There is too much information in this mailout, but some really good stuff hit the desk today. Texas is no longer compiling or providing detailed Covid information for daily release. Take your time and just read a couple of articles a day over the long holiday. Have a nice Holiday, perhaps our last bad Covid holiday?
”…Geoffrey Cumming, who made a global fortune in oil and gas, as well as solar power investments and management, is putting up what is purportedly the largest ever gift to medical research in Australia to create the Cumming Global Center for Pandemic Therapeutics. Stunned by the economic and political impact of COVID-19, he “wanted to do something to protect the world in the next pandemic,” says James Angus, a former dean of medicine at the University of Melbourne and a friend of Cumming…”
”…Overall, we found that breakthrough infections with the BA.5 subvariant were less likely among persons with a previous SARS-CoV-2 infection history in a highly vaccinated population, especially for previous BA.1 or BA.2 infection, than among uninfected persons…”
(J. Harris: From Portugal study of highly vaccinated population. Suggests to me that the new vaccine should be helpful.)
(J. Harris: An alternative to genetically engineered vaccines)
1. “…UNITED STATES
The US CDC is reporting 94.3 million cumulative cases of COVID-19 and 1,040,314 deaths. Average daily incidence continues to decline, down from the most recent high of 129,363 new cases per day on July 21 to 88,286 on August 30—the lowest average since May 12. Average daily mortality continues to decline, down to 383 on August 30 from a recent high of 486 on August 12….
”…United Kingdom-based AstraZeneca plc announced today that Evusheld, a long-acting antibody combination, has been approved in Japan for both prevention and treatment of symptomatic COVID-19 disease caused by SARS-CoV-2 infection….
The decision by Japan’s Ministry of Health, Labour and Welfare (MHLW) marks the first global marketing approval for Evusheld (tixagevimab and cilgavimab) as a treatment for COVID-19.
We stopped and explored the St. Giles Cathedral during our Royal Mile walk. The Cathedral stands out in my mind for two reasons: 1) the purpose of the Thistle Chapel and 2) the carvings within the Chapel.
History says a church has stood on this spot since 854 but the Cathedral building mostly dates from the 15th – 19th century. A primary reason for very little of the first churches remains being available to view is invading English armies torched these churches twice in the 1400s. St. Giles was built as a Catholic church but today is considered the primary church of the Church of Scotland and the “Mother Church of Presbyterianism”.
The Reformation reformer John Knox (1514 – 1572) preached his sermons from St. Giles. Knox led the Scottish change from Catholicism to Protestantism. The Scottish Parliament in 1560 decreed Scotland was a Protestant country. Knox also played a role in the dethroning and eventual beheading of Mary Queen of Scots. In today’s world Knox would be called misogynistic but in his time he held the common (male) thought that women were not capable of being leaders, etc.
1. INCUBATION PERIOD According to a study published August 22 in JAMA Network Open, the incubation period of COVID-19 has decreased gradually as SARS-CoV-2 has continuously evolved and mutated, producing variants with different enhanced transmission and virulence. The incubation period is the interval between exposure and development of symptoms and is an important epidemiologic indicator for understanding transmission. Based on the authors’ meta-analysis, the initial “wild type” strain first detected in Wuhan, China, in 2019 had an incubation period of approximately 5.2 days. Later in 2020, the Alpha variant that quickly became dominant in the UK had an incubation period of about 5 days. The Beta variant was identified shortly after and showed a shortened incubation period of 4.5 days, followed by the Delta variant with 4.41 days. The incubation period for Omicron infection is currently 3.42 days. While a decrease in incubation period often is associated with more severe disease, the decrease with COVID-19 means it makes it much more difficult to control transmission, because the faster someone becomes contagious, the faster an outbreak spreads. Knowledge of this key epidemiological parameter is helpful not only in reducing local transmission but also in understanding presymptomatic transmission.
