Category: Corona Virus Vaccine

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COVID-19 Vaccine Available – Heart of the Rockies Radio

October 23, 2023

Posted By: Dan R October 20, 2023

Chaffee County Public Health has finally received its first shipment of Covid vaccine for those who have private insurance and are 12 years old and older.

Public Health also has Covid vaccine for those who are 6 months and older and are uninsured or underinsured.Chaffee Public Health will be offering additional extended clinic hours throughout the fall and winter season to meet local demand.

To make an appointment, call 539-4510.

You can now order free at-home Covid-19 tests.

Danny Dan R Ridenour has been in radio and television broadcasting for over 40 years, starting as a senior in high school in Rogers, Arkansas. His radio career has had stops in Nashville, Memphis, Oklahoma, and eventually, Colorado. Dan enjoys being involved in the community, having been a member of the Upper Arkansas Service Club and is currently on the board of directors for the Salida Community Center and is a member of the Chaffee County Fair Committee. He and his wife Carrie spend their days doing everything the mountains have to offer: hiking, camping, fishing and skiing. They've raised 3 children and have 2 grandchildren.

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COVID-19 Vaccine Available - Heart of the Rockies Radio

Pfizer and Moderna Don’t See Eye to Eye on This 1 Particular Point – The Motley Fool

October 23, 2023

Pfizer (PFE -1.73%) and Moderna (MRNA -2.39%) have been in agreement on a lot since the beginning of the pandemic. They both recognized the importance of eventually launching combined vaccines -- such as those covering flu and coronavirus -- and consider them the ticket to stronger vaccine uptake. The vaccine leaders also have predicted the coronavirus vaccine market is likely to follow that of the flu market, with many Americans going for an annual jab.

But, in recent days, each company has made a statement showing they don't see eye to eye on one particular point. It has to do with something that offers us clues about long-term vaccine demand -- and revenue potential. Let's take a closer look at what both companies had to say and what that could mean for investors.

Earlier in the year, Pfizer and Moderna both made forecasts for annual vaccine sales. The companies recognized the declines in demand as we head toward a post-pandemic situation, but they still were able to offer an estimate of what the market might look like this year. Both companies collect some revenue from government contracts, but they also now are selling doses directly to healthcare providers in what's known as a commercial market.

Pfizer and Moderna originally launched coronavirus vaccines back in late 2020 and since have generated billions of dollars in earnings. In recent times, though, the big question has been whether these players will continue to bring in significant revenue from their vaccines into the future. Both companies, which recently launched updated vaccines, say this year's vaccination season could offer clues.

Now, let's get to the point that separates Pfizer and Moderna. Pfizer just recently cut its forecasts for sales of its coronavirus vaccine, Comirnaty, this year by $2 billion based on trends it's seeing in the market. It originally had predicted $13.5 billion in vaccine sales for the year. In a call with investors, the company said today it assumes about 17% of Americans will go for a COVID shot this fall.

After Pfizer's move, Moderna issued a statement saying it sticks by its vaccine sales guidance range of $6 billion to $8 billion this year. This is in the context of 50 million to 100 million doses administered, which represents about 15% to 30% of the U.S. population. Moderna also said it's too early in the vaccination season to make a more precise estimate.

At this point, we could say Moderna from the start may have been a bit more cautious by issuing a wide forecast for vaccine sales this year.

Meanwhile, Pfizer's observations so far pushed the company to launch a plan to realign costs with its future revenue opportunity. The big pharma aims to save at least $3.5 billion.

As for costs, Moderna might be in a stronger position because its entire pipeline may benefit from the investments it's made in research and development and infrastructure for the coronavirus program. That's because the mRNA technology used in the vaccine is used across Moderna's pipeline. For example, Moderna aims to build a billion-dollar respiratory vaccine franchise so the investments it's made so far for its coronavirus vaccine are and will be useful for these additional products.

Pfizer also is working on other mRNA candidates -- but this technology isn't the backbone of its entire pipeline. And that means the investments in the coronavirus vaccine platform won't necessarily serve all of its programs -- and Pfizer is right to realign costs.

Pfizer sees now as the moment to make initial observations about this fall's vaccine demand -- and take action. Moderna says it's too early to draw any conclusions. Considering each company's business, as I talked about above, they both are right.

So, as an investor, there's reason to be confident about Pfizer and Moderna and the way they're handling the current situation. And both of these companies offer solid long-term prospects beyond the vaccine. They aim to launch several new products over the next few years that should translate into billions of dollars in revenue.

Of course, shares of Pfizer and Moderna probably won't recover overnight as investors focus on vaccine trends and sales. But, the investors who decide to get in on these stocks today, while they're down, may reap rewards over time -- once the focus shifts from the vaccine to the companies' entire pipeline.

Adria Cimino has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Pfizer. The Motley Fool recommends Moderna. The Motley Fool has a disclosure policy.

