First peer-reviewed coronavirus vaccine shows promise in mice

A new potential vaccine against the coronavirus sweeping the world has showed promise in mice, researchers at the University of Pittsburgh School of Medicine said Thursday.
In a peer-reviewed study published in the medical journal EBioMedicine, the researchers said their new development comes from earlier vaccines they had created to fight the two other deadly coronavirus strains already known: SARS, which broke out in China in 2003, and MERS, which hit Middle Eastern countries and South Korea in 2014.
“We have been designing coronavirus vaccines since 2003,” Andrea Gambotto, an associate professor of surgery at the Pitt School of Medicine and one of the study’s two lead authors, told The Hill in an interview.

The researchers repurposed those earlier vaccines to target a specific protein that protrudes from the new version.
“For us, it was easy to switch gears from one target to the other,” Gambotto said. “We had all the pieces together.”
The study showed that when tested in mice, the vaccine produced antibodies that were specific to the current coronavirus, and in quantities that are likely sufficient to neutralize the virus.
Unlike many vaccines, the Pitt-developed version would be delivered by a fingertip-sized patch that scratches the surface of a recipient’s skin. The scientists said the immune system reacts more strongly to irritations on the skin, in hopes of triggering it to recognize the coronavirus more quickly.
The delivery method is similar to a vaccine used to eradicate smallpox, said Louis Falo, chair of the dermatology department at the Pitt School of Medicine and the University of Pittsburgh Medical Center. Falo said the team hoped to begin tests on human volunteers in short order.
“We’d like to begin testing in patients as soon as possible,” Falo said. “We would like to be in a phase one clinical trial in weeks. Not a week, maybe a month.”

The Pitt vaccine is at least the fourth potential candidate in the research pipeline so far. Johnson & Johnson said this week it had identified what it called a promising candidate, and that it would begin human trials by September. Last month, the first human trials of an experimental vaccine developed by Moderna began at the Kaiser Permanente Washington Health Research Institute in Seattle. The German research firm CureVac is developing its own vaccine.
Experts warned that no vaccine is proven to work until it has gone through the rigorous testing process — and in some historical cases, vaccines that have rushed to market have turned out to cause more harm than they solved.
It is not uncommon for multiple research teams to develop their own vaccines for the same disease. Every year, different groups try to come up with a vaccine for influenza that would cover multiple strains.
The Pitt researchers said they believe their methods make them a “front-runner,” in Gambotto’s words, in the current race to develop a vaccine against the coronavirus — but that they would be just as happy if someone else develops a viable vaccine faster.
“It’s a race because of the urgency. We have to race against the virus. If the competition makes it quicker, competition is welcome,” Gambotto said.
https://thehill.com/policy/healthcare/490866-first-peer-reviewed-coronavirus-vaccine-shows-promise-in-mice

Jobs growth comes to screeching halt in March

March nonfarm payrolls: -701K vs. -150K consensus and +275K previous (revised from +273K).

Unemployment rate: 4.4% vs. 3.9% consensus and 3.5% prior.

https://seekingalpha.com/news/3558156-jobs-growth-comes-to-screeching-halt-in-march

March jobs report numbers might appear better than reality

Be prepared for a shock — the employment report for March that’s coming out on Friday may not be as bad as people are expecting.
But don’t misunderstand what I’m saying.
The job market right now is the worst it has been in over a decade. But quirks in how the monthly numbers are derived might make the statistics look a little less atrocious than they really are.
As a point of reference, the “experts” are expecting the US Labor Department to announce that 100,000 jobs were lost in March and that the unemployment rate jumped to 3.8 percent.
That compares with a whopping 273,000 new jobs that were created in February and a jobless rate for that month of just 3.5 percent.
Here are some reasons Friday’s initial figures for March might not be as bad as they could have been.
For one thing, the Labor Department’s surveys of companies and of individuals are done during the week that contains the 12th day of the month. And in March this wasn’t the week all the strictest coronavirus rules went into effect. It also wasn’t the week that the bulk of layoffs and furloughs began.
New claims for unemployment insurance suddenly exploded the week that began on March 16 and ended on the 21st. That’s when new jobless claims spiked to an all-time high of 3.3 million.
So the figures the Labor Department will release on Friday missed the worst of the job losses by a few days. ADP, which does a private survey of jobs, reported a loss of only 27,000 jobs at companies in March because of this timing glitch.
For those of you who like bad news, don’t worry. The figures will catch up to the devastation in the April figures released in early May. And downward revisions to the March numbers will trickle in over the next months and even years.