2. PAXLOVID REBOUND The US FDA has requested that Pfizer conduct a study examining an extended course of its antiviral Paxlovid among individuals who experience a rebound of COVID-19 after taking an initial 5-day course. The FDA wants to know if a second 5-day course of the antiviral would help prevent disease rebound, and has requested that Pfizer produce initial results of such a trial by September 30, 2023. While Pfizer claims that disease rebound following Paxlovid treatment remains rare, several high-profile cases have prompted the FDA’s request for further study into the phenomenon.
3. US BOOSTER CAMPAIGN Following recent news regarding the authorization of variant-adapted SARS-CoV-2 vaccine boosters in the UK and applications for emergency use authorization (EUA) of BA.4/BA.5 boosters in the US (both Pfizer-BioNTech and Moderna), US government officials have signaled that variant-adapted booster doses could be available for individuals aged 12 years and older by early September. The bivalent vaccines will target both the original strain of SARS-CoV-2 and both the BA.4 and BA.5 sublineages (since they share common mutations to the spike protein).
While human clinical trials have not yet been conducted, the agency’s Director of the Center for Biologics Evaluation and Research (CBER), Dr. Peter Marks, indicated that he is “extremely confident” that the trials will demonstrate the candidate boosters to be safe and efficacious. In contrast to regulatory review of previous SARS-CoV-2 vaccine candidates, the FDA is not waiting on the completion of human clinical trials. Rather, the agency will base their assessment primarily on data from animal models and previous clinical trial data on BA.1-adapted bivalent candidate vaccines, a process similar to how the FDA reviews seasonal influenza vaccines. Clinical trials for the candidate boosters in humans are expected to begin this month. Reportedly, the FDA does not intend to convene its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss the candidate boosters; however, the CDC’s Advisory Committee on Immunization Practices (ACIP) has tentatively scheduled a meeting for September 1-2 in anticipation of a FDA decision.
Some experts have expressed doubt regarding the need for a BA.4/BA.5-specific booster, as it may provide little additional protection for the millions of people who have already been exposed to one of those variants. Similarly, antibodies generated to protect against BA.4/BA.5 may not provide sufficient protection against other emerging variants, such as BA.2.75. While some experts are concerned that the abbreviated regulatory review risks increasing vaccine hesitancy and mistrust among the public, others argue that it is critical to make variant-adapted boosters available quickly, to provide protection before the virus evolves further and new variants emerge.
(J. Harris: I plan to follow this vaccine closely.)
4. Moderna sues Pfizer and BioNTech over coronavirus vaccine patent(Washington Post) Moderna sued Pfizer and its German partner BioNTech on Friday, alleging the rival firms improperly used its foundational technology in developing their coronavirus vaccine. The suit sets up a legal battle between the most prominent companies that helped curb the coronavirus pandemic in the United States by developing highly effective shots in record time. “We believe that Pfizer and BioNTech unlawfully copied Moderna’s inventions, and they have continued to use them without permission,” Moderna Chief Legal Officer Shannon Thyme Klinger said in a company news release. The company said it filed suits in U.S. District Court in Massachusetts and in Germany, where BioNTech is headquartered.
”…Among patients 65 years of age or older, the rates of hospitalization and death due to Covid-19 were significantly lower among those who received nirmatrelvir than among those who did not. No evidence of benefit was found in younger adults.”
”…we might finally be getting inoculations that are well matched to the season’s circulating strains…..America is still stuck on … two very shaky assumptions, perhaps both doomed to fail: that the shots can and should sustainably block infection, and that “people will actually go and get the vaccine,..In terms of both content and timing, the fall shot will be one of the most important COVID vaccines offered to Americans since the initial doses… COVID vaccines, like most others, are best at staving off severe disease and death; against BA.5 and its kin, especially, that protection is likely to be durable and strong. But those same shields will be far more flimsy and ephemeral against milder cases or transmission, and can only modestly cut down the risk of long COVID. And when partnered with a compromised or elderly immune system, the shots have that much less immunological oomph…The U.S. needs people to take this vaccine because it has nothing else. But its residents are unlikely to take it, because they’re not doing anything else…Shots, to be abundantly clear, are essential to building up a properly defensive anti-COVID wall. But they are not by themselves sufficient to keep invaders out. Like bricks stacked without a foundation or mortar, they will slip and slide and crumble. Nor is a wall with too few bricks likely to succeed: If the goal is to preemptively quell a winter case surge, “a booster that will have maybe 30 to 40 percent uptake is not something we can expect to have a huge population-level impact,..”