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Pfizer and Moderna Don't See Eye to Eye on This 1 Particular Point - The Motley Fool

Silicon Valley Executive Sentenced for Defrauding Investors and … – Department of Justice

October 21, 2023

The president of a Silicon Valley-based medical technology company was sentenced today to eight years in prison and ordered to pay $24 million in restitution for participating in a scheme to defraud investors and a scheme to commit health care fraud and pay illegal kickbacks in connection with the submission of over $77 million in claims for COVID-19 and allergy testing.

A Silicon Valley executive exploited the pandemic for profit, ultimately endangering patients with unproven COVID-19 tests, said Acting Assistant Attorney General Nicole M. Argentieri of the Justice Departments Criminal Division. The Department of Justice is committed to protecting the people of this nation by investigating and prosecuting those who put public health at risk and use global emergencies to line their own pockets.

Schena put profit over public safety. He used the global pandemic as a backdrop to fuel a kickback scheme and a massive fraud upon investors and people searching for better health care during a time of great uncertainty, said U.S. Attorney Ismail J. Ramsey for the Northern District of California. Even in times of national crisis, our office will ensure that Silicon Valley remains a place where innovation and ingenuity and not fraud and deceit fuel vibrant markets for investors and inventors.

According to court documents, Mark Schena, 60, of Los Altos, California, was the president of Arrayit Corporation. Schena engaged in a scheme to defraud Arrayits investors by claiming that he had invented a revolutionary technology to test for virtually any disease using a single drop of blood from a finger stick sample. In meetings with investors, Schena and his publicist claimed that Schena was the father of microarray technology and that he was on the shortlist for the Nobel Prize. Schena also falsely represented to investors that Arrayit could be valued at $4.5 billion.

Todays outcome illustrates HHS-OIGs unwavering commitment to protecting federal health care programs under any circumstance especially when a public health emergency presents opportunities for bad actors to exploit, said Deputy Inspector General for Investigations Christian J. Schrank of the Department of Health and Human Services Office of Inspector General (HHS-OIG). We continue to work tenaciously with our law enforcement partners to bring to justice those who have constructed schemes to take advantage of the COVID-19 pandemic for personal gain.

Every time theres a disaster of some type, scammers climb out of the woodwork with schemes to bilk people out of their money, said Postal Inspector in Charge of Criminal Investigations Eric Shen of the U.S. Postal Inspection Service (USPIS). In this case, Mark Schena and the Arrayit Corporation were already involved in deceiving the public before the COVID-19 pandemic hit. When the pandemic hit, the company then attempted to develop a COVID-19 antibody test but were unsuccessful. Despite having no product and on the verge of bankruptcy, Schena continued to defraud investors, claiming to have multimillion-dollar contracts and other business developments that all proved to be bogus.

In furtherance of the scheme, Schena failed to release Arrayits financial disclosures as required by the Securities and Exchange Commission (SEC) and concealed that Arrayit was on the verge of bankruptcy. Schena lulled investors who were concerned that the company was a scam by engaging in television appearances and filming videos that fraudulently portrayed the laboratory as busy and high-tech. Schena also issued false press releases and public statements on social media that Arrayit had entered into lucrative partnerships with companies, government agencies, and public institutions, including a childrens hospital and a major California health care provider. The press releases and statements falsely claimed that such entities had agreed to use the Arrayit technology, when in fact no such agreements existed or were of minimal value.

Those who used the pandemic for illicit profit by engaging in health care fraud and defrauding investors must face the consequences of their actions, said Assistant Director Luis Quesada of the FBIs Criminal Investigative Division. The FBI and its partners will work relentlessly to protect the American people from abuses to our financial and health care systems, and this sentencing reflects those efforts.

Schena also orchestrated an illegal kickback and health care fraud scheme that involved submitting fraudulent claims to Medicare and private insurance for unnecessary allergy testing. Arrayit ran allergy screening tests on every patient for 120 different allergens regardless of medical necessity. To obtain patient blood specimens, Schena paid kickbacks to marketers in violation of the Eliminating Kickbacks in Recovery Act and orchestrated a deceptive marketing plan that falsely claimed that the Arrayit test was highly accurate in diagnosing allergies, when it was not, in fact, a diagnostic test. The Health Care Fraud Units Data Analytics Team supported the prosecution and, as the evidence at trial showed, Arrayit billed more per patient to Medicare for blood-based allergy testing than any other laboratory in the United States.

This sentence holds the defendant accountable for his large-scale fraud scheme that impacted multiple federal agencies and robbed the taxpayers of millions of dollars, said Inspector General Michael J. Missal of the Department of Veterans Affairs Office of Inspector General (VA-OIG). The VA-OIG will continue to work zealously with our law enforcement partners to ensure schemes like this are uncovered, investigated, and prosecuted to the fullest extent of the law.

Mr. Schenas sentencing is a fitting resolution that holds him accountable for a multimillion-dollar fraudulent scheme driven purely by greed and devoid of fiscal responsibility or concern for the patients that would ultimately use his nearly useless products, said Director Kelly P. Mayo of the Department of Defense (DoD) Office of Inspector General, Defense Criminal Investigative Service (DCIS). DCIS remains committed to working with its partners to identify and eliminate fraudulent schemes that potentially endanger patient safety and corrupt the integrity of TRICARE, the DoDs health care program.

