How much worse will coronavirus crisis get in LA?

How bad will the next few weeks get?

The number of COVID-19 deaths in California and Los Angeles County — an epicenter of the pandemic — is setting records or near-records almost daily. There is clear evidence that the post-Christmas holiday surge in cases is worsening, as the numbers continue to spike, particularly in L.A. County.

But the big question is whether this new wave of cases will result in a similar increase in hospitalizations as occurred during the post-Thanksgiving surge, which has pushed hospitals to the breaking point, resulting in terrifying shortages of staffing and certain supplies and affecting the quality of medical care given to critically ill patients.

Around Thanksgiving, about 300 new COVID-19 patients a day were admitted into hospitals in L.A. County; that number rose precipitously for about a month, finally stabilizing at about 750 to 800 new hospitalizations a day around Christmas Eve. Another doubling or tripling of new hospitalizations per day would be catastrophic.

For as dire as the crisis has become, most hospitals have yet to enter a sustained, widespread period of rationed care. But that would probably come if the Christmas surge is dramatically worse.

Teams of triage officers — usually led by critical care and emergency doctors — would have to be fully activated. Faced with shortages in staff and supplies, they would be forced to make the most heart-wrenching decisions: determining who receives the most aggressive lifesaving care and the limited time of the best-trained professionals and equipment, and who is given a lesser chance of survival and provided treatment to comfort them as they die. How hospitalizations break this week will give officials a sense of what to expect.

“We are all waiting with a certain amount of anxiety in seeing how the hospital admission data unfold over the coming days,” said Dr. Roger Lewis, director of COVID-19 hospital demand modeling for the L.A. County Department of Health Services.

“The hospital-based system is literally at the breaking point, where a substantial increase in demand could result in situations where we cannot provide to people the care that we would all expect to be able to provide or to receive when we’re critically ill,” he added.

Patients suffering from COVID-19 who are now entering the hospitals were mostly infected in the post-Thanksgiving, pre-Christmas period. The flattening of new hospitalizations probably resulted from the imposition of stay-at-home orders issued by the county and state.

But the effect of holiday gatherings over Christmas will soon begin to show up in hospitals. Soon, a certain percentage of people who got infected over Christmas and have tested positive will begin getting so sick they’ll need hospital care. If the number of new daily hospital admissions for COVID-19 patients worsens, that’s a big sign of trouble.

Now, it’s possible that the increasing hospitalizations could be moderated if, for instance, it’s mostly younger, otherwise healthier people who got infected over the holiday season, and quarantined or isolated themselves to avoid infecting older family and friends who are at a higher risk of dying.

But it’s also plausible the vulnerable and elderly people attended Christmas and New Year’s gatherings or were later infected by younger people who didn’t stay away from them — something that happened over the Thanksgiving holiday.

“The fear, or the intuition, of most of the people doing predictive modeling is that it is going to get worse. The uncertainty is in how much worse. And in order to quantify how much worse, that requires the data that will only be available to us next week,” Lewis said.

The post-Christmas surge in new coronavirus cases has been growing by the day. L.A. County’s average number of new coronavirus cases on Thursday, Friday and Saturday was about 18,000 — significantly above the average of about 14,000 new cases a day over the last week.

“This very clearly is the latest surge from the winter holidays and New Year’s — no question about it,” said the L.A. County Department of Public Health’s chief science officer, Dr. Paul Simon. “It had gradually started earlier in the week, but [definitely] here in the last day or two.”

About 1 in 5 coronavirus tests performed daily in Los Angeles County are coming back positive, a huge increase from early November when about 1 in 25 tests confirmed an infection. And when community transmission is this prolific, officials warn that activities that seemed mundane months ago carry a higher risk of infection than ever.

Simon said the increase in daily coronavirus cases is likely to continue over the next week or two, which will translate into even worse hospitalizations and more deaths. The number of daily COVID-19 deaths is already breaking records; in early December, about 30 people a day in L.A. County were dying of COVID-19 on average over a seven-day period; now, about 200 people a day are dying.

The number of people dying of COVID-19 daily is now exceeding the average number of deaths in L.A. County for all other causes, including heart disease, cancer, stroke, diabetes, car crashes, suicides and homicides, which is about 170 deaths a day.