(J. Harris: My personal plan is to take one of the modified vaccines even though they have not been well studied on humans. The basic vaccine has been studied and it works and is as safe as most any other vaccine. I don’t know if I will “Mix and Match” and take Moderna after have had 4 jabs of Pfizer with satisfactory results.)
NORWEGIANS ON VACATION
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Yesterday was a Rest Day – I went to the grocery store and Nancy did laundry and we both caught up on emails, reading and resting. Our one-bedroom apartment is large, contemporary in furnishings, and comfortable with lots of windows.
Today we have decided to tackle the Royal Mile using Rick Steves as our guide or at least his tour outlined in his guidebook. We Uber’ed to Edinburgh Castle to save our legs for a long day of walking.
Mistake on my part was I didn’t make a ticket reservation for Edinburg Castle and no tickets were available for the following three days we would be here. Reservations is a way of travel in the UK – damn.
I like the justice system for determining witches. If accused, you were tied up and thrown into a swampy lake. If you sank (and drowned) you were innocent. If you floated, you were guilty of being a witch and burned at the stake.
” …What’s next? One Omicron subvariant, called BA.4.6, is taking hold in the U.S. It doesn’t have a mutation on the spike protein, but another mutation is giving it a slight advantage, causing a very slow take over. We don’t think this will cause a wave, but BA.4.6 may become dominant…
(J. Harris: She has nice, brief summaries which are understandable and seem accurate to me. )
1. Omicron-specific Covid booster shots are just weeks away. Here’s who will—and won’t—be eligible(CNBC) Newly updated Covid booster shots designed to target omicron’s BA.5 subvariant should be available within in the next three weeks. That begs an important question: Who’s going to be eligible to get them? The short answer: anyone ages 12 and up who has completed a primary vaccination series, a Centers for Disease Control and Prevention spokesperson tells CNBC Make It. It’s unlikely to matter whether you’ve received any other booster doses or not before, the spokesperson says — but if you’re unvaccinated, you won’t eligible for the updated formula until you complete a primary series with the existing Covid vaccines.
We overslept this morning – I set my alarm for 7:30 PM instead of 7:30 AM. I was awake about two minutes before the owner of the Horse and Hound knocked on our door at 9:00 AM letting us know we were late for breakfast. However, by 10:00 we were driving the winding single lane roads with abbeys to see and Edinburgh to sleep as our goals for the day.
We enjoyed the Horse and Hound Pub because of its name not its small room. However, we thought the small room was a great room because it was the only room within 25 miles or more that was available to two Americans who aren’t used to making reservations more than 24 to 48 hours in advance. The pub had beer and pub food which means the beer was good and the food was OK.
Leaving Horse and Hound we had less than an eight-mile journey which I drove in less than 30 minutes. What was amazing about this trip was I made no wrong turns and there was a parking space in front of the abbey ruins – I am not sure which was the bigger miracle.
J. Harris: Anyone can sign up for Hopkins viral sites. Free! They are quick to read and very thorough and the most complete and extensive source of information. They send out news several times per week. We haven’t talked about Hopkins’ services to humanity in the last couple of years.
FROM HOPKINS SUGGESTIONS:
1. In an Effort to Address its Missteps During Covid, CDC Plans an ‘Ambitious’ Agency Overhaul(STAT News) The Centers for Disease Control and Prevention, an agency that has had its reputation battered by a series of missteps in the Covid-19 pandemic, and a slow response to the monkeypox outbreak, will undergo an “ambitious” overhaul, Director Rochelle Walensky announced Wednesday. In an email to staff, Walensky said the renewal effort will focus on making the agency more nimble and responsive to needs that arise in health emergencies. The priority will be to gather data that can be used to rapidly dispense public health guidance, rather than craft scientific pape
”A tuberculosis vaccine that’s 100 years old and costs less than a dollar per dose could have a shot at preventing COVID-19 infections, according to researchers from Boston’s Massachusetts General Hospital…
In a 15-monthslong trial conducted before COVID-19 vaccines were available, the researchers administered three jabs of the Bacillus Calmette-Guerin vaccine, which was first introduced in 1921, to 144 patients with Type 1 diabetes. The vaccine garnered 92 percent efficacy, according to an Aug. 16 press release….