In early 2020, Schena falsely announced that Arrayit had a test for COVID-19. Schena told federal agents that it was simple to develop a test for COVID-19 because the switch from testing for allergies to testing for COVID-19 was like a pastry chef who switches from selling strawberry pies to selling rhubarb and strawberry pies. Seeking to capitalize on the nationwide shortage of COVID-19 testing, Schena orchestrated a deceptive marketing scheme that falsely claimed that Dr. Anthony Fauci and other prominent government officials had mandated testing for COVID-19 and allergies at the same time, and required that patients receiving the Arrayit COVID-19 test also be tested for allergies. Schena also concealed from investors and patients that the Food and Drug Administration had informed him that the Arrayit test was not accurate enough to receive an Emergency Use Authorization for use in the United States.

A federal jury convicted Schena on Sept. 6, 2022.

The HHS-OIGs San Francisco and Detroit Regional Offices, USPIS, FBI, VA-OIG, and DCIS investigated the case.

Principal Assistant Chief Jacob Foster and Trial Attorney Laura Connelly of the Criminal Divisions Fraud Section and Assistant U.S. Attorney Christina Liu for the Northern District of California prosecuted the case.

The Fraud Section leads the Criminal Divisions efforts to combat health care fraud through the Health Care Fraud Strike Force Program. Since March 2007, this program, comprised of 15 strike forces operating in 25 federal districts, has charged more than 5,000 defendants who collectively have billed federal health care programs and private insurers more than $24 billion. In addition, the Centers for Medicare & Medicaid Services, working in conjunction with HHS-OIG, are taking steps to hold providers accountable for their involvement in health care fraud schemes. More information can be found at http://www.justice.gov/criminal-fraud/health-care-fraud-unit.

The Fraud Section uses the Victim Notification System (VNS) to provide victims with case information and updates related to this case. Victims with questions may contact the Fraud Sections Victim Assistance Unit by calling the Victim Assistance phone line at 1-888-549-3945 or by emailing Victimassistance.fraud@usdoj.gov. To learn more about victims rights, please visit http://www.justice.gov/criminal-vns/victim-rights-derechos-de-las-v-ctimas. If you believe you are a victim who has invested in Arrayit, or you have taken a COVID-19 test prepared or marketed by Arrayit, please visit http://www.justice.gov/criminal-vns/case/Arrayit.

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Silicon Valley Executive Sentenced for Defrauding Investors and ... - Department of Justice

Canine transmission models provide insights into the neurological … – News-Medical.Net

October 21, 2023

In a recent study published in Emerging Infectious Diseases, researchers used dogs to investigate the histopathologic alteration caused by the severe acute respiratory syndrome coronavirus 2 (SARSCoV2) on mammalian neurological systems.

Study:Neurologic Effects of SARS-CoV-2 Transmitted among Dogs. Image Credit:el-ka/Shutterstock.com

Their findings reveal that infection by SARS-CoV-2 results in significant damage to the brain, especially concerning the blood-brain barrier.

They further discovered the presence of phosphorylated tau, a protein linked to neurodegenerative alternations in mitochondria. Researchers observed these changes in both symptomatic and asymptomatic dogs.

Given the similarity between the histopathology of SARS-CoV-2 across both human and non-human hosts, these findings may provide insights into the neurological effects of the coronavirus disease 2019 (COVID-19) on the brains of its human survivors.

Since the emergence of the coronavirus disease 2019 (COVID-19) in late 2019, most severe acute respiratory syndrome coronavirus 2 (SARSCoV2), its causative pathogens hosts, have been human.

However, given that the angiotensin-converting enzyme 2 (ACE2) receptor of many mammals is highly conserved and very similar to those of humans, animals such as cats, non-human primates, rodents, and dogs have been infected.

The World Health Organization (WHO) reports almost 750 million confirmed cases of COVID-19 in humans, 7 million of which were lethal.

Scientific and clinical studies conducted on cohorts of survivors reveal that, in addition to COVID-19 symptoms that persist for months or even years following infection (long COVID), some survivors present neurological symptoms, including fatigue, headaches, and cognitive dysfunction.

Magnetic resonance imaging (MRI) of some of these individuals brains has revealed white matter hyperintensities indicative of blood-brain barrier (BBB) damage.

Other research has identified markers of neuroinflammatory responses, damage to the brains coagulatory systems, and microglial cell activation. Similar patterns of ARs-CoV-2 pathology have been reported in murine models.

The etiology of neuropathologic changes following COVID-19 infection, however, remains elusive. Protein modeling has confirmed that ACE2 in dogs can bind to human SARS-CoV-2, which epidemiological and genetic studies have discovered allows cross-species transmission from humans to their four-legged friends.

Mutant strains of SARS-CoV-2 in dogs cause histopathologic changes in lung tissues and increased expression of muscle damage markers in the blood.

Given their close similarity, the patterns of neuropathologic damage in humans and dogs are hypothesized to be alike. Studies on the effects of COVID-19 on dogs may provide glimpses into the mechanisms underpinning SARS-CoV-2-induced neural damage in humans.

