Another Cuomo Cover-Up

 At last, Joe Biden, Anthony Fauci and CNN are no longer presenting New York Democrat Andrew Cuomo as the model governor in pandemic response. The question now is how many lives were lost due to his reckless policy of forcing vulnerable populations to accept greater risk of infection—and then hiding the results. Nursing homes were not the only places forced to accept Covid-positive patients.

Maria McFadden Maffucci writes at National Review: “Cuomo’s edicts put another vulnerable population in inexcusable peril: New Yorkers with intellectual and developmental disabilities (IDD) living in group homes.” Ms. Maffucci writes:

You know that notorious March 25 order, sending contagious nursing-home patients back to their homes from hospitals? Well, it had a twin. An April 10 memo from the Office of People with Developmental Disabilities (OPWDD) to operators of certified residential facilities had identical language to the nursing-home memo, to wit: “No individual shall be denied re-admission or admission to a Certified Residential Facility based solely on a confirmed or suspected diagnosis of Covid-19. . . . Additionally, providers of Certified Residential Facilities are prohibited from requiring a hospitalized individual, who is determined medically stable, to be tested for [Covid-19] prior to admission or readmission.”

Guess how that worked out for disabled New Yorkers. As is Cuomo custom, the state government withheld crucial information from public disclosure. Therefore scientists and policy makers had to try to make sense of limited data. Ms. Maffucci says that researchers often had to rely on voluntary reporting from advocacy organizations.

The available data told another highly disturbing story. Last year a study in Disability and Health Journal titled “COVID-19 outcomes among people with intellectual and developmental disabilities living in residential homes in New York state” reported some dismal statistics:

People with IDD living in residential group homes were at greater risk of severe COVID-19 outcomes: case rates – 7,841 per 100,000 for people with IDD compared to 1,910 for New York State; case-fatality – 15.0% for people with IDD compared to 7.9% for New York State; and mortality rate – 1,175 per 100,000 for people with IDD compared to 151 per 100,000 for New York State.

If the Cuomo government ever allows a full accounting, perhaps researchers can estimate the precise impact of the directive to facilities on accepting Covid-positive patients.

The overall policy may live forever in the annals of bureaucratic cruelty. At the same time the Cuomo administration was turning down offers to expand treatment space for Covid patients—and instead forcing them into group homes, raising the risks for disabled residents there—Team Cuomo was also severely limiting family visits at such facilities. In other words, official Cuomo administration policy required people with disabilities to accept both greater risk of infection by strangers and less time with relatives. Last July James Bernstein wrote in Long Island’s Long Beach Herald:

On Father’s Day this year, Dan Mulvaney used his [iPad] to tap out a note to his mother in Long Beach: “How long until I’m free...unfair...I’m ok. Ask state. So tired of lockdown...make change for all.”

...Mulvaney is autistic, and lives with three others in a group home in Baldwin. Since the coronavirus pandemic, he and all the others in homes for the developmentally-disabled on Long Island and across the state, have been living under strong restrictions, their relatives say.

Only since Father’s Day weekend have the group home residents been allowed to receive visitors, for 30 minutes only... Before, no visits were allowed, and the residents were permitted outside only in the company of an aide, for a walk down the block.

The added bureaucratic insanity of this situation was that Mr. Mulvaney had already been infected and had already recovered from Covid. Yet state policy was still restricting his mobility and ability to see loved ones. Of course he was not the only one forced to endure a terrible isolation. The Herald’s Mr. Bernstein reported on another family:

... all Lloyd Groveman of Old Westbury knows is that the restrictions have been hard on his son, Jack, 18, who is autistic and lives in a group home In Lido Beach.

“He doesn’t understand the concept” of the restrictions, Groveman said. “It is cruel and unusual circumstances.” Groveman said that in the months of the pandemic, he has been able to see his son only twice. When he did see his son, Groveman said, “He would run to the window. He was happy to see us. He wants to leave” the house.

Ms. Maffucci notes that during that same month the Cuomo administration finally issued less restrictive rules. But the resistance to public disclosure continued.

“Why Such Secrecy?,” asked a headline in the Albany Times-Union in November. The newspaper editorialized:

Last week, an advocacy group, Disability Rights New York, filed suit to get long-delayed information from the Office of People with Developmental Disabilities on how many group home residents and staff have been infected with or died from the virus -- a delay the group said hampers the ability to minimize the risk of infection in a vulnerable population and assess the state’s efforts to protect it.