The results, which are published in the Cell Reports Medicine journal, also showed high efficacy in combating other infectious diseases. The researchers hope to start a larger trial to further test the tuberculosis vaccine’s efficacy among patients with Type 1 diabetes, a group that has a high risk for severe illness from COVID-19.”
”…some parents and experts are trying to improve ventilation in schools, since better air quality in buildings can reduce COVID-19’s spread and even improve other health outcomes. But, despite readily available resources—including millions of dollars in funding from the federal government—many schools have not invested in upgrading their air quality…. experts recommend that classroom ventilation meets the threshold of six air changes per hour, meaning new, clean air is circulating through the room every ten minutes. …School leaders need to learn more about air quality issues in order to understand how important they are, experts say. Even if an administrator recognizes the value of better ventilation, they likely need to hire an HVAC expert to examine existing building systems, then vet that expert’s recommendations and evaluate potential upgrades—all of which may be “far beyond their area of expertise..”
(J. Harris: In my medical opinion, this young Ph.D epidemiologist is wise beyond her years. She writes beautifully while clearly exploring and explaining pertinent and practical medical and public health issues. My highest compliment is “ELEGANT,” and she is.)
FROM HOPKINS SELECTIONS:
1. COVID Rebound is Surprisingly Common — Even without Paxlovid(Nature) After the game-changing COVID-19 antiviral Paxlovid began to be used in late 2021, researchers noticed a perplexing trend. In some people taking the drug, symptoms and detectable virus vanish, only to mysteriously return days later. After months of grasping at straws, scientists are beginning to make some headway in understanding ‘Paxlovid rebound’. Two recent studies suggest that it is surprisingly common for SARS-CoV-2 to return in untreated cases of COVID-19, while hinting that the virus’s comeback is fiercer and more common in people who take Paxlovid.
2. Covid Vaccine Designed to Target Two Variants Approved for Use in UK(The Guardian) A vaccine designed to target two different forms of Covid has been approved by the UK regulator for use as booster jabs in people over the age of 18. Manufactured by the US firm Moderna, the vaccine targets not only the original coronavirus – as is the case for vaccines currently in use – but is designed specifically to target the Omicron variant BA.1, which fuelled a wave of Covid in the UK last winter. The UK is the first country to approve the bivalent vaccine, known as “Spikevax bivalent Original/Omicron”. It is now up to the UK’s Joint Committee on Vaccination and Immunisation (JCVI) to decide whether it will, as expected, be used in the planned autumn booster programme, expected to begin in September.
Tests for dementia were rescored under the N.F.L.’s concussion settlement to avoid race-based criteria.
Dozens of Black retired N.F.L. players will now be eligible for payouts worth hundreds of thousands of dollars from the league’s billion-dollar concussion settlement, reversing previous decisions made because of cognitive tests that used race-based measures to determine whether the players had dementia.
The decision, included in a status report filed by the settlement administrator that was entered into the court docket Thursday, came two years after two former players sued the league to end the use of race as a criterion in evaluating the players’ claims, a process known as “race-norming.”
The settlement administrator found that 646 players who had been tested for dementia but did not qualify for cash payouts could have their tests automatically rescored without using race as a criterion.
Of those, 61 were found to have moderate or severe dementia and may receive payouts worth $500,000 or more. The payouts vary based on a player’s age and the number of years he was in the league.
Another 246 former players were found to have mild dementia and will receive additional testing to monitor their conditions. Thousands of other players have qualified for examinations that will not use race as a factor; these players could qualify for payouts in the coming months and years.
