Appeals court blocks CDC restrictions on cruises in win for Florida

 A federal appeals court on Friday sided with Florida in its challenge against the Centers for Disease Control and Prevention over federal regulations for cruise ships that the state said were too onerous and were costing it millions of dollars in foregone tax revenue.

The two-page ruling from the 11th U.S. Circuit Court of Appeals marks an unusual reversal from the appeals panel’s ruling in the matter delivered on Saturday.

The court did not explain the reason for the change, though the latest ruling came just hours after Florida brought the case to the Supreme Court, seeking to reverse the 11th Circuit’s previous move. That action will likely be withdrawn now.

The CDC rules have hampered the cruise industry from returning fully to business amid the nation’s vaccine-driven recovery from the Covid-19 pandemic. Early in the public health crisis, cruise lines were subject to a number of high-profile outbreaks. The industry was among the hardest hit by the coronavirus.

A federal district court in Florida sided with the state last month in response to a lawsuit filed by Ashley Moody, the Republican attorney general. Over the weekend, the 11th U.S. Circuit Court of Appeals temporarily halted that decision, which allowed the CDC rules to remain in place.

The 11th Circuit decision on Saturday was made by a vote of 2-1. Friday’s decision was unanimous.

Shares of cruise lines Carnival Cruises, Royal Caribbean and Norwegian Cruise Line each fell further than the broader market following the release of the 11th Circuit decision on Monday.

On Friday afternoon, Moody brought the case to the Supreme Court in an emergency filing, asking the top court to reverse the appeals court’s decision.

“The CDC’s Order is manifestly beyond its authority, as the district court correctly concluded in preliminarily enjoining it,” Moody wrote in the filing.

Moody said that the CDC’s rules amount to an “an ever-changing array of requirements” that are posted to the agency’s website.

In addition, she wrote, the CDC rules require cruise lines to “establish COVID-19 testing laboratories, run self-funded experiments called ‘test voyages,’ and comply with social-distancing requirements throughout ships, including in outdoor areas like swimming pools and while waiting in line for the bathroom.”

Moody wrote that only five ships out of 65 subject to the CDC’s cruise rules had been approved to sail at the time the 11th Circuit issued its ruling. She wrote in the filing that the restrictions on cruises have cost Florida tens of millions of dollars in tax and port revenues. Without further action, the restrictions were set to remain in place until November 2021.

The CDC did not immediately return a request for comment.

The 11th Circuit decision comes as the nation is seeing a rise in Covid-19 cases, largely among individuals who have not been vaccinated, attributed to the highly transmissible delta variant.

Moody said Wednesday that she had contracted Covid-19 despite receiving a vaccine. In a post Friday on Twitter, Moody said she was still experiencing mild symptoms and encouraged people to get vaccinated.

https://www.cnbc.com/2021/07/23/florida-asks-supreme-court-to-curb-cdc-restrictions-on-cruises.html

NanoVibronix: 'Compelling Study Results' for Portable Ultrasound Devices in UTIs

  NanoVibronix, Inc., (NASDAQ: NAOV), a medical device company that produces the UroShield® and PainShield® Surface Acoustic Wave (“SAW”) Portable Ultrasonic Therapeutic Devices, today announced that The Journal of Medical & Surgical Urology is publishing an article with overwhelmingly positive findings from a study of patients that used its UroShield in real world settings.

“This independent study is further proof of the effectiveness and applicability of our UroShield device in reducing the incidence of urinary tract infections and the pain and discomfort caused by urinary catheters,” stated Brian Murphy, Chief Executive Officer of NanoVibronix, Inc. “As we would expect, the patient experiences in the study were statistically significant, with all responding patients reporting that our device was simple, easy to use and materially benefitted them. The patient experiences were so profoundly positive that 100% of the study’s participants are continuing to use the device following the conclusion of the study.”

Murphy added, “Importantly, the study was conducted in real world settings, including private residences and long-term care facilities. Study participants, who often relied on family members and other assistants, achieved positive outcomes without the benefit of trained clinicians and skilled care givers, reinforcing our assertion of the ease of use of the UroShield device.”

