In recent years, I have found myself waking up in the middle of the night, my mind racing back to certain moments in my past. It’s as if my subconscious has become a storyteller, recounting events that took place long ago. Sometimes it’s my first day of grade school, other times it’s my first day of work at a Naval Shipyard. Regardless of the event, my mind becomes fixated on the details and replays them over and over again.
Last night was no different. I lay in bed, telling myself to get some sleep, while my mind continued to ramble on for what felt like hours. But then I had an idea – maybe if I wrote down these stories, I could finally put them to rest and get the sleep that I so desperately need.
This morning, over a cup of coffee, I made a list of the 18 events that my mind insists on recounting in the middle of the night. And with that list, a plan began to form. I decided to write a chapter about each event, in the hopes that getting them down on paper will help me let go of them.
I’m not sure if this project will work as a sleeping pill for my mind, or if I’ll even be able to complete it. But I do know that I’m going to try. And while I’m aware that people often write grandiose passages when they write about themselves, I promise to be as honest and authentic as possible.
It’s worth noting that I’ll be writing from memory, without the aid of notes. And considering that these events span over 70 years of my life, there will likely be some inaccuracies. But with that being said, I’m ready to take on this project and see where it leads me.
So, with a deep breath and a fresh cup of coffee, let’s get started.
Art Smart is a regular contributor to EastTexasExposed.com and iExposed.us. Each month we submit a blog article that contains a link to some of Mr. Smart’s articles contributed during that month.
Caddo Lake in the Winter
By Art Smart
Caddo Lake, located in Northeast Texas and adjacent to the Caddo Lake Wildlife Refuge, is a stunning destination in any season, but it is particularly beautiful in the winter. With its cypress trees, Spanish moss, and calm, still waters, Caddo Lake has a serene, almost otherworldly quality in the colder months.
As you take a leisurely walk or drive around the lake, you’ll notice that the trees are adorned with hoarfrost, giving them a magical, almost fairy-tale like appearance. The air is crisp and refreshing, and the silence is broken only by the occasional birdcall or the crunch of leaves underfoot.
But Caddo Lake isn’t just a place for peaceful contemplation. It’s also home to a wide variety of wildlife, including birds, reptiles, and mammals. The Caddo Lake Wildlife Refuge, which spans over 7,000 acres, is home to over 300 species of birds, including egrets, herons, and woodpeckers. It’s also home to beavers, otters, and even the occasional alligator.
The Don CeSar, also known as the “Pink Palace,” is an iconic resort located on the beautiful St. Pete Beach in Florida. This luxurious property is a perfect choice for a romantic getaway, offering stunning oceanfront views, a secluded beach, and a variety of amenities and activities to choose from.
One of the highlights of the Don CeSar is its award-winning spa, which offers a wide range of treatments and services to help you relax and rejuvenate. Whether you’re in the mood for a massage, a manicure, or a facial, the spa has something for everyone.
The Don CeSar is also home to some of the best dining in the area. The Maritana Grille, the resort’s signature restaurant, serves gourmet cuisine inspired by the flavors of the Mediterranean. The hotel also has a variety of other dining options, including a poolside bar and a casual café.
The Sea Ranch Chapel is a breathtakingly beautiful and peaceful place located along Highway 1 in Sonoma County, California. Nestled between San Francisco and Mendocino, this isolated chapel is the perfect place to stop and take a moment to reflect and meditate during a long drive.
As soon as you approach the chapel, you’ll be struck by its stunning exterior architecture. The building is constructed from cedar shingles and glass, which creates a warm and welcoming atmosphere. The chapel is surrounded by beautiful, lush green trees, which provide a sense of privacy and seclusion.
The Ginocchio Building in Marshall, Texas was a longstanding fixture in the downtown area, with its distinctive red brick exterior and ornate architectural details. For years, it had been a source of pride for the community, with many locals reminiscing about the times they had spent there as children. However, over the years, the building had fallen into disrepair and was in desperate need of a renovation.
Enter Allan Loudermilk, a local businessman with a passion for restoring this historic building. When he first laid eyes on the Ginocchio Building, he knew he had to take on the challenge of bringing it back to its former glory.
With the support of the community, Allen set to work on the renovation, determined to do whatever it took to restore the building to its former splendor. He spent countless hours researching the building’s history and carefully planning out every detail of the renovation.
On December 20, 2022, a magnitude 6.4 earthquake struck Ferndale in Humboldt County in California. This was very sad news. I have visited Ferndale many times and have fond memories of its unmatched architecture.
Ferndale, known as the “Victorian Village,” is a small town with a rich history dating back to the mid-19th century. It was founded in 1852 by New Englanders who were drawn to the area by the abundance of natural resources and the possibility of a new life on the West Coast. These settlers established dairy farms and raised livestock, which became the mainstay of Ferndale’s economy for many years.
As the town grew and prospered, a number of Victorian-era buildings were constructed, giving Ferndale its unique character and charm. Today, these beautifully preserved buildings serve as a testament to the town’s history and are a popular attraction for visitors.
One of the most iconic buildings in Ferndale is the Ferndale Museum, a Victorian-era building that was once a livery stable. The museum houses a collection of artifacts and exhibits that tell the story of Ferndale’s history, from its early days as a dairy farming community to its present-day status as a popular tourist destination.
1. US PANDEMIC MORTALITY On average, more than 300 people in the US die each day from COVID-19. While the death toll is significantly lower than during the peak of the Delta wave, the number is 2 to 3 times higher than the average number of deaths from flu. Increasingly, COVID-19 is becoming a disease of the elderly. In summer 2021, about 58% of COVID-19 deaths occurred among adults aged 65 or older. Today, that proportion is 9 of 10 COVID-related deaths, according to US CDC data. This upward trend is expected to continue, and despite the nation’s pursuit of normalcy, is set to cause significant disruptions to the health system.
Mortality trends have shifted throughout the pandemic. A study published this week in the Annals of Internal Medicine by investigators at Brigham and Women’s Hospital in Boston, Massachusetts (US), found that the proportion of younger people who died from COVID-19 in 2021 surpassed that of 2020, with the median age of COVID-related deaths falling from 78 years old in 2020 to 69 years old in 2021. Researchers calculated years of life lost (YLL) and compared timeframes in 2020 and 2021. Using this calculation, the team was able to assess premature deaths based on the number of years an individual would have lived. In 2021, there were about 21% fewer deaths compared to 2020. However, YLL per COVID-19 death increased by 36%. Better understanding age shifts in COVID-19 mortality can help inform prevention and treatment approaches, public policy, and community measures to minimize the impacts of this increasingly preventable disease.
2. LONG COVID Nearly a third of people in the US with COVID-19 will develop long-term symptoms, according to a recent report from the US Department of Health and Human Services (HHS). Health experts are warning that this collection of post-acute symptoms, commonly known as long COVID, could be the next public health crisis—so far impacting as many as 23 million people, a number expected to grow as COVID-19 continues to circulate. In addition to increased medical expenses, individuals and families dealing with long COVID could face a reduced quality of life, reduced income, higher household debt, and lower retirement savings, further widening existing inequalities and costing the US economy US$3.7 trillion, according to one estimate. A Swiss study published in Nature Communications examined the prevalence of post-COVID conditions among children, with the findings suggesting that risk factors for lingering symptoms included older age, lower socioeconomic status, and having an existing chronic health condition, particularly asthma.