At a time when residents and businesses are being called to a common fight to slow the coronavirus’ spread, the state’s selective secrecy only feeds and validates the speculation that there are things the Cuomo administration is purposely trying to hide -- in particular, that it’s not necessarily living up to its tough standards for employers and high-minded talk of a shared burden.

When will a tough standard be applied to Mr. Cuomo, who imposed some of the country’s most dangerous burdens and then prevented the public from learning about the resulting destruction?

https://www.wsj.com/articles/another-cuomo-cover-up-11614029575

Rare Diseases Have Significant Economic Impact Each Year in US

 The National Economic Burden of Rare Disease Study conducted on behalf of the EveryLife Foundation for Rare Diseases took a first-of-its-kind look at the economic burden of rare diseases in the United States for the year 2019.

Because the study only examined the financial costs of 379 rare diseases, Annie Kennedy, Chief of Policy and Advocacy at EveryLife Foundation said the research is “only the tip of the iceberg” of the overall economic burden in the rare disease community. In an interview with BioBuzz ahead of the study’s release, Kennedy said it was critical to establish the hard data in order to ensure the conversation can move from “anecdotal evidence to what the actual economic cost of rare disease is.”

The study includes both direct medical costs, as well as indirect costs that affect the families of these patients. Of that $966 billion, $418 billion (43%) was in direct medical costs, while $548 billion (57%) was in indirect costs, the study shows. Direct medical costs include inpatient and outpatient services and prescription medications, while indirect medical costs include employee absenteeism, forced retirement, and healthcare services not covered by insurance.

Kennedy said it was important for this study to show the indirect costs since so many of these are silently borne by the families of the patients. Prior to the study, Kennedy, a longtime advocate for the rare disease community, said they were not surprised the indirect economic burden was higher than the direct costs of rare diseases.

“For families, these are costs that accumulate. This is a one-year snapshot and it doesn’t show the whole picture of living with rare disease,” Kennedy said. “There’s so much more to this story.”

The survey shows that on average, the per-person excess direct medical cost of rare disease is $26,887 more than that for comparison individuals without a rare disease. The average annual direct medical excess cost for a child with a rare disease is $32,037, $29,647 for working-age adults with a rare disease, and $21,772 for rare disease patients age 65 and older.

The highest per-person excess medical cost is for “Lysosomal storage diseases” regardless of the age group. The study shows the cost breakdown at $132,757 for children and $54,996 for adults. The second most expensive rare disease group among children based on per-person excess costs is “Other endocrine or metabolic disorders,” which has an average excess medical cost of $72,285. Among adults, the second most expensive group is “Diseases of the blood and blood-forming organs,” which has an average cost of $52,201.

The estimated total indirect and non-medical cost of rare disease was $548 billion in 2019, with $343 billion to persons with rare diseases and another $205 billion to unpaid caregivers.

To create the study, EveryLife Foundation, a rare disease policy organization based in Washington, D.C., had more than 100 patient organizations work with them to identify data points to collect. The organization conducted a survey of rare disease families and received a response from 3,484 households. Of those, 1,409 (40.4%) completed the survey.

Of those 39 respondents were not included because the name of the disease entered was not considered a rare disease, which is defined by the Orphan Drug Act of 1983 as a condition that affects fewer than 200,000 people in the U.S. The diseases included in the new report include some of the more prevalent rare diseases, such as cystic fibrosis and hemophilia, but also included ultra-rare diseases, Kennedy said.

The National Institutes of Health estimates there are between 25 million and 30 million Americans living with a rare disease. Although it is expected there are about 7,000 rare diseases, only a few in the U.S. are actually tracked with International Classification of Diseases (ICD) codes.

That lack of ICD codes is a significant issue Kennedy and the rare disease community hope to address. Currently, only about 500 rare diseases have such codes. That lack of codes for the other 6,500 rare diseases makes diagnostics, access to care, and therapeutics difficult, Kennedy said.

On Thursday, Kennedy and her team released the data during a high-level presentation with the Rare Disease Caucus in the U.S. House of Representatives. Ahead of the meeting, she said she planned to go into detail about the economic burdens in hopes of incentivizing biomedical investment from the U.S. government, particularly the NIH and the U.S. Food and Drug Administration.

“We really need to begin to drive funding and policy to better align with the public health impact of rare disease,” Kennedy said. “The funding prioritization for rare disease does not meet what’s going on with pharma, the NIH, the FDA and others.”