For the study, 23 patients with reoccurring UTIs were offered to use UroShield for a minimum period of 12 weeks. Objective and subjective measures of improvement were recorded every week, including the number of UTIs, antibiotic treatment, catheter blockage and changes, bladder washout, hospitalizations or nurse visits due to UTIs, level of pain, sleep and mobility. In the findings, patients reported a significant decrease in the number of UTIs and antibiotic treatment, had fewer catheter blockages and catheter changes and pain was reduced significantly by the end of the study.

Researchers at Coventry University concluded that ‘UroShield reduced the number of UTIs, catheter blockages and changes, and consequently the need for antibiotics. Patients reported the device is easy to use, were related to little to no pain, and overall improved patients’ well-being and mobility.’ The researchers suggest that the device should be considered as an appropriate treatment in long-term persistent UTIs.

The peer reviewed publication has been submitted to the National Institute for Clinical Excellence (NICE) as further clinical evidence towards UroShield achieving NICE Guidance.

A link to the complete article will be made available on the company’s website at: nanovibronix.com.

https://finance.yahoo.com/news/nanovibronix-announces-publication-compelling-study-121500471.html

Aging-in-Place Market Valued at $151B, Still Overshadowed by Other Care Settings

 Aging in place — which includes daily essential activities, health and safety awareness, care coordination, transition support and home-based care — is a $151 billion market.

That’s according to a new report from The Holding Co. and Pivotal Ventures.

“The [market growth] is driven from older adults themselves,” Jocelyn Ling Malan, business design partner at The Holding Co., told Home Health Care News. “It’s a huge space because people are looking to thrive in their older years. They’re looking for different solutions, products or services to help them live their best chapter.”

The report examines and sizes the overall care economy, which The Holding Co. and Pivotal Ventures estimates to be a $648 billion market. This includes child care, household management, non-home-based long-term care, as well as aging in place.

Comparatively, the care economy is larger than the U.S. pharmaceutical industry and is set to see significant growth. The report singles out the aging-in-place industry as an especially hot growth area.

Source: The Holding Co. and Pivotal Ventures

Demographic shifts have, no doubt, played a role in the continued growth that the aging-in-place market is seeing. The number of seniors is estimated to double between 52 million in 2018 to 95 million in 2060.

There’s also a longevity aspect to this,” Malan said. “The life expectancy of older adults in the U.S. is increasing. … We’re living longer than ever, and we’re also working longer than ever, so there’s more money in the system.”

Additionally, roughly 70% of individuals have severe needs for long-term services and support, according to the Global Coalition on Aging.

Plus, 65% of seniors would prefer to avoid moving into a retirement home, according to the report.

The report determined that the aging-in-place market can be broken down into two subsets. About $60 billion of the market is comprised of businesses that offer personal care, care coordination, respite care, health and safety, awareness, transition support and social well-being services.

The remaining $91 billion of the market is home care provision for seniors and adults with disabilities. This includes home health, home nursing support, home therapy and durable medical equipment.

Given the spotlight the COVID-19 emergency has placed on home-based care and the overwhelming preference for aging in place, it is likely that both subsets of the market will see continued growth.

In fact, the aging-in-place market is expected to grow at a compound annual rate of 13%, according to the report.

“This is really exciting for us to continue to track and follow,” Malan said. “Once the pandemic is done, I think that will also have really interesting effects on what the aging-in-place and home-based care segment is going to look like.”

Source: The Holding Co. and Pivotal Ventures

In comparison, the non-home-based long-term care market is a $239 market. This includes nursing care facilities, retirement centers, assisted living facilities, hospice, palliative care and long-term care insurance.

The report also found that seniors have an increased level of overall use and savviness when it comes to technology. Specifically, 75% of seniors are using the internet, 53% of seniors own a smartphone and 59% of seniors have broadband access.

Looking ahead, Malan believes access to technology will fuel innovation in the aging-in-place market.

