-willing-to-have-elective-procedures-as-covid-19-surges/589503/

5 major airlines roll out digital health passport for travelers

 

• Following a successful trial with United Airlines in October, four more major airlines plan to roll out a digital health pass for international travel, called CommonPass, in December.
• The technology launched by the Commons Project Foundation and the World Economic Forum allows travelers to document their COVID-19 status electronically and present it when boarding an airplane or crossing a border.
• CommonPass as operated by the CommonTrust Network, a nonprofit aimed at giving people digital access to health information, including vaccination records and lab results, using interoperable standards like HL7 FHIR. It includes hundreds of health systems and hospitals, along with accredited labs and other providers, in the U.S. and worldwide.

As the world continues to grapple with the pandemic, countries face the quagmire of how to safely reopen borders for travel and commerce. Many airlines and destinations require COVID-19 test results for travel ahead of a vaccine, but there's no standard result format or verification system.

The fragmented set of requirements for entry and exit in a country, plus the range of different test types required by different governments, has resulted in a confusing system for airlines, immigration officials and passengers to navigate, experts say. The bevy of types of documentation and requirements can lead to health check errors and even fraud, threatening a country's efforts to contain coronavirus spread.

​Digital tech is one avenue to harmonize standards in verifying passenger data pre-flight or pre-entry, proponents say. A handful of groups are working at so-called digital health passes to try to allow travel while ameliorating fears of virus transmission during the pandemic.

On Tuesday, the Airport Council International, a group representing almost 2,000 airports around the world, and JetBlue, Lufthansa, Swiss International Airlines, United Airlines and Virgin Atlantic joined the CommonTrust Network.

United was the first U.S. carrier to trial CommonPass, on an transatlantic flight Oct. 21 from London's Heathrow airport to Newark airport in New Jersey. That was followed by another trial on a Cathay Pacific Airways flight between Hong Kong and Singapore in November. Both trials were successful, according to the groups.

Next month, CommonPass will be available for JetBlue, Lufthansa, Swiss International Airlines, United Airlines and Virgin Atlantic passengers flying out from New York, Boston, London and Hong Kong.

CommonPass isn't the only digital health pass being tested. One called AOKpass developed by the International Chamber of Commerce is currently being used between Abu Dhabi and Pakistan. And global airline lobby International Air Transport Association also announced recently its own digital health pass, called the IATA Travel Pass, is in the final development phase and will come to market for Apple and Android devices next year.

Public health officials have urged people to cease non-essential travel as the U.S. faces a rising surge in COVID-19 cases going into the holiday season, typically air carriers' busiest time of year. Yet many states and countries are allowing outside travel, with varying requirements for entry.

Some destinations, such as Hawaii and France, are allowing travelers to skip a two-week quarantine period if they show a negative COVID-19 test result within 72 hours of departure. Some, like Abu Dhabi and Croatia, are more stringent, requiring a negative test result within 48 hours of departure, while a handful including Brazil and Turkey don't have any barriers to entry at all.

​As a result, many major carriers, including United and American, are offering COVID-19 tests at the airport, nearby drive-through locations or mail-in tests.

https://www.healthcaredive.com/news/5-major-airlines-to-roll-out-digital-health-passport-for-travelers-next-mon/589810/

CMS expands ability for hospital-level care at home; sees Thanksgiving surge

 

• CMS is expanding the ability of hospitals to treat their acute care patients at home ahead of an expected surge in COVID-19 hospitalization following the Thanksgiving holiday, when many Americans ignored public health advice against gatherings.
• The guidance released last week also tweaks earlier changes allowing ambulatory surgical centers to provide greater inpatient care by stating 24-hour nursing services need to be available only when a coronavirus patient is at the center.
• Six health systems were immediately granted waivers for the new Acute Hospital Care At Home program to treat more than 60 acute conditions. CMS said it has been in discussion with other hospitals and expects new applications to be submitted.

Public health experts warned this weekend the worst surges of COVID-19 could be in the coming weeks, as community spread is extensive throughout the country as many in the U.S. still traveled to be with family for Thanksgiving.

And hospitals are already stretched to the brink, scrambling to create additional ICU capacity ahead of the expected jump in hospitalizations that typically follows record-high case counts.

The new acute-care at home program builds on the Hospitals Without Walls initiative CMS launched in March, which allowed facilities to provide inpatient services in other buildings like hotels or dorm rooms.

CMS said that under the program, 85 ASCs are providing inpatient care, and it predicts the additional flexibilities just announced will prompt more to enter.

The new guidance focuses on at-home care for conditions that can often warrant a hospital stay, like asthma, pneumonia, congestive heart failure and chronic obstructive pulmonary disease.

Such services existed before the coronavirus pandemic and were growing. Health systems have turbocharged those plans as the COVID-19 crisis continued and telehealth use in general boomed. 

Intermountain Healthcare announced a hospital-at-home service in June and Universal Health Services partnered with Bayada a month later to provide post-acute home care.

At-home care is often preferred by patients, especially during the pandemic when hospital care means friends and family cannot be present. Some research has shown it to be less costly and result in fewer readmissions.

Patients can only be admitted for at-home acute care from an emergency room or inpatient bed, and they will receive at least two in-person visits a day from a registered nurse or paramedic. Hospitals are also required to perform screening for non-medical factors that could impede at-home care like not having working utilities or a risk for domestic violence.

The six health systems participating at launch — Brigham and Women's Hospital in Massachusetts; Massachusetts General Hospital; Hunstman Cancer Institute in Utah; Mount Sinai Health System in New York City; Presbyterian Healthcare Services in New Mexico; and UnityPoint Health in Iowa — cover multiple major metro areas.

The Association of American Medical Colleges applauded the move, but warned capacity isn't the only difficulty hospitals are facing. Healthcare workers are needed to treat patients and operate specialized equipment, but they are facing sickness themselves, along with burnout from the unprecedented requirements.

"Although teaching hospitals are uniquely prepared to deal with public health emergencies, the nation’s health care workforce is stretched thin on the front lines of this pandemic," AAMC wrote.

Although clinicians have learned more about the best ways to treat COVID-19 since the early days of the pandemic, patients often require a hospital stay and can quickly end up in the ICU. Capacity in those wards varies greatly across the country, and hospitals in previous hot spots have found themselves overwhelmed.

This can force a facility to curtail or halt lucrative elective procedures, which some have had to do. That can be a major financial drag for hospitals, which have reported lower volumes as people avoid routine care.

The trend continued in October, as hospitals reported falling volumes and margins amid rising expenses. So far this year, total expenses per adjusted discharge have increased 14% year over year, according to the latest flash report from Kaufman Hall.

And the Jefferies hospital traffic index for last week showed flat volumes — down more than 2% from the post-recovery high — amid rising COVID-19 cases.

https://www.healthcaredive.com/news/cms-expands-ability-for-hospital-level-care-at-home-as-thanksgiving-surge-e/589812/