CORONAVIRUS INFO PROVIDED BY DR. JIM HARRIS – 7/6/2022

MY MAIL SERVER MAY HAVE FAILED TO SEND THIS OUT YESTERDAY? I CAN’T TELL FOR SURE.

UP TO DATE AREA COUNTS: We still have lots of Covid but not in the hospitals. 

FROM THE NYT: GOOD NEWS:

A cancer drug greatly reduces deaths in hospitalized Covid patients.

”…A number of antiviral drugs have proved effective at keeping Covid patients out of the hospital, but only if they’re given early in the course of their disease. Paxlovid, for instance, can reduce the risk of hospitalization for unvaccinated people with Covid risk factors by about 90 percent…Sabizabulin blocks cells from building microtubules, critical molecular cables that shuttle material from one part of the cell’s interior to another…In the latest trial, 134 volunteers received sabizabulin and 70 a placebo. Over the course of 60 days, the death rates of the two groups were significantly different: 45.1 percent of the placebo group died compared with just 20.2 percent of those who received the new drug. That difference translated to a 55.2 percent reduction in the risk of death.…he trial was relatively small, with just 134 patients receiving the drug. …The patients were allowed to simultaneously receive other treatments that have been shown to be effective at saving lives of hospitalized Covid patients. A steroid called dexamethasone, for example, reduces the risk of death by one-third….For hospitalized patients, doctors have fewer drugs from which to choose. In addition to dexamethasone and baricitinib, another anti-inflammatory drug called tocilizumab has been shown to help….[EXPERTS] predicted that if the trial had gone longer, the benefits of the drug might have emerged as more modest…

REFERENCE FOR THE STUDY:

Oral Sabizabulin for High-Risk, Hospitalized Adults with Covid-19: Interim Analysis

(J. Harris: This TN study is encouraging and included old, fat, men on respirators)

FROM REUTERS:

  Omicron sub-variants BA.4, BA.5 make up 70% of COVID variants in U.S. – CDCThe fast-spreading BA.4 and BA.5 sub-lineages of Omicron are estimated to make up a combined 70.1% of the coronavirus variants in the United States as of July 2, the U.S. Centers for Disease Control and Prevention said on Tuesday. AND LASTLY:  NYT Sports Writer, Ken Belson, who has written several stories about Marshall and who has many local friends, published a beautifully written but tragic story from 6 July. It is worth the read despite being so very, very sad. An N.F.L. Star’s C.T.E. Diagnosis Offers Only Partial InsightMILTON TOMATO NEWS:The heat has taken a toll on Milton. After producing 40-50 elegant tomatoes, Milton in now bare! He is distraught and may be “pulling up stakes” soon. His neighbor. Carl, has lent him a couple of young, green sprouts to help concel his impotence, but it’s probably all over for Milton for this year. He reckons he might as well stay in Mexico if East Texas remains as hot as it has been this year. He’s still got his smile, however.   

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P.O. Box 721

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75688

CORONAVIRUS INFO PROVIDED BY DR. JIM HARRIS – 7/5/2022

HELLO,

COVID COUNTS ARE NOT ACCURATE. OVER THE HOLIDAY, NO ONE IS TESTING OR RECORDING DATA  OR REPORTING DATA.  GOOD DATA MAY BE AVAILABLE WED OR THURS. 

TUES FROM THE NYT :

1. Fear of public shaming keeps masks on, and infections low, in Japan.

”…Japan’s Covid death rate, just one-twelfth of that in the United States, is the lowest among the world’s wealthiest nations. With the world’s third-largest economy and 11th-largest populace, Japan also tops global rankings in vaccination and has consistently had one of the globe’s lowest infection rates….

Although no government authority has ever mandated masks or vaccinations or instituted lockdowns or mass surveillance, Japan’s residents have largely evaded the worst ravages of the virus. Instead, in many ways, Japan let peer pressure do a lot of the work.

2. Updated Covid shots are coming, but will they be too late?

”…Vaccine updates are becoming more urgent by the day, many scientists said. The most evasive forms of Omicron yet, known as BA.4 and BA.5, appear to be driving a fresh surge of cases across much of the United States. The same subvariants have sent hospital admissions climbing in Britain, France, Portugal, Belgium and Israel…

Covid deaths in the United States, which had been hovering for months near their lowest levels of the pandemic, are rising again. In the worst case, epidemiologists have predicted some 200,000 Covid deaths in the United States within the next year….get that booster… And help mature their immune response and help prevent another wave…”

FROM LA TIMES:

New COVID-19 subvariants cause concern in California…

In a sign of how the new coronavirus wave continues to spread across California, two-thirds of the state’s counties are now in the high COVID-19 community level, in which the U.S. Centers for Disease Control and Prevention recommends universal masking in indoor public spaces.

FROM JAMA:

1. Association of BNT162b2 Vaccine Third Dose Receipt With Incidence of SARS-CoV-2 Infection, COVID-19–Related Hospitalization, and Death Among Residents of Long-term Care Facilities, August to October 2021

”…The third dose of BNT162b2 vaccine was associated with a reduced burden of SARS-CoV-2 infection, COVID-19–related hospitalizations, and COVID-19–related deaths in long-term care facilities[in Israel]…”

2. Analysis of COVID-19–Related Croup and SARS-CoV-2 Variant Predominance in the US

”…Recent reports have found an association between SARS-CoV-2 and croup.1-3 We aimed to investigate whether SARS-CoV-2 variants were associated with the proportion of children with croup, as well as hospital and intensive care unit (ICU) admissions and racemic epinephrine (RE) treatment…The proportion of children with COVID-19–related croup was significantly increased during Omicron (10.9%) compared with Alpha or other variant (4.1%) and Delta…Given that COVID-19 is likely to become endemic, our findings suggest that pediatric health systems should consider variation in SARS-CoV-2 phenotypes and their association with patient care…”

(J. Harris: Yes, Covid can cause Croup in children)

3. Association Between BNT162b2 Vaccination and Long COVID After Infections Not Requiring Hospitalization in Health Care Workers

”…A [PREVIOUS] study of older US veterans showed 15% reduction of long COVID after vaccination; however, study limitations included the low number of women and suboptimal vaccination schedules…”

”…[ITALIAN STUDY]We defined long COVID as reporting at least 1 SARS-CoV-2–related symptom with a duration of more than 4 weeks. Hospitalized individuals were excluded to avoid bias related to severe disease, as were individuals with a date of infection less than 28 days before the survey. We included asymptomatic infections in the acute infection group (they could not have long COVID by definition) to avoid overestimating the prevalence of long COVID. The analysis was restricted to health care workers who were tested every 1 or 2 weeks with complete demographic data and a documented positive result for SARS-CoV-2 between March 2020 and March 2022...

”Of 2560 participants, 739 individuals (29%) had COVID-19 (89 asymptomatic), of whom 229 (31.0%; 95% CI, 27.7%-34.5%) had long COVID (Table 1). The prevalence of long COVID varied across the pandemic waves, from 48.1% (95% CI, 39.9%-56.2%) in wave 1 to 35.9% (95% CI, 30.5%-41.6%) in wave 2 to 16.5% (95% CI, 12.4%-21.4%) in wave 3. The number of vaccine doses was associated with lower long COVID prevalence: 41.8% (95% CI, 37.0%-46.7%) in unvaccinated patients, 30.0% (95% CI, 6.7%-65.2%) with 1 dose, 17.4% (95% CI, 7.8%-31.4%) with 2 doses, and 16.0% (95% CI, 11.8%-21.0%) with 3 doses. Older age, higher body mass index, allergies, and obstructive lung disease were associated with long COVID….In this longitudinal observational study conducted among health care workers with SARS-CoV-2 infections not requiring hospitalization, 2 or 3 doses of vaccine, compared with no vaccination, were associated with lower long COVID prevalence. Study limitations include that symptoms and duration were self-reported, and causality cannot be inferred….”

