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Friday, April 2, 2021

Fauci: U.S. may not need AstraZeneca COVID-19 vaccine

 The United States may not need AstraZeneca’s COVID-19 vaccine, even if it wins U.S. regulatory approval, Anthony Fauci, the nation’s top infectious disease doctor told Reuters on Thursday.

The vaccine, once hailed as another milestone in the fight against the COVID-19 pandemic, has been dogged by questions since late last year, even as it has been authorized for use by dozens of countries, not including United States.

Fauci, director of the National Institute of Allergy and Infectious Diseases and chief medical adviser to the White House, said the United States has enough contracts with other vaccine makers to vaccinate its entire population, and possibly enough for booster shots in the fall.

Asked whether the United States will use the AstraZeneca vaccine doses, he said, “That’s still up in the air. My general feeling is that given the contractual relationships that we have with a number of companies, that we have enough vaccine to fulfill all of our needs without invoking AstraZeneca.”

Late last year, the drugmaker and Oxford University published data from an earlier trial with two different efficacy readings as a result of a dosing error. Then in March, more than a dozen countries temporarily suspended the use of AstraZeneca’s vaccine after reports linked it to a rare blood clotting disorder.

Also in March, a U.S. health agency said data from the company gave an incomplete picture of its efficacy. Days later AstraZeneca published results showing diminished, though still strong, efficacy.

Fauci said that “If you look at the numbers (of doses) that we’re going to be getting, the amount that you can get from J&J, from Novavax from Moderna if we contract for more, it is likely that we can handle any boost that we need, but I can’t say definitely for sure.”

https://www.reuters.com/article/us-health-coronavirus-astrazeneca-exclus/exclusive-fauci-says-u-s-may-not-need-astrazeneca-covid-19-vaccine-idUSKBN2BO6XS

Aveanna Health files for $100M IPO

 We are a leading, diversified home care platform focused on providing care to medically complex, high-cost patient populations. We directly address the most pressing challenges facing the U.S. healthcare system by providing safe, high-quality care in the home, the lower cost care setting preferred by patients. Our patient-centered care delivery platform is designed to improve the quality of care our patients receive, which allows them to remain in their homes and minimizes the overutilization of high-cost care settings such as hospitals. Our clinical model is led by our caregivers, primarily skilled nurses, who provide specialized care to address the complex needs of each patient we serve across the full range of patient populations: newborns, children, adults and seniors. We have invested significantly in our platform to bring together best-in-class talent at all levels of the organization and support such talent with industry leading training, clinical programs, infrastructure and technology-enabled systems, which are increasingly essential in an evolving healthcare industry. We believe our platform creates sustainable competitive advantages that support our ability to continue driving rapid growth, both organically and through acquisitions, and positions us as the partner of choice for the patients we serve.

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IPO Data
IPO File Date04/01/2021
Price Rangen/a
Offer Shares (mm)n/a
Deal Size ($mm)$100
Lock-Up DateIPO Pro Only
Street ResearchIPO Pro Only
Underwriters
Barclays
J.P. Morgan
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Company Data
HeadquartersAtlanta, GA
Founded2016
Employees42,000
Websitewww.aveanna.com
https://www.renaissancecapital.com/Profile/AVAH/Aveanna-Healthcare/IPO


Thursday, April 1, 2021

Home Oxygen Program Helped COVID Pneumonia Patients

 Few COVID-19 patients in Los Angeles with pneumonia discharged on a practice of home oxygen use died or had to be readmitted to the hospital within 30 days, researchers found.

Among 621 patients discharged from either the hospital or the emergency department, the all-cause mortality rate was 1.3% (95% CI 0.6%-2.5%) and the 30-day all-cause hospital readmission rate was 8.5% (95% CI 6.2%-10.7%), reported Brad Spellberg, MD, of Los Angeles County/University of Southern California Medical Center, and colleagues, writing in JAMA Network Open.

They developed the SAFE @ HOME O2 Expected Practice, which stated that clinically stable patients with COVID-19 pneumonia requiring at least 3 L per minute of nasal cannula oxygen to achieve at least 92% oxygen saturation should be discharged to be treated in an ambulatory setting. Patients were dispensed the necessary equipment for home monitoring, such as a pulse oximeter, oxygen tank, and concentrator.

This practice also required patients discharged with oxygen to be called by a nurse, with physician support if necessary, within the first 12-18 hours after discharge. Calls were performed daily, 7 days a week, until patients showed that they understood both how to use the equipment and the indications for return care.

Spellberg and colleagues examined data from 621 patients with COVID-19 pneumonia from March 20 to August 19, 2020. Patients received either inpatient or emergency department care at two large urban medical centers, and were discharged with home oxygen.

Participants' median age was 51, two-thirds were men, and three-quarters were discharged from inpatient admissions. About three-quarters were insured by Medicaid, and about 85% spoke Spanish. Median follow-up was 26 days.