Although the rare disease community in the U.S. has traditionally enjoyed bipartisan support from Congress, Kennedy said she hopes this economic data impact study will spur more support for the community. Next week, rare disease advocates from across the country, armed with the economic impact data, will meet with members of Congress in hopes of appropriating the authorization for the appropriate funding levels needed in rare disease. Kennedy said the 2019 economic snapshot will serve as a springboard for the community.

“We’re only getting started,” she said.

https://biobuzz.io/rare-diseases-have-significant-economic-impact-each-year-in-the-united-states/

Covid Toll at NY Psych Facilities Stays Disproportionately High

 

Kingsboro Psychiatric Center (photo: New York State Office of Mental Health)

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One-fifth of patients in state-run inpatient psychiatric centers have contracted COVID-19 since the outbreak began last March, and 58 out of a total 8,200 individuals admitted to those institutions have died, according to new data provided by the New York State Office of Mental Health (OMH) after a Gotham Gazette inquiry. The facilities embody one of several types of congregate living settings where residents are more vulnerable to the virus, and while they have smaller populations and receive less attention than other congregate settings, the latest data shows the state’s psychiatric facilities have also been home to dire outcomes.

Like much the rest of the state, psychiatric centers were caught off-guard at the outset of the pandemic last spring. Infection was rampant and the death toll rose quickly, with more than a third taking place over the course of a week in April. Reports from people living and working in the facilities painted a picture of chaos and grief as facilities struggled to contain the virus.

While the number of deaths per capita in psychiatric hospitals is dwarfed by nursing home resident deaths, which account for close to a third of the 46,600 statewide fatalities thus far, it far exceeds the rate in state prisons, where advocates have raised alarms about covid-related conditions. Little public and government attention has been paid to how covid is impacting residents and staff of state psychiatric facilities. The latest data raises new questions about the vulnerability of New Yorkers with the most severe mental illnesses and the care the state is providing them in its 23 psychiatric centers.

Between March 2020 and February 10 this year, 58 patients died of COVID-19 either in psychiatric centers operated by OMH or in medical hospitals after being transferred, according to OMH. That amounts to .7 percent of the 8,172 total individuals admitted to inpatient psychiatric facilities or on-campus supportive residences at some point in the previous 11 months. The OMH census on February 10 was 4,455.

The fatality rate, although less than 1%, is at least a factor of ten greater than the per capita death rate among people incarcerated in state prisons. That is based on the prison census, which varied between 44,200 in January 2020 and 32,600 in February 2021, out of which 32 incarcerated people have been killed by the virus, according to the Department of Correction and Community Supervision (DOCCS).

Nearly 1,700 psychiatric patients and residents have contracted the virus -- 846 presumed and 838 confirmed through testing -- since March, a full one-fifth (21%) of the total patient population. With roughly 5,800 recorded positive cases among DOCCS inmates as of late February, the per capita inmate infection rate is somewhere between 13 and 18%. (OMH began a broad-scale testing regime in inpatient facilities last summer, which means more asymptomatic cases were likely discovered.)

OMH would not provide information on which facilities the deaths of psychiatric patients occurred in and when they took place, limiting the assessment that can be done of both the vulnerability of long-term psychiatric patients and the performance of OMH in protecting them.

Both prisons and psychiatric facilities are state-run congregate living settings where residency is largely involuntary -- formally so in prisons and functionally so, at least in an immediate sense, in psychiatric facilities. Both contain diverse populations in terms of age, race, and geography, and both are part of a larger system of individual state trusteeship. A year into the pandemic, a lack of public data about total infections among nursing homes residents, the total number of incarcerated individuals who passed through state prisons since March 2020, per capita covid rates in homeless shelters, and a more granular breakdown of death and infection rates in psychiatric facilities makes further comparisons difficult.

A number of factors could influence the larger death and infection rates in psychiatric facilities, but it largely comes down to two: demographic differences between inpatient and incarcerated populations, and differences in the OMH and DOCCS settings that could impact a person's risk of contracting or dying from the disease: social distancing practices, sanitation, and the quality of health care provided.

"You are comparing a prison setting, where movement is restricted, to hospital and residential settings which do not have the same restrictions," wrote OMH Director of Public Information James Plastiras in an email to Gotham Gazette, when asked about the higher per capita rates in state psychiatric facilities.

"Additionally, our patients are more likely to be medically compromised with underlying conditions. They are also on average much older," Plastiras said, calling the comparison to prisons "misleading."