With little known about the underlying causes of lasting symptoms and a lack of a clear definition, healthcare professionals are stuck between wanting more evidence for effective therapies and trying to treat vulnerable and suffering patients. Some people with long COVID are turning to expensive and untested therapies, from vitamin supplements to stem cell treatments. The US NIH created the RECOVER Initiative to learn more about the long-term effects of COVID-19 and recently announced a clinical trial to investigate the antiviral Paxlovid for treatment of long COVID, with results expected in 2024. But many experts argue a more agile research model is needed to more quickly address the growing problem.
3. FUTURE OF VACCINESGlobal efforts are underway to prepare vaccine research, development, and production facilities for the next pandemic. This week, the Coalition for Epidemic Preparedness Innovations (CEPI) launched its 100 Days Mission, a US$3.5 billion plan to invest in vaccine research and development and achieve equitable access to vaccines for emerging viruses with pandemic potential, with the goal of producing a safe and effective vaccine within 100 days. This effort, if successful, would significantly shorten the time it took scientists to develop shots for COVID-19, a record 326 days. In Africa, Afrigen Biologics & Vaccines, the Biovac Institute, and a variety of partners are working to bring mRNA vaccines—for COVID-19 and other diseases—to the continent and adapt them for the setting, such as doing away with the need for deep freezing and making them more stable at room or refrigerated temperatures. Those involved in the effort hope more African national governments will prioritize vaccine development and manufacturing, ultimately allowing them to own the intellectual property on domestically produced vaccines that can help protect their own populations.
4. SARS-CoV-2 Serology and Self-Reported Infection Among Adults — National Health and Nutrition Examination Survey (CDC MMWR) During August 2021–May 2022, 41.6% of a c.onvenience sample of adults had both anti-spike antibodies (indicating previous infection or vaccination) and anti-nucleocapsid antibodies (indicating previous infection only); 43.7% of these persons were possibly asymptomatically infected. Prevalence of serologic patterns consistent with vaccination without infection was lower among adults who were younger, Hispanic and non-Hispanic Black or African American adults, and persons with less education.
5. As Officials Ease Covid Restrictions, China Faces New Pandemic Risks (NYT) As one country after another succumbed to outbreaks this year, China kept the coronavirus at bay, buying valuable time to prepare for the inevitable: a variant of the virus so shifty and contagious that China, too, would struggle to contain it. But rather than laying the groundwork for that scenario, China stepped up its commitment to “zero Covid,” deploying snap lockdowns and contact tracing. Now, the costs of that approach are piling up, putting China in a bind from which there appears to be no easy escape, scientists said in interviews.
6. Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine in Children Under 5 Years (Pfizer) Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have submitted an application to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third 3-µg dose in the three-dose primary series for children 6 months through 4 years of age. With the high level of respiratory illnesses currently circulating among children under 5 years of age, updated COVID-19 vaccines may help prevent severe illness and hospitalization.
7. Severe COVID could cause markers of old age in the brain (Nature) Severe COVID-19 is linked to changes in the brain that mirror those seen in old age, according to an analysis of dozens of post-mortem brain samples. The analysis revealed brain changes in gene activity that were more extensive in people who had severe SARS-CoV-2 infections than in uninfected people who had been in an intensive care unit (ICU) or had been put on ventilators to assist their breathing — treatments used in many people with serious COVID-19. The study, published on 5 December in Nature Aging, joins a bevy of publications cataloguing the effects of COVID-19 on the brain.
”…Long Covid will be around long after the pandemic subsides, impacting our communities, our health-care system, our economy and the well-being of future generations,” a November HHS report said. “We can reduce the severity and breadth of that impact, however, if we act collectively and urgently.”
Below are cited multiple new articles that validate the effectiveness of some of the vaccines against the newer Omicron variants. Even Norwegians and Tomatoes should be convinced to continue taking the vaccines, especially if they have a bit of age on them. Covid is waning in our part of East Texas.
FROM HOPKINS:
1. ”US RESPONSE As the COVID-19 pandemic enters its third fall in the US, the White House has signaled it plans to slowly restructure its response efforts, including the phaseout of the White House COVID-19 Response Team mid-2023. With dwindling federal funds, responsibility for vaccinations and therapeutics is shifting to private industry and consumers within the next 6 months. Any remaining funds are largely being used for vaccination campaigns promoting this fall’s updated boosters and the purchase of at-home, rapid tests for the Strategic National Stockpile and Test-to-Treat locations. Officials are tentatively hopeful that the national public health emergency declaration for the pandemic may be allowed to expire in early 2023. While part of this transition can be attributed to fewer COVID-19 cases, deaths, and related hospitalizations, as well as the widespread availability of vaccinations and therapeutics, most response activities need to wind down due to a lack of new funding from the US Congress. Experts and officials emphasize that the pandemic is far from over, with COVID-19 on track to remain the third leading cause of death in the nation….”
2. Additionally, recent research conducted by economists from Stanford University and Massachusetts Institute of Technology estimates that the labor force shrunk by about 500,000 people due to COVID-19 illness. Millions of people left the workforce for various reasons, including lack of childcare, fear of COVID, and retirement. But this research examines the direct impact of COVID-19 illness, estimating that workers with week-long COVID-19-related work absences are 7 percentage points less likely to be in the labor force one year later compared to otherwise-similar workers who do not miss a week of work for health reasons. In August, the total size of the labor force reached 164.7 million people, exceeding prepandemic levels for the first time. However, workforce recovery is experiencing slow-growth compared to prepandemic numbers, and economic recovery will depend on an expanded workforce in the long term.
3. BRAIN FOG When the COVID-19 pandemic first began, brain fog was not included in the list of possible symptoms. However, many COVID-19 patients report experiencing the condition, both during acute infection and lasting 3 or more months after recovery. Brain fog symptoms appear to be independent of initial disease severity. According to one review of multiple studies, about 22% of individuals report cognitive impairment 12 or more weeks following their initial diagnosis. Brain fog is often described as a disorder of executive function, the set of abilities that includes holding attention, remembering and recalling information, and blocking out distractions. Cognitive tasks that once seemed simple become excruciatingly difficult, and in some cases, impossible. Some people have had to leave their jobs due to an inability to perform their tasks, and many have faced frustration in obtaining medical care, often being dismissed as having anxiety or depression. Complicating the matter is that few clinicians are aware that many viral infections, not only COVID-19, can lead to brain fog and there are few reliable diagnostic tools.
Other neurological complications have been reported following COVID-19 infection, including stroke, delirium, and encephalitis. A recent study published in the journal Brain showed that patients hospitalized with COVID-19 had elevated levels of sera markers of brain injury, neurofilament light (NfL) and glial fibrillary acidic protein (GFAP). However, no specific pathogenic mechanism was determined responsible. Researchers continue to investigate what leads to brain fog—with possible causes including neuro-inflammation, autoimmune responses, or microclots that inhibit blood flow, and therefore oxygen supply—and are hopeful treatments can be developed.
4. In South Korea, experts are concerned over simultaneous outbreaks of COVID-19 and influenza during the colder fall and winter months, calling for the development of better diagnostic tests, including one that could detect flu and COVID-19 at the same time, and for healthcare services to offer individuals both vaccines during the same visit. …”
5. The Future of Hospitals’: Flexible Space for the Next Pandemic(The New York Times) The early waves of the pandemic came crashing into hospitals, revealing intensive care units without enough beds, hallways and waiting rooms that forced the healthy and sick to commingle, and ventilation systems that became conduits for airborne pathogens. Given that hindsight, many hospitals are remodeling with a philosophy of flexible design, the idea that spaces should be adaptable for different purposes at different times. When the next pandemic comes, they’ll be able to better meet the moment.
