Coronavirus vaccine passports won’t be mandated by feds: Fauci

 The federal government won’t be mandating so-called coronavirus "vaccine passports" — proof that one has been vaccinated against COVID-19 — for travelers or businesses after the pandemic is over, according to the nation’s top infectious disease expert. 

"I doubt that the federal government will be the main mover of a vaccine passport concept," Dr. Anthony Fauci, who also serves as President Biden's chief medical adviser, told the Politico Dispatch podcast on Monday. 

"They may be involved in making sure things are done fairly and equitably, but I doubt if the federal government is going to be the leading element of that," he added.

Some argue that mandating vaccine passports could speed the re-opening of international travel. But the issue of vaccine passports is complicated and has been hotly debated around the world, raising questions about how much governments, employers and venues have a right to know about a person’s virus status.

In the U.K., for example, Prime Minister Boris Johnson on Monday confirmed the government will test out a "vaccine passport" system as a tool to help travel and large events return safely.

In the U.S., the issue has become largely partisan. Republicans are largely against the concept. Two Ohio state legislators, for instance, recently told Fox News that they are planning to introduce a bill that will preemptively ban vaccine passports over concerns about privacy and government overreach. 

Rep. Al Cutrona, a Republican who represents parts of eastern Ohio, said vaccine passports mandated by the government would create "privacy concerns that should be startling to anyone."

"I want to make sure that we put a stop on this from the government," Rep. Cutrona, who runs an infectious disease medical practice in Ohio, said. "It's a false sense of security, a false sense of normalcy, and frankly, I think it's a very slippery slope that we're heading down."

Separately, Florida Gov. Ron DeSantis issued an executive order on Friday banning the use of vaccine passports in the state. 

Meanwhile, New York became the first state to roll out a digital vaccine passport when it recently launched the so-called "Excelsior Pass." 

"As more New Yorkers get vaccinated each day and as key public health metrics continue to regularly reach their lowest rates in months, the first-in-the-nation Excelsior Pass heralds the next step in our thoughtful, science-based reopening," Gov. Andrew Cuomo said of the vaccine passport rollout. 

Still, some private businesses and organizations may look at developing ways to confirm that someone is vaccinated. Fauci spoke to this during his appearance on the Politico Dispatch podcast, noting that businesses or schools may require them to enter their buildings. 

"I'm not saying that they should or that they would, but I'm saying you could foresee how an independent entity might say, 'well, we can't be dealing with you unless we know you're vaccinated,' but it's not going to be mandated from the federal government," he said. 

https://www.foxnews.com/health/coronavirus-vaccine-passports-wont-be-mandated-federal-government-fauci

Capacity Crowd Expected For Rangers Home Opener

 One month after Texas Governor Greg Abbott lifted the mask mandate and all other anti-pandemic restrictions amid declining hospitalizations and infection rates, the Texas Rangers held their first full-capacity sports game on Monday. 

For now, the lockdown nightmare is over, for millions of Texans, with at least 38,238 of them attending the first home game for the team at Globe Life Field in Arlington.  

FOX 4 News Dallas-Fort Worth said the game was declared a "sellout" as fans have been waiting nearly a year to attend a game. 

"Been waiting for a while; we are fired up and ready to go," said fan Lane Smith.

In fact, this is one of the first full capacity major sports events in the US since the COVID-19 pandemic began more than a year ago. With the stands full, event staff made sure fans were abiding by safety guidelines.

"After being safe for a year, to be in a large crowd, it's just a little nervous," said fan Carmen Smith.

"Yes, there are some mild concerns, but it seems as if people are being safe, and we are being as safe as we can be," said Tommy Ware.

Some of the safety guidelines included mandatory mask-wearing inside the ballpark despite Abbott's lift on the mask mandate.

Abbott's anti-pandemic measures had drawn the ire of other governors, CDC, and the Biden administration. 

The Rangers game comes one day after Michael Osterholm, an adviser to President Biden's coronavirus task force, told NBC's "Meet the Press" that "the highest number of cases reported globally since the beginning of the pandemic" will occur in the coming weeks. 

Despite the federal government's fearmongering, Texas health officials reported around 1,000 new infections on Monday, the lowest since June 2020. 