The true horror of what we are going through won’t be missed by history.
Speaking of history, you have to go back more than 10 years to find a period of employment that is this bad. The last time there was any decline in the monthly job figures was in September 2010 when the economy shed 65,000 jobs. In March 2009, the Labor Department reported an enormous decline of 800,000 jobs.
We could’ve beat that record this time. But because of the quirks I’m telling you about, the job-loss figures might be spread out more evenly over several months.
Here’s another thing: The standard when considering if a job exists isn’t very strict.
If someone is paid for any part of a month — even for one hour — that person is considered to have had a job and the job is considered to have existed.
In our current predicament, lots of people were paid in early March before their salaries were suddenly cut off.
Friday’s report won’t be good news. But it might not be as bad as it could have been.
https://nypost.com/2020/04/01/march-jobs-report-numbers-might-appear-better-than-reality/

Tracking COVID-19 hospital expenses important for federal funding

COVID-19 relief funding for hospitals will be coming through several government sources, so experts recommend that hospitals immediately begin tracking all their expenses and lost revenue.

Hospitals could be eligible for funds through the Federal Emergency Management Agency, several funding streams set up by Congress in the Coronavirus Aid, Relief, and Economic Security Act, state grants and HHS programs. Each of the funding sources can be used for different purposes, have different requirements and are likely to be audited later.

As hospital administrators are already dealing with a mounting crisis, Robert Reeves, a partner at Ernst & Young, recommends that hospitals identify a team to document expenses and lost revenue, identify funding sources, prioritize funding applications, and ensure documentation is in place so funds aren’t clawed back later for being improperly used.

“We really recommend clients after any disaster take a really holistic, enterprise-wide approach to financial recovery,” Reeves told providers on Monday.

Facilities that accurately track COVID-19 surge capacity expenses, staffing costs and policies that led to the cancellation or delay of elective procedures will be better able to back up their funding requests, RSM US healthcare partner Rick Kes said.

“If an organization has more sophistication in defining their costs and lost revenue, they will have a better answer if and when the government calls years from now. We are telling clients to take that part really seriously,” Kes said.

Timeliness is especially important for a $100 billion fund Congress set aside for providers in the CARES Act. Providers would be eligible for reimbursement for both costs and lost revenue due to COVID-19 and the funds will be doled out on a rolling basis. HHS hasn’t released full details about how the funds will be released, but Manatt Health managing director Brenda Pawlak said the application period will likely be “fast and furious” as acute-care hospitals, critical access hospitals, community health centers, long-term care facilities, inpatient rehabilitation facilities, ambulatory surgery centers, behavioral health providers and others could be eligible for assistance.

“Everybody will need to apply quickly, and they need to be prepared and willing to do that,” Pawlak said.

Hospitals are already jockeying to ensure they get most of the funds, and quickly. The American Hospital Association told HHS Tuesday that they want every hospital across the country to directly and immediately get $25,000 per hospital bed, with additional payments for hospitals in COVID-19 hotspots. The baseline funding request alone would cost $23 billion, the group estimated.

The Federation of American Hospitals on Wednesday asked HHS to ensure a “substantial majority” of the funds are allocated to hospitals.

Background materials on the CARES Act released by Senate Democrats said that if providers received reimbursement for the same expenses from two sources, the CARES Act provider grant funds would have to be repaid.

Providers may also be eligible for corporate loans with strings attached including restrictions on executive pay and small-business loans if they have fewer than 500 employees. These loans stem from the CARES Act.

FEMA grant processes will vary state-by-state as not all states have declared emergencies, and funds cannot be used for lost revenue. Only not-for-profit institutions would be eligible.

https://www.modernhealthcare.com/finance/tracking-covid-19-hospital-expenses-important-federal-funding

Home healthcare agency to take COVID-19 referrals from hospitals

The Visiting Nurse Service of New York is accepting COVID-19 referrals from local hospitals. The goal is to offset some of the burden.

The approach comes with challenges, however.

“We want to do everything possible to alleviate the strain on the New York metro area’s hospital system,” said Michael Bernstein, executive vice president and chief administrative officer at VNSNY.

For COVID-19 patients who are stable enough to be discharged after a hospital stay, VNSNY will provide home care for their flulike symptoms and underlying medical conditions such as diabetes and chronic obstructive pulmonary disease. The intent is to free up hospital beds for patients who are in serious condition and need ventilators.

“We are working rapidly to deploy more telehealth and remote patient visits,” Bernstein said. Using virtual services for some routine visits enables more staff members to visit COVID-19 patients’ homes.

The organization spent about $200,000—an unbudgeted expense—to secure additional tablets and equipment for remote patient monitoring, he said. And it’s spending hundreds of thousands of dollars more to buy personal protective equipment.

On top of masks, gowns and gloves, equipment needed to safely care for COVID-19 patients in their home includes disposable thermometers, stethoscopes and blood-pressure cuffs.