6. UNITED STATES
The US CDC is reporting 95.2 million cumulative cases of COVID-19 and 1,046,195 deaths. Daily incidence continues to decline, down to 60,558 new cases per day. This is the lowest average since May 1 and a 54% decrease from the most recent peak on July 16. Daily mortality continues to decline as well, down to 350 deaths per day. This is the lowest average since July 9 and a decrease of 30% from the most recent high on August 12. The CDC reported a slight increase in both daily incidence and mortality on September 12, but this is likely due to delayed reporting over the US Labor Day holiday weekend.*
7. LONG COVID IN EUROPE An estimated 17 million people across the WHO’s Europe region experienced post-acute sequelae or long-term symptoms of COVID-19, also known as long COVID, during the pandemic’s first 2 years, according to a modeling study conducted by the Institute for Health Metrics and Evaluation (IHME) for WHO/Europe. The region comprises 53 Member States across Europe and Central Asia that are home to nearly 900 million people. The report highlights the ongoing public health challenges posed by the condition, which is characterized by cognitive and mental health problems, fatigue, shortness of breath, and other symptoms experienced 12 weeks or more following a COVID-19 diagnosis.
The report, published September 13, found the number of new long COVID cases identified between 2020 and 2021 rose threefold, driven by the rapid increase in confirmed COVID-19 cases from late 2020 through 2021; women are twice as likely than men to suffer from the condition; and the risk of long COVID increases dramatically among people with severe infections who need hospitalization. WHO officials and the report authors said that although most people fully recover from COVID-19, the findings underline the need for additional analysis and investment to determine the long-term effects of the disease, including implications for the workforce and the need for rehabilitative and support services.
”…We are losing ~400 Americans a day. In the last 7 days, we have lost 2,299 people. During August 2022 alone, we lost 15,284 Americans to COVID-19.
This means COVID-19 remains the third leading cause of death in our repertoire of threats. And it’s largely preventable. In the U.S., death rates are not back to pre-pandemic times; excess deaths are still 10% above “expected.” This is changing our average life expectancy. In fact, the U.S. experienced the sharpest two-year decline in life expectancy in nearly 100 years….
It’s abundantly clear the majority of deaths continue to be among the unvaccinated (20% of Americans are still without even one dose)…In addition, there is a clear dose response with vaccines: the more vaccine doses one has, the more that person is protected from death. According to the CDC, vaccinated people with one booster had 3 times the risk of dying compared to people vaccinated with two boosters. Unvaccinated people had 14 times the risk of dying compared to those with two boosters.
Interestingly, the under- or un-vaccinated are more and more likely to have been infected. So, models are no longer comparing vaccinated people to immune naïve; rather, they are comparing vaccinated (or hybrid immunity) to those with more and more infection-induced immunity. This indirectly highlights a positive effect of vaccines against death compared to infection.
(J. Harris: A quick, easy, and important read. I had no idea that more people in FL are more unwise than many in NY.)
Data are limited regarding the effectiveness of the BNT162b2 vaccine (Pfizer–BioNTech) against the BA.4 and BA.5 sublineages of the B.1.1.529 (omicron) variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that drove the recent fifth wave of infection in South Africa.1 We previously reported a vaccine effectiveness of 70% after two doses of the BNT162b2 vaccine against severe disease during the fourth wave of omicron infection driven by the BA.1 sublineage in South Africa.1,2….. after either two doses or three doses of the BNT162b2 vaccine, we found rapid waning of vaccine effectiveness against the current sublineages of the omicron variant with respect to protection against hospitalization. Our data indicate that boosting maintains vaccine effectiveness against severe disease caused by the current omicron sublineages, although the evidence of rapid waning of durability indicates the need for regular boosting as early as 4 months after the last dose or the need for vaccines to incorporate variants of concern to maintain protection.
(J. Harris: So keep getting your Covid Boosters when the CDC says to do so — like right now. A later study is said to show “A booster dose of mRNA-1273 after the initial two-dose vaccination resulted in neutralization titers against the BA.2.75 variant that were similar to those against BA.1 and BA.2 and higher than those against BA.5 (letter).”
”Findings In this cross-sectional study of US adults hospitalized with COVID-19 during January 2022 to April 2022 (during Omicron variant predominance), COVID-19-associated hospitalization rates were 10.5 times higher in unvaccinated persons and 2.5 times higher in vaccinated persons with no booster dose, respectively, compared with those who had received a booster dose. Compared with unvaccinated hospitalized persons, vaccinated hospitalized persons were more likely to be older and have more underlying medical conditions.
Meaning The study results suggest that COVID-19 vaccines are strongly associated with prevention of serious COVID-19 illness.
”…we compared vaccinated individuals with those unvaccinated and those uninfected, in terms of post-acute self-reported symptoms. Of the 951 infected, 637(67%) were vaccinated. In the study population, the most prevalent symptoms were: fatigue (22%), headache (20%), weakness of limbs (13%), and persistent muscle pain (10%). After adjusting for age, time from beginning of symptoms to responding to the survey, and baseline symptoms, those who received two vaccine doses were less likely than unvaccinated individuals to report any of these symptoms (fatigue, headache, weakness of limbs, persistent muscle pain) by 62%, 50%, 62%, and 66% respectively, (Risk ratios 0.38, 0.50, 0.38, 0.34, p < 0.04 in the listed sequence). Compared to the 2447 included individuals who never reported SARS-CoV-2 infection, double-vaccinated participants were no more likely to report any of the mentioned symptoms. Vaccination with 2+ doses of BNT162b2 was associated with a reduced risk of reporting most of the common post-acute COVID-19 symptoms. Our results suggest that BNT162b2 vaccination may have a protective effect against longer term COVID-19 symptoms.
”Discussion: Our study found that 4 doses of BNT162b2 or mRNA-1273 reduced the risk for symptomatic SARS-CoV-2 infection, hospitalization, and severe COVID-19 illness versus 3 doses among persons 80 years of age or older, corroborating studies in a younger cohort in Israel (4, 5). In Singapore, the risk reductions in hospitalization and severe disease were helpful in managing the case surge from BA.5, avoiding the need to tighten control measures as was done for the Omicron BA.1/BA.2 wave in January through April 2022. Consistent with findings of sustained protection against severe disease from Israel (6), we found no waning of this protection after 60 days.”
York and National Railroad Museum – 14 July 2022 – York, United Kingdom
Editor note:
More from Tom
By Tom Allin
It was a beautiful day for a bus ride. So, we decided to take the Hop On/Off Bus tour and stop for the National Railroad Museum. The Railroad Museum is something we most likely wouldn’t have visited but all the guidebooks gave it high ratings and we found the ratings well deserved. I believe we spent close to two and a half hours at the Railroad Museum.
We have done several Hop On/Off Bus Tours. Some have been great such as Hong Kong. Others not so great such as Cape Town. The information is always good, the presenter or audio is always a crap shoot, and if the bus can’t or isn’t allowed to navigate to the sights then the ride is boring.
Note his jacket, the person sitting to his left with hood up – it was cool. Five days later the hottest recorded day in York’s history was 101 degrees.
Clifford Tower was a part of York Castle which no longer exists. This is the second Tower or Castle Keep. The first was destroyed in 1190 when the City’s Jews took refuge inside and eventually committed suicide to avoid being murdered by Christian rioters.
”…coronavirus tests that analyze both nasal and throat swabs … pick up more Omicron infections than those that rely on just a nasal swab….
The first paper focuses on 14 people who enrolled in the study before or at the same time that their infections began, allowing the researchers to capture the earliest stage of infection….This group of participants provided a total of 260 nasal swabs, 260 throat swabs and 260 saliva samples over the course of their infections, allowing the scientists to make multiple comparisons between the amount of virus in different specimens and people at different times…
The researchers found significant differences in the viral load of different sample types from the same individuals….