“The use of technology is important because it really unlocks a whole new wave of types of products and services that you can use to reach older adults,” she said. “I think a really huge myth is that older adults don’t know how to use technology at all — and that is a myth that we are trying to debunk.”

https://homehealthcarenews.com/2021/07/aging-in-place-market-valued-at-151b-but-still-overshadowed-by-other-care-settings/

McKinsey Analysis: Up to $250B of Healthcare Could Be Virtualized

 In the face of the COVID-19 pandemic, telehealth has helped expand access to care while protecting both providers and patients. Plenty of patient care organizations around the U.S. have experienced massive surges of virtual care visits, and now, a new analysis from consulting firm McKinsey & Company predicts that the telehealth market could grow to $250 billion.

The analysis noted that providers have rapidly scaled offerings and are seeing 50 to 175x the number of patients via telehealth than they did before. Recent health system examples of this trend have been profiled by Healthcare Innovation, such as at MedStar Health, which has experienced a 500x growth in video visits.

Pre-COVID-19, according to McKinsey & Company, the total annual revenues of U.S. telehealth players were an estimated $3 billion, with the largest vendors focused in the “virtual urgent care” segment: helping consumers get on-demand instant telehealth visits with physicians (most likely, with a physician they have no relationship with). However, they added, “with the acceleration of consumer and provider adoption of telehealth and extension of telehealth beyond virtual urgent care, up to $250 billion of current U.S. healthcare spend could potentially be virtualized.”

Of the $250 billion—or 20 percent of all Medicare, Medicaid, and commercial outpatient, office and home health spend—that could potentially be virtualized, the analysts further broke it down by healthcare delivery segment. They believe that 35 percent of home health services could move to virtual, as could 24 percent of office visits/outpatient encounters, with another 9 percent moved to “near virtual,” as well as 20 percent of ED visits that can be diverted to virtual.

According to the firm’s researchers “This shift is not inevitable. It will require new ways of working for a broad set of providers, step-change improvements in information exchange, and broadening access and integration of technology. The potential impact is improved convenience and access to care, better patient outcomes, and a more efficient healthcare system. Healthcare players may consider moves now that support such a shift and improve their future position.”

More telehealth survey data is in

More data from the organization’s multiple consumer and physician surveys from this spring emphasizes how much virtual care has surged under COVID-19, as approximately seven in 10 in-person visits were cancelled due to the crisis. For example, compared to just 11 percent consumer use in 2019, 76 percent of survey respondents now indicate that they’re likely or moderately likely to use telehealth going forward, with 74 percent of telehealth users reporting high satisfaction.

Overall, health systems, independent practices, behavioral health providers, and others rapidly scaled telehealth offerings to fill the gap between need and cancelled in-person care, and are reporting 50 to 175x the number of telehealth visits pre-COVID. Additionally, the research revealed, 57 percent of providers view telehealth more favorably than they previously did before COVID-19, and 64 percent said they’re more comfortable using it.

To this end, a recent Frost & Sullivan analysis predicted that in 2020, “the telehealth market is likely to experience a tsunami of growth, resulting in a year-over-year increase of 64.3 percent.”

One key reason for this evolution, as highlighted in the McKinsey research, is that the Centers for Medicare & Medicaid Services (CMS) is temporarily approving more than 80 new telehealth-based services as well as lifting restrictions on originating site, allowing Medicare Advantage plans to conduct risk assessments via telehealth, and adding other regulatory flexibilities to increase access to virtual care.

According to the researchers, “Many of these dynamics are likely to be in place for at least the next 12 to 18 months, as concerns about COVID-19 remain until a vaccine is widely available. During this period, consumers’ preferences for care access will continue to evolve, and virtual health could become more deeply embedded into the care delivery system.”

Core telehealth challenges do still remain, though, the analysts pointed out, such as providers’ concerns about security, workflow integration, and effectiveness compared with in-person visits, along with the future for reimbursement. Similarly, there is still a gap between consumers’ interest in telehealth (76 percent) and actual usage (46 percent). Factors such as lack of awareness of telehealth offerings, education on types of care needs that could be met virtually, and understanding of insurance coverage are some of the drivers of this gap, they noted.

