Qatar Omicron-wave study shows slow decline of natural immunity, rapid decline of vaccine immunity

 A recent Pfizer or Moderna mRNA-vaccine booster provided good but temporary protection against infection by the SARS-CoV-2 Omicron variant, according to a study from researchers at Weill Cornell Medicine—Qatar.

In the study, published June 15 in the New England Journal of Medicine, the researchers analyzed the Omicron wave in Qatar last winter, comparing prior infections, vaccine immunity and combinations thereof among more than 100,000 Omicron-infected and non-infected individuals.

The analysis showed, as expected, that full mRNA vaccination plus a booster dose, atop natural immunity due to infection by an earlier variant, was associated with the strongest protection from Omicron infection. However, vaccine immunity against new infection appeared to wane rapidly, whereas people with a prior-variant infection were moderately protected from Omicron with little decline in protection even a year after their prior infection.

The study, the most comprehensive of its kind in investigating different combinations of immunity for Omicron-variant SARS-CoV-2 infections, also found evidence that both vaccination and prior infection provided strong and durable protection from severe, critical, or fatal COVID-19 during the Omicron wave.

“We found that the rates of severe COVID-19 during Qatar’s Omicron wave were very low even among those who had only two doses of vaccine or only a prior infection,” said study first author Dr. Heba Altarawneh, a postdoctoral research associate who conducted this study working with study senior author Dr. Laith Abu-Raddad, a professor of population health sciences at Weill Cornell Medicine—Qatar and at Weill Cornell Medicine in New York.

Qatar’s highly centralized and comprehensive electronic health records database, which includes all RT-PCR tests for SARS-CoV-2 performed in the country, permits unusually rapid and large-scale epidemiological studies. Dr. Abu-Raddad and colleagues have already published prominent papers on infection and illness rates for prior SARS-CoV-2 variants and waves.

For the new study, the researchers catalogued positive PCR tests associated with infection symptoms in Qatar during the country’s omicron (B.1.1.529) wave, from Dec. 23, 2021, through Feb. 21, 2022. They paired each of these infected, symptomatic individuals with a PCR-negative individual from the database—matching by sex, week of testing, age range and nationality (Qatar has a highly diverse resident population that includes many guest workers from Asia and Africa). The researchers then analyzed how the prior-wave infections and vaccination histories of the two groups differed. The analysis included 104,490 people in all.

A key finding was that a history of vaccination with the standard two doses of either the Pfizer or Moderna mRNA vaccine, but no history of prior infection, brought no significant protection against symptomatic omicron infection. Having a booster dose appeared to be about 60 percent protective, though most boosters were received just weeks before the Omicron wave. Overall, the analysis suggested—consistently with prior studies—that mRNA vaccines and boosters work fairly well in protecting against symptomatic omicron infection, though their protective effect wanes rapidly and disappears within six months or so.

For those with no history of vaccination, SARS-CoV-2 infection during a prior-variant wave appeared to provide about 50 percent protection against symptomatic infection during the Omicron wave, and this “natural immunity” was associated with almost the same degree of protection even a year after infection.

The combination of prior, full vaccination and prior infection was maximally protective: Individuals with prior infection and three doses of either mRNA vaccine were, overall, nearly 80 percent protected from symptomatic infection during the Omicron wave.

The results also indicated that vaccination, prior infection alone or a combination, was protective against severe illness from Omicron infections—the protective effect ranging from about 72 percent for previous infection alone to 100 percent for previous infection plus three vaccine doses.

“These findings demonstrate the benefits of vaccinating those with prior infection for optimal protection against the Omicron variant,” said Dr. Abu-Raddad.

The analysis distinguished between infections with two different sub-lineages of the Omicron variant, BA.1 and BA.2, but found very similar results for both, as well as similar results for both Pfizer’s and Moderna’s vaccines.

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JOURNAL

New England Journal of Medicine

https://www.eurekalert.org/news-releases/956073

Neurological symptoms that persist in majority of covid long-haulers

 Researchers at University of California San Diego School of Medicine are conducting a longitudinal study to track neurological symptoms in COVID-19 "long-haulers."

The first round of results, published June 15, 2022 in Annals of Clinical and Translational Neurology, revealed the prevalence of various short- and long-term symptoms and found that, while many patients showed improvement, the majority still had some neurological symptoms after six months. A subset of individuals also exhibited significant coordination and cognitive issues, which had not been previously described.

Following mild-to-moderate SARS-CoV-2 infections, 56 persons with neurological symptoms were recruited to the study between October 2020 and October 2021. They completed a neurological exam, cognitive assessment, self-reported questionnaires and an optional brain scan. Baseline measurements were taken a few months after their initial infection and repeated three and six months later.

At the time of their first visit, 89 percent of participants were experiencing fatigue and 80 percent reported headaches. Other common neurological symptoms included memory impairment, insomnia and decreased concentration. Eighty percent of participants said these symptoms impacted their quality of life.