In most participants, the virus was detectable in saliva or throat swabs before it was detectable in nasal swabs. “You can have very high, presumably infectious, viral loads in throat or saliva before nasal swabs,…”
(J. Harris: It was hoped that the BA2.75 which started in India would not be an important varisn. Now called “Centaurus” in Australia, it isn’t as deadly as some variants, but much like BA .5 in the US, it is filling up some of the hospitals. Most of the world’s deaths from Covid are in folks over about 74.)
1. 3. Time-Release Microparticles Could Deliver “Self-Boosting” Vaccines (GEN) Most vaccines, from measles to COVID-19, require a series of multiple shots before the recipient is considered to be fully vaccinated. To make that easier to achieve, MIT researchers have developed microparticles that can be tuned to deliver their payload at different time points, and which could be used to create what the scientists describe as “self-boosting vaccines.” Using these particles, which resemble tiny coffee cups sealed with a lid, researchers could design vaccines that would need to be given just once, and would then “self-boost” at a specified point in the future. The particles can remain under the skin until the vaccine is released and then break down, just like resorbable sutures. The same strategy could also feasibly be used to deliver a range of other therapeutics, including cancer drugs, hormone therapy, and biologic drugs.
(J. Harris: We have the first acute polio case in the US in quite a while.)
From THE CDC:
Correlation Between Clinical and Wastewater SARS-CoV-2 Genomic Surveillance, Oregon, USA (CDC EID) SARS-CoV-2 variant proportions in a population can be estimated through genomic sequencing of clinical specimens or wastewater samples. We demonstrate strong pairwise correlation between statewide variant estimates in Oregon, USA, derived from both methods (correlation coefficient 0.97). Our results provide crucial evidence of the effectiveness of community-level genomic surveillance.
”Question Can a behavioral nudge delivered through text messages with a reserved date for vaccination over a 2-week period accelerate employee adherence with a health system COVID-19 vaccination policy?
Meaning This randomized clinical trial found that a behavioral nudge delivered by text message with a reserved date for vaccination accelerated adherence to a health system COVID-19 vaccination policy; however, other approaches may be needed to change overall adherence rates by the time of the policy deadline.”
This study found that full vaccination against COVID-19 was associated with a reduced risk of AMI [HEART ATTACK] and ischemic stroke after COVID-19. The findings support vaccination, especially for those with risk factors for cardiovascular diseases.
”…In this study of US blood donations, the combined seroprevalence from infection or vaccination reached 94.7% by December 2021. Despite this, record levels of infection and reinfections were reported as the Omicron variant became predominant in early 2022.2 The high infection rates are likely related to increased transmissibility and enhanced immune escape mutations of the Omicron variant, along with waning protection from previous vaccination and infection.3-5 During 2021, the infection-induced seroprevalence increased more in regions with low vaccination rates compared with those with high ones. The ability of SARS-CoV-2 variants to cause widespread transmission in the setting of high seroprevalence illustrates the value of COVID-19 vaccines, including recommended booster doses, to maximize protection.
FROM HOPINS SUGGESTIONS:
1. “…Published July 19 in Science, a study of spike protein function and neutralizing capability of 7 different SARS-CoV-2 vaccines against Omicron sublineages shows that a large number of the sublineage mutations lead to enhanced ACE2 binding and reduced plasma neutralizing activity. However, homologous or heterologous boosters markedly increased neutralizing antibody titers against BA.1, BA.2, BA.2.12.2, and BA.4/5 across all vaccines evaluated to provide sufficient protection against Omicron-induced severe disease. The vaccines evaluated included mRNA vaccines from Moderna and Pfizer-BioNTech, viral-vectored vaccines from J&J-Janssen, AstraZeneca-Oxford, and Sputnik V, as well as the Novavax and Sinopharm vaccines that use different platforms.
ADDITIONALLY FROM SCIENCE ARTICLE: ”…The recent evaluation of intranasal vaccine administration could also be important to not only prevent severe disease but also curtail viral infection and transmission through induction of mucosal immunity (75–78). For these reasons, it is important to monitor new variants, assess the effectiveness of currently available vaccines, and continue to test and implement new vaccination strategies that may provide stronger, longer lasting, or broader protection against SARS-CoV-2 and the entire sarbecovirus subgenus…”
2. US PANDEMIC PREPAREDNESS The administration of US President Joe Biden is reorganizing the US Department of Health and Human Services to elevate the Office of the Assistant Secretary for Preparedness and Response (ASPR) from a staff division into an independent operating division—similar to the US CDC, FDA, and NIH—responsible for leading the nation’s responses to future pandemics and health emergencies. Under the reorganization, ASPR will now be known as the Administration for Strategic Preparedness and Response, and efforts to stand up the new division will be phased in over the next 2 years. ASPR oversees the Strategic National Stockpile, the national Medical Reserve Corps, and contracts for and distribution of vaccines and certain medicines in health emergencies. Though many current and former HHS officials welcomed the move, other experts say that shifting some health emergency coordination responsibilities to ASPR could undercut response efficacy, create confusion and tension, and does not address ongoing challenges at CDC, which has much closer relationships with states.
3. Prior Omicron Infection Protects Against BA.4 and BA.5 Variants (Nature) The Omicron BA.4 and BA.5 subvariants of SARS-CoV-2 have proven to be stealthier at evading people’s immune defences than all of their predecessors. But recent research shows that previous infection with an older variant (such as Alpha, Beta or Delta) offers some protection against reinfection with BA.4 or BA.5, and that a prior Omicron infection is substantially more effective. That was the conclusion of a study that evaluated all of Qatar’s COVID-19 cases since the wave of BA.4 and BA.5 infections began1. The work, which was posted on the medRxiv preprint server on 12 July and has not yet been peer reviewed, feeds into broader research on “how different immunities combine with each other”, says study co-author Laith Abu-Raddad, an infectious-disease epidemiologist at Weill Cornell Medicine-Qatar in Doha.
”...this spike protein found in the blood could be a “biomarker,” specifically for long COVID…”
”… researchers still haven’t pinned down what causes the condition or how to treat it…..Now researchers may have found a marker for the disabling condition: a piece of SARS-CoV-2, the virus that causes COVID, floating around in the blood of some long COVID sufferers well after their initial infection… detecting a fragment of SARS-CoV-2 in blood samples from long COVID sufferers up to a year after their original infection. The fragment is a spike protein, one of the protrusions around the outside of SARS-CoV-2 that give this coronavirus its namesake corona, or crownlike appearance. During an initial COVID infection, the spike protein typically breaks off into smaller pieces when it penetrates human cells, but the spike proteins observed in this study were still in one piece. The findings have not yet been peer-reviewed….“If you had an infection, and you cleared it, then normally, you would not see [the spike protein] because all the antibodies you produced would clear everything that enters the bloodstream,… Instead, …tissues such as those in the gut and brain could be a haven for SARS-CoV-2 within the body, preventing long COVID patients from fully clearing their infections and acting as a source of spike proteins. “Maybe the virus can just persist there. It evades the immune system somehow.”……[A] “The presence of circulating viral proteins may be helpful to identify which subset of long COVID patients might have the persistent viral etiology”—the version of long COVID caused by the ongoing presence of SARS-CoV-2 in the body—…The rest of the long haulers might suffer from other causes.” These other causes could include… [B] an overblown immune response that leads COVID patients’ body to develop immune proteins—“autoantibodies”—that attack its own cells in the same way they would attack an intruder such as a virus or bacterium. These autoantibodies have been found in people’s body during an initial COVID infection, as well as in the bodies of some long COVID patients…. [C]Another possibility is that a COVID infection makes people more susceptible to other viruses already present in the body, such as the Epstein-Barr virus. This pathogen lies dormant in most people but has been found reactivated in some long COVID patients…
While there will likely be new COVID-19 variants to worry about in the future, omicron relative BA.2.75 is not the next big one to fret over, experts predict…
“BA.2.75 is a scariant. It’s not spreading anywhere besides a couple of provinces in India without BA.5 to compete with,” Eric Topol, MD, founder and director of the Scripps Research Translational Institute in San Diego, said in a July 19 tweet, citing a graph based on data from global data-sharing virus platform GISAID that indicates the strain hasn’t spread much outside of several states in India. “There will be other new variants to be concerned about, but it doesn’t look like this is one of them.”