(J. Harris: Helpful study performed during the worst part of the pandemic — so far.)

4. Neurodevelopmental Outcomes at 1 Year in Infants of Mothers Who Tested Positive for SARS-CoV-2 During Pregnancy

”Question  Is COVID-19 exposure in utero associated with increased risk for neurodevelopmental disorders in the first year of life?

Findings  In this cohort study of 7772 infants delivered during the COVID-19 pandemic, those born to the 222 mothers with a positive SARS-CoV-2 polymerase chain reaction test during pregnancy were more likely to receive a neurodevelopmental diagnosis in the first 12 months after delivery, even after accounting for preterm delivery.

Meaning  These preliminary findings suggest that COVID-19 exposure may be associated with neurodevelopmental changes and highlight the need for prospective investigation of outcomes in children exposed to COVID-19 in utero.

 5. Epidemiology of Myocarditis and Pericarditis Following mRNA Vaccination by Vaccine Product, Schedule, and Interdose Interval Among Adolescents and Adults in Ontario, Canada

”…This population-based cohort study of 297 individuals in Ontario, Canada, with myocarditis or pericarditis following COVID-19 vaccination found higher rates of myocarditis or pericarditis associated with receipt of mRNA-1273 [MODERNA] compared with BNT162b2 [PFIZER] as a second dose, particularly among male individuals aged 18 to 24 years. Higher rates were also observed with shorter interdose intervals. 

From THE WASHINGTON POST: For the Veterans

Senators kill sweeping plan to reshape sprawling VA health-care system

FROM BECKERS:

1. COVID-19 hospitalizations can be predicted through Google searches

FROM HOPKINGS SUGGESTIONS:

1. The Secrets of Covid ‘Brain Fog’ Are Starting to Lift (Wired) Many of these hard-to-define Covid-19 symptoms can persist over time—weeks, months, years. Now, new research in the journal Cell is shedding some light on the biological mechanisms of how Covid-19 affects the brain. Led by researchers Michelle Monje and Akiko Iwasaki, of Stanford and Yale Universities respectively, scientists determined that in mice with mild Covid-19 infections, the virus disrupted the normal activity of several brain cell populations and left behind signs of inflammation. They believe that these findings may help explain some of the cognitive disruption experienced by Covid-19 survivors and provide potential pathways for therapies.

2. Bad News for Paxlovid? Coronavirus Can Find Multiple Ways to Evade COVID-19 Drug (Science) Prescriptions for Pfizer’s blockbuster drug Paxlovid have skyrocketed in recent weeks. That’s good news for many COVID-19 patients, as the pill has been proven to reduce severe disease from SARS-CoV-2 infections. But a bevy of new lab studies shows the coronavirus can mutate in ways that make it less susceptible to the drug, by far the most widely used of the two oral antiviral drugs authorized to treat COVID-19 in the United States. Researchers have found some of those mutations in variants already circulating in infected people, raising fresh concerns that physicians could soon lose one of their best therapies for fighting COVID-19.

3. New York City Will Offer Paxlovid at Mobile Testing Sites, a First in the U.S. (New York Times) New York City is creating the first mobile testing units in the United States that will allow people who test positive for the coronavirus to immediately receive for free the antiviral treatment Paxlovid. Mayor Eric Adams announced the new program on Thursday in Manhattan with Dr. Ashish Jha, the White House Covid-19 response coordinator.

Efficacy Of Pfizer’s Paxlovid COVID Drug Less According To New NIH-Funded Study

”…The drug—the most prescribed FDA-approved oral COVID medication in the United States—has seen its efficacy rate drop in half, according to the report. The findings may validate the concerns of some researchers that predict Paxlovid’s efficacy could decrease over time, given its reliance on antiviral mode-of-action…Adjusting for limitations arising from differential access and uptake of COVID-19 vaccines, diagnostics, and treatment, the study found the overall risk of hospitalization was 45% lower among patients prescribed Pfizer’s Paxlovid. While still significant, the efficacy rate provided in the NIH-funded study is appreciably lower than the 89% reduction in hospitalizations indicated in Paxlovid’s high-risk clinical trial, which took place during the Delta wave.

(J. Harris: 45% ”beats the hell out of a snowball.”)

AND LASTLY: THIS IS A TWO JOKE DAY.

Thank you, Tom Allin

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CORONAVIRUS INFO PROVIDED BY DR. JIM HARRIS – 7/1/2022

I WISH YOU A SAFE AND JOYOUS JULY 4TH. BE CAREFUL — THERE ARE MANY COVID CASES AS WELL AS ASYMPTOMATIC CARRIERS IN EAST TEXAS AT THIS TIME. 

FROM SOUTHWESTERN MEDICAL SCHOOL IMPORTANT PRESS RELEASE JUNE 30, 2022 (THURSDAY)

”In just a few hours, UT Southwestern scientists can tell which variant has infected a COVID-19 patient – a critical task that can potentially influence treatment decisions but takes days or weeks at most medical centers…”Last year, pathologist Jeffrey SoRelle, M.D., and colleagues developed CoVarScan, a rapid COVID-19 test that detects the signatures of eight hotspots on the SARS-CoV-2 virus. Now, after testing CoVarScan on more than 4,000 patient samples collected at UT Southwestern, the team reports in Clinical Chemistry that their test is as accurate as other methods used to diagnose COVID-19 and can successfully differentiate between all current variants of SARS-CoV-2…“Using this test, we can determine very quickly what variants are in the community and if a new variant is emerging,” said Dr. SoRelle, Assistant Professor of Pathology and senior author of the study. “It also has implications for individual patients when we’re dealing with variants that respond differently to treatments.”…To test how well CoVarScan works, Dr. SoRelle’s team ran the test on more than 4,000 COVID-19-positive nasal swab samples collected at UT Southwestern from April 2021 to February 2022 – from patients both with and without symptoms. The tests were validated with the gold-standard whole genome sequencing, and the results were used by doctors to choose treatments in some critically ill COVID-19 patients.

Multiplex Fragment Analysis for Flexible Detection of All SARS-CoV-2 Variants of Concern

(PUBLICATION SITE)

DR FAUCHI AND HIS CASE OF COVID AND POSSIBLE REBOUND:

Fauci says he’s taking 2nd course of Paxlovid after experiencing rebound with the antiviral treatment

Fauci says he believes Paxlovid kept him out of the hospital, even though he tested positive again.

FROM THE NYT:

F.D.A. advisers recommend updated boosters that target forms of Omicron.

”…Despite all the uncertainties, the panel came down 19-2 in favor of redesigning booster shots to also target Omicron or its subvariants, rather than simply the original version of the virus.    The committee debated but did not specify which formulation might work best. The F.D.A. was clearly leaning toward a combination of the existing vaccine and one tailored to two subvariants of Omicron, BA.4 and BA.5.  According  to new estimates from the Centers for Disease Control and Prevention, those subvariants together now make up more than half of new cases in the country.   The meeting highlighted the scientific angst over how to combat a virus that is evolving faster than clinical trials involving humans can deliver results. The panel skipped over the divisive question of who should be eligible for a fall booster. Committee members argued for continuing to use the existing vaccines for people who have not yet gotten initial shots. “I don’t think we should lose the prototype,” Dr. Amanda Cohn, a top C.D.C. official, said. “I think it’s a known entity and it’s doing really well in its current job.”  …But some panelists questioned whether Moderna and Pfizer, along with its partner BioNTech, had proposed the best booster candidates. Several said that Novavax, a company whose vaccine is not yet even available for initial doses in the United States, presented more impressive data.