The Ranges said Abbott's lifting of health restrictions allowed full capacity for Monday's home game.

"We waited for one year to open this business with Rangers fans in it. Certainly excited when the governor issued the executive order on March 2 to give us that capability," said Rob Matwick, the Rangers executive vice president of ballpark operations. "When we found out that would be the opportunity, we certainly look forward to welcoming as many fans as we can this season."

About a month after Abbott eased virus restrictions, the state has not observed a surge in new infections. People are cautiously emerging from their homes, trying to remember what it was like in pre-COVID times. Perhaps the best way to feel liberated from the draconian lockdown measures is for people to get outside and attend a good old fashion baseball game.\Those in other states who don't have the luxury to attend a major sports event because of restrictions, try visiting parks, pick up a new outdoor hobby, and or just go outside and relax.

https://www.zerohedge.com/markets/rebound-full-swing-capacity-crowd-expected-rangers-home-opener

Valneva COVID-19 shot set for Phase Three trial this month

 Valneva on Tuesday reported positive results for its COVID-19 vaccine in early-stage clinical trials and said it planned to launch a Phase Three trial this month.

The French drugmaker, whose shot uses the technology behind its licensed Japanese encephalitis vaccine, tested its vaccine in 153 adults with three dose levels based on a schedule of two doses with vaccinations three weeks apart.

Valneva shares were up 8% in early trading.

The vaccine, Valneva said, was "generally safe and well tolerated across all dose groups tested, with no safety concerns identified by an independent Data Safety Monitoring Board."

The company said the vaccine was also "highly immunogenic", with "more than 90% of all study participants" developing significant levels of antibodies to the coronavirus spike protein.

Valneva has signed a deal with Britain for up to 190 million doses by 2025 in a transaction potentially worth up to 1.4 billion euros ($1.65 billion). The company is also in talks with the European Union to supply it with 60 million doses.

The company said it intended to submit the vaccine for approval in Britain in the autumn of this year and said discussions with other regulatory bodies were ongoing.

https://www.marketscreener.com/quote/stock/VALNEVA-SE-54466/news/Valneva-nbsp-COVID-19-shot-set-for-Phase-Three-trial-this-month-32891327/

Michigan's daily coronavirus cases hit record high

 The U.S. state of Michigan on Monday reported a record number of daily coronavirus cases in less than five months, according to a Reuters tally.

The state reported 11,082 cases, bringing the total to 779,974, surpassing its previous peak of 10,140 on Nov. 20.

Daily deaths increased by 23 to 17,282.

https://www.reuters.com/article/us-health-coronavirus-michigan-cases/michigans-daily-coronavirus-cases-hit-record-high-reuters-tally-idUSKBN2BT0N0

Cara Therapeutics Set to Join S&P SmallCap 600

 Cara Therapeutics Inc. (NASD:CARA) will replace MTS Systems Corp. (NASD:MTSC) in the S&P SmallCap 600 effective prior to the opening of trading on Thursday, April 8. S&P 500 constituent Amphenol Corp. (NYSE: APH) is acquiring MTS Systems in a deal expected to be completed soon pending final closing conditions.

https://finance.yahoo.com/news/cara-therapeutics-set-join-p-225500927.html

In-home Care Will Outlast the Pandemic: Three Keys to Success

 As COVID-19 continues to strain hospitals, pushing them to – or beyond – capacity, we’ll see more and more patients recover from COVID-19 at home this winter, either declining admission themselves, or unable to meet more stringent admission requirements. The increasing demand for hospital-level care at home allows patients to recover with the support of family and in a comfortable environment, but it also presents challenges, particularly in treating patients experiencing adverse downstream effects of social determinants of health.

According to the CDC, during the first quarter of 2020, the number of telehealth visits increased by 50 percent, compared with the same period in 2019, with a 154 percent increase in visits noted in surveillance week 13 in 2020, compared with the same period in 2019. Last January, telehealth was seen as a nice-to-have by hospitals and providers. Now, it’s a requirement, especially as more and more patients recover at home. The shift to in-home care has given a rise to another new phenomenon: the informal caregiver. More and more often, family members or friends are overseeing care regimens for at-home patients, becoming a new central element to the patient care circle. 