Some veteran epidemiologists suspect higher levels of hospitalizations and deaths will, in fact, materialize and that hospitals will be forced to adopt “crisis standards of care,” in which triage doctors may have to choose who receives lifesaving treatment.

“I anticipate that with the increased numbers of cases that we are seeing — which will translate into inevitable increased numbers of hospitalizations and ICU patients — that hospitals will be forced into operating under crisis protocols that may include rationing of care,” said UCLA medical epidemiologist and infectious-diseases expert Dr. Robert Kim-Farley.

Kim-Farley said he suspected there will be a renewed increase in hospitalizations soon that will continue rising through the end of January. A fraction of those people won’t survive their illness, and a peak in daily COVID-19 deaths will probably occur in mid-February, Kim-Farley said, due to the lag between initial hospitalization and death.

It was wise that state officials are ready to distribute dozens of large refrigerated trailers that can act as temporary morgues for bodies that are being dispatched to counties, Kim-Farley said. Funeral homes across the state are already overwhelmed by the surge in bodies and some have been forced to turn families away.

“Unfortunately, the surge capacity being done for morgues will in fact be needed,” Kim-Farley said.

L.A. County has now reached new milestones in the pandemic: more than 12,000 dead from COVID-19 and more than 900,000 coronavirus cases.

On Saturday, 218 COVID-19 deaths were reported in L.A. County. That came the day after the county set a single-day record of 318.

L.A. County officials Saturday confirmed three additional cases of the coronavirus-related inflammatory disease in children known as MIS-C. A total of 54 children in L.A. County have contracted the severe illness, and one has died. The disease can cause fever and inflame the heart, lungs, kidneys, brain, skin, eyes and gastrointestinal organs. The disease is disproportionately affecting Latino children, who account for about 3 of 4 reported cases.

In L.A. County in recent days, available ICU beds fell to zero or one in each of the following regions: central L.A., the Westside, southeast L.A. County, the San Gabriel Valley and the Antelope Valley. The South Bay-and-Long Beach region had as few as three available ICU beds in recent days, and the San Fernando Valley as few as six.

In Santa Clara County, which has some 2 million residents, about 20 to 25 available ICU beds remained Friday; in Fresno County, with about 1 million residents, only 10 beds were available.

Dr. Rais Vohra, Fresno County’s interim health officer, said hospitals are preparing for “a very hard rest of January and possibly February,” including scrambling to find supplies related to providing oxygen treatments and providing ways to perform infusions of antibodies to keep patients from needing hospitalization.

Some help has started to arrive: Staffers from the U.S. Department of Defense, as well as ICU nurses recruited by the state, have been deployed around hospitals in the region, said Dan Lynch, director of the Fresno County Emergency Medical Services agency. And one hospital in San Mateo County has offered to take in critically ill patients from Fresno County.

But it won’t be easy to do those transfers in practice. “It is a risky move when you’re moving them for a long distance,” Lynch said.

Though California’s existing pandemic surge is dire, the state has one of the lower cumulative numbers of COVID-19 deaths on a per capita basis, ranking 38th among the 50 states, probably a result of the early imposition of the stay-at-home order in the spring and summertime closures of certain high-risk businesses. New Jersey’s cumulative COVID-19 death rate is triple that of California’s; Arizona’s is double.

https://www.latimes.com/california/story/2021-01-10/la-me-coronavirus-christmas-surge 

Covid-busting Nasal Spray Begins UK Trials January 11

 The first UK clinical trials of a nasal spray proven to kill 99.9% of the coronavirus that causes Covid-19 will begin on January 11th at Ashford and St Peter’s Hospitals NHS Foundation Trust, in Surrey.

The SaNOtize Nitric Oxide Nasal Spray (NONS) is designed to kill the virus in the upper airways, preventing it from incubating and spreading to the lungs.

The treatment, developed by SaNOtize Research and Development Corp. based in Vancouver, Canada, proved 99.9% effective in killing the coronavirus in independent lab tests at Utah State University’s Antiviral Research Institute. Additional studies in rodents with COVID-19 infection showed over 95% reduction within the first day after infection. It is currently undergoing Phase II clinical trials throughout Canada approved by Health Canada, and in other countries.

The SaNOtize treatment is based on nitric oxide, a natural nanomolecule produced by the human body with proven anti-microbial properties shown to have a direct effect on SARS-CoV-2, the virus that causes Covid-19. The treatment can be delivered by nasal spray, throat gargle or nasal lavage.