The F.D.A. recommends Covid boosters be retooled to target the Omicron subvariants BA.4 and BA.5.

(J. Harris: More of the same)

FROM MY LOCAL EPIDEMIOLOGIST: 

EXTENSIVE VACCINE UPDATE: Clarity for fall: We’re getting an Omicron booste

Patients treated with monoclonal antibodies during COVID-19 delta surge had low rates of severe disease

(J. Harris: Article sent to me by a reader who recently had Covid and took this medicine successfully.)

FROM THE NEJM:’

1. Duration of Shedding of Culturable Virus in SARS-CoV-2 Omicron (BA.1) Infection

Our data suggest that some persons who are infected with the omicron and delta SARS-CoV-2 variants shed culturable virus more than 5 days after symptom onset or an initial positive test.In this longitudinal cohort of participants, most of whom had symptomatic, nonsevere Covid-19 infection, the viral decay kinetics were similar with omicron infection and delta infection. Although vaccination has been shown to reduce the incidence of infection and the severity of disease, we did not find large differences in the median duration of viral shedding among participants who were unvaccinated, those who were vaccinated but not boosted, and those who were vaccinated and boosted.

(J. Harris: So 5 days hunkered down at home is not long enough. Try 10 days?)

2.  The Vaccine-Hesitant Moment

(J. Harris: Readable review.)

FROM HOPKINS SELECTIONS”

1. LONG COVID/PASC Researchers worldwide are investigating the potential causes of post-acute sequelae of SARS-CoV-2 infection (PASC), commonly known as long COVID. Blood clots, persistent virus, and immune system abnormalities—or a combination of those or other underlying mechanisms—are leading theories about what could be causing long-term symptoms following recovery from acute infection. To date, there is no agreement on how to define and diagnose long COVID, and estimates of its prevalence range from 5% to 50% of recovered patients. Recent data published by the US CDC, collected between June 1 and June 13, 2022, show that nearly 1 in 5 US adults who previously had COVID-19 continue to experience symptoms of long COVID, such as fatigue, rapid heartbeat, shortness of breath, muscle weakness, chronic pain, or cognitive difficulties. Overall, about 1 in 13 US adults, or 7.5% of the population, have symptoms lasting 3 or more months after COVID-19 recovery that were not experienced prior to infection. Women were more likely than men to currently have long COVID (9.4% vs. 5.5%), according to the data, findings that are supported by a review published June 20 in Current Medical Research and Opinion. …

 CDC data show that older adults are less likely to have long COVID than younger adults, but the symptoms are often overlooked in older individuals and some research suggests seniors are more likely to develop long-term symptoms. A study from Denmark published June 22 in The Lancet Child & Adolescent Health found that among children ranging in age from 0 through 14 years, those who previously tested positive for SARS-CoV-2 were more likely to experience at least 1 symptom for 2 months or more than children who never tested positive. Additionally, one-third of children who previously tested positive experienced at least 1 long-term symptom they did not have prior to infection, including mood swings, rashes, and stomach aches, memory and concentration problems, and fatigue. While any person of any age can experience long COVID, the question of why remains a mystery. But most scientists and public health officials agree that unraveling that mystery, including standardizing the condition’s definition and diagnosis and finding treatments, represents an urgent global emergency to prevent mass suffering.

2. COVID-19 RECOVERY As world leaders drop the COVID-19 pandemic from their agendas, and US federal, state, tribal, and local governments roll back pandemic-related funding and mitigation efforts—such as mask mandates—local officials, grassroots organizations, and frontline community health workers continue to push for and implement piecemeal strategies to help increase vaccination rates, draw attention to the need for research into long COVID, and improve trust in and funding for public health systems. There is a need for the US to create “a sustainable infrastructure that can keep more people from getting COVID, regardless of their social circumstances,” writes Ed Yong in The Atlantic. Indeed, the US Government Accountability Office (GAO) last week released a report recommending that the US Department of Health and Human Services (HHS) prioritize the development of a real-time, public health situational awareness network to help raise public awareness to facilitate the early detection of and rapid response to future and potentially catastrophic disease outbreaks, such as COVID-19.

3. Effects of human mobility and behavior on disease transmission in a COVID-19 mathematical model

”…We perform simulations and analyze how distinct social behaviors and restrictive measures affect the dynamic of the disease within a population. The model proposed in this study revealed that the main focus on the transmission of COVID-19 is attributed to the “home” location setting, which is understood as family gatherings including relatives and close friends. Limiting encounters at work, school and other locations will only be effective if COVID-19 restrictions occur simultaneously at all those locations and/or contact tracing or social distancing measures are effectively and strictly implemented, especially at the home setting…”

4. First Reported Case of a Person Getting COVID From a Cat (Nature) A team in Thailand reports the first solid evidence of a pet cat infecting a person with SARS-CoV-2 — adding felines to the list of animals that can transmit the virus to people. Researchers say the results are convincing. They are surprised that it has taken this long to establish that transmission can occur, given the scale of the pandemic, the virus’s ability to jump between animal species, and the close contact between cats and people.

(J. Harris: Someone, please show this to my grandchildren.)

FROM BECKERS:

1. Pfizer’s modified vaccine is ‘substantially’ better against omicron

”Pfizer’s updated vaccine candidates, a monovalent and a bivalent option, both delivered a “substantially higher immune response” against omicron compared to its current version among study participants 56 and older when used as a fourth booster dose. ….In a phase 2/3 study, the monovalent vaccine targeting omicron resulted in a 13.5-times increase in neutralizing antibody titers with 30 micrograms and a 19.6-times increase with 60 micrograms. The bivalent vaccine, which targeted omicron and the original coronavirus strain, proved a 9.1- and 10.9-times increase, respectively, at the 30 and 60 microgram levels….”Based on these data, we believe we have two very strong omicron-adapted candidates that elicit a substantially higher immune response against omicron than we’ve seen to date,” Pfizer CEO Albert Bourla, PhD, said in a June 25 press release. …The research shows a stronger response against omicron’s BA.1 strain compared to “sister variants” BA.4 and BA.5. 

Novavax COVID vaccine surprisingly effective against all Omicron variants

”…The new data revealed by Novavax indicates its original vaccine formulation seems to generate broad immune responses, resulting in antibodies that display effective responses to all new Omicron variants, including the most immune-evasive BA.5 subtype. In particular, the data indicates a booster shot of Novavax’s vaccine generates neutralizing antibody responses to Omicron variants comparable to what was seen against the original strain of SARS-CoV-2 at the peak of its initial Phase 3 trial….”

(J. Harris: Company release. This might make a good “mix and match” vaccine alternative in the future if the data hold up.”

The genetic and evolutionary determinants of COVID-19 susceptibility

(J.Harris: This article will be of interest to those with a great knowledge of modern genetics; others of us can follow parts of it. I think I almost understand the Neanderthal information.)