The new dynamic demands new tools and integrations. Patients and their families need to be provided with the tools to track health at home, the means to communicate seamlessly with providers on the medium that makes the most sense, and the contextual information to play a meaningful role in their care. Here are the key crucial elements needed for successful in-home care: 

• Access to telehealth: Telehealth gives patients and their in-home care team the ability to video chat, asynchronous messaging, or both with the medical care team for healthcare guidance and support. It is also important because it allows the patient to stay in the comfort of their home, remain connected to their family, and reduce additional exposure. Hospitals need to facilitate telehealth activities and provide a seamless patient experience that includes engagement tools like appointment reminders, post-appointment follow-up, and more. 
• Ability to monitor vital signs: Monitoring vital signs begins with the basics, a diary to track symptoms and medications. Thermometers, pulse oximeters, and blood pressure monitoring devices are needed for tracking temperatures, oxygen saturation levels, heart rate, and blood pressure levels. The combination of symptoms and vitals need to be communicated on a agreed-upon basis with the medical care team to guide care recommendations. We’ll also see consumer-grade wearables, like smartwatches and other IoT devices, become increasingly incorporated in remote care, offering real-time vital health data to predict or identify issues before they become serious.
• Supportive home environments: Family members need to be able to pick up and administer prescription medications as needed and take other measures to ensure that the patient sticks to their care plan. Most importantly, they need to be the patient’s healthcare advocate with their medical care team ensuring they get the healthcare attention needed. To facilitate this, hospitals and providers need to be aware of environmental and social factors in the home – does the patient or their family have the physical space, for example, to be able to isolate sick family members? Is the patient able to get medications filled? Do they understand how to take those medications and any side-effects? Are informal caregivers shift workers who may not be able to remain available for the patient creating potential gaps in care? Are there childcare needs in the home to consider? Through outreach and rounding, hospitals should consider the presence of social determinants of health and other factors when considering or designing at-home care regimens. 

As hospitals and ICUs reach capacity for COVID-19, we’ll continue to see a ramp-up in virtual and remote care, at least until the current wave of cases subsides. As they are adapting, healthcare providers also need to think about the future. They need to take inventory and look at the approaches they used, what worked, what did not work, and where there is room for improvement — for the patients, caregivers, and providers. As we move past COVID-19, we need to constantly be thinking about how to improve remote care, digital engagement is no longer a nice-to-have but a prerequisite. Many experts believe, It is no longer a matter of if there will be another pandemic but when. While we all hope that there will never be another pandemic, we have learned much from this devastating year and realize that incorporating those learnings into future emergency planning is essential. 

https://www.healthcarebusinesstoday.com/in-home-care-will-outlast-the-pandemic-three-keys-to-success/

Statin Use Prior to Admission to Severity, Recovery in COVID-19 Inpatients

 

• Lori B. Daniels, MD, MAS 
• Amy M. Sitapati, MD
• Jing Zhang, MS
• Christopher A. Longhurst, MD, MS
• Michael H. Criqui, MD, MPH
• Karen Messer, PhD
• Show all authors

DOI:https://doi.org/10.1016/j.amjcard.2020.09.012

PDF: https://www.ajconline.org/action/showPdf?pii=S0002-9149%2820%2930947-4

The impact of statins, angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers (ARBs) on coronavirus disease 2019 (COVID-19) severity and recovery is important given their high prevalence of use among individuals at risk for severe COVID-19. We studied the association between use of statin/angiotensin-converting enzyme inhibitors/ARB in the month before hospital admission, with risk of severe outcome, and with time to severe outcome or disease recovery, among patients hospitalized for COVID-19. We performed a retrospective single-center study of all patients hospitalized at University of California San Diego Health between February 10, 2020 and June 17, 2020 (n = 170 hospitalized for COVID-19, n = 5,281 COVID-negative controls). Logistic regression and competing risks analyses were used to investigate progression to severe disease (death or intensive care unit admission), and time to discharge without severe disease. Severe disease occurred in 53% of COVID-positive inpatients. Median time from hospitalization to severe disease was 2 days; median time to recovery was 7 days. Statin use prior to admission was associated with reduced risk of severe COVID-19 (adjusted OR 0.29, 95%CI 0.11 to 0.71, p < 0.01) and faster time to recovery among those without severe disease (adjusted HR for recovery 2.69, 95%CI 1.36 to 5.33, p < 0.01). The association between statin use and severe disease was smaller in the COVID-negative cohort (p for interaction = 0.07). There was potential evidence of faster time to recovery with ARB use (adjusted HR 1.92, 95%CI 0.81 to 4.56). In conclusion, statin use during the 30 days prior to admission for COVID-19 was associated with a lower risk of developing severe COVID-19, and a faster time to recovery among patients without severe disease.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is responsible for the clinical syndrome of coronavirus disease 2019 (COVID-19), which has caused significant morbidity and mortality worldwide. Individuals with underlying cardiovascular disease (CVD), hypertension, and diabetes have been identified as groups at particularly high risk for developing severe COVID-19.