No patients died at home or during transport to acute care.

In addition, while a formal cohort analysis was not performed, hospital mortality for readmitted patients after a trial of home oxygen was "consistent with overall observed hospital mortality" for patients without a preceding or subsequent trial of home oxygen (15% vs 14%, respectively), the researchers said.

Limitations to the data, the team noted, include the observational nature and limited generalizability, as comparable data on acute care duration and patients not discharged and not requiring home oxygen was unavailable.

The authors concluded that this program "may be considered part of a strategy to ensure right care, right place, and right time for patients with COVID-19 pneumonia, and to preserve acute care access during the pandemic," and that the results underscore the program's safety.


Disclosures

New treatments spur rethinking of what heart failure is

 Spurred by great enthusiasm for the latest treatments for heart failure, some groups are putting greater emphasis on clearly defining what exactly heart failure is, and how to communicate it to patients without demoralizing them.

There are now five classes of life-saving heart failure drugs, as angiotensin receptor-neprilysin inhibitors and SGLT2 inhibitors were added to heart failure treatment algorithms in new guidance from the American College of Cardiology (ACC).

This is an "exciting time," said Anuradha Lala, MD, of Mount Sinai Health System in New York City. "Now our efforts need to be focused on implementation, making sure that patients who will benefit from these ​medications are actually on these ​medications."

A More Comprehensive Definition of Heart Failure

As such, the new universal definition of heart failure -- drafted by the Heart Failure Society of America, European Society of Cardiology, and Japanese Heart Failure Society -- helps clarify who exactly would be eligible for which therapies and future trials according to clear cutoffs for reduced, preserved, mildly reduced, and improved ejection fraction.

There are lots of definitions of heart failure floating around, but the universal definition is more complete and accurate than any prior ones, according to Maya Guglin, MD, PhD, of Indiana University School of Medicine in Indianapolis and chair of the ACC council of heart failure and transplant as well as a reviewer for the consensus statement.

"We all pretty much agree on what heart failure is," Guglin told MedPage Today.

The new document adds the knowledge about heart failure that has been gained since the ACC and American Heart Association last defined heart failure as "a complex clinical syndrome that results from any structural or functional impairment of ventricular filling or ejection of blood" in 2013 guidelines.

"Our understanding of heart failure, its pathophysiology, its prognosis ... it's evolving. It's not surprising that 7, 8 years later there was a need for another more comprehensive or more modern definition of heart failure that reflects our current understanding of the concept," Guglin said.

In particular, she cited better understanding of the greater unifying role of congestion or ventricular filling, with ejection fraction being of less importance than previously thought.

Accordingly, the universal definition of heart failure is "a clinical syndrome with symptoms and/or signs caused by a structural and or functional cardiac abnormality and corroborated by elevated natriuretic peptide levels and or objective evidence of pulmonary or systemic congestion."

'Function' Not 'Failure'

Notably, the new definition also introduces clearer, more precise language. For example, the authors favor describing heart failure that is "persistent" or "in remission" rather than "stable." Additionally, "pre-heart failure" now describes patients who have structural abnormalities but no symptoms.

The importance of word choice was highlighted by an editor's note in the Journal of Cardiac Failure by Lala and editor-in-chief Robert Mentz, MD, of Duke University Medical Center in Durham, North Carolina, published in the same issue as the new universal definition.

"Few words in the English language universally invoke the negative emotions of fear and disappointment as does the word 'failure,'" the duo wrote.

"Our introductions in the clinical space may be met with fear and disappointment, even as we provide reassurance as to advances in therapy, and attempt to instill hope for continued life with improved quality -- despite the diagnosis. Some patients prefer to not confront the notion of failure at all, and delay or avoid care all together," Lala and Mentz said.

They proposed greater adoption of the term "heart function" when communicating with patients, as is the case in Canada, for instance, where patients visit "heart function clinics."

"Our hope is that being clear on definitions ​and intentional with our words will allow for more implementation of guideline-directed medical therapy ​and best practices to improve outcomes for our patients," Lala said in an interview.

"If we move our vernacular to speaking more about 'function' and focusing on its improvement, then it could ​potentially allow for a more fruitful interaction ​and engagement between patients and their clinicians and caregivers," she said. "Focusing on 'function' allows for inclusion of speaking about prevention and lifestyle, whereas 'failure' implies in a way that we've reached some end of the spectrum that may not necessarily be addressable."

Guglin agreed with the use of "heart function" and the change in language depending on whether one is speaking to other health professionals or a layperson.

Ultimately, she emphasized, the goal is always for information to be conveyed as accurately as possible. "When it comes to patients, yes, we don't want to scare them too much, but on the other hand, you have to convey the seriousness of the issue. Otherwise, they will not take recommendations as closely to heart," she warned.