Lab tests on the SaNOtize treatment at Utah State University’s Antiviral Research Institute confirmed that the company’s Nitric Oxide Releasing Solution inactivated more than 99.9% of SARs-CoV-2, the virus that causes Covid-19, within two minutes.

Rodent studies performed at Colorado State University showed an average of over 95% reduction in SARS-CoV-2 viral load tested on the day following infection with half the rodents having no detectable virus at all. This was following inoculation with the virus and two treatments of SaNOtize’s nasal spray.

“Any intervention for treating coronavirus – the virus responsible for Covid-19 – is to be welcomed. The fact that a relatively easy and simple nasal spray could be an effective treatment is welcome news and offers a significant advance in our therapeutic armoury against this devastating disease. Ashford and St Peters Hospitals NHS Foundation Trust is proud to be at the forefront of trialling this intervention,” said Pankaj Sharma MD PhD FRCP, Professor of Neurology and Director of the Institute of Cardiovascular Research at Royal Holloway, University of London.

The importance of nitric oxide within the human body and its healing properties was first discovered by Prof Ferid Murad of Stanford University, among others, for which he shared the Nobel Prize in Medicine in 1998. Prof Murad is a member of the board of SaNOtize.

https://www.businesswire.com/news/home/20210110005028/en/Covid-busting-Nasal-Spray-Begins-UK-Trials-January-11th

NC governor activates National Guard to help with COVID vaccine distribution

 Gov. Roy Cooper has mobilized the state’s National Guard to help with North Carolina’s vaccine effort that is showing delays and logistical challenges just a few weeks into the distribution.

“Ensuring COVID-19 vaccines are administered quickly is our top priority right now. We will use all resources and personnel needed,” Cooper wrote in a tweet Tuesday.

The N.C. National Guard has started to form six-member “immunization strike teams” that will travel the state to work at COVID-19 vaccine sites “to help North Carolina get needles into arms,” Brig. Gen. Jeff Copeland said Tuesday.

The Governor’s Office didn’t provide additional details, and the National Guard didn’t say how many members would be activated. Cooper’s office referred questions to the National Guard spokesperson Lt. Col. Matt DeVivo.

DeVivo said details are still being worked out but that the Guard is working with the N.C. Department of Public Safety and Department of Health and Human Services on “how to best deploy Guard personnel and resources that are mobilizing.”

Cooper’s National Guard activation comes as data from the Centers for Disease Control and Prevention shows that North Carolinians are receiving their first dose of vaccine at a slower rate than much of the rest of the country. The state’s rate of 966 vaccinations per 100,000 people, as of 9 a.m. Monday, was the sixth lowest in the country.

Dr. Mandy Cohen, the state DHHS secretary, told The News & Observer that some of the state’s health departments and hospitals have used all of their vaccine allocation, while others are grappling with issues ranging from data entry to information technology issues to not having enough staff to actually administer vaccine.

“We’re two-and-a-half weeks into this, and I know folks are working hard, so I do expect us to really speed up over the next number of weeks,” said Cohen in an interview Tuesday afternoon. “And from the state perspective, our job is to support our local partners in their efforts to do this hard work, and I think that’s what we’re going to do.”

As of 8:30 a.m. Tuesday, 109,799 North Carolinians have received the first dose of a COVID-19 vaccine, according to data released by the N.C. Department of Health and Human Services. Both Pfizer and Moderna vaccines that have received Food and Drug Administration emergency use authorization require two shots to be fully effective, and 461 people statewide have been given both shots.

DHHS cautions that the data is preliminary and reporting can lag by as much as 72 hours. The state only reports updated vaccination data on Tuesdays.

An additional 13,338 people who live or work at long-term care facilities had received first doses from CVS or Walgreens through a partnership with the federal government. The pharmacies have received 165,990 doses of North Carolina’s total allocation.

Cohen said it’s possible that more people have actually received vaccine, since some health departments are struggling with data entry. Vaccines administered through CVS and Walgreens also isn’t included in the state’s vaccine dashboard.

“Another place where we’re trying to work to understand really what is happening on the ground is, is the vaccine really administered and it’s just not in the system?” Cohen said.

Initially, DHHS distributed vaccine based on the population of the recipient county, how many acute care and intensive care beds the county had and whether facilities had freezers that could reach the ultra-cold temperatures required for the Pfizer vaccine.