Age has been one of the most salient factors contributing to COVID-19 deaths, and death rates in both OMH and DOCCS facilities pale in comparison to the number of nursing home residents who have died.

The average age of psychiatric "inpatient adult clients" is 51 years old, according to Plastiras, and 41 of the 58 deaths were of patients over 65. According to a spokesperson for DOCCS the average age of state prison inmates in December was 40.5 years old.

Psychiatric patients, who are admitted for severe mental health issues from depression to schizophrenia, tend to have more co-occurring health conditions than the general population and for that reason may be more susceptible to the coronavirus.

"If you are living with schizophrenia and you're going to the doctor and you're not as able to explain exactly what's going on with you physically, it's probably very difficult for that practitioner to treat you," said Wendy Burch, executive director of the the state chapter of the National Alliance on Mental Illness, in a phone interview. "And as we know, when it comes to covid, anyone with these underlying conditions are more susceptible to having a more severe case."

"Mental health patients may not always be able to wear a mask or follow other COVID safety protocols," wrote Rob Merrill, a spokesperson for the Public Employees Federation, which represents psychiatric staff, in an email to Gotham Gazette. "OMH has stated that they cannot force patients to wear a mask, whereas DOCCS has more control over rule enforcement in a facility."

Studies have found adults with mental health disorders are at higher risk for COVID-19 infection and are more likely to have worse outcomes as a result. One recent study from NIH’s National Institute on Drug Abuse found adults with recent diagnoses of depression are at greatest risk of infection among the populations surveyed, followed by schizophrenia. Within those groups the outcomes tend to be more severe for African-Americans and women. According to the CDC, smoking, another risk factor for poor COVID-19 outcomes, is more common among people with mental illness.

But it is unclear the extent to which disparate infection and death rates from prisons are the result of comorbidities and age and to what extent they are influenced by the operations in OMH psychiatric centers. In terms of infections, specifically, the disparity may also be a reflection of the widespread testing that OMH undertook in its facilities last year.

OMH's Covid Response
As Gotham Gazette first reported last spring, the state's 23 psychiatric centers were ravaged by the virus at the peak of the outbreak last March and April, with 10 confirmed deaths in mid-April rising to 30, with another 7 suspected deaths, a week later. Doctors, nurses, patients, and the lawyers assigned to represent them described harrowing conditions in facilities, with close-quarter living, communal dining, limited personal protective equipment, and staff and residents struggling to maintain basic levels of disinfection.

Psychiatric centers across the state, but particularly in upstate facilities, experienced an uptick in covid cases at the end of the year, which have since fallen, according to multiple sources with knowledge of facilities. Without information on where and when the deaths occurred, which OMH would not provide, it is difficult to tell how the agency has fared in controlling the spread of the virus and whether it faced a second outbreak crisis this fall and winter or if cases were more spread out.

Union officials have criticized the agency for a lack of transparency around psychiatric hospitals. "From the start of the COVID-19 pandemic, New York State has been largely uncooperative about providing PEF with infection rates among patient and staff populations at in-patient facilities," Merrill wrote. "We have repeatedly asked for data to track trends and make recommendations about control measures, but we have not received it."

Psychiatric hospital residents and staff became eligible for vaccination early on, unlike the majority of prison and jail populations, which are still ineligible.

In December, the state began opening vaccines to psychiatric center patients and staff, which may account for a recent dip in positive cases. By February 23, roughly 3,140 patients had received a first dose of the vaccine, with 2,650 having received both doses, according to OMH. "As of February 20, we are now down to 13 active cases among our current census of 4462," Plastiras wrote to Gotham Gazette, down from 22 cases on February 10. "These numbers highlight the excellent job our facilities have done managing COVID cases and reducing the risk of exposure to the virus."

Roughly 7,000 of the 12,7000 employees at inpatient and residential psychiatric facilities had received their first shot by February 10, of which about 5,700 had received both shots, according to OMH.

"On a positive note, OMH ramped up a broad-based testing program fairly quickly and has administered the vaccine to staff," Merrill of PEF wrote. "They now have ample PPE and a reserve stockpile."

Most people in prison are still ineligible to receive vaccines. On February 5, the state opened eligibility to inmates over 65 and as of February 24 "more than 6,750 vaccinations have been administered," wrote Thomas Mailey, a DOCCS spokesperson, in an email. "We expect to complete the first vaccines for all interested staff and incarcerated individuals 65+ by the end of the week."

Lacking Oversight
OMH would not say directly what metrics or tools the agency uses to evaluate outbreaks in its inpatient and residential facilities, which would provide insight into how officials view the problem and whether deaths could have been avoided.