Lala acknowledged concerns that pivoting from "failure" to "function" may appear to minimize the severity of the disease.

For patients who truly have the clinical syndrome of heart failure, "I do reiterate that they have ​heart failure, ​the gravity of the disease, and that the goal is to​ institute guideline-directed therapies to facilitate a transition to heart failure in remission," she explained. "But for those patients who are not symptomatic, or were symptomatic and now feel better or whose function has improved from a variety of standpoints, incorporating the ​word ​'function' ​in our visits more and more has anecdotally been empowering."

Moving forward, it would be important to study how patients' behaviors and perceptions of their disease may change depending on how clinicians talk to them, Lala said.

"We know so many heart failure patients are referred to heart failure teams too late in the course of their disease," she noted. "If [the phrase] didn't have negative connotations, would they come earlier? Would they be​ potentially more engaged or receptive to see us? ​How would it affect their quality of life?"


Disclosures

Non-severe SARS-CoV-2 infection characterised by very early T cell proliferation

 --independent of type 1 interferon responses and distinct from other acute respiratory viruses

Aneesh ChandranJoshua RosenheimGayathrie NageswaranLeo SwaddlingGabriele PollaraRishi GuptaJose Afonso Guerra-AssuncaoAnnemarie WoolstonTahel RonelCorrina PadeJoseph GibbonsBlanca Sanz-Magallon Duque De EstradaMarc Robert de MassyMatthew WhelanAmanda SemperTim BrooksDaniel M AltmannRosemary J BoytonAine McKnightCharlotte ManistyThomas Alexander TreibelJames MoonGillian S TomlinsonMala K MainiBenjamin M ChainMahdad NoursadeghiCOVIDsortium investigators

Pathophysiology of SARS-CoV-2: Mount Sinai COVID-19 autopsy experience

 

  • Clare Bryce
  • Zachary Grimes
  • […]
  • Mary E. Fowkes 

  • PDF: https://www.nature.com/articles/s41379-021-00793-y.pdf

  • Abstract

    Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and its associated clinical syndrome COVID-19 are causing overwhelming morbidity and mortality around the globe and disproportionately affected New York City between March and May 2020. Here, we report on the first 100 COVID-19-positive autopsies performed at the Mount Sinai Hospital in New York City. Autopsies revealed large pulmonary emboli in six cases. Diffuse alveolar damage was present in over 90% of cases. We also report microthrombi in multiple organ systems including the brain, as well as hemophagocytosis. We additionally provide electron microscopic evidence of the presence of the virus in our samples. Laboratory results of our COVID-19 cohort disclose elevated inflammatory markers, abnormal coagulation values, and elevated cytokines IL-6, IL-8, and TNFα. Our autopsy series of COVID-19-positive patients reveals that this disease, often conceptualized as a primarily respiratory viral illness, has widespread effects in the body including hypercoagulability, a hyperinflammatory state, and endothelial dysfunction. Targeting of these multisystemic pathways could lead to new treatment avenues as well as combination therapies against SARS-CoV-2 infection.

  • https://www.nature.com/articles/s41379-021-00793-y

  • J&J Statement on U.S. COVID-19 Vaccine Manufacturing

     Since January of 2020, Johnson & Johnson has been working directly with governments, health authorities and other companies to help end the global pandemic. We continue to expect to deliver our COVID-19 vaccine at a rate of more than one billion doses by the end of 2021.

    We are pleased we have met our commitment to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20 million people in the United States. This is part of our plan to deliver 100 million single-shot vaccines to the U.S. during the first half of 2021, aiming to deliver those doses by the end of May.

    As with the manufacturing of any complex biologic medication or vaccine, the start-up for a new process includes test runs and quality checks to ensure manufacturing is validated and the end product meets our high-quality standards. This approach includes having dedicated specialists on the ground at the companies that are part of our global manufacturing network to support safety and quality.

    This quality control process identified one batch of drug substance that did not meet quality standards at Emergent Biosolutions, a site not yet authorized to manufacture drug substance for our COVID-19 vaccine. This batch was never advanced to the filling and finishing stages of our manufacturing process.

    This is an example of the rigorous quality control applied to each batch of drug substance. The issue was identified and addressed with Emergent and shared with the United States Food & Drug Administration (FDA).

    Quality and safety continue to be our top priority. Therefore, as we continue to work with FDA and Emergent toward the Emergency Use Authorization of the Emergent Bayview Facility, Johnson & Johnson is providing additional experts in manufacturing, technical operations and quality to be on-site at Emergent to supervise, direct and support all manufacturing of the Johnson & Johnson COVID-19 vaccine. In coordination with the U.S. Department of Health & Human Services, these steps will enable us to safely deliver an additional 24 million single-shot vaccine doses through April.

    https://www.jnj.com/johnson-johnson-statement-on-u-s-covid-19-vaccine-manufacturing