In the present study, researchers used canine transmission models to elucidate dogs susceptibility to the Delta variant of SARS-CoV-2. Fifteen 6-month-old beagles (female) were divided into three cohorts Control (n = 3), infection (n = 6), and contact (n = 6).

Dogs in the infection cohort were intranasally inoculated (105 PFU of Delta variant) and subsequently placed in cohabitation with a dog from the contact cohort to mimic natural transmission models in humans.

Once the infection in the contact cohort was established, researchers used quantitative reverse-transcription PCR to investigate SAR-CoV-2 nucleic acid in the dogs brains and immunofluorescence assays to observe the presence of viral particles.

To monitor the continuous spectrum of changes accompanying COVID-19 infection, nasopharyngeal, fecal swab, oropharyngeal, and blood samples were collected at 10, 12, 14, 38, 40, and 42 days postinfection (dpi) for use in experiments across day 4 through 35 dpi.

The complete cohort of tests included immunohistochemistry, immunofluorescence staining, quantitative reverse transcription PCR, enzyme-linked immunosorbent assay (ELISA), and the plaque reduction neutralization test. All experiments were conducted in triplicate. Finally, statistical analyses involved using plotted dose-response curves and Student t-tests.

The present research found no significant change between dogs body weight and temperature before and after Delta variant infection. All of the dogs were neurologically and respiratorily asymptomatic for COVID-19 infection.

Quantitative reverse-transcription PCR and immunofluorescence assays detected the presence of viral particles in the brain during the early- but not late stages of the infection period.

Our observations indicate that SARS-CoV-2 may infect the brain during the early infection period and may be cleared by the later infection period.

Modified immunofluorescence assay using antibodies specific to the blood-brain barrier (BBB) compartments revealed loss of matrix (laminin and collagen IV) and tight junction (claudin 5) proteins.

Platelet-derived growth factor receptor-beta (PDGFR- ) densities were lower during the late stages of viral infection, suggesting damage to the BBB.

Last, infiltration of CD4+ T cells was found in the brain by trespassing into the BBB matrix protein layer, suggesting severe damage to the BBB integrity and subsequent recruitment of these cells into the brain. Those observations indicate that SARS-CoV-2 infection could induce pathologic changes in the structural and functional integrity of the BBB.

Together, these damages would allow immune cells and peripheral molecules to cross the BBB, resulting in small vessel disease (SVD).

Glial activation investigative staining revealed significant increases in the brain white matter of dogs from the infected cohorts compared to the controls, suggesting the COVID-19 infection could instigate neuroinflammatory responses, thereby promoting neurodegenerative pathology.

Tau is a family of major microtubule-associated proteins (MAPs) of a normal mature neuron and a hallmark of the Alzheimers condition. To evaluate tauopathy in COVID-19-infected brains, phosphorylated tau staining was employed.

we detected phosphorylation of tau at Ser202/Thr205 by using an AT8 antibody in the brains of dogs in the infection group during the early period and dogs in the infection and contact groups during the late period. Those results suggest that SARS-CoV-2 infection could induce accumulation of the pathologic form of tau in a site-specific manner.

Finally, decreases in the number of neuronal cells in the infected cohorts during later infection periods reinforce damage to the BBB and SVD.

The present research uses canine models to gain insight into the neurodegenerative changes occurring in mammalian brains as a proxy for human neuronal impairment.

Their findings reveal that the Delta variant of SARS-CoV-2 can infect dogs by direct contact and dog-to-dog transmission. This study also suggests that long-COVID-19-like symptoms may plague canine survivors.

Their findings highlight viral damage to the BBB and that neuroinflammatory responses are prominently localized to the white matter, not the grey matter.

Overall, these data can be used as translational research data to interpret the potential neuropathologic changes that may be observed in humans.

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Canine transmission models provide insights into the neurological ... - News-Medical.Net

Using Your Safety Management System (SMS) to Mitigate Infectious … – Federal Transit Administration

October 21, 2023

Transit agencies nationwide have led a historic response to the COVID-19 pandemic. As the industry continues to recover and adapt, transit agencies are implementing new and enhanced measures to ensure the safety of their employees and passengers and increase public confidence in transit. FTA is committed to helping the public transportation industry in the U.S continue to recover and adapt.

The Bipartisan Infrastructure Law requires that transit agencies subject to the Public Transportation Agency Safety Plans (PTASP) regulation include strategies in Agency Safety Plans (ASP) to minimize exposure to infectious diseases, consistent with guidelines from the Centers for Disease Control and Prevention (CDC) or a State health authority.

FTA encourages each transit agency to consider identifying mitigations or strategies related to exposure to infectious diseases and other respiratory hazards such as smoke or residue from controlled substances through the Safety Management System (SMS) Safety Risk Management process described in the agencys ASP.

Transit agencies may find the following resources useful as sources of hazard identification data and potential mitigations to inform the Safety Risk Management process. This list is non-exhaustive and is provided for technical assistance only.