When participants returned for their six-month follow-up, only one-third reported complete resolution of symptoms. The other two-thirds of participants reported persistent neurological symptoms, though most had diminished in severity. The most prevalent symptoms at six months were memory impairment and decreased concentration.

The authors noted that none of the individuals with persistent symptoms at six months had any history of pre-existing neurological conditions prior to their SARS-CoV-2 infections.

"It's encouraging that most people were showing some improvement at six months, but that wasn't the case for everyone," said senior author Jennifer S. Graves, MD, PhD, associate professor at UC San Diego School of Medicine and neurologist at UC San Diego Health. "Some of these participants are high-level professionals who we'd expect to score above average on cognitive assessments, but months after having COVID-19, they're still scoring abnormally."

Researchers were also surprised to find a novel phenotype within the cohort. Seven percent of participants displayed a previously unidentified set of symptoms that included cognitive deficits, tremor and difficulty balancing. The authors labeled the phenotype Post-Acute Sequelae of COVID-19 infection with Tremor, Ataxia and Cognitive deficit (PASC-TAC).

"These are folks who had no neurological problems before COVID-19, and now they have an incoordination of their body and possible incoordination of their thoughts," said Graves. "We didn't expect to find this, so we want to get the word out in case other physicians see this too."

Researchers are still investigating how much the SARS-CoV-2 virus directly invades the brain, but Graves said it is more likely that these delayed neurological symptoms are caused by the infection triggering an inflammatory autoimmune response in the brain.

The team plans to continue monitoring participants' symptoms annually for up to 10 years. Additional efforts will evaluate how different COVID-19 variants and vaccines affect long-term neurological symptoms.

"To have people's cognition and quality of life still impacted so long after infection is something we as a society need to be taking a serious look at," said Graves. "We still need to know how common this is, what biological processes are causing this, and what ongoing health care these people will need. This work is an important first step to getting there."

Co-authors include: Jacqueline E. Shanley, Andrew F. Valenciano, Garrett Timmons, Annalise E. Miner, Visesha Kakarla, Jennifer H. Yang, Amanda Gooding, Marc A. Norman, Sarah J. Banks, NeuCovid Team, Michelle L. Ritter, Ronald J. Ellis and Lucy Horton at UC San Diego, as well as Torge Rempe at University of Florida.

Story Source:

Materials provided by University of California - San Diego. Original written by Nicole Mlynaryk. Note: Content may be edited for style and length.

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Journal Reference:

1. Jacqueline E. Shanley, Andrew F. Valenciano, Garrett Timmons, Annalise E. Miner, Visesha Kakarla, Torge Rempe, Jennifer H. Yang, Amanda Gooding, Marc A. Norman, Sarah J. Banks, Michelle L. Ritter, Ronald J. Ellis, Lucy Horton, Jennifer S. Graves. Longitudinal evaluation of neurologic‐post acute sequelae SARS‐CoV‐2 infection symptoms. Annals of Clinical and Translational Neurology, 2022; DOI: 10.1002/acn3.51578

https://www.sciencedaily.com/releases/2022/06/220615130820.htm

Sitting time and cardio health

 New research is adding further weight to the argument that prolonged sitting may be hazardous to your health. An international study surveying more than 100,000 individuals in 21 countries found that people who sat for six to eight hours a day had a 12-13 per cent increased risk for early death and heart disease, while those who sat for more than eight hours daily increased that to a sobering 20 per cent.

The study, co-led by Simon Fraser University health sciences professor Scott Lear and Wei Li of Beijing's Chinese Academy of Medical Sciences, is published today in the journal Jama Cardiology. Their research followed individuals over an average of 11 years and determined that high amounts of sitting time were associated with increased risk of early death and cardiovascular disease. While sitting was problematic in all countries, it was especially so in low-income and lower-middle-income countries.

"The overarching message here is to minimize how much you sit," says Lear. "If you must sit, getting in more exercise during other times of the day will offset that risk."

Not surprising, those who sat the most and were the least active had the highest risk -- up to 50 per cent -- while those who sat the most but were also the most active had a substantially lower risk of about 17 per cent.

"For those sitting more than four hours a day, replacing a half hour of sitting with exercise reduced the risk by two per cent," Lear notes. "With only one in four Canadians meeting the activity guidelines there's a real opportunity here for people to increase their activity and reduce their chances of early death and heart disease."

The study found a particular association in lower income countries, leading researchers to speculate that it may be because sitting in higher income countries is typically associated with higher socio-economic status and better paying jobs.

Clinicians should focus on less sitting and more activity as it's a low-cost intervention that can have enormous benefit, Lear notes.

But while clinicians need to get the message out about countering sitting with activity, individuals need to better assess their lifestyles and take their health seriously, Lear adds. "Our study found that a combination of sitting and inactivity accounted for 8.8 per cent of all deaths, which is close to the contribution of smoking (10.6 per cent in Lear and Li's study). "It's a global problem that has a remarkably simple fix. Scheduling time to get out of that chair is a great start."

Story Source:

Materials provided by Simon Fraser University. Note: Content may be edited for style and length.