YOU CAN HAVE A GOOD TIME WHILE BEING VERY CAREFUL AND WEARING YOUR MASK.
FROM THE NYT today:
(J. Harris: Notice the recent Covid counts in East Texas are markedly elevated. Fortunately, most of these folks do not require hospitilization — which means most likly that we now have the Omicron subvariants BA .4-.5 making a visit. I personally know several local and Texas people who have become ill this week.)
”…These data show that the BA.2.12.1, BA.4, and BA.5 subvariants substantially escape neutralizing antibodies induced by both vaccination and infection. Moreover, neutralizing antibody titers against the BA.4 or BA.5 subvariant and (to a lesser extent) against the BA.2.12.1 subvariant were lower than titers against the BA.1 and BA.2 subvariants, which suggests that the SARS-CoV-2 omicron variant has continued to evolve with increasing neutralization escape. These findings provide immunologic context for the current surges caused by the BA.2.12.1, BA.4, and BA.5 subvariants in populations with high frequencies of vaccination and BA.1 or BA.2 infection…”
2. SARS-COV-2 REINFECTION The newest Omicron subvariants of BA.4 and BA.5 are driving increases in new SARS-CoV-2 infections in several regions, with many people experiencing reinfections despite immunity from prior infection or vaccination (1+ shots). These subvariants appear to be able to evade antibodies more easily than their predecessors, possibly due to new and different spike proteins. Though global COVID-19-associated mortality appears to be decreasing, a new preprint study posted on Research Square cautions that reinfections pose an increased risk of hospitalization (HR 2.98), all-cause mortality (HR 2.14), and sequelae in pulmonary and other organ systems. The risk of these adverse outcomes—including those impacting the heart, blood, kidneys, lungs, and brain—were most pronounced in the acute phase of infection but persisted throughout the 6-month follow up. Additionally, for every reinfection (1, 2, 3+) there was a stepwise increase in risk for all sequelae evaluated, including hospitalization. Although not yet peer-reviewed, the study serves as a signal that the COVID-19 pandemic remains a threat to the health of the world’s population, and individuals must continue to take precautions to prevent infection.
Moderna expects to distribute its bivalent booster vaccine candidate by August and has already produced the doses as it awaits approval.
“We’ve been producing millions of doses over the last couple of months,” Moderna’s president, Stephen Hoge, MD, told the Financial Times. “We would hope to have tens of millions to hundreds of millions of doses available in August, September and October to support boosting prior to the fall respiratory virus season.”
The candidate boosted antibodies “5.4-fold above baseline” against omicron subvariants BA.4 and BA.5 among the phase 2/3 trial’s 800 participants, according to a June 22 press release. Moderna said it has “already shared these data” with regulators and, if authorized by the CDC and FDA, expects rollout to be this fall.
The subvariants accounted for almost 35 percent of COVID-19 cases as of June 18, according to CDC data. The week earlier, they caused 21.6 percent of cases.
Mexico reported 16,133 new COVID-19 cases in the country on Thursday, the highest daily number reported since late February, according to data released by the Health Ministry.
”…since the beginning, it has been clear that reported cases represent only a fraction of all SARS-CoV-2 infections….According to COVID-19 Cumulative Infection Collaborators findings, a staggering number of people, 3·39 billion (95% uncertainty interval 3·08–3·63) or 43·9% (39·9–46·9) of the global population, are estimated to have been infected one or more times between March, 2020, and November, 2021. Remarkably, this was before the highly transmissible omicron (B.1.1.529) variant swept the globe. These estimates of total infections are wildly different from the number of reported cases, which stood at 254 million as of Nov 14, 2021.3..COVID-19 Cumulative Infection Collaborators study also highlights vast regional discrepancies, painting a very different picture from that provided by reported cases. From case reports, one would conclude that the highest cumulative incidence was observed in Europe and North America and the lowest in Africa. However, this study estimated that 70·5% (61·6–75·9) of the population in sub-Saharan Africa has been infected with SARS-CoV-2, compared with 30·9% (28·8–32·8) of the population in high-income North America. Underlying this apparent reversal of patterns are stark differences in case detection; fewer than 1% of infections were reported as cases in sub-Saharan Africa whereas nearly half were reported in high-income North America. It is crucial that this underreporting is considered when we compare the impact of the pandemic and the effectiveness of responses among nations…..one could argue that the proportion of the population ever infected is no longer a meaningful metric of population immunity…how do layers of vaccine-induced and virus-induced immunity combine to confer protection to the population? Perhaps most importantly at this moment in the pandemic, we need to identify the sub-populations that remain susceptible to severe disease and death. Serosurveys combined with morbidity and mortality surveillance and detailed monitoring of vaccine coverage are essential to identify the groups lacking immunity from vaccination or previous infection.5, 6, 7 Integrating data enables the kinds of insights offered by COVID-19 Cumulative Infection Collaborators to inform the next phase of the pandemic response, and we should sustain this effort…”
(J. Harris: This Comment in Lancet is very readable and very sobering. It seem “the fat lady” hasn’t sung yet — if fact, she doesn’t even have the musical score yet. Hell.)
I WISH YOU A NICE WEEKEND, BUT DON’T TAKE UNNECESSARY CHANCES.
REPEAT COMMENTS FROM JUNE 8 NYT REGARDING BA .4 AND .5
”…Globally, the most recent data suggest that BA.4 and BA.5 still represent a relatively small share of cases, but that could change in the weeks ahead. In a recent report, the U.K. Health Security Agency noted that in many countries, the two subvariants were replacing BA.2 about as quickly as BA.2 replaced the original version of Omicron….The subvariants have become especially common in parts of the southern United States. In the region comprising Arkansas, Louisiana, New Mexico, Oklahoma and Texas, BA.4 and BA.5 account for more than one in five infections, according to the new figures….”
”…Latest trends IN LA FROM NYT
An average of 1,421 cases per day were reported in Louisiana in the last week. Cases have increased by 38 percent from the average two weeks ago. Deaths have increased by 38 percent..”
(J. Harris: Bossier and Caddo Parishes are right next door. They may test more there, but we
will be increasingly plagued by the new BA.4 and BA.5 variants. I have just been told that “BA” stands for Bad Ass in Norwegian.)
IF YOU HAVE HAD COVID BUT ARE STILL TEST POSITIVE, ARE YOU CONTAGIOUS?
1. The effectiveness of previous infection alone against symptomatic BA.2 infection was 46.1%
2. The effectiveness of vaccination with two doses of BNT162b2 and no previous infection was negligible , but nearly all persons had received their second dose more than 6 months earlier.