Based on accounts from multiple sources, there appears to be wide variability in covid response among the psychiatric centers around the state. Lawyers and staff who work with patients expressed a feeling that the approach of staff on the ground, rather than a centralized methodology from OMH, made the difference in the severity of outbreaks in individual facilities.

"Even though its required to mask in a hospital," in some facilities, particularly upstate and in OMH's corrections-based operations, "they take minimal to no precautions," said Darlene Williams, an occupational therapist at New York State Psychiatric Institute in Washington Heights and a regional PEF coordinator, in a recent interview.

Unlike state prisons and nursing homes, there have been no oversight hearings around state psychiatric facilities in either of the State Legislature's mental health committees, and little attention anywhere else.

"I haven't been in any of the psychiatric facilities but...I'm sure they have utilized infection control practices in those places because we would have heard it on the news about transmissions within a facility and I have yet to hear it," said Assembly Member Aileen Gunther, who chairs the chamber's mental health committee, in an interview with Gotham Gazette. "I've heard some in some of the prisons but I really haven't heard anything and no one has contacted me about increased transmission of covid from the outside-in."

"There is always oversight. They have reporting mechanisms but I have not heard of anything about an increased rate of covid," Gunther added.

When presented with the latest figures on death and infection rates, Gunther said: "Not good. Not good. I haven't received that report myself."

"I don't know about the infection control practices in there but overall any death is tragic," she added.

https://www.gothamgazette.com/state/10207-covid-new-york-state-psychiatric-facilities-disproportionately-high

Astrazeneca has sold its stake in Moderna for more than $1B

 AstraZeneca Plc has sold its stake in Moderna Inc for more than $1 billion after the American biotechnology company’s shares soared on the back of its coronavirus vaccine breakthrough, The Times reported.

The report added that it was not clear when and over what period AstraZeneca sold its full holding in Moderna.

https://www.reuters.com/article/us-astrazeneca-moderna-stake/astrazeneca-has-sold-its-stake-in-moderna-for-more-than-1-billion-the-times-idUSKCN2AS0RO

U.S. expects first shipments of J&J vaccine to be delivered Tuesday

 Initial deliveries of the newly approved Johnson & Johnson COVID-19 vaccine should start on Tuesday, helping to boost vaccination rates across the country, senior administration officials said on Sunday.

The officials acknowledged that vaccination rates among minorities were “not where we ultimately want them to be”, but said federal officials were closely monitoring distribution to ensure it was equitable.

They urged everyone in the United States to get a vaccination as soon as it was their turn, and said Black and brown Americans should understand that safeguards had been put in place after past cases of discrimination in the medical field.

https://www.reuters.com/article/us-health-coronavirus-vaccine-usa/u-s-expects-first-shipments-of-jj-vaccine-to-be-delivered-tuesday-idUSKCN2AS0SE

Sarepta FDA OK for another Duchenne drug may lift sales post-earnings

 

• Sarepta Therapeutics announced Thursday that another one of its medicines for a rare muscular illness has received approval from the Food and Drug Administration.
• The medicine, which will be sold as Amondys 45, is now cleared for use in patients with Duchenne muscular dystrophy who have specific mutations in the gene responsible for making dystrophin, a key muscle-building protein. Sarepta estimates 8% of Duchenne patients have mutations in exon 45, the part of the gene targeted by Amondys 45.
• Like its two other approved products, Sarepta's latest offering is priced by weight, with treatment for a 20 kilogram child costing $300,000 per year. The addition of Amondys 45 means there are now medicines available to treat about 30% of Duchenne patients, according to data from CureDuchenne, a patient advocacy group sponsored in part by drugmakers like Sarept

The FDA's review for Amondys 45 was relatively quiet compared to Sarepta's two earlier products, known as Exondys 51 and Vyondys 53.

Exondys 51, in particular, stands as one of the most controversial approval decisions in the agency's recent history. Clinical testing showed the drug provided small increases in dystrophin, while leaving its purported benefits on patients' lives unclear. Several high-ranking officials within the FDA pushed for its rejection. But they were overruled by Janet Woodcock, the longtime head of the agency's drug review division and, currently, its acting commissioner.

Woodcock's decision not only cleared the path for Exondys 51, which became the first marketed drug specifically for Duchenne in 2016, but also set a precedent for subsequent medicines that work similarly.