The results were the latest chapter in the landmark concussion settlement that has resulted in about $1 billion in claims being paid to players with a range of cognitive and neurological diseases including dementia. For years, former players and their families have accused the league of making it difficult, if not impossible, to receive payouts from the settlement, and they have claimed that the plaintiffs attorney who represents every player in the class-action settlement was not doing enough to fight for them.
”...While the CDC did away with quarantine recommendations, the new guidance says people exposed to COVID-19 should wear a high-quality mask for 10 days and get tested on day five…he new COVID-19 recommendations focus on mitigating the risk of severe disease, rather than infection itself…We’re in a stronger place today as a nation, with more tools — like vaccination, boosters and treatments — to protect ourselves and our communities, from severe illness from COVID-19…This guidance acknowledges that the pandemic is not over but also helps us move to a point where COVID-19 no longer severely disrupts our daily lives.”
FIVE CDC UPDATES
1. The guidance underscores the importance of staying up to date with vaccination, “especially as new vaccines become available.” Omicron-targeted vaccines are expected to be available in the fall.2. The six-foot standard for social distancing is no longer an explicit recommendation. The guidelines place less emphasis overall on physicial distancing as a key measure to avoid exposure, instead describing it as “just one component of how to protect yourself and others.” The updated recommendations place more onus on individuals to assess the risks and take more precautions in particular settings, such as crowded indoor spaces.
3. The CDC no longer recommends routine screening of people without symptoms in most community settings, including schools4. Isolation guidance for people with COVID-19 remains the same: Isolate for at least five days at home and wear a high quality-mask when around others. Isolation may be ended after five days if a person is fever-free for 24 hours without medication and symptoms are improving, though a mask should be worn through day 10. Immunocompromised people and those who had more severe illness should isolate through day 10.
5. The FDA on Aug. 9 released a safety alert advising people to perform repeat testing to avoid false negative results when using at-home rapid antigen tests. If a symptomatic person tests negative, they should test again 48 hours later. People without symptoms who may have been exposed should take up to three tests after receiving their first negative result, each separated by a 48-hour period….Be aware that at-home COVID-19 antigen tests are less accurate than molecular tests,” the FDA said. “COVID-19 antigen tests may not detect the SARS-CoV-2 virus early in an infection, meaning testing soon after you were exposed to someone with COVID-19 could lead to a false-negative result, especially if you don’t have symptoms. This is the reason why repeat testing is important.”
1 Omicron Subvariants Gain More Ground, Including BA.4.6 in the Midwest (CIDRAP) Though the 7-day average for new daily COVID-19 cases is slowly declining, the more transmissible and immune-evasive Omicron subvariants became even more dominant last week, with an offshoot called BA.4.6 gaining traction in some Midwestern states. Health officials brace for a possible spike in activity after school starts and people begin gathering more indoors in the fall. In its weekly variant proportion updates, the U.S. CDC said the proportion of BA.5 viruses in sequenced samples last week rose from 84.5% to 87.1%, while BA.4 declined slightly, from 8.2% to 6.6%. However, the proportion of BA.4.6 viruses rose from 4.2% last week to 4.8% this week. The subvariant has also been reported in other US regions, especially in the east.
2. Community transmission in the US is primarily driven by the Omicron BA.5 sublineage. BA.5 is now projected to account for 87.1% of sequenced specimens. The BA.4 sublineage accounts for about 6.6% of cases, while the BA.4.6 sublineage accounts for 4.8% of cases. Together, BA.2.12.1 and BA.2 now account for only about 2.9% of cases. According to the estimate, Omicron variants represent all new cases in the US.
3. EDUCATORS MIGHT NOTE:
INDOOR AIR WORKSHOP The Environmental Health Matters Initiative (EHMI) of the National Academies of Sciences, Engineering, and Medicine will host its first virtual workshop in a 3-part series on Indoor Air Management of Airborne Pathogens on August 18 from 11:30 am to 3:30 pm EDT. These workshops—follow ups to the 2020 workshop on the airborne transmission of SARS-CoV-2—will explore strategies needed for airborne disease control and risk reduction in enclosed places by drawing on accumulated community and institutional knowledge, on-the-ground observations of indoor environments management during the pandemic, and novel and promising scientific discoveries. For more information and to register, visit https://www.nationalacademies.org/event/07-21-2022/indoor-air-management-of-airborne-pathogens-lessons-practices-and-innovations.