Beginning next week, though, DHHS will also consider how many doses a health department or hospital reports has recorded as given in the state’s vaccine management system.

“We will allocate our vaccination supply to those facilities who are in need because they are effectively administering vaccines. Further, this data may be considered by the CDC in determining how to allocate constrained supply to the states. So, any location’s failure to provide accurate and complete data can impact the vaccine supply to the entire state,” wrote Amanda Fuller Moore, a pharmacist in the state’s public health department.

By the end of this week, 583,850 “first” doses of vaccine, as well as 85,800 “second doses” of the Pfizer-BioNTech vaccine will be allocated to North Carolina.

The CDC released Tuesday the allocations for the week of Jan. 11, which include 61,425 first doses and 61,425 second doses of the Pfizer vaccine, as well as 60,800 first doses and 175,900 second doses of the Moderna vaccine.

NATIONAL GUARD ROLE

This is the fourth week of a national distribution of vaccines, and states across the country have reported logistical challenges in ensuring the vaccine is available to those who should get it next.

The rollout is happening as the pandemic is rapidly accelerating, both statewide and beyond, with record numbers of people in the hospital for COVID-19.

Last week, North Carolina officials announced an update to the state’s vaccination plan. Anyone who is at least 75 years old will be in the first group of the state’s updated Phase 1b, The News & Observer reported. Next eligible for vaccine will be people who are at least 50 years old and working as either health care providers or frontline essential workers.

The National Guard teams are expected to work at least into April, working down the list of groups as they become eligible, Copeland said.

Copeland said the teams will work in urban areas with large medical facilities as well as in underserved rural areas. He provided details Tuesday afternoon, after Cooper’s announcement, during a live town hall event on Facebook with a panel of NCNG leaders.

Teams will consist of two combat medics and four administrative support members, Copeland said, with the medics administering the shots and the support staff entering patient information into computers and managing logistics.

The National Guard will give the two-step Moderna vaccine, which unlike the Pfizer vaccine, doesn’t require deep-cold storage, from supplies acquired by the U.S. Department of Defense. Vaccinations will be prioritized using the systems established by DoD and the state Department of Health and Human Services, Copeland said.

National Guard soldiers and airmen who have been summoned to duty for the COVID-19 response will able to get vaccinated first, along with Guard members who are actively working in health care, other essential Guard personnel and some senior leaders. Copeland said vaccinations are expected to begin on Thursday.

Guard members are not required to get vaccinated, panel members said, because the vaccine was authorized under emergency use provisions. That could later change.

LOGISTICAL CHALLENGES

Some counties are expected to start rolling out vaccine this week to people in the 1b phase, starting with anyone who is at least 75 years old. But Gaston and Mecklenburg counties have reported that vaccine registration hotlines have faced difficulties, The Charlotte Observer reports.

In Mecklenburg, county officials warned that some people haven’t been able to get through because of the high number of calls and told people to book online if they can’t get through. Gaston officials told residents not to leave more than one voicemail trying to make an appointment.

The Lee County Health Department announced Tuesday morning that it would start vaccinations for all groups in Phase 1b at 9 a.m. Those interested could call one of two phone numbers. By 5 p.m., though, the county had curbed the vaccination to just Group 1 of Phase 1b — people who are 75 years or older.

“The department expected a significant interest in the community for the COVID-19 vaccine, but our staff has been overwhelmed by the volume of calls today,” said Heath Cain, the Lee County health director, in a statement. “As such, we knew we had to adjust our plans to better serve the community.”

Other counties don’t anticipate moving into Phase 1b until next week at the earliest.

“Some places are ready raring to go and are starting to vaccinate 75 and up, that’s great,” Cohen said. “Others are still working on their healthcare workers and are not quite ready to move into 1b yet. That’s OK. So there is going to be a little bit of difference on the ground as we go.”

People who are at least 75 years old should call their local health department or hospital to see if vaccine is available where they live, Cohen said. Even if they are not taking vaccine appointments just yet, they likely will be over the next couple of weeks.

DHHS plans to launch a hotline this week that people can call to learn about the vaccine and to better understand where they can seek out a shot. The DHHS hotline will not be used to book appointments, Cohen said.