Vyondys 53 followed, securing approval in 2019 after testing demonstrated similarly modest effects on dystrophin levels. That review also proved dramatic, as the FDA initially rejected Vyondys 53 because of safety concerns, only to about-face four months later. The agency then cleared Viltepso, a competing drug from Japan's NS Pharma, one year later.

Amondys 45 appeared to simulate more dystrophin production than Exondys 51 and nearly as much as Vyondys 53 had in their respective clinical trials. In testing, patients' dystrophin levels went from less than 1% at the start to about 2% after treatment with Amondys 45.

But it's still unclear, as with Sarepta's other drugs, whether Amondys 45 improves patients' health outcomes. The FDA notes that while dystrophin production is "reasonably likely" to predict a clinical benefit like improved motor function, research has yet to prove Amondys 45 does so. A placebo-controlled, confirmatory trial known as ESSENCE is ongoing, but won't produce results until 2024.

Each of Sarepta's drugs is supposed to bind to the gene that encodes for dystrophin, but only at specific points that have been altered because of mutations. For Amondys, that point is exon 45. For the other two drugs, it's exons 51 and 53, respectively. CureDuchenne estimates that 13% of patients are eligible for exon 51-skipping therapies, while exon 53- and 45-skipping therapies could each treat another 8% of the population.

Exondys 51 and Vyondys 53 helped to support Sarepta as the company built a lengthy list of drug programs, many of which focus on gene therapy research. Over the first nine months of 2020, Sarepta recorded $333 million in net product sales, a nearly 20% year-over-year increase, but posted a $365 million net loss. The company is scheduled to deliver its full 2020 earnings report next week.

Amondys 45 could lift Sarepta sales even further. Piper Sandler analyst Tyler Van Buren, for instance, expects the drug to bring in roughly $300 million in sales by 2025.

Yet the drug's approval also comes at a potentially challenging time for the company. The August approval of Viltepso provided the first direct source of competition to a Sarepta drug. And more recently, Sarepta's high-profile gene therapy program hit a major setback when treatment failed to significantly improve motor function in Duchenne patients.

The disappointing outcome was made all the more stinging as, the very same day, Pfizer disclosed that the first patient had been dosed in a large study of its competing Duchenne gene therapy. Sarepta shares fell more than 50% on the news, erasing about $6.5 billion from the company's market value.

Following the Amondys 45 approval announcement, Sarepta stock was up a little more than 1% at market's close Thursday, to trade a $85.25.

https://www.biopharmadive.com/news/sarepta-amondys-45-approved-fda-duchenne/595754/

2 Most Important Things to Look for in Novavax's Earnings

I'll be looking at Novavax's (NASDAQ:NVAX) earnings report on March 1. But my focus won't be on the financial aspects. Novavax doesn't have products on the market yet, which means the biotech company is yet to report an annual profit. At the same time, research and development expenses have generally increased throughout the years as programs advance through the pipeline. I don't expect a different story for 2020.

But what Novavax has to say in this report may change the story for 2021. That's because the company's coronavirus vaccine candidate is approaching the finish line. Novavax recently reported U.K. phase 3 trial results and just completed enrollment in a U.S. phase 3 trial. Possible regulatory authorizations sit on the horizon. Considering all of this, here are two key items to watch for when you read through Novavax's earnings report next week.

1. Potential timing of authorizations

Earlier this month, Novavax said regulatory agencies in the U.S., U.K., Europe, and Canada have begun the rolling review process. That means the agencies have started looking at Novavax's trial data so far -- and Novavax will submit additional results as they become available. Regulators can get a head start rather than waiting until all trials are complete to begin considering a potential product. And this speeds up the review process.

In the meantime, these agencies could decide to offer the investigational vaccine emergency authorization. So far, Novavax hasn't specifically spoken of the potential timing of such authorizations. But CEO Stanley Erck has said he's hoping the U.S. Food and Drug Administration (FDA) may consider the U.K. trial data as a basis for its Emergency Use Authorization (EUA). That would be instead of waiting for the U.S. trial results later next month. I'll be looking to see if Novavax speaks in more detail about this possibility during the earnings report.

And any other details about authorization timing are welcome, too. They would offer us clues about when to expect product launch -- and revenue.

2. Progress on a booster shot

Novavax is working on a solution to the problem of new coronavirus strains. In January, the company started studying a potential booster or combination vaccine to handle new strains. Novavax said earlier this month that it would choose candidates "in the coming days." The company plans to start clinical studies of a potential candidate in the second quarter. It's very possible Novavax will present us with more news on this project during its earnings report.