The report then identified five models for virtual or virtually enabled non-acute care and analyzed the full potential of healthcare volume and spend that could be delivered this way. Those models are:

• On-demand virtual urgent care as an alternative to lower acuity emergency department (ED) visits, urgent care visits, and after-hours consultations

• Virtual office visits with an established provider for consults that do not require physical exams or concurrent procedures

• Near-virtual office visits that combine virtual access to physician consults with “near home” sites for testing and immunizations, such as worksite clinics or retail clinics

• Virtual home health services that leverage virtual visits, remote monitoring, and digital patient engagement tools

• Tech-enabled home medication administration

The researchers concluded, “The window to act is now. The current crisis has demonstrated the relevance of telehealth and created an opening to modernize the care delivery system. This modernization will be achieved by embedding telehealth in the care continuum at scale. A $3 billion revenue market has the potential to grow to $250 billion. The seeds for success will be sown in the next few months during the COVID-19 crisis.”

https://www.hcinnovationgroup.com/population-health-management/telehealth/news/21140444/mckinsey-analysis-up-to-250b-of-healthcare-could-be-virtualized

Biden Admin Drops Probe of Cuomo in Deaths of Over 15,000 Nursing Home Residents

 The Biden administration is officially dropping the investigation into embattled New York Governor Andrew Cuomo and the executive order he signed that became a death warrant for over 15,000 nursing home residents.

During the Trump administration, the Department of Justice sought information about Cuomo’s coronavirus nursing home order after his administration has repeatedly failed to produce an accurate number of nursing home deaths and covered up the numbers for months. But with Biden in charge, the probe has been dropped.

The Democrat governor’s order has been widely considered to be disastrous because it placed COVID-19 patients with the elderly and people with disabilities, those most vulnerable and likely to die from the virus. Cuomo later reversed the order, but he continually has refused to take responsibility for it. Recent reports showed that the scale of data manipulation continued for several months and was more extensive than first alleged.

Janice Dean, a senior meteorologist at Fox News, has been a leading critic of Cuomo after both her in-laws died from the coronavirus in March in assisted living and nursing home facilities in New York. She posted the news on twitter and issued a heartbroken statement.

“A terrible day for thousands of families. In a letter to @SteveScalise, @TheJusticeDept  wrote that they were dropping the nursing home investigations in all states including New York. There will be no justice for our loved ones, and it feels like we’ve lost them all over again,” she said.

New York has the highest coronavirus death count and the second highest death rate in the U.S. in large part because of the nursing home deaths.

In May, Cuomo insisted during a press conference that he did nothing wrong in his handling of nursing homes during the coronavirus pandemic and would not resign from his position.

Cuomo said that the investigation into his handling of nursing homes “was a political investigation started by Donald Trump.” He insisted that the former president politicized nursing home policies during the pandemic and unfairly blamed Democratic governors for cases and deaths in nursing homes.

“It was all our fault,” Cuomo said. “And then had his political Department of Justice start an investigation. And they were a political Department of Justice, there’s no doubt about that.”

 “I did nothing wrong … period,” the governor added. “And I’m not resigning and I’m doing my job every day.”

Times Union columnist Chris Churchill, the Associated Press and others believe the 6,700-plus reported nursing home deaths are a “significant undercount.

”Last year, the Department of Justice asked the state for data about the 600-plus nursing homes in the state as well as detailed information about hospital deaths related to COVID-19. Officially, New York reported 6,722 deaths at nursing homes due to the coronavirus this year. However, the state tally only includes people who died at the facility; nursing home residents who were transferred to hospitals and died there are not included in the total.

“The state is hiding the truth in other words – perhaps to make a controversial March 25 order requiring that nursing homes accept COVID-19 patients appear less catastrophic than it really was,” Churchill wrote in reaction to the new Department of Justice request.

Churchill said Cuomo keeps criticizing the investigation as a political, partisan attack, but it is not true. News outlets with right and left political leanings have been questioning the governor, as have Democrat and Republican lawmakers.

“Journalists and state lawmakers from both parties have repeatedly asked for the full count, only to be stonewalled by Cuomo and the Department of Health,” he wrote. “There’s no logical reason for the secrecy, other than protecting the governor’s reputation.”