Wake County officials have warned that the large number of healthcare workers in the county means it will likely take them longer to move through Phase 1a than many other places in the state. Phase 1a includes vaccinating frontline healthcare professionals and those who work with COVID-19 patients as well as people who live in long-term care facilities and nursing homes.

Wake County has not yet decided how people will be able to sign up for vaccination slots, but hopes to finalize the process this week, Leah Holdren, a Wake County spokeswoman, wrote in an email to The News & Observer Monday.

“We can’t stress enough how little vaccine there is for the population of Wake County,” Holdren said. “Right now, there is not enough vaccine to move to Phase 1b just yet.”

North Carolina legislative leaders, asked to comment on the National Guard’s new role in the vaccine distribution, said the state’s plan would be discussed Jan. 12 at the N.C. General Assembly’s Joint Legislative Oversight Committee on Medicaid and N.C. Health Choice.

Speaker Tim Moore’s office said in a statement that his office is “working with health committee leaders to ensure this oversight meeting addresses concerns with the distribution expressed by state lawmakers and stakeholders.”

Sen. Joyce Krawiec, a Winston-Salem Republican, added in a statement: “There are a number of questions about vaccine distribution planning and execution, and we hope that some oversight will result in improvements and advance everyone’s shared goal of vaccinating all who want it as soon as possible.”

There are 435,000 people who qualify for vaccine in the first group of Phase 1b, according to a DHHS memo, meaning they are at least 75 years old.

The state health department also estimates that there are another 875,000 people who are eligible to receive the COVID-19 vaccine in groups two and three of Phase 1b. Those include an estimated 583,000 frontline essential workers and another 292,000 healthcare employees who work directly with patients.

“For future phases, supplies are very limited and will likely continue to be for the next several months. States are informed about their allocations weekly, so we cannot predict the timeline for each phase,” Catie Armstrong, a DHHS spokeswoman, wrote in a prepared statement.

TRIANGLE PREPARATIONS

Orange County is trying this week to wrap up Phase 1a and hopes to enter Phase 1b early next week, said Todd McGee, a county spokesman.

But many details of what that entails have not been explained.

North Carolina has launched a COVID-19 Vaccine Management System that can be used to determine eligibility, but McGee said questions remain about whether recipients are supposed to register with it or only providers.

Orange County’s plan includes reaching out to people at least 75 years old who are eligible under Phase 1b, but McGee said he doesn’t know how the county would develop that list.

Health departments and hospitals likely will provide the next phase of vaccine in Orange County, but McGee warned that public health workers across the country will need help with the vaccine effort.

“The expectation that county health departments can manage that is ambitious,” McGee said. “The more people we have who can give the vaccine should also help us pick up the pace.”

McGee pointed to the federal government’s lack of involvement in vaccine distribution to explain the lack of details, which has resulted in a state-by-state and county-by-county effort.

“It just seems like it would have been much better off if there were a lot more thought given to this months ago to set this up months ago,” McGee said.

Copeland noted that the N.C. National Guard has been involved in the response to COVID-19 since the pandemic hit, helping out with the distribution of PPE, making food bank deliveries and running testing sites. That’s in addition to the Guard’s normal training and duties.

Guard members who work as civilians in the medical field will not be called up and assigned to the strike teams, Copeland said, because they are needed in their community hospitals and medical centers.

https://www.newsobserver.com/article248285010.html

When will primary care docs get COVID-19 vaccine? Many still in the dark

 While front-line health workers across the country began receiving the COVID-19 vaccine last month, many primary care doctors and their staff members are left in the dark about their turn in line.

"Generally speaking, unaffiliated community practices are having tremendous challenges obtaining vaccines for the physicians and care teams at those sites," Shawn Martin, executive vice president and CEO for the American Academy of Family Physicians (AAFP), told Fierce Healthcare.

"There are some large health systems that are collaborating with community physicians to provide access to vaccines, but for physicians not aligned with a health system or hospital, as a general rule, they are having a high degree of difficulty," he said.

Only about a quarter (23%) of primary care doctors say they know where they are getting the vaccine, and just 20% know how the vaccine will be stored, according to a survey from the Primary Care Collaborative conducted back in mid-December.

The survey results from nearly 1,500 primary care clinicians highlight the growing concern that doctors who are not affiliated with hospitals have no direct link to the vaccine rollout and are being left out of the process.