Here's why this element is so important: Today, new coronavirus strains present one of the biggest challenges for vaccine makers. Pfizer (NYSE:PFE) and Moderna (NASDAQ:MRNA) brought their vaccines to market under EUAs in December -- before the strains became prevalent. Since, in vitro tests have shown their vaccines work against the latest variants. But experts -- such as White House health advisor Dr. Anthony Fauci -- have said efficacy is lower when faced with these new strains.

The company that produces a vaccine or booster that effectively conquers new strains is sure to gain market share. Pfizer and Modera technically "won" the coronavirus vaccine race by finishing first and second, respectively. But Novavax could be the winner of the next stage of this race if its booster or combined vaccine is successful. Moderna, too, is investigating a booster to address new strains. It will be important to watch both companies as the programs move forward.

Any details regarding Novavax's coronavirus vaccine candidate are worth your attention during the upcoming earnings report. But the above two are crucial as they will determine when Novavax will start generating revenue and its chances of gaining a large share of the vaccine market. And all of this will define Novavax's next annual earnings report -- and its share price performance ahead.

https://www.fool.com/investing/2021/02/24/here-are-the-2-most-important-things-to-look-for-i/

Are Short-Sellers Right About Inovio?

 Inovio Pharmaceuticals (NASDAQ:INO) started the coronavirus vaccine race on the right foot. Investors cheered last spring when the company became one of the first to bring a coronavirus vaccine candidate into human trials. And then Inovio lost steam. Some investors were disappointed by a lack of detail in the phase 1 clinical trial report. Later in the year, the U.S. Food and Drug Administration (FDA) placed a partial clinical hold on its phase 2/3 trial.

Inovio is no longer a leader from a timeline perspective. Pfizer (NYSE:PFE) and Moderna (NASDAQ:MRNA) have brought vaccines to market. And Johnson & Johnson (NYSE:JNJ) and Novavax (NASDAQ:NVAX) are requesting regulatory authorization. Meanwhile, short-sellers are betting that shares of Inovio -- up more than 56% since the start of the year -- are going to fall. Are they right?

Let's take a look at the timeline first. Inovio launched its phase 2 study in early December 2020. At that time, the FDA lifted the partial clinical hold on phase 2 but maintained it on the phase 3 portion of the trial.

The FDA originally initiated a partial hold because it had questions about the phase 2/3 study and Inovio's administration device, which is called Cellectra. The handheld device uses electrical pulses to deliver Inovio's vaccine candidate into skin cells. Inovio has said it will answer all of the FDA's questions during the phase 2 portion of the trial. The FDA has 30 days to issue a response from that point. Even if both parties make an effort here, the big risk is that the hold will delay the start of phase 3.

Inovio hasn't provided an update. But we may expect more news when the company reports earnings on March 1.

Now, let's turn to the data. In December, Inovio said it had published phase 1 data in The Lancet's EClinicalMedicine journal. Investors' earlier concern had been a lack of detail regarding the production of neutralizing antibodies. In the report, Inovio said 84% of participants given the higher dose used in the trial developed neutralizing antibodies. On this metric, Inovio still lags behind rivals like Moderna and Pfizer. Those vaccines produced neutralizing antibodies in all participants. And antibody levels were higher than those of recovered coronavirus patients.

On a brighter note, Inovio reported T-cell responses in 100% of volunteers in the higher dose group. T-cells, known for killing infected cells, recognized various parts of the spike protein. The spike protein is what the coronavirus uses to infect healthy cells. Safety data was another positive. Inovio reported no serious adverse events.

Inovio versus rivals

At this point, Inovio's results don't look as strong as those of its more advanced competitors. Inovio is lagging behind from a timeline and data perspective. But new data could still save the day, in two ways: If the T-cell responses prove to be as important as neutralizing antibody levels, and if the vaccine can handle new strains. Phase 2 information should offer us a clearer picture.

Finally, one other feature may help bring Inovio's vaccine to the forefront. It may be kept at room temperature for more than a year. This is a big plus when it comes to storage and transportation. By comparison, Pfizer's vaccine must be kept at freezing temperatures and Moderna's requires refrigeration.

The ride has been bumpy for Inovio so far. And risk remains high. But if the FDA lifts the partial clinical hold and phase 2/3 data are strong, Inovio still may have a chance to carve out a spot in the coronavirus vaccine market.