The content linked below is available for historical purposes. FTA is no longer updating this content and it may not reflect current COVID-19 guidance.

From March 2020 to September 2022, FTA collected information from FTA recipients and subrecipients on the impacts of COVID-19, including transit workforce counts, service impacts, and transit worker positives, fatalities, and recoveries. All agencies that provided transit service and submit reports to the National Transit Database as urban reporters or tribal transit agencies reported this information directly. State recipients of Section 5311 grants are reported on behalf of their applicable subrecipients. FTA used this data to inform FTA actions in support of the transit industrys COVID-19 response and recovery efforts and implementation of the federal mask requirement for public transportation.

While reporting is no longer required, agencies may access previously submitted baseline and recurring forms on FTAs Transit Integrated Appian Development Platform for information and to update any previous responses as needed.

From January 2021 to April 2022, the federal government required masks on public transportation conveyances and at transportation hubs. As a result of a court order, effective April 18, 2022, the CDC's January 29, 2021 Order requiring masks on public transportation conveyances and at transportation hubs is no longer in effect. As of April 18, 2022, the CDC stopped enforcing its Order, and the Transportation Security Administration (TSA) stopped enforcing its mask-related security directives.

This does not preclude transit agencies or local governing bodies from implementing their own requirements for face masks. Transit agencies may continue to recommend or require face masks on public transit. The CDC continues to recommend that people wear masks in indoor public transportation settings.

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Using Your Safety Management System (SMS) to Mitigate Infectious ... - Federal Transit Administration

COVID-19 raises the risk of cardiovascular disease in people with HIV – aidsmap

October 21, 2023

People with HIV who were diagnosed with COVID-19 had a 35% higher risk of a major cardiovascular event in the following year compared to other people with HIV, a Spanish study presented on Thursday at the 19th European AIDS Conference (EACS 2023) in Warsaw reported.

The difference in risk was concentrated in three types of cardiovascular problem: thrombosis (disorders caused by blood clots), heart failure (failure of the heart to pump sufficient blood) and other heart disorders including aneurysms (where a blood vessel balloons and may suddenly rupture). People with HIV with a diagnosis of COVID-19 did not have higher rates of heart attack or stroke.

Several large studies in the general population have reported that people diagnosed with COVID-19 are at higher risk of experiencing a major cardiovascular event such as heart attack compared to the rest of the population.

A large study of people receiving care through US Veterans hospitals found that a COVID-19 diagnosis raised the risk of numerous cardiovascular outcomes during the following year, from stroke and heart attack to deep vein thrombosis, angina and disturbances in heart rhythm such as atrial fibrillation. The study found that the risk was raised regardless of whether people were hospitalised with COVID-19 or not, and regardless of whether they had a prior history of cardiovascular disease.

Other studies in the United Kingdom, Sweden and Denmark have also reported an increased risk of major cardiovascular events in people who had been diagnosed with COVID-19.

Although studies have shown that unvaccinated people with HIV have a somewhat higher risk of being admitted to hospital and dying of COVID-19, the risk of new cardiovascular events after a COVID-19 diagnosis has not been studied in people with HIV.

The question is especially important for people with HIV, as numerous studies have shown that people with HIV have raised cardiovascular risks due to HIV itself, dyslipidaemia caused by antiretroviral treatment and lifestyle factors such as smoking and weight. Does COVID-19 exacerbate the existing risks for people with HIV?

To investigate the risk of cardiovascular events in people with HIV after a COVID-19 diagnosis, Dr Raquel Martin Iguacel and colleagues looked for COVID-19 diagnoses in the PISCIS HIV cohort database between March 2020 and July 2022 and for cardiovascular events in the PADRIS database, which compiles data on health service utilisation in the Spanish region of Catalonia.

Cardiovascular events eligible for inclusion in the analysis consisted of dysrhythmia (disturbances in heart rhythm); cerebrovascular disease (stroke or brain haemorrhage); ischaemic heart disease (any disease caused by narrowing of the arteries supplying the heart, including heart attack and angina); thrombotic disorders such as deep vein thrombosis or blood clots; heart failure; inflammatory heart disease; peripheral vascular disease; aneurysms (ballooning or ruptured artery) or other disorders such as cardiac arrest.

The analysis identified 4199 people with HIV with COVID-19 and 14,004 without COVID-19. The study population was predominantly male (82%) with a median age of 45 in the COVID group and 48 in the non-COVID group. Approximately 3% had CD4 counts below 200 (a risk factor for severe COVID-19 outcomes) and the median CD4 count was 688 in the COVID-19 group. Ninety per cent had an undetectable viral load.

An interruption of blood flow to the brain, caused by a broken or blocked blood vessel. A stroke results in sudden loss of brain function, such as loss of consciousness, paralysis, or changes in speech. Stroke is a medical emergency and can be life-threatening.