It also echos an alarming pattern seen throughout the COVID-19 pandemic where primary care doctors and community-based physicians have lacked access to resources such as personal protective equipment and COVID-19 tests, said Ann Greiner, president and CEO of the Primary Care Collaborative, in an interview with Fierce Healthcare.

The federal government has largely left vaccine rollout to the states and public health departments, and they, in turn, are relying on hospitals to be the main distribution points. Many states are following the recommendations of the Centers for Disease Control and Prevention (CDC) in its phased vaccine distribution plan, and healthcare workers, including primary care doctors and staff, are included in phase 1a.

"But the CDC policy is silent as to how and where to get those vaccines to primary care physicians if they are not associated with a hospital or with a retail pharmacy," Greiner said.

For primary care doctors, the process to get a vaccine varies state by state, with some states setting up dedicated online portals for clinicians to put their names on the list while other states still have no process in place, according to Emily Maxson, M.D., chief medical officer at Aledade, a company that works with more than 7,300 providers across 27 states.

"In many states, they are being left out of the initial vaccination efforts, and we even see health system employees get vaccinated who don't have exposure to patient care," she said.

As a result, primary care clinicians continue to be dangerously exposed to the virus while caring for patients, she said.

"[Primary care physicians] are frankly getting to the point where they are just totally discouraged and disappointed and feel undervalued. With COVID, PCPs are being asked to step into uncertainty and expose themselves to patients who may or may not be wearing masks or staying home and they're being asked to triage, test, and care for these patients."

In some areas, vaccines are available if clinicians know about it. For instance, with Virginia still requiring vaccinations only go to those in tier 1a, or healthcare workers, Inova Health System currently has more available slots for distributing the vaccine than they have arms to put shots in—a point of frustration for the health system, said Inova President and CEO Stephen Jones, M.D.

After Inova ensured its own front-line workforce had a chance to get the vaccine, the Fairfax, Virginia-based health system opened up vaccination slots for all other healthcare workers in the community.

"Anyone who can prove that they're a healthcare worker, we're bringing them in and getting them their vaccine," Jones said. "And even with that, we've got the ability to expand it more if we're allowed."

In Pennsylvania, the secretary of health has mandated that 10% of the vaccine stock be allocated to the vaccination of community-based independent physicians and their staff, according to Jaan Sidorov, M.D., CEO of the PA Clinical Network, a clinically integrated network for independent practices. 

"We're hearing that the hospitals and chain pharmacies are still figuring that out, but that may be a model for other states to emulate," he said.

In areas where primary care doctors are being included in vaccine rollout plans, one key factor appears to be strong leadership by public health departments and greater efforts to collaborate with local providers, according to Martin.

Primary care's role in vaccination efforts

Inoculating the primary care workforce is key to fighting the COVID-19 pandemic, industry stakeholders say. These clinicians are on the front lines, and it's critical to create a safe environment for patients to get care.

Primary care doctors also have an established, trusted relationship with their patients.

Survey data indicate that patients feel more comfortable getting vaccinated by their primary care doctors, and these clinicians can help combat misinformation about the vaccine as well as answer questions about safety and efficacy, Maxson said.

"I don’t think we can rely on retail pharmacies to convince patients [to get vaccinated]," she said.

Reports of rare allergic reactions to the COVID-19 vaccine have generated skepticism among doctors and patients that the pharmacies will be able to handle an adverse event, and that could hamper downstream vaccination rates, Sidorov said.

"It remains to be seen if patients are going to say, 'I’m willing to take the chance of an adverse reaction in the cash register area of a drug store,'" he said, noting that physicians are equipped to handle an adverse reaction if one should occur.

Independent practices and community-based clinics also can play a critical role in encouraging vulnerable and marginalized populations to get the COVID-19 vaccine, stakeholders say.

The Primary Care Collaborative survey found that 89% of primary care doctors will take the vaccine themselves, and 90% are recommending the vaccine to their patients.

But most practices haven't received word on when they will receive vaccine doses for their patients, and few practices are set up to distribute the COVID-19 vaccine, the survey found.

Primary care clinic vaccinations are hampered by the freezer requirement, as the Pfizer vaccine needs to be kept extremely cold: minus 70 degrees Celsius.

There are also minimum batch size order requirements that are putting this further out of reach for many practices, Sidorov said.

"What we've heard is that the batch size order was in excess of 900 doses," he said.