Cuomo is not alone. Four other Democrat governors also ordered nursing homes to take coronavirus patients: New Jersey, California, Pennsylvania and Michigan. These five states have some of the highest nursing home death numbers, according to data from the Centers for Medicare & Medicaid Services.

Like so many others, Dean said she wants to know why the governor put vulnerable nursing home patients at risk, why he did not use the other makeshift hospitals for COVID-19 patients instead and why the state still has not released the total number of nursing-home deaths linked to the virus.

“This is not political. It’s about accountability @NYGovCuomo,” she wrote on Twitter. “We won’t stop.”

The New York Times reported April 28 that Cuomo’s aides purposefully prevented state health officials from releasing the true number of nursing home deaths to the public. The effort took place over five months in 2020.

One study found that 35% of all coronavirus deaths were in nursing homes by July of 2020, but the published report said that the number was 21%. Cuomo’s aides also put immense pressure to prevent a report from State Health Commissioner Howard Zucker from being sent to the state assembly speaker while they were investigating nursing home deaths, according to the Times. Zucker’s letter said that a total of 9,835 nursing home residents had died from coronavirus.

Elkan Abramowitz, a lawyer representing Cuomo’s office, told The New York Times that the administration was “reluctant” to release unreliable information and called the situation “overblown.”

https://www.lifenews.com/2021/07/23/biden-admin-drops-investigation-of-andrew-cuomo-killing-over-15000-nursing-home-residents/

Blackrock Neurotech, ClearPoint Neuro Eye Novel Brain-Computer Interface Surgical Solution

 ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global therapy-enabling platform company providing navigation and delivery to the brain, today announced a joint agreement with Blackrock Neurotech to develop an automated surgical solution for implanting Brain Computer Interfaces (BCIs) into patients with a wide range of neurological disorders including paralysis, ALS, blindness, hearing loss and more. This partnership will seek to leverage ClearPoint’s platform and software to deliver, for the first time, a clinical solution for surgeons that is more streamlined and effective than other BCI implantation surgeries performed to date.

“The challenge of making people walk, talk, move and feel again is an enormous one,” said Marcus Gerhardt, Co-Founder and CEO at Blackrock Neurotech. “To make this vision a reality, we believe in partnering and collaborating with the best in the field. We are excited that ClearPoint is joining us in this endeavor to provide their expertise in navigation and surgical processes to create an integrated solution.”

BCIs read, analyze, and translate brain activity into commands, which are then relayed to output devices that carry out desired actions. Blackrock’s Utah Array is the leader in implantable BCIs, with 29 human patients using Blackrock’s BCI implants for up to 7 years. As the only electrode array of its kind, FDA-cleared for temporary monitoring of brain electrical activity, Blackrock’s BCI is also being used to explore numerous functional applications including sleep, paralysis, chronic pain, ALS, and more.

“The partnership with Blackrock will allow us to leverage our expertise in neuro-navigation and robotic delivery to create a system capable of assisting surgeons to implant these BCI arrays in a predictable and replicable manner,” explained Joe Burnett, President and CEO at ClearPoint Neuro. “Automation and predictability are crucial to getting a sophisticated device like the Blackrock BCI out of the research domain and into the clinic. We are thrilled to be an enabling partner to Blackrock and the BCI market in a similar fashion to what we are doing in Biologics and Drug Delivery and Medical Devices as well.”

Under the agreement, Blackrock will help fund the development of this new surgical solution, which will leverage the ClearPoint platform and growing global installed base. Blackrock’s recent infusion of capital from re.Mind Capital and others was designed to accelerate enrollment in clinical trials, advance surgical procedures such as this, and prepare for a commercial launch across multiple clinical indications. The joint agreement between ClearPoint and Blackrock will further advance the accessibility of Blackrock’s portfolio of BCI implants to a growing patient population and represents a combined total addressable market in excess of $1.0 Billion annually for both the BCI implants and neuro-navigational systems.

https://finance.yahoo.com/news/blackrock-neurotech-clearpoint-neuro-address-200500162.html

How Intranasal COVID Vaccines Could Be 'Holy Grail' of Vaccination

 Beyond the obvious advantage for the needle-phobic, the seven intranasal COVID-19 vaccines in development could offer two additional layers of protection against SARS-CoV-2 infection, experts say.