The result of a statistical test which tells us whether the results of a study are likely to be due to chance and would not be confirmed if the study was repeated. All p-values are between 0 and 1; the most reliable studies have p-values very close to 0. A p-value of 0.001 means that there is a 1 in 1000 probability that the results are due to chance and do not reflect a real difference. A p-value of 0.05 means there is a 1 in 20 probability that the results are due to chance. When a p-value is 0.05 or below, the result is considered to be statistically significant. Confidence intervals give similar information to p-values but are easier to interpret.

The presence of one or more additional health conditions at the same time as a primary condition (such as HIV).

Disease of the heart or blood vessels, such as heart attack (myocardial infarction) and stroke.

Forty per cent of those with COVID-19 and 36% of those without COVID-19 had at least one co-morbidity associated with increased COVID-19 risk, most commonly chronic liver disease (11%), a cancer of the blood (13%) or dyslipidaemia (10%) and there was no substantial difference between study arms in the prevalence of any co-morbidity except high blood pressure, which was more common in people who did not contract COVID-19 (11% vs 6%).

Cardiovascular disease had been previously diagnosed in 11.8% prior to COVID-19 diagnosis, compared to 10.5% of the non-COVID group.

Among those diagnosed with COVID-19, 7% were admitted to hospital and 25 people out of 4199 required intensive care after hospitalisation. Thirteen per cent of those diagnosed with COVID-19 experienced at least two infections with COVID-19.

During a median follow-up period of 243 days, 211 people with a COVID-19 diagnosis and 621 without COVID-19 had a cardiovascular event, an incidence rate of 70.2 and 56.8 per 1000 person-years, respectively.

In a multivariable analysis that adjusted for demographic factors, HIV-related factors, COVID-19 and co-morbidities associated with COVID-19, a diagnosis of COVID was associated with 35% increased risk of any cardiovascular event (adjusted hazard ratio 1.35, 95% CI 1.13-1.60).

The elevated risk was present in all subgroups and was especially pronounced in those people with HIV diagnosed with COVID-19 who had chronic lung disease or chronic kidney disease.

The risk of cardiovascular events was also elevated in heterosexual men (aHR 1.28, 95% CI 1.01-1.62) and in people with a previous history of cardiovascular disease (aHR 27.44, 95% CI 21.83-34-49), chronic kidney disease (aHR 1.66, 95% CI 1.17-2.37) and chronic liver disease (aHR 1.34, 95% CI 1.04-1.73).

The elevated risk was still evident when people with previous cardiovascular disease were excluded from the analysis (aHR 1.60, 95% CI 1.13-2.28).

The most frequent cardiovascular events were ischaemic heart disease (affecting 1.6% of all people diagnosed with COVID-19), heart failure (1%) and stroke (0.9%). But the only events which occurred more frequently in people with COVID-19 were thrombotic disorders (p=0.007), heart failure (p=0.009) and other cardiac disorders including aneurysms (p=0.001). There was no significant difference in rates of dysrhythmia, cerebrovascular disease, inflammatory heart disease, peripheral vascular disease, or ischaemic heart disease.The study investigators conclude that among people with HIV diagnosed with COVID-19, even if COVID-19 didnt lead to hospitalisation, cardiovascular health needs to be a focus of care in people recovering from COVID-19. Ensuring that people with HIV are vaccinated against COVID-19 and keep up to date with booster doses is important for a population that already has an increased risk of heart disease.

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COVID-19 raises the risk of cardiovascular disease in people with HIV - aidsmap

CDC study: People with HIV have elevated COVID reinfection rate – University of Minnesota Twin Cities

October 21, 2023

Moha El-Jaw / iStock

A new Centers for Disease Control and Prevention-led study finds that people with HIV (PWH) have higher COVID-19 reinfection rates than those without HIV (PWOH).

The study, published yesterday in Emerging Infectious Diseases, involved 453,587 adults in Chicago infected with SARS-CoV-2 from their first infection through May 2022. The investigators matched COVID-19 test results and vaccination data to Chicago's Enhanced HIV/AIDS Reporting System.

"HIV can compromise the immune system; persons with HIV (PWH), especially those not receiving antiretroviral therapy (ART), might be vulnerable to SARS-CoV-2 infection," the researchers wrote. "Understanding how COVID-19 affects PWH is important because approximately half of PWH are>50 years of age and have higher rates of medical comorbidities, compared with persons without HIV (PWOH)."

A total of 5.3% of the 453,587 COVID-positive residents were reinfected, including 192 of 2,886 (6.7%) PWH and 23,642 of 450,701 (5.2%) PWOH. Reinfection rates among PWH were 66 per 1,000 person-years, compared with 50 of 1,000 person-years among PWOH. PWH had a higher adjusted rate of COVID-19 reinfection (1.46 per 1,000 person-years) than PWOH.

Among reinfected residents, PWH were older (median age, 43 years) than PWOH (36 years). Relative to PWOH, PWH were more likely to be men (79.3% vs 40.9%) and Black (53.7% vs 27.0%) and to have received a primary COVID-19 vaccine series and booster (31.8% vs 22.1%). Of those reinfected, PWH were less likely than PWOH to be unvaccinated at their first infection (87.5% vs 91.0%).