3. The effectiveness of three doses of BNT162b2 and no previous infection was 52.2%
4. The effectiveness of previous infection and two doses of BNT162b2 was 55.1%
5. The effectiveness of previous infection and three doses of BNT162b2 was 77.3%.
CONCLUSIONS:”No discernable differences in protection against symptomatic BA.1 and BA.2 infection were seen with previous infection, vaccination, and hybrid immunity. Vaccination enhanced protection among persons who had had a previous infection. Hybrid immunity resulting from previous infection and recent booster vaccination conferred the strongest protection.
(Most of the people with whom I confer, have had a total of 4 jabs of vaccine — and are waiting now for a recommendation for a new vaccine or a “mix and match” with existing vaccines.
ALSO FROM NEJM LETTER TO THE EDITOR:
In this study, we characterized infection-induced immunity and vaccine-induced immunity against newly emerged omicron subvariants. Booster vaccination provided sufficient neutralizing-antibody titers against the BA.4/5 and BA.2.12.1 subvariants, albeit to a lower extent than against BA.1 and BA.2.4,5 These findings underscore the importance of booster vaccination for protection against emerging variants.
FROM HOPKINS:
1. ACUTE HEPATITIS & LONG COVID Researchers from Israel published findings from their study on instances of long-term COVID-19 liver manifestation among children. The study, published in the Journal of Pediatric Gastroenterology and Nutrition, involved a retrospective investigation of 5 patients hospitalized in an Israeli children’s hospital. Each of the patients had a confirmed SARS-CoV-2 infection and presented with long-term liver injury stemming from their infection. Two of the patients in the study, both under 6 months of age, presented with acute liver failure, the other 3 patients, ranging between ages 8 and 13 years, presented with acute hepatitis and cholestasis.
This review adds to the growing list of evidence tying post-acute sequelae of COVID-19 (PASC/Long COVID) to cases of acute hepatitis of unknown origin. Last month, multiple technical and news media publications documented an international cohort of children with severe hepatitis. Many experts have suggested that COVID-19 could be a potential source for this unexplained manifestation, considering the lack of apparent epidemiological explanations. The US CDC is examining a series of US cases of acute hepatitis as well, and a recent update indicates that adenovirus type 41 could be a possible causative agent as well. While much has been written about Long COVID, many questions remain, and advocates continue to call for expanded research efforts into explanations and treatments.
2. BA.4 & BA.5 SUBVARIANTS IN EUROPE The European CDC published an epidemiological update on the emergence and prevalence of the BA.4 and BA.5 sublineages of the SARS-CoV-2 Omicron variant of concern (VOC). The subvariants were first detected in Europe in March, and in May, Portugal was the first European country to report a COVID-19 surge associated with one of the subvariants (BA.5). Notably, Portugal’s daily incidence appeared to peak in late May/early June. While most European countries have reported relatively low prevalence of these subvariants, they represent an increasing proportion of new sequenced specimens in multiple countries over the past several weeks, including Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Spain and Sweden. In particular, the BA.4 and BA.5 subvariants represent more than 25% of sequenced specimens in Belgium over the second half of May, and more than 10% in some communities in Spain. The increasing prevalence of BA.4/BA.5 corresponds to increasing COVID-19 daily incidence in most of those countries as well.
The ECDC projects that BA.4 and BA.5 will become the dominant variants across Europe “in the coming weeks” and that the continent can expect an associated COVID-19 surge like those in the countries noted above. The daily incidence in Europe has increased nearly 30% since June 6, with even larger increases in the UK. While there is “no evidence” these subvariants pose higher risk of severe disease, the ECDC notes that an overall increase in transmission can be associated with subsequent increases in hospitalizations and mortality.
J. Harris: So why is the USA reducing vigilance in travelers from Europe?
3. WASTEWATER SURVEILLANCE Researchers from the University of Illinois and University of Florida published (preprint) findings from a study on the implementation of neighborhood-scale SARS-CoV-2 wastewater surveillance systems. The COVID-19 pandemic has popularized wastewater surveillance as a tool to provide early warning of impending outbreaks; however, most of these efforts have focused on large-scale sewer systems. Neighborhood-scale systems can provide more targeted early warning capacity, but as the catchment population decreases, the volume of fecal matter is less consistent, which can make it more difficult to analyze the concentration of SARS-CoV-2 and accurately detect emerging outbreaks. This study covered 7 neighborhood-scale wastewater surveillance systems in Champaign County, Illinois, from January-November 2021, with catchment populations ranging from 853 to 2,402 individuals. In an effort to improve the system’s accuracy, the researchers developed a methodology to normalize the concentration of SARS-CoV-2 N gene fragments by the concentration of pepper mild mottle virus (PMMOV) detected in the system. The presence and concentration of PMMOV served as an analogue for the presence of fecal matter in the sample, which enabled the researchers to establish more accurate baseline metrics and better analyze the relative concentration of SARS-CoV-2. Based on the concentration of SARS-CoV-2 N gene fragments to PMMOV, the system output a binary risk assessment (ie, Low or High). Over the 11 months of the study, the 7 neighborhoods experienced 26 total local COVID-19 outbreaks, and the surveillance system identified High COVID-19 risk corresponding to 19 of those time periods (73% sensitivity). The system identified 17 total High-risk time periods, and 12 of those corresponded to local COVID-19 outbreaks (71% specificity). The researchers also indicated that the surveillance system was capable of providing sufficiently accurate risk assessment for specific variants of SARS-CoV-2, which could provide early warning of the geographic spread of variants of concern. This study provides evidence that smaller-scale wastewater surveillance systems can provide indication of increased transmission risk among specific communities, particularly during periods of relatively low local incidence
4. Newest Omicron Covid-19 Lineages Gaining Ground in United States (STAT News) The Omicron lineage BA.2 and its spinoff, BA.2.12.1, drove cases this spring, building into waves of infections in places like the Northeast and parts of California. Now, two other forms of Omicron, BA.4 and BA.5, are eating into the BA.2 group’s dominance. More than 1 in 5 Covid-19 infections last week were caused by BA.4 and BA.5, according to updated estimates posted by the Centers for Disease Control and Prevention. That’s up from 13% the week prior. The rest of the cases are from the BA.2 lineages. BA.4 and BA.5 are picking up speed because they’re able to evade the body’s antibody response even more so than other variants, meaning they’re very good at establishing infections in people who have some level of protection.
5. Pfizer Reports Additional Data on PAXLOVID (Pfizer) Today, we shared data from the Phase 2/3 EPIC-SR study evaluating the use of PAXLOVID™ tablets and ritonavir tablets in patients who are at standard risk for developing severe COVID-19. In previously reported interim analyses, the company disclosed that the novel primary endpoint of self-reported, sustained alleviation of all symptoms for four consecutive days was not met, and a non-significant 70% relative risk reduction was observed in the key secondary endpoint of hospitalization or death (treatment arm: 3/428; placebo: 10/426). An updated analysis from 1,153 patients enrolled through December 2021 showed a non-significant 51% relative risk reduction (treatment arm: 5/576; placebo: 10/569). A sub-group analysis of 721 vaccinated adults with at least one risk factor for progression to severe COVID-19 showed a non-significant 57% relative risk reduction in hospitalization or death (treatment arm: 3/361; placebo: 7/360).
6. How Months-long COVID Infections Could Seed Dangerous New Variants (Nature) Virologist Sissy Sonnleitner tracks nearly every COVID-19 case in Austria’s rugged eastern Tyrol region. So, when one woman there kept testing positive for months on end, Sonnleitner was determined to work out what was going on. Sonnleitner and her colleagues collected more than two dozen viral samples from the woman over time and found through genetic sequencing that it had picked up about 22 mutations. Roughly half of them would be seen again in the heavily mutated Omicron variants of SARS-CoV-2 that surged around the globe months later. “When Omicron was found, we had a great moment of surprise,” Sonnleitner says. “We already had those mutations in our variant.”