”… the genetic legacy of ancient admixture with Neanderthals around 50,000 years ago still affects the health of humans today, even in the specific context of the COVID-19 pandemic.”…One of the most remarkable aspects of such outbreaks is the stunning interindividual variability observed in the course of infection… Predispositions to many infections have since been shown to be controlled by a narrow set of core genes, specific to each type of infection. For example, since 2015, it has been shown that life-threatening influenza pneumonia is linked to inborn errors of TLR3-, IRF7-, and IRF9-dependent type I interferon (IFN) immunity [14, 15]. These groundbreaking discoveries paved the way for the first breakthrough in dissecting the genetic basis of susceptibility to severe COVID-19….it is now estimated that ~20% of patients with critical COVID-19 over 80 years of age, and ~20% of patients of all ages who died from the disease, carried autoantibodies neutralizing type I IFNs…a meta-analysis including 125,584 cases and over 2.5 million controls across 60 studies from 25 countries conducted by COVID-19 HGI, has identified 23 loci significantly associated with disease severity or susceptibility to infection [33]….these observations lend further support to the notion that Neanderthal introgression has had profound consequences for the adaptation of our species to viral challenges, and that such past adaptation events can affect the present-day health status of individuals infected with SARS-CoV-2….”

AND LASTLY:

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CORONAVIRUS INFO PROVIDED BY DR. JIM HARRIS – 6/28/2022

THIS IS A GOOD TIME TO PLAY IT COOL, MAN. EAST TEXAS COVID COUNTS ARE HIGH, BUT NOT HOSPITAL NUMBERS, YET.

FROM THE MNM AND JUDGE SIMS:

FROM JAMA

Olfactory Dysfunction in Patients With Mild COVID-19 During Gamma, Delta, and Omicron Waves in Rio de Janeiro, Brazil

”…Olfactory dysfunction is a common symptom of COVID-19, with reported rates as high as 70%. This symptom can be associated with mild COVID-19, mostly occurs within 5 days after symptom onset, and can persist for a few days to several months after infection resolution.1 The mechanism of SARS-CoV-2–related olfactory dysfunction is not completely understood…Host genetics,2 acute inflammation in the olfactory epithelium,3 local ACE2 expression,4 and downregulation of olfactory receptors5 seem to play a role; however, the viral contribution remains to be explored. We conducted a retrospective analysis of individuals with mild COVID-19 during different SARS-CoV-2 variant waves to assess the prevalence of self-reported olfactory dysfunction.

This study found that individuals with mild COVID-19 infected during the Gamma and Omicron waves had lower odds of reporting olfactory dysfunction than individuals infected during the period of the original lineages. These results suggest that the type of SARS-CoV-2 variant might be a risk factor for olfactory dysfunction, along with host genetic susceptibility. The association with Omicron also was observed after controlling for vaccination status, supporting its independence of host immunologic factors…”

FROM HOPKINS SELECTIONS:

1. FROM HOPKINS:

1. Covid-19 Vaccines Prevented Nearly 20 Million Deaths in a Year, Study Estimates (STAT News) Covid-19 vaccines cut the potential global death toll by more than half in the first year they were available, according to a study published Thursday in The Lancet Infectious Diseases. The study modeled the spread of the disease in 185 territories and countries and found that without Covid vaccines, 31.4 million people would have died of the disease between December 2020 and 2021. While the pandemic has taken a devastating toll around the globe, with more than 3.5 million deaths since the first vaccine was administered in December 2020, the study estimated that vaccinations also prevented 19.8 million deaths.

2. Hospitalization and Emergency Department Encounters for COVID-19 After Paxlovid Treatment — California, December 2021–May 2022 (CDC MMWR) COVID-19–related hospital admissions and emergency department (ED) encounters occurring 5–15 days after Paxlovid treatment were described using data from a large integrated health care system. Reports of such hospitalizations or ED encounters occurred infrequently, representing <1% of Paxlovid-treated patients over the study period. When administered as an early-stage treatment, Paxlovid might prevent COVID-19–related hospitalization among persons with mild-to-moderate COVID-19 who are at risk for progression to severe disease.

3. Association of Kidney Comorbidities and Acute Kidney Failure With Unfavorable Outcomes After COVID-19 in Individuals With the Sickle Cell Trait (JAMA Internal Medicine) In this genetic association study of 2729 persons with SCT and 129 848 who were SCT negative, individuals with SCT had a number of preexisting kidney conditions that were associated with unfavorable outcomes following COVID-19. The presence of SCT was associated with increased risk of mortality and acute kidney failure following COVID-19. Results strongly support the inclusion of SCT as an adverse prognostic factor for COVID-19.

THREE VACCINE ARTICLES AND MORE NEWS TO COME TODAY:

 Pfizer and BioNTech Announce Omicron-Adapted COVID-19 Vaccine Candidates Demonstrate High Immune Response Against Omicron (Pfizer) Pfizer Inc. and BioNTech announced positive data evaluating the safety, tolerability, and immunogenicity of two Omicron-adapted COVID-19 vaccine candidates: one monovalent and the other bivalent, a combination of the Pfizer-BioNTech COVID-19 Vaccine and a vaccine candidate targeting the spike protein of the Omicron BA.1 variant of concern. Data from the Phase 2/3 trial found that a booster dose of both Omicron-adapted vaccine candidates elicited a substantially higher immune response against Omicron BA.1 as compared to the companies’ current COVID-19 vaccine. The robust immune response was seen across two investigational dose levels, 30 µg and 60 µg.

 Sanofi, GSK Variant-specific COVID Shot Found Effective Against Omicron (Reuters) Late-stage data on an experimental COVID-19 vaccine from Sanofi and GSK has showed the shot confers protection against the Omicron variant of the virus, the companies said on Friday. The so-called bivalent vaccine targets the Beta variant – first identified in South Africa – as well as the original Wuhan strain of the virus. In a trial involving 13,000 adults, the vaccine demonstrated an efficacy rate of 64.7% against symptomatic COVID, and 72% efficacy against infections specifically caused by the Omicron variant. When used in people who previously had COVID, the results were stronger. The vaccine generated an efficacy rate of 75.1% against symptomatic COVID and 93.2% in Omicron-confirmed symptomatic cases, the companies said.

 China’s First mRNA Vaccine is Close — Will That Solve Its COVID Woes? (Nature) China is getting closer to approving its first mRNA vaccine to protect people against COVID-19. In a small clinical trial, the Chinese vaccine candidate triggered a stronger antibody response in vaccinated adults when given as a booster shot than did a jab containing inactivated SARS-CoV-2, the vaccine platform that the country has mostly relied on so far. The experimental jab, called ArCoV, is a strong candidate to become China’s first approved mRNA vaccine. But what it would mean for the government’s handling of the pandemic is hard to know, say researchers. A highly effective mRNA vaccine would reduce the chances of widespread serious infections that could overwhelm hospitals. However, it is unlikely to bring an end to the country’s strict ‘zero COVID’ strategy, which uses mass testing and lockdowns to quash all infections.

FROM A CERTAIN NORWEGIAN:

WHO official says the more times a person gets COVID-19, the more likely they are to be ‘unlucky’ and get long COVID

AND LAST BUT NOT LEASED:

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CORONAVIRUS INFO PROVIDED BY DR. JIM HARRIS – 6/22/2022

THE HONEYMOON IS OVER AND THE COUNTS ARE SIGNIFICANTLY ELEVATED IN TEXAS, ESPECIALLY EAST TEXAS:

FROM BECKERS:

1. Mark Cuban’s generic drug prices would save Medicare billions of dollars: Harvard study

FROM DR. KATLINE JETELINA, YOUR LOCAL EPIDEMIOLOGIST:

BA.4/5 is sweeping the globe

”…The newest Omicron variant, BA.4/5, is gaining traction, causing case, hospitalization, and death curves to trend upwards in many countries. This variant was first detected in South Africa in early 2022 and caught our attention because it had several mutations on the spike protein…..In the lab, we see that Omicron is getting better at escaping our first line of defense—neutralizing antibodies. ..BA.4/5 does not fully escape immunity. This means, in the short-term, boosters help prevent infection and thus transmission…. BA.4/5 drove a substantial case wave in South Africa regardless of their high level of immunity. Case waves across Europe are now well on their way, too. In the U.K., reinfections are on the rise, even among 60+ year olds.