PWH should follow the recommended COVID-19 vaccine schedule, including booster doses, to avoid SARS-CoV-2 reinfections.

Of 131,682 residents vaccinated before their first SARS-CoV-2 infection, 54.2% had completed a primary Pfizer/BioNTech vaccine series. Of 23,834 reinfected residents, 39.6% (9,444 of 23,834) had completed a primary series but had not received a booster before reinfection.

Regardless of variant wave and calendar quarter, PWH consistently had a higher rate of reinfection than PWOH. The highest incidence for PWH occurred during Omicron strain predominance (50 cases per 1,000 person-years). Overall, an excess of 16 reinfections per 1,000 person-years were reported among PWH.

"PWH should follow the recommended COVID-19 vaccine schedule, including booster doses, to avoid SARS-CoV-2 reinfections," the authors wrote.

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CDC study: People with HIV have elevated COVID reinfection rate - University of Minnesota Twin Cities

AdvaMed Statement on USITC report, "COVID-19 Diagnostics and … – AdvaMed

October 21, 2023

WASHINGTON, D.C. The United States International Trade Commission (USITC) released its highly anticipated report,COVID-19 Diagnostics and Therapeutics, Supply, Demand, and TRIPS Agreement Flexibilities on October 17. Evidence presented in the 496-page report supports AdvaMeds position that there is no justification for the World Trade Organization (WTO) to waive intellectual property protection for products used to treat or diagnose COVID-19.

The report contains and reinforces many of AdvaMeds objections to limiting IP protection for COVID-19 products, said Ashley Miller, Executive Vice President, Global Strategy and Analysis. As we did throughout the pandemic, AdvaMed and our members will continue to work with the U.S. Government, other governments, and multilateral organizations to address impediments to patient access to diagnostics, including those reflected in the report.

Other key findings for diagnostics in the report include:

First, manufacturers of COVID-directed diagnostics, located in countries with a wide variety of income levels, including China and India, rapidly developed and scaled up production of COVID-19 tests early in the pandemic even before effective vaccines were widely available. New manufacturers entered the market throughout 2022 and 2023 even as demand for testing declined and has since remained low. To achieve this rapid production rise, WTO members did not need to use voluntary or compulsory licenses for COVID-19-directed diagnostics. As the USITC observed, the best evidence that patents did not act as a primary barrier to the production of these tests is that many new producers and products, including in developing countries, came online relatively quickly. The USITC noted, instead, that only R&D agreements were used in connection with COVID-19-directed diagnostics, which highlights the industrys cooperative response through which the industry was able to meet global demand in record time.

Second, the USITC stressed that defining the vast scope of COVID-19 diagnostics covered by patents is complicated and subject to interpretation, which means that a potential waiver would risk undermining IP protection for almost any diagnostic and therapeutic device determined by any government as being needed for COVID-19 and could lead to abuse of the IP waiver by countries seeking to gain competitive economic advantage.

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AdvaMed Statement on USITC report, "COVID-19 Diagnostics and ... - AdvaMed

Study finds high prevalence of drug interactions in adults taking … – University of Minnesota Twin Cities

October 21, 2023

Adults who were treated with nirmatrelvirritonavir (Paxlovid) for their COVID infections in an outpatient setting during the earlier Omicron variant months had a high prevalence of drug-drug interactions, Canadian researchers reported yesterday in PLOS One.

In its clinical guidance, the Centers for Disease Control and Prevention (CDC) urges health providers to be aware of Paxlovid eligibility criteria and the potential for drug interactions. The drug carries a boxed warning about significant drug interactions. Treatment guidelines from the National Institutes of Health urge clinicians to carefully review patients medications but adds that many commonly used drugs can be safety administered, despite the interaction potential.

For the study, they assessed 637 consecutive patients who were prescribed Paxlovid at a Toronto clinic between March 3, 2022, and September 20, 2022. The median age was 70, and the median number of risk factors for severe disease was two, with 45% having immunocompromising conditions. Most (82%) of patients had received at least three COVID vaccine doses.

About 95% of the patients completed their 5-day Paxlovid course, with 68% reporting full symptom resolution by 28 days. Sixty (11%) of the patients had rebound symptoms. Only 3.3% of patients were hospitalized, with 1.2% linked to COVID. No known deaths were reported.

The median number of concurrent medications was seven. Researchers found that 70% had at least one drug-drug interaction (DDI), which increased to 82% in patients ages 70 and older. Most DDIs required clinical intervention, with most needing assistance from a pharmacist. The most common drugs involved with the DDI events were cardiovascular drugs and those for benign prostatic hyperplasia, followed by central nervous system drugs and oral antithrombotic agents.

Researchers also found a high rate of adverse drug events, at 62%, though they pointed out that effects didnt usually prompt patients to stop Paxlovid treatment. The most common ones were a persistent bad taste in the mouth (dysgeusia) and diarrhea.

The team said Paxlovid continues to be a mainstay for treating mild COVID in people at risk for severe disease and that the study findings underscore the need to manage drug interactions for patients taking Paxlovid. They urged prescribers to be aware of the high real-world prevalence of DDIs and adverse events, as well as strategies to mitigate them, which they said helps support treatment adherence.