So, what are the short-sellers saying? Short positions make up about 21% of Inovio's float. That's a decent percentage of investors betting on the stock's decline. But that's actually down from a peak of nearly 36% a few months ago. (In short selling, investors borrow shares to sell at the market price. They then must buy them back later -- hopefully at a lower price -- to return to the original lender.)

INO PERCENT OF FLOAT SHORT DATA BY YCHARTS

Investors may be regaining confidence in Inovio. Ultimately, though, short-sellers won't determine what happens with Inovio's stock. The clinical trial results will. Until Inovio reports more data, it's best to be cautious. But, considering the positive points I mentioned above, we might do so with a bit more optimism than several months ago.

https://www.fool.com/investing/2021/02/21/are-short-sellers-right-about-inovio/

Healthcare Technology's Digital Dilemma

 In the space of 1 year, the healthcare sector has undergone a veritable transformation in how care is delivered. The impetus for such a swift change was, of course, COVID-19. In the thrall of the pandemic, clinicians quickly embraced digital tools and technologies in order to avoid the health risks of face-to-face encounters. This will have broad implications across multiple sectors and populations.

The impact of the pandemic on the healthcare technology sector has been, and will continue to be, substantial. Recently, a colleague at Credit Suisse Securities forwarded me a copy of its publication projecting digital growth and innovations for 2021.

The surveys of investors and industry stakeholders on their expectations around various developments in digital health revealed that digital health adoption was "one of the silver linings in 2020," the report found. With the healthcare system under extreme stress during the pandemic, there has been a pressing need for technology and processes to boost capacity. This has led to what researchers described as a huge spike in adoption and use of digital health platforms, with once-underutilized digital tools and technologies now used to their full potential as staples in providing care.

In the coming year, the analysts predict a realignment in digital health as interrelated trends drive digital health growth and innovation. Their list of potential positive trends is lengthy and well within the realm of probability – e.g., continued adoption of virtual care; acceleration in employer activism; increased focus on addressing the mental health crisis (one that has been compounded by the pandemic); a continued shift to home-based care; continued progress on addressing waste, fraud, and abuse in the healthcare system; a reinvention of primary care; a shift to value-based care; and a recognition of the importance of cybersecurity.

While the preceding report shows industry stakeholders to be very bullish on virtual care, telemedicine, and healthcare information technology in general, a broader context takes into account the effects of these changes on various patient populations. The "great digital divide" is a serious ongoing issue for many in this country, and particularly for the elderly population. Herein lies the dilemma.

For instance, data from the National Poll on Healthy Aging conducted at the University of Michigan Institute for Healthcare Policy suggest that, although most major health systems are using patient portals (e.g., MyChart) to schedule COVID-19 vaccinations, many older adults are unable to set up these accounts without assistance. The poll found that 45% of adults ages 65 to 80 (and 42% of all adults ages 50 to 80) reported they had not set up an account with their provider's portal system. Although the percentages represent a small improvement over time, it is clear that more encouragement and assistance is needed. For example, a trusted adult might be appointed as a proxy to access accounts of those without computers, or of those who need help navigating technology.

Of particular concern, wide gaps in patient portal use were observed among various subsets of older adults who have the highest risk for severe cases of COVID-19 if unvaccinated. Almost 50% of Black older adults and 53% of Hispanic older adults lacked patient portal accounts as of June 2020, compared with 39% of White older adults.

The most significant gap in patient portal use was related to income. Approximately 54% of older adults with income less than $60,000/year did not have a patient portal account, whereas only 35% percent of older adults with income over $60,000 lacked an account. A similar gap was noted with regard to the level of education: 53% of those with less than a high school education lacked a patient portal, compared with 31% of those with college degrees.

In polls prior to the pandemic, older adults reported unawareness, lack of comfort using technology, and dislike of communicating about their health online as reasons for not setting up a patient portal account. Although the recent poll shows an increase in the percentage of older adults reporting participation in telehealth visits (4% in 2019 versus 26% in August 2020), the digital divide persists.

From my perspective, it seems an ideal time to pause and take stock. Is the plethora of "MyChart" accounts making things even more complicated than having no patient portals at all? Does the continued proliferation of patient portal platforms without interconnectivity make sense? To date, there is no coherent policy on electronic medical records. Shouldn't we be working on one?

Perhaps connectivity should be considered a "vital sign" -- something we routinely ask about, and check on, at every patient visit. Without connectivity, or even intermittent connectivity, we won't be able to maintain health in the digital world of the future.

https://www.medpagetoday.com/columns/focusonpolicy/91392