..We don’t have epidemiological data on duration of booster effectiveness against BA.4/5. Data from the U.K. showed that boosters provided strong initial protection against BA.1 or BA.2 infection but quickly diminished to 0% five months later. We expect BA.4/5 to shorten this timeline even more…..

In Europe, Portugal is the BA.4/5 leader, with 70% of COVID-19 cases accounting for this new variant. With one of the highest vaccination rates in the world, they largely escaped death from Delta. However, now, after recently reaching their BA.4/5 case peak, excess mortality hit the highest level since their vaccination campaign began…In Portugal, increase in hospitalizations is occurring mainly in people over 60 years old. In fact, in a recent analysis, unvaccinated people over 80 had a case fatality rate (CFR) of 9.5% … Among those with only the primary vaccine series, CFR [CASE FATALITY RATE] is 5%; among those with a booster, it is 1.7%….. While Portugal does have a higher booster rate than the U.S., it isn’t perfect. . Vaccines are not perfect, and if we have a virus burning through a population, it can still cause high levels of death among vulnerable pockets, like the elderly….BA.4/5 hospitalizations are now making headway in other European countries…[WITH] the global upswing in hospitalizations as BA.4/5 entered the scene. But, so far, remains much lower than previous peaks….Bottom line:This virus continues to mutate to escape our first line of defense causing (re)infections. If you don’t want to get sick, it’s time to leverage other layers of protection, like masking. Thankfully, other immune system mechanisms continue to work to reduce severe disease. The transmissibility of the virus is causing upswings of hospitalizations and deaths among the most vulnerable of our populations. We aren’t out of the woods yet but we are inching closer and closer to a manageable virus…”

(J. Harris: Dr. Jetelina is a PhD epidemiologist who has a day job and writes this blog at night. She has small children and accepts contributions. I have found her to be well-informed and to have the ability to explain pertinent  basic and new information to laymen and old Internists. The above article is worth reading in its entirety. I subscribed to her efforts.)

AND LASTLY:

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P.O. Box 721

Scottsville Texas

75688

CORONAVIRUS INFO PROVIDED BY DR. JIM HARRIS – 6/21/2022

From Judge Sims and THE MNM:

FROM THE NYT TODAY:

1. A Chinese Omicron study finds a low risk of severe illness, renewing debate over the ‘zero Covid’ policy.

2. Deaths stay near pandemic lows, despite another virus surge.

3. CALL TO OVERHAUL THE US PUBLICK HEALTH SYSTEM

”…While other countries have centralized public health authorities, public health in the United States is largely managed at the state and local level. The Centers for Disease Control and Prevention, the federal public health agency, does not have the authority to compel states to act — it cannot, for example, investigate outbreaks of infectious disease in a particular state unless it has an invitation from state officials to do so….State health agencies and the C.D.C. have a long history of working collaboratively, but throughout the pandemic, elected state officials — particularly those in red states — have been reluctant to cede control. When the C.D.C. asked states to sign agreements to share vaccination data with the federal government, for example, a number of states balked….The Senate health committee has passed a bipartisan measure that would require the C.D.C. director to be confirmed by the Senate, and that calls for additional steps to improve coordination among the nation’s public health agencies....The commission’s recommendations are more sweeping. The panel… calls for the creation of a new position — Under Secretary for Public Health — within the Department of Health and Human Services, to oversee the national public health system…The under secretary would coordinate the work of more than a dozen federal agencies that play a role in public health, and would have the power to set minimum health standards for the states…“Our system of public health is a federalist system with states and localities having considerable autonomy — and appropriately so, as they adapt to the needs of their states and communities,” Dr. Hamburg said in an interview. “However, the public health protections that individuals receive shouldn’t be wholly dependent on where you live. There should be a core set of expectations.”

(J. Harris: We need to make significant changes in the US Public Health System, from top to bottom, in my opinion. The system seems rudderless and politically hindered at the top and poorly functional in many locales — including and especially in rural areas. Local public health systems, medically, could be more efficient with more guidance and supervision by well-trained public health experts and physicians with mandates and necessary follow-up audits, especially when future medical epidemics arise as they will. …..It appears to me that the Texas Department of Health Services has functioned very well during the Covid Pandemic and has improved as the crisis deepened, especially in the dissemination of general information and data to medical practitioners, institutions, and the public. Unfortunately, like many other rural, “red” and undereducated areas, the vaccination rates in most Texas Counties are absolutely pitiful, The Marshall-Harrison Department of Health is fortunate to have a well-educated, highly motivated leader, but we don’t seem to have a good local system of information dissemination (broadband???). Also, it would be nice if there were more state and national solution programs available for epidemiological control in times of crisis. Need I say that I would have approved of the incarceration and isolation of “Typhoid Mary” way back when?)

FROM HOPKINS SELECTIONS:

1. Covid Vaccine Hesitancy Threatens Flu Vaccine Uptake (CIDRAP) Polarized views and worries about COVID-19 vaccination had spillover effects on flu vaccination in adults, according to researchers who examined data over two pandemic years on both vaccines by state. The authors of the study say the findings are a warning of declining trust in public heath, which comes at a vulnerable time as eased COVID-19 measures put populations at risk for the return of disease threats such as flu. Late-season flu activity is still under way in some parts of the United States, and health officials are closely watching Australia, where an early-season surge is already worse than some of the country’s pre–COVID pandemic flu seasons. The group, based at University of California-Los Angeles Health Services, published its findings yesterday in a letter to the New England Journal of Medicine.

FROM THE NYT:

C.D.C.’s science advisers grapple with assessing two very different vaccines for the youngest Americans.

”…Unvaccinated people aged 5 and older had 10 times the risk of dying of Covid-19, compared with those who received at least two shots of the vaccine,…. The figures “provide real world-evidence that most deaths from Covid-19 are preventable through vaccination…”

The two vaccines[for young children] differ in almost every aspect. For young children receiving the Moderna vaccine, the Food and Drug Administration has authorized two doses of 25 micrograms each, one-fourth the amount used for adults, spaced four weeks apart…But according to the data presented on Friday, two doses of the Pfizer vaccine — each just three micrograms, or one-tenth of the adult dose — fell short of producing strong immunity against the virus in young children…To be effective, the Pfizer-BioNTech vaccine will need to be administered in three doses: the first two spaced three weeks apart, and a third at least two months after that…Pfizer has reported that three doses of its vaccine has an effectiveness of about 80 percent against symptomatic illness. But that estimate is based on infections in just three children who were immunized in the company’s trials, the C.D.C. committee members noted.

(J. Harris: Pediatricians will ”call the shot” and tell you which and when to vaccinate young children. At this time, Moderna might be the best choice?)

FOLLOW TEXAS COVID VARIANTS

(J. Harris: This is a good site to play with as the variants come and go.)

COVID-19 vaccine info for trusted messengers: Kids <5 years My Toddlers Already Had COVID-19. I’m Still Getting Them Vaccinated Right Away

(J. Harris: written by a young female epidemiologist who puts out a nice email frequently.)