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Study finds high prevalence of drug interactions in adults taking ... - University of Minnesota Twin Cities

Impact of COVID-19 gap in MS likely to cost over $500M in Canada – Multiple Sclerosis News Today

October 21, 2023

The overall financial impact of changes in treatment and delayed diagnoses for people with multiple sclerosis (MS) in Canada due to the COVID-19 pandemic likely will be in the hundreds of millions of dollars between 2020 and 2024 in terms of extra healthcare costs and lost productivity, as well as worsened well-being for patients.

Thats according to a new report by Deloitte Access Economics on the so-called COVID-19 gap in Canada as it relates to MS. The research report put the costs of reduced patient well-being due to pandemic-related disruptions in care by itself at more than $400 million (about $290 million). More than $100 million (about $73 million) was estimated for increased costs of healthcare and drops in productivity for patients.

Based on these findings, MS Canada is calling on the Canadian government to invest money into MS specialty care and research into ways to prevent or treat the neurodegenerative disease, in an attempt to close the pandemic gap.

If we want to mitigate this impact to the MS community, governments can step up and ultimately save themselves money by doing these things: investing $15 million [about $11 million] immediately in prevention and treatment research building on the breakthrough discovery linking Epstein-Barr virus (EBV) to MS, and boosting MS specialist care by funding additional MS healthcare professionals from MS nurses to neurologists, Pamela Valentine, PhD, president and CEO of MS Canada, said in a press release from the organization.

Australia has just announced $18 million in research funding to follow up on a breakthrough link between MS and Epstein-Barr virus (EBV), which could foreseeably lead to a preventative vaccine. Canada must do the same, Valentine said.

Living with MS carries a hefty price tag. In addition to the cost of care for medications and other types of medical care and support, MS can make it harder to consistently work a job, resulting in lost economic productivity. The disease also can reduce patients wellbeing, which in economic terms can be quantified as lost value.

In this report, the researchers first estimated the total cost of MS care in Canada in 2019, before the COVID-19 pandemic. That number was estimated to be $3.4 billion (about $2.5 billion), which based on the frequency of MS in Canada works out to $42,880 (about $32,000) per person. Direct costs related to healthcare and indirect costs related to lost productivity made up most of these costs in the models.

During the first years of the COVID-19 pandemic from 2020 to 2022 spending on MS-related healthcare decreased by a total of about $566 million (about $413 million) in Canada, in comparison with what would have been expected based on trends before the pandemic.

This decrease in spending is likely reflective of pandemic-related disruptions in MS care, such as patients not receiving appropriate treatment or not getting diagnosed in a timely manner, according to the researchers.

The impact of these pandemic-related disruptions in care, sometimes termed the COVID-19 gap, has worrying implications for the future, especially in terms of patient health. Available treatments for MS are able to slow the diseases progression, but they cannot undo damage once it occurs. As such, people with MS who didnt get adequate care as a result of the pandemic are likely going to experience more severe disability and need more intensive care in the future.

Early diagnosis and timely intervention with the most effective treatment is key to protecting brain health, preserving function, and minimizing the impact on our healthcare system, Valentine said.

The COVID-19 gap has led to a health services backlog and unmet health needs for Canadians living with MS, Valentine said, adding, It has led to progression of MS in many Canadians, due to delayed or halted treatments this will impact these individuals and their families quality of life and livelihood.

This is especially concerning, according to MS Canada, as the country has one of the highest rates of MS in the world. An average of 12 Canadians are diagnosed with MS daily, and more than 90,000 people in Canada are living with the disorder, per the nonprofit.

Delays and changes to treatment can lead to irreversible disease progression and disability, Valentine said.

There is a saying that time is brain meaning delayed care means irreversibly worse outcomes for the patient, she said, adding, When nervous tissue is lost or damaged, it cannot be recovered. You cant catch up later with treatment.

While the changes in the provision of health services reduced MS-related health expenditure between 2020 and 2022, evidence from this study suggests that these costs are now rising above the level that would have been expected in the absence of the pandemic to clear the backlog in health services.

From the economic models, the researchers estimated that pandemic-related disruptions will lead to about $578.2 million (about $425 million) in additional MS-related costs between 2020 and 2024. This included $138 million in increased healthcare costs and lost productivity, as well as more than $400 million in reduced wellbeing for patients.

While the changes in the provision of health services reduced MS-related health expenditure between 2020 and 2022, evidence from this study suggests that these costs are now rising above the level that would have been expected in the absence of the pandemic to clear the backlog in health services, the scientists wrote.

Coupled with significant excess costs related to a worsening in the disease state of many people with MS due to treatment changes and delayed diagnoses, this trend towards higher costs is expected to continue and rise in future years, they added.

The researchers called for further study to quantify the impact of COVID-19 in MS, and said the given estimates will need to be updated as the longer-term outcomes from the pandemic are realised.

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Impact of COVID-19 gap in MS likely to cost over $500M in Canada - Multiple Sclerosis News Today

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