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 Because a large proportion of patients with these conditions are on statins and either angiotensin-converting enzyme (ACE) inhibitors or angiotensinogen II receptor blockers (ARBs), there has been speculation about whether these cardiovascular medications may influence COVID-19 risk.

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 ACE2 may be a mechanistic link between CVD, use of statins, ACE inhibitors or ARBs, and COVID-19. ACE2 is an enzyme with multiple roles, serving as the receptor through which SARS-CoV-2 enters human cells, as well as playing an integral part in countering activation of the renin-angiotensin-angiotensinogen system.

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 ACE2 is a membrane-bound aminopeptidase expressed broadly in humans, including in the heart and on lung alveolar epithelial cells.

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 ACE2 acts on angiotensin II to form angiotensin-(1 to 7) which has anti-inflammatory, anti-fibrotic, and vasodilatory effects.

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 ACE inhibitors and ARBs may increase the expression of ACE2, leading some to speculate that these medications may increase susceptibility to COVID-19; others have postulated protective effects via anti-inflammatory actions.

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 Statins upregulate ACE2 as well, and have additional pleotropic effects to counter inflammation and oxidative stress.

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 Further, statins may block SARS-CoV-2 infectivity via direct binding to the main protease.

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 The purpose of this single-center observational study of patients hospitalized for COVID-19 was to investigate the association of use of statins, ACE inhibitors, or ARBs, with (1) progression to severe disease (death or intensive care unit [ICU] admission), and (2) time to the onset of severe disease or to recovery, defined as hospital discharge without development of severe disease.

Methods

The study population included all patients hospitalized for treatment of COVID-19 between February 10 and June 17, 2020 at University of California San Diego Health (UCSDH), as ascertained by data capture within the system-wide electronic health record (EHR) system (Epic Systems, Verona, Wisconsin).

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 Patients were designated as COVID-positive if there was history of positive COVID-19 polymerase chain reaction. Beginning in mid-March 2020, UCSDH policy was to ascertain COVID-19 status of all admitted patients. Patients were excluded if they were hospitalized for reasons unrelated, and exhibited no symptoms attributable, to COVID-19 (n = 28). We also excluded 21 patients in whom medications prior to admission could not be verified. In sensitivity analyses, we included all patients admitted during this timeframe who were negative for COVID-19, as contemporaneous negative controls. The study was approved by the Institutional Review Board at UCSD; a waiver of informed consent was granted.

Data collected via automatic extraction from the EHR included demographics, COVID-19 test dates and results, past medical diagnoses, outpatient medication history, dates of hospitalization, reason for hospitalization, dates of ICU admission, and vital status. Data were verified manually for all COVID-positive patients, and for a random sample of COVID-negative patients. The primary exposures of interest were use of statins, ACE inhibitors, and ARBs within the 30 days prior to admission. Medication use was considered present if the patient had regularly taken the medication during the 30 days prior to hospital admission, as reported by the patient or a caregiver. We excluded patients in whom we were unable to verify the medication history. In sensitivity analyses including hospitalized COVID-negative patients, medication use was also considered present if the patient had filled a prescription in the 30 days prior to admission based on dispense data. Comorbid conditions included obesity, hypertension, CVD (defined as history of coronary artery disease, stroke and/or transient ischemic attack, peripheral arterial disease, or heart failure), diabetes mellitus, and chronic kidney disease (CKD).