Rapid, scalable assessment of SARS-CoV-2 cellular immunity by whole-blood PCR

”…As the deployment of vaccines attenuates the pandemic3, vaccine effectiveness and the duration of protective immunity will need to be systematically assessed and monitored at a global level. Long-term protection from viral infection is mediated by both humoral (antibodies) and cellular immunity4. Quantification of SARS-CoV-2-specific IgG and neutralizing antibodies is often used as a marker of immune protection5, but measurement of T cell responses is rarely performed because of the associated technical challenges. ...Fast, high-throughput methods for measuring the level and duration of protective immune responses to SARS-CoV-2 are needed to anticipate the risk of breakthrough infections. Here we report the development of two quantitative PCR assays for SARS-CoV-2-specific T cell activation. …”

(J. Harris: I have a few readers that might understand this article. I can follow some of it. The article below helps.)

A New Test Can Help Reveal If You’re Immune to COVID-

(J.Harris: FROM TIME 

”…But an international group of researchers recently developed a different tool to help assess COVID-19 immunity: a blood test that can measure T cells, white blood cells that work alongside virus-fighting antibodies to mount an immune response. Their work is described in a new study published in Nature Biotechnology….Testing for antibodies only tells part of the story, since T cells are also a critical piece of the body’s immune response. And while antibody levels drop off significantly within a few months of vaccination or infection, cellular immunity can last up to a year, Guccione says. “Monitoring both will give us a much clearer picture [of immunity] and will hopefully inform our re-vaccination strategies,” Guccione says. The wide use of this test could help define how long protection lasts and how often booster doses are needed.

How Long-COVID Risk Varies By Variant

(J. Harris: good quick read.)

”…The Omicron variant is less likely to give you long COVID than a previous strain of the virus, British researchers say…..But because the Omicron variant is far more contagious than Delta, more people get infected with Omicron and, therefore, more experience long COVID, they added…For the study, Steves and her colleagues used the U.K.-based ZOE COVID Symptom study app to collect data on 56,000 people infected with the Omicron strain. They were compared with more than 41,000 people infected with the Delta strain…The upshot: Odds of getting long COVID were 20% to 50% lower with Omicron than Delta. The odds were dependent on a patient’s age and time since vaccination.

Paxlovid rebound symptoms rare, Mayo study finds

”…Last month, an FDA official cautioned that the antiviral treatment couldn’t block recurring symptoms. Pfizer CEO Dr. Albert Bourla disagreed, arguing a symptom relapse was rare…

The CDC issued an alert May 24 warning that some Paxlovid patients were symptomatic two to eight days after testing negative.

With an 89 percent efficacy rate in diminishing symptoms, Paxlovid is currently the nation’s most popular COVID-19 treatment.

Moderna’s vaccine had fewer side effects than Pfizer’s in study

”…An observational study of nearly half a million inoculated people found the Pfizer and Moderna COVID-19 vaccines had similar side effects, but the risk was lower in Moderna’s…

Of the 433,762 veterans studied over a 38-week period, receivers of the Pfizer shot had a higher risk of ischemic stroke, kidney injury, myocardial infarction and other thromboembolic events compared to those jabbed with Moderna’s vaccine, according to the research published June 13 in JAMA…

Side effect risk of both mRNA-based vaccines was relatively low overall. The median age in the study was 69, and men made up 93 percent of participants.

AND LASTLY:

NORWEGIAN FATHERS DAY JOKES: (TRANSLATIONS AVAILABLE)

1. If you see a crime at an Apple store, are you an iWitness?

2 The wedding was so beautiful, even the cake was in tiers.

3. I used to be able to play the piano by ear, but now I have to use my hands.

4. To whoever stole my copy of Microsoft Office, I will find you. You have my Word!

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P.O. Box 721

Scottsville Texas

75688

CORONAVIRUS INFO PROVIDED BY DR. JIM HARRIS – 6/14/2022

COVID NUMBERS FROM A REAL DOCTOR:

J. Harris: An Internist friend in the Woodlands with 1200 patients is currently seeing about 3 acute Covid cases per day at present. All have been vaccinated. None are extremely ill. In this episode of Covid (Omicron) none of his patients have required hospitalization, so far. 

His few patients who are unvaccinated may be reluctant to call in when they get sick.

FROM BECKERS

1. FDA to get authority to pull fast-tracked drugs that don’t work

FROM THE WHO:

Preliminary Report for the Scientific Advisory Group for the Origins of Novel Pathogens (SAGO)

(J. Harris: “…more study needed. ” I did not see anything new in the summary.)

FROM THE NYT:

1. How long does Covid immunity last? Will a second illness be worse?

(J. Harris: Good short article that should be read!)

”…Getting vaccinated and boosted… is a good idea even after you’ve had Covid. You only need to wait a few weeks after an infection to get a shot. The vaccines will bolster your antibody levels, and research shows that they are effective in preventing severe outcomes if you get sick again.”

”…as the latest wave heads toward the Western region of the country and the virus shows no signs of easing up, reinfections seem to have become common. Already, many people are reporting second or even third infections with newer variants…..However, the coronavirus doesn’t yet fit into clear seasonal patterns like the other common cold viruses. It can also cause debilitating symptoms that persist for months or years in some people, and has claimed the lives of millions of others….After Omicron emerged, prior infections only provided about 50 percent protection against reinfection,…The coronavirus had acquired so many mutations in its spike protein that newer versions became more transmissible and better able to evade immunity. That means you can catch a version of Omicron after recovering from an older, non-Omicron variant. You can even get sick with one of the newer Omicron subvariants after getting over a different version of it….in a study published in February that has not yet been peer-reviewed, scientists from Denmark found that some people got reinfected with the BA.2 sublineage of Omicron as soon as 20 days after they got infected with the original Omicron BA.1…. while it’s unclear if some people are simply more susceptible to Covid-19 reinfection, researchers are beginning to find some clues. People who are older or immunocompromised may make very few or very poor quality antibodies, leaving them more vulnerable to reinfection,..And early research shows that a small group of people have a genetic flaw that cripples a crucial immune molecule called interferon type I, putting them at higher risk of severe Covid symptoms. Further studies could find that such differences play a role in reinfection as well….The good news is that your body can call on immune cells, like T cells and B cells, to quash a reinfection if the virus sneaks past your initial antibody defenses. T cells and B cells can take a few days to get activated and start working, but they tend to remember how to battle the virus based on previous encounters…second or third infections are likely to be shorter and less severe...reinfections among large groups of people in Qatar, has already started seeing this promising pattern in patient records: Of more than 1,300 reinfections that his team identified from the beginning of the pandemic to May 2021, none led to hospitalization in an I.C.U., and none were fatal….”

FROM HOPKINS SUGGESTIONS:

1. Updated US Infection- and Vaccine-Induced SARS-CoV-2 Seroprevalence Estimates Based on Blood Donations, July 2020-December 2021 (JAMA) 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. 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. 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.

2. Sanofi Says Next-gen COVID Booster Shot Has Potential Against Main Variants (Reuters) French drugmaker Sanofi (SASY.PA) said on Monday an upgraded version of the COVID-19 vaccine candidate it is developing with GSK (GSK.L) showed potential in two trials to protect against the virus’s main variants of concern, including the Omicron BA.1 and BA.2 strains, when used as a booster shot. While the two companies’ first experimental COVID shot is undergoing review by the European Medicines Agency, Sanofi and GSK have continued work on a vaccine that is molded on the now-supplanted Beta variant, hoping still that it will confer broad protection against future viral mutations.