Martin recommends that primary care physicians contact their state governor's office or public health departments to get more information about the process to obtain vaccines for practice staff and patients.

"We need to escalate the issue that primary care physicians have been left unvaccinated and that means our triage workforce could be taken out, which would exacerbate a public health emergency. State and local public health agencies should recognize this and make sure they have a line of sight on how PCPs and their staff can be vaccinated so our infrastructure for public health doesn’t crumble," Maxson said.

https://www.fiercehealthcare.com/practices/when-will-primary-care-docs-get-covid-vaccine-most-are-still-dark

Creating an 'Operation Warp Speed' for Alzheimer's

 Medical science can do astonishing things.

Eleven months after the first COVID-19 case was diagnosed in the United States, two of the companies developing vaccines to prevent the virus are applying to the FDA for emergency authorization of their drugs. Calling the initiative to discover a cure “Operation Warp Speed” may actually be an understatement.

What we’re witnessing is historic. The money, resources, technology, talent and coordination committed to developing vaccines has been staggering—and the result will go down as one of the most extraordinary feats in the annals of medicine. The task is enormously complex, as is the virus itself, but the pharmaceutical companies have figured out how to compress that complexity and distill a breakthrough that would have otherwise taken years.

Just a few weeks earlier, a different kind of pharmaceutical story was making headlines: the FDA Advisory Committee denial of approval of aducanumab, Biogen’s drug developed as a treatment for cognitive decline. For the millions of families and advocates hoping for an Alzheimer’s-disease breakthrough, the news was devastating.

Biogen had worked for 10 years on the project, and its application to the FDA was the first new Alzheimer’s drug in two decades. It’s been a long time in the wilderness for those of us hoping that drug research will yield a cure for this mystifying and catastrophic illness.

The desperation for an effective Alzheimer’s therapy is profound: “While the trial data has led to some uncertainty among the scientific community, this must be weighed against the certainty of what this disease will do to millions of Americans absent a treatment,” the Alzheimer’s Association wrote in a letter to the panel. “The potential to delay decline would be denied to millions, and that time lost for those spouses, partners, moms, dads, grandmothers, grandfathers, aunts, uncles, friends and neighbors cannot be recovered. In the balance of these considerations, we urge approval.”

An Operation Warp Speed for Alzheimer’s?

Coming so close to the remarkable COVID drug announcements, it begs the question: What if the same urgency and effort were marshaled for an Alzheimer’s cure? While dementia and the COVID-19 virus are vastly different illnesses, is it possible to build on the existing research so that, given a similarly-scaled operation, a discovery could emerge? It’s tempting to consider.

I believe that someday a drug will be discovered, or, more probably, a range of drugs, as the neurological culprits of this complicated disease are unlikely to be identified with a sweeping marker.

Even aducanumab—which works by binding to clumps of a protein called amyloid-beta, a plaque that has been a long-time target of Alzheimer’s research—has been specifically targeted for the two million Americans estimated to have mild Alzheimer’s-related cognitive decline. To put it in context, there are currently 5.6 million Americans with Azheimer’s, a number that is projected to nearly triple by 2050 as the population aged 65 and older soars.

People shouldn’t have to wait

It’s not imperative that people wait, worry and suffer. While the current failure of aducanumab to receive FDA approval is disappointing, it doesn’t have to be a setback for other advancements in the treatment of Alzheimer’s. Early intervention has been shown to reduce the risk of Alzheimer’s by as much as 40%.

Treatment shouldn’t only have to come in a bottle. Technology is transforming assessments for cognitive health, measuring cognitive strength and the presence of symptoms of decline. Digital data creates reliable and sophisticated information that can be shared with a doctor, enabling a more precise diagnosis and—most importantly—therapy.

Changing habits now can change long-term cognitive health 

Managing brain health is no different than taking care of any other major organ. Awareness, testing and lifestyle choices can combat and reduce the risk of illness.

The groundbreaking 2014 FINGER protocol (The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability) showed cognitive gains resulting from behavior modifications such as nutrition, exercise, cognitive training, social engagement and management of metabolic and vascular risk factors.

Lifestyle interventions adopted by the study’s 1200 participants resulted in a 25% overall cognitive improvement, 83% improvement in executive function and 150% improvement in processing speed.