VNSNY will keep the equipment at patients’ homes. Kits—which need to be replenished after five visits—also include 13-gallon trash bags for safely removing and disposing of materials.

As an extra precaution, home care visits for COVID-19 patients are being scheduled at the end of the workday.

Aside from home care, VNSNY has begun providing hospice care for patients with the virus.

To help home care agencies better ease the burden hospitals are facing, Bernstein called for the federal government—with the support of state government—to ensure that agencies are using telemedicine to safely take care of other patients while diverting resources for those with the virus.

“It’s critically important for the entire home care industry to be able to provide telehealth services and get fairly reimbursed for it,” he said. The federal Centers for Medicare and Medicaid Services has not ruled that remote patient monitoring is a billable way to provide service.

“Home care is the infantry: We go into the field. We go into people’s homes,” Bernstein said. “As long as we are equipped with the right personal protective equipment, that’s what we can do. And that can help alleviate the strain on the healthcare system.”

https://www.modernhealthcare.com/providers/home-healthcare-agency-take-covid-19-referrals-hospitals

Joint makers report pandemic pain

Sales of implants are set to fall sharply as non-urgent procedures are deferred.

For some medtechs the Covid-19 crisis has spurred demand for services: those that make the tests for coronavirus infections; makers of ventilators necessary to aid patients’ breathing; or telemedicine developers whose technology has taken off at a time when doctors can only see in person the most seriously ill.
Many more device companies, however, are being hit hard. As hospitals fill with the desperately sick, other patients requiring elective surgery are postponing their operations. Orthopaedics groups in particular are suffering. Companies including Stryker and Smith & Nephew withdrew their 2020 revenue guidance this week, conceding that use of their products would fall throughout the year.
In an SEC filing on Tuesday Stryker said it was withdrawing its first-quarter and full-year 2020 sales growth and earnings per share guidance, originally posted at the end of January. The group blamed the “unprecedented” measures that have been enforced by various governments to slow the spread of the virus, including the deferral of elective procedures and restrictions on social contact.
Joint deconstruction
Stryker will likely see the greatest effect on its hip and knee implants and endoscopy products, since the procedures these are used for are relatively easy to defer by a few months.
These products made up around a third of its total sales last year. Its trauma, extremities and spine businesses will be less severely affected since these are more often used in emergency surgeries, and the same goes for its neurovascular devices that are used to treat strokes.
The pandemic might also hit another aspect of the group’s business: its $5.4bn takeover of Wright Medical, currently slated to close in the second half (A Covid-19 threat to business acquisitions, 3 April 2020). The SEC filing does not mention the acquisition, so perhaps Stryker thinks the deal will conclude on schedule. Most of Wright’s sales come from devices to treat extremities – upper extremities such as shoulders in particular – so it could be affected slightly less than Stryker itself.

The top five joint reconstruction companies
	Annual sales ($bn)
Company	2019e	2024e	CAGR
Zimmer Biomet	5.0	5.9	+3%
Johnson & Johnson	3.3	3.8	+3%
Stryker	2.8	3.3	+3%
Smith & Nephew	1.7	2.1	+3%
Wright Medical Group	0.8	1.3	+9%
Source: EvaluateMedTech.

In fairness to Smith & Nephew, when it announced its 2020 outlook in February it did so with the proviso that the Covid-19 “situation normalises early in Q2”. This now being impossible, the group says that in China elective procedures have restarted,but remain considerably below pre-outbreak levels. In Europe and the US, though, all but the most urgent surgical procedures have been halted.
The UK group now expects underlying revenue growth for the first quarter to be around 8% down year on year, and its second-quarter sales and first-half trading margin will be “substantially down”.
Exposure 
The makeup of S&N’s business makes it far more exposed than Stryker; almost all its products are used predominantly in non-urgent procedures. Joint reconstruction devices made up about a third of S&N’s sales last year and endoscopy another third; its other main business, wound care, accounted for a quarter of revenues. Some of its wound care products will be used for injuries requiring immediate treatment but many are used to treat wounds resulting from joint arthroplasties – which are not now happening.
A contract with the UK government to build a new kind of ventilator specifically designed to allow large-scale production is good news, but will fall far short of making up for its orthopaedics losses. The OxVent device is under review by the UK’s MHRA; if approved, it will be made at S&N’s advanced wound management facility in Hull, UK.
Other orthopaedics companies rowing back their guidance include Conformis, which has furloughed around a third of its employees, stating that demand for arthroplasty has dropped significantly. Another tiny firm, Orthopediatrics, has withdrawn its guidance too. Intriguingly Othopediatrics has decided that this is a good time for M&A: yesterday it bought Apifix, which makes a device to treat young people with scoliosis, for $39m in cash and stock.
The effects of the pandemic on device sales will be felt in all sectors. Boston Scientific, mainly a cardiology company, and the patient monitoring specialist Masimo, have already abandoned prior guidance. Many more medtechs will have to do the same in the days to come.