”There was no detectable increase in vaccination uptake among patients receiving text messaging compared with telephone calls only or behaviorally informed message content.”
”…A total of 411 myocarditis or pericarditis, or both, events were observed among 15 148 369 people aged 18–64 years who received 16 912 716 doses of BNT162b2 and 10 631 554 doses of mRNA-1273. Among men aged 18–25 years, the pooled incidence rate was highest after the second dose, at 1·71 (95% CI 1·31 to 2·23) per 100 000 person-days for BNT162b2 and 2·17 (1·55 to 3·04) per 100 000 person-days for mRNA-1273. The pooled IRR in the head-to-head comparison of the two mRNA vaccines was 1·43 (95% CI 0·88 to 2·34), with an excess risk of 27·80 per million doses (–21·88 to 77·48) in mRNA-1273 recipients compared with BNT162b2….Interpretation
An increased risk of myocarditis or pericarditis was observed after COVID-19 mRNA vaccination and was highest in men aged 18–25 years after a second dose of the vaccine. However, the incidence was rare. These results do not indicate a statistically significant risk difference between mRNA-1273 and BNT162b2, but it should not be ruled out that a difference might exist. Our study results, along with the benefit–risk profile, continue to support vaccination using either of the two mRNA vaccines.
”…Local public health experts don’t know exactly why the area’s hospitals are seeing so few COVID patients, but they suspect it’s a combination of COVID strains that cause less severe illness, widespread immunity, and possibly even Texas’ warm climate…..COVID cases are still climbing across North Texas. Dallas and Tarrant counties could each see more than 600 new infections daily in the next several weeks, according to a June 1 forecast from UT Southwestern….though North Texas is seeing few hospitalizations currently, that could change quickly. Immunity from previous infections and vaccinations can wane within months…..Anyone age 5 or older is eligible for booster doses of the COVID-19 vaccine. Children ages 5 through 11 can get a booster shot five months after the initial Pfizer vaccine series. People 12 or older who are immunocompromised can get a second booster at least four months after their first booster dose, while anyone 50 or older can receive a second booster in the same time frame…”
FROM JOHNS HOPKINS SELECTIONS:
1. NOVAVAX VACCINE The US FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is meeting today to discuss and vote on the question of whether the benefits of Novavax’s 2-dose SARS-CoV-2 vaccine outweigh the risks of use among adults. The Novavax vaccine uses decades-old technology, and a vaccine using more traditional technology could help fill gaps in vaccination coverage among those who are hesitant to be vaccinated with shots using newer mRNA technology. In clinical trials, the vaccine demonstrated 90.4% efficacy in preventing mild, moderate, or severe infections with older variants, and 100% efficacy in preventing moderate or severe infection. However, it is unclear how effective the vaccine is against currently circulating Omicron subvariants. There also are concerns over the risk of the heart conditions myocarditis and pericarditis associated with the vaccine, particularly among young men, outlined in a briefing document for the meeting. These rare occurrences of heart inflammation also are associated with the Pfizer-BioNTech and Moderna mRNA vaccines. Notably, there is not enough data to evaluate the Novavax vaccine for use among pregnant women, children, or immunocompromised individuals.
If VRBPAC recommends the vaccine and the FDA grants emergency use authorization, after also evaluating information about the company’s manufacturing processes, the vaccine will be the fourth authorized for use in the US and could be available later this summer.
2. Pregnant people are at an increased risk of severe COVID-19 outcomes, including death, and health experts recommend that pregnant people and those looking to become pregnant remain up to date on their vaccinations. Notably, vaccination of pregnant people likely has benefits to newborns, as well.
3. A new report, which is not yet peer-reviewed, estimates the US death toll of each variant. According to the researchers from Yale University and Public Citizen, nearly half of COVID-19 deaths (46%) have occurred after the ancestral strain of SARS-CoV-2 was replaced by variants. The research dispels the myth that Omicron causes less severe disease than previous variants. This year, more deaths have been among older adults, especially those in long-term care facilities. The research highlights the importance of continuing vaccination and other public health strategies as long as the virus is circulating and underlines the need for additional surveillance to detect the emergence of new variants.
4.” …An accepted manuscript by researchers in Israel published last week in Clinical Infectious Diseases evaluates the effectiveness of Paxlovid in a real-world setting among vaccinated and unvaccinated adults during Omicron variant predominance. According to the study, treatment with Paxlovid reduced the risk of severe COVID-19 or death by about half (46%) regardless of vaccination status, while up-to-date vaccination reduced the risk 80%. Notably, Paxlovid was more effective in older patients, immunocompromised patients, and those with underlying neurological or cardiovascular disease, and no interaction was observed between Paxlovid therapy and vaccination status.”
5. Pfizer to Invest $120 Million to Produce COVID-19 Oral Treatment in the U.S. (Pfizer) Pfizer announced today that it will further strengthen its commitment to United States manufacturing with a $120 million investment at its Kalamazoo, Michigan, facility, enabling U.S.-based production in support of its COVID-19 oral treatment, Paxlovid. The investment will expand the production of active pharmaceutical ingredient and registered starting materials used in the manufacture of nirmatrelvir, a novel main protease (Mpro) inhibitor originating in Pfizer’s laboratories. This investment is another major step in Pfizer’s effort to bring more key biopharmaceutical manufacturing to the U.S., increasing Pfizer’s capability to produce and supply treatments and medicines for patients in the U.S. and around the world.
6. The Omicron variant of concern (VOC) continues to account for essentially all analyzed SARS-CoV-2 samples worldwide. Together, the BA.2 sublineages represent 86.2% of all sequenced specimens last week***. Both the BA.4 (4.1%) and BA.5 (8.8%) sublineages are increasing in prevalence, and collectively, the BA.1 sublineage represents less than 0.2% of sequenced specimens last week. The WHO now categorizes the Delta VOC as “previously circulating,” joining the Alpha, Beta, and Gamma variants.
1. Novavax COVID vaccine gets backing of U.S. FDA advisers
Advisers to the U.S. Food and Drug Administration on Tuesday voted to recommend authorization of Novavax Inc’s COVID-19 vaccine for adults.
2. Novavax says COVID vaccine for U.S. to be manufactured by India’s Serum
Novavax Inc said on Tuesday that its COVID-19 vaccine initially available in the United States, if authorized, will be manufactured by the Serum Institute of India.
3. Omicron sub-variants BA.4 and BA.5 account for up to 13% of COVID variants in U.S. – CDC
The BA.4 and BA.5 sub-variants of Omicron are estimated to make up nearly 5% and 8% of the coronavirus variants in the United States as of June 4, the U.S. Centers for Disease Control and Prevention (CDC) said on Tuesday.
”…But Covid cases could be undercounted by a factor of 30, an early survey of the surge in New York City indicates. “It would appear official case counts are under-estimating the true burden of infection by about 30-fold…”
(J. Harris: Readable. Contains some food for thought.)
”… Concerns about the high frequency of myocarditis in athletes infected with SARS-CoV-2, and the possibility of life-threatening arrhythmias, led to various protocols and the development of prospective registries. In the current study, the Outcomes Registry for Cardiac Conditions in Athletes Study Group prospectively followed 3675 athletes from 45 colleges and universities to assess their risk for adverse cardiovascular events after SARS-CoV-2 infection…Cardiovascular testing including electrocardiogram, troponin, echocardiogram, or cardiac magnetic resonance imaging was performed in 97% of athletes. Definite or probable myocarditis was found in 21 athletes (0.6%), who were temporarily restricted from sport and later cleared to resume...