The primary outcome was severe disease, defined as either admission to the ICU or death. Patients discharged from the hospital without ever experiencing a severe outcome were considered to be recovered from COVID-19. Patients who had not reached either severe status or been discharged at the time of data lock were considered to have unresolved status and were censored.

For each predictor of interest, means or proportions are presented, stratified by presence or absence of severe disease. The mean difference between severe and non-severe subjects are presented for each predictor, with a 95% confidence interval (CI) computed using t tests for continuous variables and Fisher's exact tests for categorical variables. Among COVID-positive patients, association between the presence of severe disease and use of statins, ACE inhibitors and ARBs was investigated using a multivariable logistic regression, adjusting for potential confounders including age, sex, and a list of comorbid conditions (obesity, hypertension, diabetes, CKD and CVD) which were considered a priori to be potentially related to both severe disease and use of medications of interest. Patients with unresolved status were omitted from this analysis. As sensitivity analyses, the same logistic regression model was fit for (1) COVID-negative hospitalized patients, and (2) COVID-negative hospitalized patients who were part of the UCSDH registry prior to February 1, 2020. We also checked for a significant interaction term between COVID-19 status and each variable in these models. A competing risks analysis

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 was used to investigate the time to onset of severe disease or to recovery, whichever came first, among COVID-positive patients; the starting timepoint was the earliest date of either first positive COVID-19 test or hospitalization. Cause-specific cumulative incidence curves for severe disease and recovery were calculated using Aalen-Johansen estimators. We investigated the association of statins, ACE inhibitors and ARBs with time to recovery and time to onset of severe disease. For each of these 2 outcomes, a Cox proportional hazards regression model was used in which the competing outcome was treated as a censoring event. Patients with unresolved status were also censored. Models were adjusted for the same potential confounders as in the logistic regression analysis. Additional sensitivity analyses included competing risk analyses with statin, ACE inhibitor, and ARB use modelled separately. The proportional hazards assumption was tested by examining Schoenfeld residuals and all variables passed except hypertension in the recovery model for ACE inhibitors and obesity in the recovery model for all 3 drugs. For all analyses, associations with p < 0.10 are reported along with 95%CIs; p < 0.05 was considered statistically significant. All analyses were conducted using R v3.4.4.

Results

The primary study population included 170 patients hospitalized with a diagnosis of COVID-19 at UCSDH, including 90 (53%) with a severe outcome (ICU or death), 78 (46%) who recovered, and 2 (1%) with unresolved status at the time of analysis. Of the 90 with a severe outcome, there were 22 deaths. A total of 88 of the 90 severe patients required ICU admission. Of these 88 patients, 61 (69%) required invasive mechanical ventilation. We also analyzed 5281 COVID-negative subjects, including 1278 (24%) with a severe outcome.

Among COVID-positive patients, 58% were male; the average age was 59 ± 19 years (Table 1). Just over half (55%) were of Hispanic race and/or ethnicity, with the remainder non-Hispanic white (21%), African-American (6%), Asian (5%), or other and/or mixed race (12%). Among comorbid conditions, 56% of patients were obese, 44% had a history of hypertension, 21% had CVD, and 20% had diabetes. Other comorbid conditions with 5% or greater prevalence included asthma (8%), CKD (18%), and cancer (14%).

Discussion

In this series of 170 patients hospitalized for treatment of COVID-19 at UCSDH, use of statins prior to admission was associated with a more than 50% reduction in risk of developing severe COVID-19, after controlling for associated comorbid conditions and for concomitant use of ACE inhibitors or ARBs. In a competing risks time-to-event analysis, there was strong evidence that statin use was associated with considerably faster time to recovery; there was weaker evidence for association with a reduced rate of progression to severe COVID-19. These effects on timing combine to account for the overall reduction in the occurrence of severe outcomes among patients who used statins. Among all hospitalized patients, median time from hospitalization to severe disease was only 2 days, while median time to recovery was 7 days.

There is some biologic plausibility for a protective role of statins in COVID-19 through known anti-inflammatory and immunomodulator effects as well as via upregulation of ACE2 and direct effects on the virus.

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 Statins may inhibit SARS-CoV-2 infectivity by direct binding and inhibition of the main protease, a key coronavirus enzyme.

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 Coronaviruses can induce an inflammatory cascade through activation of the toll like receptor 4 myeloid differentiation response protein 88-nuclear factor kappa B pathway.