While the behavior-modification approach was once dismissed as “soft science,” its clinical results have gotten the attention of Alzheimer’s researchers and organizations like the World Health Organization, which has embraced the potential of lifestyle intervention and established guidelines for action.

The FINGER breakthrough has launched a consortium of countries that have initiated “World Wide Fingers” to share information and research that builds on the initial study. In the United States, the Alzheimer’s Association is behind the initiative, partnering with Wake Forest University Medical Center on “a lifestyle intervention trial to support brain health and prevent cognitive decline.”

Solving the Alzheimer’s riddle

Let’s go back to the Operation Warp Speed proposition. What if that degree of urgency were dedicated to a hybrid effort for an Alzheimer’s cure—where the promise of the new assessment-and-therapy advances was furthered, and combined with continued research of drugs like aducanumab that attack Alzheimer’s core biology?

The COVID-19 pandemic has demonstrated what medical science is capable of in response to a public health crisis. There is no long-term health crisis more pervasive than Alzheimer’s disease. Assessment and therapy are already providing an answer. With the right effort, we can do even more.

Jordan Glenn, Ph.D., is the senior vice president of clinical development at Neurotrack, a company that develops digital solutions for cognitive health.

https://www.fiercehealthcare.com/tech/industry-voices-creating-operation-warp-speed-for-alzheimer-s

HHS expands COVID-19 public health emergency til April, keeps telehealth perks

 The Department of Health and Human Services (HHS) has extended the public health emergency surrounding the COVID-19 pandemic until April, extending key waivers for regulations on a variety of topics such as telehealth.

The public health emergency declaration was originally scheduled to expire Jan. 21. HHS Secretary Alex Azar extended the emergency Thursday, according to a notice.

This is the fourth time HHS has expanded the emergency, with the last one occurring in October.

The emergency, first installed Jan. 31, 2020, launched a series of blanket waivers that suspended several federal oversight and reporting requirements.

One of the biggest areas of flexibility is under telehealth coverage. The agency was able to waive some requirements. For instance, under the emergency, HHS has allowed more types of providers to bill Medicare for telehealth services, such as physical therapists and others.

It also granted waivers for the reimbursement of audio-only telehealth services for all providers.

The agency waived certain reporting requirements for hospitals in the intensive care unit and other areas to help hospitals that have been swamped with fighting the virus.

https://www.fiercehealthcare.com/hospitals/hhs-expands-covid-19-public-health-emergency-until-april-preserving-key-telehealth

New coronavirus cases in China double, mainly in Hebei province

 The daily number of new coronavirus cases has doubled in China, prompting tougher movement restrictions and, in the capital, passengers must scan a health code before boarding a cab or ride-hailing car, officials said on Sunday.

Mainland China reported 69 cases on Jan. 9, compared with 33 reported a day earlier, the country’s national health authority said on Sunday.

The new rule on cab journeys follows the discovery on Saturday that a ride-hailing driver in Beijing was an asymptomatic carrier of the new coronavirus, city health official Pang Xinghuo told media.

Since Jan. 1, 96 drivers on a ride-hailing app Didi have been fined a total of 1 million yuan ($154,440) for improperly implementing coronavirus prevention measures, such as wearing a mask, Rong Jun, a Beijing city transport official, said.

Over the course of the pandemic, mainland China has reported a total of 87,433 confirmed coronavirus cases, with 4,634 deaths.

In its daily bulletin, the National Health Commission said 21 of the new cases were imported.

Most of the locally-transmitted cases, 46 out of 48, were in Hebei, the province surrounding Beijing that entered a “wartime mode” this week as it seeks to contain rising infections.

China reported 27 asymptomatic cases on Jan. 9, down from 38 a day earlier. China does not classify these patients, who have been infected by the SARS-CoV-2 virus that causes the disease, but are not showing any COVID-19 symptoms, as confirmed cases.

Hebei has finished testing all 13 million people in the major cities of Shijiazhuang and Xingtai, a provincial officer said in a briefing on Sunday.

Shijiazhuang, the provincial capital, is in lockdown and people and vehicles are barred from leaving the city. Public transport has also been halted.

Separately, 5.79 million people in school hostels and prisons received coronavirus testing and none was found to be positive, the provincial official added.

https://www.reuters.com/article/us-health-coronavirus-china-cases/new-coronavirus-cases-in-china-double-mainly-in-hebei-province-idUSKBN29F01V