3. COVID and Smell Loss: Answers Begin to Emerge (Nature) Researchers are finally making headway in understanding how the SARS-CoV-2 coronavirus causes loss of smell. And a multitude of potential treatments to tackle the condition are undergoing clinical trials, including steroids and blood plasma. A study published last month surveyed 616,318 people in the United States who have had COVID-19. It found that, compared with those who had been infected with the original virus, people who had contracted the Alpha variant — the first variant of concern to arise — were 50% as likely to have chemosensory disruption. This probability fell to 44% for the later Delta variant, and to 17% for the latest variant, Omicron. But the news is not all good: a significant portion of people infected early in the pandemic still experience chemosensory effects. A 2021 study followed 100 people who had had mild cases of COVID-19 and 100 people who repeatedly tested negative. More than a year after their infections, 46% of those who had had COVID-19 still had smell problems; by contrast, just 10% of the control group had developed some smell loss, but for other reasons. Furthermore, 7% of those who had been infected still had total smell loss, or ‘anosmia’, at the end of the year. Given that more than 500 million cases of COVID-19 have been confirmed worldwide, tens of millions of people probably have lingering smell problems.

4. NIAID Mouse Study Shows Benefits of COVID-19 Nasal Vaccine vs. Intramuscular (NIAID) A new comparison study in PNAS from NIAID intramural scientists clearly shows that for SARS-CoV-2, nasal vaccination – particularly in two doses – has clear advantages over muscular delivery in laboratory mice. The vaccine tested uses an old immune-activation concept: modified vaccinia virus Ankara (MVA), which is a licensed smallpox and monkeypox vaccine, and is being actively pursued as a vector, or carrier, to deliver a viral protein for other infectious diseases. For this vaccine candidate, the MVA vector delivers the spike protein of SARS-CoV-2, which sits on the surface of the virus, to spur an immune response. Both the nasal and muscular vaccines were durable, maintaining neutralizing levels of antibodies against SARS-CoV-2 for more than six months; the antibodies neutralized the initial virus strain and the Beta and Omicron variants, although to a lesser extent. Potency waned at a rate of about 20 percent per month, consistent with what researchers have observed with mRNA COVID-19 vaccines. Although the study did not explore the vaccine’s ability to halt virus transmission, scientists theorize that a vaccine that can prevent or quickly eliminate virus in nasal passages would likely reduce the likelihood of person-to-person transmission.

5. Cases and mortality by country

FROM THE WASHINGTON POST:

WHAT ELSE SHOULD THE GOVERNMENT BE DOING?

”…There’s now a much better understanding of airborne transmission of respiratory diseases. If we got our act together, we could do for indoor air sanitation something similar to what we did to water after discovering waterborne diseases, in terms of regulating it to make it safer with better air cleaning filters, ventilation and other methods. We would see benefits against all the other respiratory viruses that are airborne too. It would be costly at first, but we would recoup that cost because illness is very costly — in terms of the human suffering but also financially…”

AND LASTLY:

TROUBLE IN THE TOMATO PATCH:

Milton’s nearest neighbor (Carl) is causing trouble. Carl, who is said to have a theatrical or legal background — or both — is concerned about Milton’s more advantageous garden location. Carl alleges that Milton has an unfair advantage over all the other tomatoes by virtue of having less crowding, fewer ”pepperish” neighbors, better drainage, more sunlight, more access to nutrients, better medical care, and, especially, superior water rights. In addition, Carl is convinced that Milton gets more attention, affection, and admiration from me. He demands justice and equality and threatens legal action. He may leave and not come back. In fact, he is now learning how to speak Norwegian. Carl says t at he may withhold his tomatoes from the harvest, but, if his tomatoes are harvested, he demands a greater percentage of the proceeds. 

Milton, on the other hand, complains that despite Carl’d overlarge size, he is relatively unproductive and breeds mostly small, sickly-looking, smelly, holey tomatoes with chronic tomato worms and other disfiguring and distasteful skin and internal conditions. Milton also alleges that Carl has large, ugly, chronically exposed roots that he refuses to keep covered. What’s more, these ugly obscene roots chronically trespass on Milton’s space. 

I may need to get help in mediating this situation. Of course, Milton also got here. first.  I don’t know how this will turn out. Of course, Hi-Ho,  I  control the hoe!

                                                                *****

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P.O. Box 721

Scottsville Texas

75688

CORONAVIRUS INFO PROVIDED BY DR. JIM HARRIS – 6/10/2022

Have a nice weekend. This report has mostly good news except that our local Covid numbers are going up. The hospitals are not crowded. JHH

FROM THE LANCET

Risk of myocarditis and pericarditis after the COVID-19 mRNA vaccination in the USA: a cohort study in claims databases

”…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.

FROM THE NYT:

1. Two new versions of Omicron are gaining ground in the U.S., according to C.D.C. estimates.

2. Moderna says new trial results show that a revised vaccine works better against Omicron.

3. Even with federal funds, U.S. schools still rely on low-cost methods to slow Covid, a study shows.

FROM THE DMN:

After a brief increase, Dallas COVID hospitalizations have stabilized

”…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.

FROM SCIENTIFIC AMERICAN:

How to Compare COVID Deaths for Vaccinated and Unvaccinated People

FROM REUTERS: 

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.

FROM THE GUARDIAN:

We’re playing with fire’: US Covid cases may be 30 times higher than reported

”…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.)

FROM THE NEJM VIA JOURNAL WATCH:

Cardiac Events in College Athletes 1 Year After SARS-CoV-2 Infection

”… 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.

FROM THE BOSTON GLOBE:

Omicron booster shots are taking longer than expected. Will the wait be worth it?

”…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!

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CORONAVIRUS INFO PROVIDED BY DR. JIM HARRIS – 5/27/2022

I WISH YOU A HAPPY AND SAFE MEMORIAL DAY WEEKEND. 

FROM BECKERS:

1. US has a new dominant COVID-19 strain

FROM THE NYT:

1. Your Lingering Covid Questions, Answered

(J. Harris: Good general reference to keep for Covid. Readable.Keep.)

2. Some universities and schools in the U.S. are reimposing indoor mask mandates.

”…Another Omicron subvariant, known as BA.2.12.1, which spreads more rapidly than previous versions, has become the dominant form of the virus among new U.S. cases, according to federal estimates. For the first time since February, the country is now averaging more than 100,000 new confirmed cases a day, according to a New York Times database, and the widening use of at-home testing means the true number of infections is probably higher…”

3. The White House pushes to get Paxlovid pills into more Covid patients’ hands.

”…Significant obstacles persist in getting Paxlovid to everyone who could benefit from it; more than a million courses of Paxlovid purchased by the government are still available, according to data collected by the Department of Health and Human Services. Because of vague eligibility guidelines that are open to broad interpretation — the medication is authorized for people 12 and older with “mild-to-moderate” Covid-19 who are at risk of severe illness — some doctors are hesitant to prescribe the pill, or require extensive consultation…”

FROM HOPKINS:

1. MONKEYPOX OUTBREAKS UPDATE Read our latest update from May 23 on the monkeypox outbreaks. A new fact sheet also is available. We will continue to analyze the situation and provide updates, as needed. If you would like to receive these updates, please sign up here.

FROM REUTERS:

Canada’s Quebec confirms 15 cases of monkeypox

The Canadian province of Quebec has confirmed 15 cases of monkeypox as of Monday, the provincial health department said on Tuesday.

FROM JAMA:

1. Cardiac Complications More Common After COVID-19 Than Vaccination

2. Transmission and Infectious SARS-CoV-2 Shedding Kinetics in Vaccinated and Unvaccinated Individuals

”…Fully vaccinated individuals had a shorter duration of viable viral shedding and a lower rate of secondary transmission than partially vaccinated or unvaccinated individuals.”