During a median follow-up of 1.2 years among all athletes, only two cardiac events occurred (incidence rate, 0.05%). One was a cardiac arrest in an athlete subsequently discovered to have a preexisting genetic structural cardiac disease, and the other was atrial fibrillation that was possibly related to SARS-CoV-2 infection.
”…By the time the US Food and Drug Administration convenes a meeting late this month to discuss plans for updating booster shots in the fall, more than 200 days will have elapsed since Moderna and Pfizer began working on their Omicron vaccines…So what’s the holdup?…. reasons for the delay. To start, the virus keeps changing too quickly. There’s also conflicting data on the superiority of variant-specific boosters over what’s already available, casting doubt on their value. And with the majority of Americans yet to get even their first booster shot, the companies’ financial incentive for making new ones has diminished….In theory, designing the new vaccine is a simple matter of tweaking its mRNA sequence to match the genetic code of Omicron — But making enough of the vaccine to begin clinical trials takes at least several weeks…“Having the variant-specific vaccine only makes sense if that variant persists for a long enough period of time to vaccinate people against it…Running clinical trials to test the safety and efficacy of the shots is the most time-consuming step of vaccine development ― regulators need to be sure that the updated shots are safe…Although the Omicron boosters triggered somewhat higher antibody levels against that variant, Although the Omicron boosters triggered somewhat higher antibody levels against that variant, the original booster also worked fairly well…
In March, Moderna began testing a so-called bivalent booster that contains mRNA for both the original coronavirus and the Omicron strain — an effort to “hedge your bets” against the evolving virus, Thackray said. The FDA’s vaccine advisory committee will likely debate the relative merits of the original, Omicron, and bivalent boosters when it meets at the end of the month….But if the updated vaccines are not markedly better, companies may lack the financial incentive to actually produce them…And given that less than half of vaccinated Americans and fewer than one-third of all people in the United States have yet to get their first booster shot, the lack of urgency to make second-generation boosters probably shouldn’t come as a surprise……Throughout the pandemic, health officials have stressed that the goal of the vaccines is to prevent serious disease, hospitalization, and death. “I would argue that we’ve achieved that goal with the [existing] ancestral vaccine,”..“We are going to have to get used to mild and moderate infection and have a reasonable goal for this vaccine, because we are driving people crazy,…There is already booster fatigue.”…
AND LASTLY:
Milton and the Norwegian both assure me that it will rain today!
***********************************
GIVE US YOUR FEEDBACK. CLICK ON “COMMENT” TO TELL US WHAT YOU THINK or use one of the alternative methods for providing feedback.
”…Question Are neutralizing antibodies against the Omicron variant of SARS-CoV-2 sufficiently induced after 2 to 3 doses of the BNT162b2 messenger RNA vaccine in recipients of different ages?
Findings In this cohort study of 82 Japanese participants, 28% and 6% had neutralizing antibodies against the Omicron variant at 2 and 7 months, respectively, after 2 doses of the vaccine; both titer values were low in all age groups. After receiving a booster vaccination, all participants acquired much higher levels of neutralizing antibodies irrespective of age….Meaning This study suggests that booster vaccination was associated with induction of higher levels of neutralizing antibodies against the Omicron variant, irrespective of the recipient’s age.
”…Subtle variations in immune responses to the mRNA-1273 (Moderna) and BNT162b2 (Pfizer-BioNTech) COVID-19 vaccines suggest that each may confer somewhat different protection, according to a study in Science Translational Medicine. This could mean that a mix-and-match booster strategy might increase protection against future variants and could have implications for future therapy development…”
2. LONGCOVID ARTICLE: From The Lancet Respiratory Medicine, a study of nearly 1,200 individuals hospitalized with COVID-19 in Wuhan, China, followed up at 6 months, 12 months, and 2 years post-discharge to determine the persistent health effects of COVID-19. While physical and mental health improved over time, 68% of participants reported experiencing at least 1 original COVID-1 symptom at 6 months, and 55% reported at least 1 original symptom 2 years later. Around half of participants had symptoms of long COVID such as fatigue and sleep difficulties at 2 years, and those participants reported poorer quality of life, reduced ability to exercise, more mental health problems, and increased use of healthcare services than those without long COVID symptoms. Additionally, recovered patients tended to be in poorer health 2 years after discharge compared with the general population.
”… based on small numbers of infections with the Delta variant among the participants, the researchers estimated that the vaccine had an efficacy of 88 percent against infection.”
”…They were infected with the BA.2 subvariant of the virus, it said….The country declared a “maximum emergency” and ordered all cities and counties in the nation of 25 million to lock down, and told them to isolate “each working unit, production unit and residential unit from each other.”…The danger posed by the Covid outbreak is greater in North Korea than in most other nations because most of its people are unvaccinated. …North Koreans are chronically malnourished and unvaccinated, there are barely any medicines left in the country, and the health infrastructure is incapable to deal with this pandemic,…Hours after admitting to the outbreak on Thursday, North Korea launched three ballistic missiles from near Pyongyang toward the sea off its east coast…”
(J. Harris: N. Korea and probably China will continue to have a widespread dangerous Covid vulnerablity.)
”…Many people in Shanghai have written on social media about the collateral damage of confinement rules, including many patients with chronic and non-COVID-19-related diseases losing their access to medical care….. “COVID-19 has become a highly politicised disease in China, and any voice advocating for the deviation from the current zero-COVID path will be punished”, one official said…lack of protection in the groups most susceptible to severe disease makes it difficult for China to change its policy safely. “It’s mind boggling that for the most part of the last 2 years, China has had very few cases but has failed to fully vaccinate the elderly, who are at the most risk of getting infected and developing severe symptoms from the virus”…“Experience in Singapore demonstrates that a safe exit from zero COVID is possible if vaccine coverage in older adults can reach a very high level”……vaccine hesitancy has been fostered by the lack of urgency to get vaccinated in China. China’s control of COVID-19 gives citizens fewer reasons to get vaccinated, especially when there was widespread misinformation on the side-effects of vaccines such as frequent heart attacks and severe allergies. The [FAULTY] logic goes: there is no need to get vaccinated when there is no virus in the first place….”
”With the influenza season due to begin soon after the party Congress, the timeline for China’s reopening is murky at the best. “The earliest possible time for China to drop the current measures is early next year, and even that has no guarantee whatsoever…’Stepping up vaccination among older people while strengthening the health-care sector is an absolute “prerequisite”, …Informing the public about the changing nature of infection—the decreased severity of the B.1.1.529 (omicron) variant and the reduced risks following vaccination—will also be needed. One argument frequently used by the Government and those who stand by the zero-COVID strategy is that …[IF AND WHEN] the policy is relaxed, the health-care system will soon be overloaded and there will be an unmanageable increase in deaths. To tackle this issue, experts have proposed solutions that are aligned with international practice. Chen said that the Government should start drafting regulations or guidelines on the treatment of patients with varying degrees of severity, with the aim of not admitting everyone infected with the virus to hospital (as previously required) by asking for home quarantine, and leaving hospital and intensive care unit beds for those who need them most. “If you can prohibit millions of people from stepping out of home during a lockdown, then there really is no merit to the argument that you can’t ask people with mild symptoms to not visit hospitals…”
AND LASTLY:
”If you find yourself feeling useless, remember it took 20 years, trillions of dollars, and four presidents to replace the Taliban with the Taliban.”
***********************************
GIVE US YOUR FEEDBACK. CLICK ON “COMMENT” TO TELL US WHAT YOU THINK or use one of the alternative methods for providing feedback.
iEXPOSED.us Blog 