4. IMMUNE EVASION Immune escape, or immune evasion, is driving the COVID-19 pandemic’s extended life cycle. As the virus continues to infect humans, it will mutate and likely adapt to find its way around existing levels of vaccine-induced and natural immunity. The scientific community is not surprised that SARS-CoV-2 continues to evolve to evade our ever-changing immune systems, as many other viruses do the same. But because SARS-CoV-2 is a new virus to humans, attention is focused on emerging new variants and global anxiety is heightened, wondering what variant lies around the corner.
Currently, there are many questions about whether the Omicron subvariants BA.2.75 or BA.4.6 will cause the next wave of infections. BA.2.75, which has been circulating widely in India for more than a month and has been detected in at least 20 other countries, does not currently appear likely to outcompete BA.5, the global leader of SARS-CoV-2 variants. BA.4.6, which is growing in prevalence in the US and Europe, appears to be just as transmissible as BA.2.75, but it remains unclear whether either subvariant will become predominant. Scientists continue to worry that either one of these Omicron subvariants, or an as-yet undetected variant, could gain global, regional, or local dominance. This cycle of new variant-driven waves, each with increased immune evasion, describes the global experience with COVID-19 to date, and many assume the pattern will continue into the future. This is what allowed BA.4 and BA.5 to spread widely despite widespread recent infections with the Omicron BA.1 and BA.2 subvariants.
In addition to increased variant surveillance, more must be done to help further prepare for future increases in COVID-19 cases. The first priority is to address current infections by reducing transmission of circulating virus, limiting its chances to adapt and evade existing levels of immunity. However, limiting transmission is increasingly challenging, as many countries roll back mitigation measures and as funding for testing and vaccination programs dwindles. Many appear to be placing hope in the next generation of SARS-CoV-2 vaccines, which are expected to protect against a wider array of viral lineages. Several studies, including one conducted in non-human primates published this week in Science Translational Medicine, suggest that these vaccines may be a possibility, and they may be able to provide protection that extends to other coronaviruses, so-called pancoronavirus vaccines. While those vaccines remain a distant goal, manufacturers continue to work on current vaccine platforms that enable the fast production of variant-specific boosters. The CEO of Moderna recently compared the future of SARS-CoV-2 vaccines to the iPhone’s constant updates, with new generations developed as more data and technologies become available.
5. NOVAVAX VACCINE Last month, the US FDA granted emergency use authorization (EUA) for a protein-based COVID-19 vaccine made by US-based manufacturer Novavax. Many public health advocates hoped that the vaccine’s authorization would lead to an increase in vaccinations among unvaccinated populations, having faith that the more traditional protein-based vaccine technology would ease concerns surrounding vaccination with vaccines using newer mRNA platforms. However, in the month since the EUA was issued, only about 7,400 doses have been administered in the US, with only 2,300 people receiving a 2-dose primary series using Novavax. According to the US CDC, 332,000 doses of the vaccine have been distributed nationwide. Originally, the vaccine was available at only 385 locations, although that number has grown to 986 sites. Notably, more than 53,000 locations have been used to provide other vaccinations throughout the pandemic. The limited uptake of the Novavax vaccine has received criticism given the large investment the company received from Operation Warp Speed. While it is too early to decide the fate of the vaccine in the US, Novavax recently reset its sales expectations, halving its forecast to US$2 billion to US$2.3 billion from US$4 billion to US$5 billion.
AND LAST BUT NOT LEASED:
THE NORWEIGIAN REPORTS 1.5 INCHES OF RAIN. WHO SAYS PRAYER WON’T HELP.
NEVER MIND. DON’T ANSWER THAT.
”THE DEVIL MADE ME DO IT:”
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