Medtechs that have withdrawn guidance
Date guidance withdrawn	Company	Sector	Former guidance for 2020 revenues	Former guidance for organic growth
April 1	Masimo	Patient monitoring	$1.035bn	11 – 11.4%
March 31	Stryker	Orthopaedics; endoscopy; surgery; neurology	–	6.5 – 7.5%
March 30	Smith & Nephew	Orthopaedics	–	3.5 – 4.5%
March 30	Boston Scientific	Cardiology; endoscopy; neurology; respiratory; urology	–	6.5 – 8.5%
March 30	Orthopediatrics	Orthopaedics	–	22 – 24%
March 23	Conformis	Orthopaedics	–	3 – 6%
March 19	Exact Sciences	In vitro diagnostics	$1.61 – 1.65bn	–
Source: company communications, SEC.

https://www.evaluate.com/vantage/articles/analysis/spotlight/joint-makers-report-pandemic-pain

Cognitive Decline and Poor Glycemic Control Go Hand-in-Hand

Poorer glycemic control was tied to cognitive decline following a lacunar stroke in a prospective cohort study.
Among 942 individuals with type 2 diabetes who had a lacunar stroke, every 1% higher HbA1c was tied to a 0.06 drop in cognitive function at baseline measured by Cognitive Assessment Screening Instrument (CASI) z-score (95% CI -0.101 to -0.018), reported Tali Cukierman-Yaffe, MD, MSc, of Sheba Medical Center and the Sackler School of Medicine of Tel Aviv University in Israel.

This relationship was significant even after adjusting for demographic factors and clinical factors such as depression, hypertension, hyperlipidemia, body mass index, cardiovascular disease, obstructive sleep apnea, diabetic retinopathy, nephropathy, insulin use, and white matter abnormalities.
And those who started with higher average HbA1c levels at baseline tended to have lower cognitive functioning scores over time (P for interaction=0.037), Cukierman-Yaffe noted in her presentation at the virtual ENDO 2020 meeting sponsored by The Endocrine Society.
This association wasn’t stagnant either, as a 1% increase in HbA1c during follow-up was tied to a decrease in Cognitive Abilities Screening Instrument (CASI) score by approximately 0.021 points (95% CI -0.0043 to -0.038) over time.
This relationship between higher glucose levels and poorer cognitive functioning extended beyond just CASI z-score, as well, Cukierman-Yaffe noted. Higher HbA1c levels were also tied to significantly poorer performance in other psychological tests, including the clock making test of executive functioning, test of discriminative ability, and for the test of verbal fluency.

The prospective cohort analysis drew upon data from the individuals who participated in the Secondary Prevention of Small Subcortical Strokes (SPS3) trial. This included adults over the age of 30 — mean age of 63 — with an existing diagnosis of type 2 diabetes and a recent, symptomatic MRI-defined small subcortical ischemic stroke. These individuals had no evidence of cortical strokes, nor any evidence of severe cognitive functional impairment.
Many possible explanations could be underlying these significant associations seen in this study, she explained, also pointing out that this relationship is likely bidirectional.
“It may be that individuals with cognitive impairment have difficulty managing their [diabetes] disease, and thus have worse glucose control,” she stated, adding that “second, hyperglycemia may accelerate the rate of cognitive decline by either reducing capillary reperfusion or accelerating large vessel disease, or directly damaging the brain.”
But nonetheless, further research is needed to delve into these associations, she suggested. Future studies are not only needed to confirm these results, but also intervention studies should be done to delineate whether better glucose control could possibly slow the rate of cognitive declines in high-risk populations, such as this one.

In the meantime, Cukierman-Yaffe told MedPage Today that healthcare providers should be evaluating older patients with diabetes for cognitive decline, according to current guidelines from the American Diabetes Association, The Endocrine Society, and several more international societies.
“Cognitive assessment should be part of the routine check-up of older people with diabetes,” she said, noting that this is particularly important for two reasons: the relationship between cognitive dysfunction and self-care, and the fact that cognitive dysfunction is another one of many possible complications of diabetes posing a larger threat to older patients.

Disclosures

The study was supported by a grant from the National Institutes of Health.
Cukierman-Yaffe reported relationships with Sanofi, AstraZeneca, MSD, Lilly, and Medtronic.

Primary Source

Endocrine Society

Source Reference: Cukierman-Yaffe T, et al “The Relationship Between Glucose Control & Cognitive Function in People with Diabetes After a Lacunar Stroke” ENDO 2020; Abstract MON-636.

https://www.medpagetoday.com/meetingcoverage/endo/85768