First, intranasal vaccines could produce antibodies and attract other components of the immune system to the nose and upper respiratory tract, forming a first line of defense against infection. Second, if infection does occur, a local response in the nose can be faster than a systemic one, giving SARS-CoV-2 less of a chance to replicate, shed, and be transmitted to others.

At least that's the idea.

Dr Troy Randall

"We'll see how they fare in clinical trials, but research suggests that these types of vaccines should trigger a specialized immune response in the nasal passages that can help stop SARS-CoV-2 at the site of infection and reduce transmission," Troy D. Randall, PhD, told Medscape Medical News.

Randall and co-author Frances Lund, PhD, analyzed the promise of intranasal COVID-19 vaccines in a perspective article published online July 22 in Science.

Applying the vaccine directly to the inside or mucosa of the nose could be an advantage, agreed Deborah H. Fuller, PhD. "Mucosal immunity, especially for respiratory diseases, is a relatively untapped gold mine for vaccines," she told Medscape Medical News when asked to comment.

Recent research from Fuller and colleagues, as well as others, suggests that immune responses on the mucosa can limit viral replication better than immune responses localized in the blood.

"And this makes sense. If you have immune cells localized at the initial site where the virus infects, it could shut down the virus before it gets a chance to replicate," added Fuller, professor of microbiology at the University of Washington School of Medicine and chief of the Division of Infectious Diseases and Translational Medicine at the Washington National Primate Research Center, Seattle, Washington.

Best of Both Worlds?

If one or more of the intranasal formulations of COVID-19 gain US Food and Drug Adminstration emergency use authorization or approval, the ideal strategy might be to combine intramuscular vaccination with an intranasal booster dose, the authors note.

This one-two vaccine punch could increase protection by targeting two immunoglobulin (Ig) immune responses.

"Intramuscular vaccination should elicit systemic or central immunity, which supplies a robust circulating antibody – IgG – response in the blood. Intranasal vaccination should elicit mucosal immunity in the nasal passages and will preferentially trigger an IgA antibody response, mostly in the nasal passages," said Randall, a professor in the Division of Clinical Immunology and Rheumatology in the Department of Medicine at the University of Alabama, in Birmingham, Alabama.

"Having both provides more coverage," he added.

A Potential Breakthrough on Breakthrough Infections?

Intranasal vaccines also could be advantageous in reducing breakthrough infections, Fuller said. "Lately, we're hearing about breakthrough SARS-CoV-2 infections in vaccinated individuals. This is expected, since the current vaccines are designed to protect from disease primarily."

There is a question as to whether people with breakthrough infections, even those without symptoms, could still transmit SARS-CoV-2 to unvaccinated people. "We don't know yet," Fuller said. "With mucosal immunization, the expectation is that the virus won't get a chance to get started."

Time could tell. Six of the intranasal formulations are in phase 1 trials. These vaccines are being developed by the University of Oxford, Altimmune, Bharat Biotech, the University of Hong Kong, Meissa Vaccines, and Codagenix. A seventh product, from the Center for Genetic Engineering and Biotechnology, in Havana, Cuba, is being evaluated in a phase 1/2 trial.

These formulations hold a lot of promise, Fuller said. "Mucosal immunity offers the best hope to achieve the holy grail of vaccination ― sterilizing immunity, or complete protection from infection."

A Team of "First Responders"

Antibodies get a lot of attention, but other components of the immune system play important roles in response to viral infections such as those caused by SARS-CoV-2. Also, long after antibody levels start to wane, "memory cells," such as those from CD8+ T cells, remain in circulation or on mucosal surfaces, where they can recognize pathogens and become reactivated to fight future infections.

Memory B and T cells in the lung and nasal passages also act as nonredundant first responders to challenge infection. They are essential for rapid virus clearance, the authors note.