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 In murine models under periods of stress, statins can disrupt this pro-inflammatory response through inhibition of toll like receptor 4 expression and stabilization of myeloid differentiation response protein 88 expression levels.

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 Although SARS-CoV viruses employ ACE2 for cell entry, they have been shown in vivo to reduce ACE2 expression upon binding of the viral spike protein to the ACE2 receptor.

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 ACE2 downregulation leads to excessive production of angiotensin, which has been causally linked to severe respiratory failure.

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 Therefore, upregulation of ACE2 is another potential mechanism whereby statins (as well as ACE inhibitors and ARBs) might protect against COVID-19 lung injury.

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 In observational studies, statins were associated with reduced influenza-related hospitalizations,

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 and with improved outcomes in community acquired pneumonia and sepsis.

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In time-to-event analysis, when considered alone ARB medication use prior to admission was not a predictor of severe disease, but similar to statins, was associated with faster time to recovery. In multivariable analyses when both ARB and statin use were entered jointly in the model of time to recovery, the effect of ARB use was attenuated, while statin use retained a robust effect. As a significant percentage of patients use both medications, it is plausible that a major portion of the observed effect of ARB use is in fact attributable to statins. On the other hand, in the logistic regressions a higher risk of severe disease with ARBs was seen in both COVID-positive and COVID-negative cohorts.

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 This comparison to negative controls suggests that any residual confounding in the logistic regression models is biased toward increased risk of severe disease, whereas we found a significant beneficial effect in models of time to recovery, lending some support to beneficial effect of ARBs. In contrast, ACE inhibitor use was not predictive of time to either severe disease or recovery. Previous observational studies have found no association between outpatient use of ARBs or ACE inhibitors and either susceptibility to or severity of COVID-19.

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 Some observational studies of inpatient use of these medications have suggested a possible beneficial effect, which appears more robust in ARBs than ACE inhibitors.

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 Ongoing clinical trials are evaluating the use of these medications to speed recovery and improve outcomes.

Our findings that obesity and diabetes are risk factors for severe outcomes in COVID-19 are consistent with prior reports.

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 In addition, male sex consistently had estimated effects consistent with increased risk. There was an interaction between COVID-status and obesity, with obesity emerging as protective in the COVID-negative cohort but a risk factor among COVID-positive inpatients. A novel finding is that younger age was associated with a shorter time to recovery. This may reflect a more resilient population, though it could also be due to younger individuals presenting later in the time course of disease. Although current smoking was more prevalent among those with mild as opposed to severe COVID-19, the very low prevalence of smoking in this cohort (only 8 current smokers were identified) makes the validity of this finding questionable. Given some evidence that nicotine may play a role in the ACE2 pathway, further investigation is warranted.

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Limitations of the present study include its observational design which cannot prove causality and which leaves open the possibility of residual confounding, and the relatively small sample size. The sensitivity analysis including COVID-negative hospitalized patients also showed beneficial effects of statins on severe outcomes, and we cannot exclude residual confounding as a contributing factor; however the effect size for statin use was much larger in the COVID-positive cohort, and there was evidence for a difference in effect sizes between the COVID-positive and -negative cohorts. In addition, statins would be expected to affect CVD outcomes favorably in non-COVID-19 patients. The COVID-negative cohort is a heterogeneous group which is a limitation, however this is also a strength in that it allows us to control for some biases that may be broadly present. Although extensive manual chart review was performed, misclassification remains a possibility. We used date of hospitalization (or date of first positive COVID-19 test if earlier) as the beginning timepoint for our time-to-event analyses, which does not account for variation in the duration of symptoms prior to hospitalization. Our study did not evaluate the in-hospital use of statins, ACE inhibitors or ARBs and these data should not be extrapolated to the use of these medications for treating acute COVID-19. We also did not have reliable data on dose or duration of medication use; some of the effects of statins, ACE inhibitors or ARBs may be time-dependent. Similarly, with the present study design we are unable to assess the impact of statins, ACE inhibitors, or ARBs on susceptibility to COVID-19 infection, which would require widespread, systematic testing of asymptomatic individuals.

https://www.ajconline.org/article/S0002-9149(20)30947-4/fulltext