3. Viral Antigen and Inflammatory Biomarkers in Cerebrospinal Fluid in Patients With COVID-19 Infection and Neurologic Symptoms Compared With Control Participants Without Infection or Neurologic Symptoms

” These results suggest that viral components may contribute to central nervous system immune responses without direct viral invasion and highlight the clinical importance of neurologic symptoms.”

4. Association Between the COVID-19 Pandemic and Disparities in Access to Major Surgery in the US

”These findings suggest that the early response to the pandemic did not increase disparities in access to surgical care.”

FROM THE CDC:

COVID-19 Rebound After Paxlovid Treatment

”…A brief return of symptoms may be part of the natural history of SARS-CoV-2 (the virus that causes COVID-19) infection in some persons, independent of treatment with Paxlovid and regardless of vaccination status…”

FROM THE ATLANTIC:

What COVID Hospitalization Numbers Are Missing, By Ed Yong

”…Even when missing people can be replaced, missing knowledge cannot. The pandemic pushed many veteran health-care workers into early retirement, lowering the average experience level in American hospitals. “I don’t think the public really understands how great the loss of this generational knowledge is,” Cabrera told me. In her current job, she had just four days of orientation, which she describes as “shockingly short,” from some people who had been in the ER for less than a year. When inexperienced recruits are trained by inexperienced staff, the knowledge deficit deepens, and not just in terms of medical procedures. The system has also lost indispensable social savvy—how to question an inappropriate decision, or recognize when you’re out of your depth—that acts as a safeguard against medical mistakes. And with established teams now ruptured by resignations, many health-care workers no longer know—or trust—the people at their side….Absurdly, it’s often hard to get people out of the hospital, Sara Wolfson, a geriatrician at Nebraska Medicine, told me. Many elderly patients still need care after they’ve stabilized, but it’s hard to discharge them, because long-term care facilities and home-health agencies are also incredibly short-staffed and unable to accommodate new patients….”

AND LASTLY:

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P.O. Box 721

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75688

CORONAVIRUS INFO PROVIDED BY DR. JIM HARRIS – 5/24/2022

FROM THE MARSHALL NEWS MESSENGER:

FROM BECKERS:

1. COVID-19 cases trend

TWO STATES WHERE CASES ARE RISING:

Texas

Seven-day change: 49.67 percent increase

Seven-day moving case average: 4,477

Arkansas

Seven-day change: 4.11 percent increase

Seven-day moving case average: 290

FROM HOPKINS SELECTIONS

1. A BIG LONG HAUL STUDY:

A Detailed Study of Patients with Long-Haul COVID (FAIR Health) Many patients recover from COVID-19 within a few weeks, but some exhibit persistent or new symptoms more than four weeks after first being diagnosed. Patients with such post-COVID conditions are variously referred to as having long-haul COVID, long COVID or post-acute sequelae of COVID-19 (PASC). Using longitudinal data from a database of over 34 billion private healthcare claim records, FAIR Health studied a total of 1,959,982 COVID-19 patients for the prevalence of post-COVID conditions 30 days or more after their initial diagnosis with COVID-19. To FAIR Health’s knowledge, this is the largest population of COVID-19 patients so far studied for post-COVID conditions. The patients’ post-COVID conditions were analyzed, with the most common conditions identified. Particular attention was given to age and gender, mental health conditions and death.

2. The U.S. May be in a Silent Covid Surge (Washington Post) Coronavirus cases are on the rise again. Top Biden officials warned of the increase in cases yesterday, as the country surpasses an average of 100,000 new infections per day. But that number is a massive undercount and could be anywhere from five to 10 times higher, experts say, since home tests typically aren’t included in official case counts.

FROM JAMA

1. Demographic and Clinical Factors Associated With Anti–SARS-CoV-2 Antibody Levels After 2 BNT162b2 mRNA Vaccine Doses

”…  In this cohort study of 50 individuals, anti–SARS-CoV-2–specific antibody levels at 2, 4, and 6 months after COVID-19 vaccination were inversely correlated with body weight. Young and middle-aged healthy adults weighing less than 55 kg maintained a high antibody level 6 months after the second dose of BNT162b2 vaccination…”

2. Excess Mortality in Massachusetts During the Delta and Omicron Waves of COVID-19

”…More all-cause excess mortality occurred in Massachusetts during the first 8 weeks of the Omicron period than during the entire 23-week Delta period. Although numerically there were more excess deaths in older age groups, there was excess mortality in all adult age groups, as recorded in earlier waves, including in younger age groups.5,6 Moreover, the ratio of observed to expected all-cause deaths was similar in all age groups, and increased during the Omicron period compared with the Delta period….”

(J. Harris: Surprise!)

FROM THE NYT:

1. Health officials in parts of the U.S. see signals in wastewater data hinting at a worsening virus wave.

”…The data has been like a “canary in a coal mine”…Case counts are a “gross underrepresentation,” as many people are opting to take at-home tests instead of going to hospitals or doctors’ offices….“It looks like a surge in slow motion,”…Houston is another city where wastewater data has been showing ominous signs of increasing infections…”

2. New York’s fifth wave

”…This latest wave, which is New York City’s fifth, started in mid-March. At first it was driven by the BA.2 subvariant of Omicron, but now most cases are caused by newer versions — primarily BA.2.12.1, which is more transmissible than its predecessor and made up roughly 73 percent of new cases across New York, New Jersey and Puerto Rico as of mid-May, according to the C.D.C…we’re seeing more than 4,000 confirmed cases a day, but those official numbers dramatically undercount how many people are sick because they don’t incorporate at-home tests….Here’s another metric: A company called Kinsa, which distributes internet-connected thermometers, said that just over 4 percent of its users in New York City reported fevers in recent days. That’s a very high number. In non-Covid years it might be below 1.5 percent...New Covid hospitalizations are at about 150 a day. For comparison, in early January, there were a couple of days when it was over a thousand….Mayor Eric Adams has been very clear that he’s not interested in introducing new restrictions unless the hospital system is in danger of being overwhelmed, and experts say that’s not likely here.

FROM REUTERS:

Explainer: How concerned should we be about monkeypox?

”…Experts believe the current monkeypox outbreak is being spread through close, intimate skin on skin contact with someone who has an active rash. That should make its spread easier to contain once infections are identified, experts said…..Many – but not all – of the people who have been diagnosed in the current monkeypox outbreak are men who have sex with men, including cases in Spain linked to a sauna in the Madrid region..”Viruses are nothing new and expected,” said Angela Rasmussen, a virologist at the Vaccine and Infectious Disease Organization at the University of Saskatchewan in Canada… a number of factors including increased global travel as well as climate change have accelerated the emergence and spread of viruses. The world is also more on alert to new outbreaks of any kind in the wake of the COVID pandemic, she said.”

(J. Harris: Should you become infected, experts warn not to try and hang from limbs by your imaginary tail.)

FROM AUDREY KARIEL AND HER KIDS: Family Medicine featuring John Cheng, MD – YouTube

*****

AND LAST BUT NOT LEASED:

The likely G.O.P. candidate for Connecticut governor tests positive a day after an anti-mask picnic.

NO JOKE!

1. I’m getting tired of being part of a major historical event.

2. I’m at a place in my life where errands are starting to count as going out.

3. I don’t always go the extra mile, but when I do, it’s because I missed my exit.

AND FROM THE NICE NORWEGIAN LADIES SOCIETY:

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iExposed Us 

P.O. Box 721

Scottsville Texas

75688