For these memory cells to lie in wait in the respiratory tract requires direct interaction with a viral antigen. This means that "vaccines designed to recruit resident memory cells to the respiratory tract should be administered intranasally," the authors note.

Live Attenuated Virus Vaccines

Six of the intranasal vaccines in development are live attenuated virus or virus-vectored vaccines; the seventh is a protein subunit vaccine. Live attenuated virus vaccines offer advantages but, historically at least, are of major concern.

The authors explain that, unlike a vectored vaccine that targets a single component of a SARS-CoV-2 virus, such as the spike protein, "live attenuated SARS-CoV-2 has the advantage of expressing (and potentially eliciting immune responses against) all viral proteins, thereby conferring broad-spectrum immunity that should cross-react with and provide some level of immunity against variant strains of SARS-CoV-2."

In the term "live attenuated," the word "attenuated" means that scientists have altered the live virus so that it is unlikely to cause illness but will still trigger a robust immune response. The risk is that a live attenuated virus will develop a mutation that overcomes this safety feature. This process is known as "reversion."

"Although modern molecular techniques minimize the risk of reversion, live attenuated viruses retain replicative capacity and are contraindicated for infants less than 2 years, people aged more than 49 years or immune-compromised persons," the authors note.

When asked to quantify the risk, Randall said, "In my opinion, the risk is minimal for people in that age range with a normal immune system.

"However," he added, "people with immunodeficiency because of genetics or immune suppressive drugs to treat other diseases probably should not get live attenuated vaccines for SARS-CoV-2 or anything else."

"Caution will always be important with regard to the safety of live attenuated viruses," Fuller agreed.

These virus vaccines "are not plug-and-play technologies like the mRNA vaccines where you use the same backbone and simply swap out the sequence for the next variant or virus," she said.

Rather, development of each live attenuated virus is individualized and includes rigorous safety testing to ensure that it cannot revert to wild-type virus, Fuller said. This is one reason live attenuated virus vaccines take longer to develop than mRNA vaccines, she added.

An Important Caveat

Another potential catch with live attenuated virus vaccines ― neutralizing antibodies that can reduce vaccine effectiveness ― raises an important distinction between previous infection and previous immunization.

"People who may have prior exposure to SARS-CoV-2 infection will almost certainly have IgA antibodies in the nose that can neutralize a live attenuated SARS-CoV-2 vaccine. These antibodies may wane after a year or so," Randall said.

In contrast, people who have been exposed to SARS-CoV-2 vaccine through a shot in the arm will primarily have circulating IgG antibodies, he added.

Modest levels of circulating IgG will not show up in the nose and will not neutralize a subsequent vaccination with live attenuated SARS-CoV-2. However, high levels of circulating IgG will allow a little bit of IgG to get to the nose and may reduce the effectiveness of a live attenuated vaccine.

This concern is not unique to SARS-CoV-2 ― it also arises with regard to live attenuated vaccines for influenza, severe acute respiratory syndrome, respiratory syncytial virus infection, and diseases caused by other viruses. Developing an intranasal vaccine that cannot be neutralized by preexisting antibodies would be ideal, Randall added.

Future Promise

Fuller applauded the authors for appropriately outlining the potential hurdles for mucosal vaccines. For example, Randall and Lund address how the intranasal vaccines are designed to target the nose without going deep into the lungs.

"Given that vaccine delivery to the lower respiratory tract may directly cause inflammation or may exacerbate conditions such as asthma or chronic obstructive pulmonary disease (COPD), intranasal vaccines are typically administered to humans in a way that prevents antigen delivery to lungs," they write.

Fuller said that even with some limitations, "Ultimately, mucosal vaccines may offer the best strategy for combating future pandemics." An ideal pandemic vaccine is safe, is stable at room temperatures, can be self-administered, and works well in all demographics, she added.

"Mucosal vaccines offer the potential to meet most, if not all, of these features."

Randall and Lund are consultants and receive research funding from Atimmune Inc. Fuller has disclsoed no relevant financial relationships.

Science. Published online July 22, 2021. Full text

https://www.medscape.com/viewarticle/955309