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Journal Reference:

1. Sidong Li, Scott A. Lear, Sumathy Rangarajan, Bo Hu, Lu Yin, Shrikant I. Bangdiwala, Khalid F. Alhabib, Annika Rosengren, Rajeev Gupta, Prem K. Mony, Andreas Wielgosz, Omar Rahman, M. Y. Mazapuspavina, Alvaro Avezum, Aytekin Oguz, Karen Yeates, Fernando Lanas, Antonio Dans, Marc Evans M. Abat, Afzalhussein Yusufali, Rafael Diaz, Patricio Lopez-Jaramillo, Lloyd Leach, P. V. M. Lakshmi, Alicja Basiak-Rasała, Romaina Iqbal, Roya Kelishadi, Jephat Chifamba, Rasha Khatib, Wei Li, Salim Yusuf. Association of Sitting Time With Mortality and Cardiovascular Events in High-Income, Middle-Income, and Low-Income Countries. JAMA Cardiology, 2022; DOI: 10.1001/jamacardio.2022.1581

https://www.sciencedaily.com/releases/2022/06/220615152746.htm

Pancreatic beta-cell restoring therapy treats type 1 diabetes

 Researchers have successfully treated type 1 diabetes in mice using pancreatic beta-cell, target-specific, chimeric antigen-receptor (CAR) regulatory T cells (Tregs), and demonstrated the feasibility of their approach to treat the human condition according to data being presented Monday, June 13 at ENDO 2022, the Endocrine Society's annual meeting in Atlanta, Ga.

The study was led by Juan Carlos Jaume, M.D., Professor and Chief of the Division of Endocrinology, Diabetes, and Metabolism, in the Department of Medicine, and Director of the Center for Diabetes and Endocrine Research (CeDER), at the University of Toledo in Toledo, Ohio.

Historically, adoptive cell transfer therapies with CAR cytotoxic T cells have proven effective for the treatment of hematologic malignancies. Jaume and his team attempted to replicate an equally effective experimental treatment for type 1 diabetes using instead non-cytotoxic, anti-inflammatory Tregs.

"The purpose of this study was to determine if pancreatic beta-cell, target-specific, human CAR Tregs could also identify human pancreatic beta cells (target) and home to human pancreatic islets (where beta cells live) in culture as they do in mice undergoing CAR Treg treatment for T1D," Jaume said.

The researchers drew blood one to two weeks prior to pancreas surgery, followed by a collection of a small piece of the pancreas (5 cc wedge) after the pancreas was removed for a clinically indicated reason (cancer or pancreatitis).

First, they isolated Tregs from the blood samples and expanded them in vitro. Those cells were genetically modified to express a beta-cell, target-specific CAR combined with a green fluorescence protein (GFP) marker.

Second, the researchers processed the pancreas tissue for islet separation.

Then, they co-cultured the human pancreatic islets combined with the beta-cell, target-specific CAR Tregs.

Within 24 hours, confocal microscopy demonstrated the successful migration of the GFP positive, CAR Tregs onto the pancreatic islets. What's more, the CAR Tregs significantly proliferated while in physical contact with the pancreatic islets in the subsequent 72 hours.

"Ours is the first successful, pancreatic beta-cell, target-specific CAR-Treg treatment of T1D in a humanized mouse model that closely resembles the human disease. Based on our mice and human in-vitro data, we believe treatment with pancreatic beta-cell, target-specific, CAR-Tregs will allow for recovery and reconstitution of beta cells in human T1D patients as well," Jaume said.

Story Source:

Materials provided by The Endocrine Society. Note: Content may be edited for style and length.

https://www.sciencedaily.com/releases/2022/06/220614164431.htm

FDA Infant Formula Update: June 15, 2022

 Today, the U.S. Food and Drug Administration is providing an update on additional steps it has taken that will lead to more infant formula available in the U.S. under the agency's recent increased flexibilities.

Company (Product Origin): Mead Johnson Nutrition/Reckitt (Singapore)

Product(s): Base powder to manufacture Enfamil Stage 1

Type of Formula: Finished product will be general infant formula

Estimated Quantity: 4.5 million pounds of base powder that will be used to produce about 5.7 million cans (more than 66 million full-size, 8-ounce bottles).

Availability: Base powder will begin shipping in June to a Minnesota facility for conversion to final product that will be made available in the coming weeks. Monthly follow-on shipments will continue through November. The U.S. Department of Health and Human Services is evaluating options for getting the product to the U.S. as quickly as possible.

More Information and Where to Find the Products: The finished product would be used to meet contractual obligations under the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) program.

The FDA is exercising enforcement discretion for the importation of the infant formula products listed above following the review of information provided pertaining to nutritional adequacy and safety, including microbiological testing, labeling, and additional information about facility production and inspection history.

The agency is leveraging a number of flexibilities to bolster the supply of products that serve as the sole source of nutrition for many infants while ensuring the infant formula can be used safely and provides adequate nutrition. The FDA remains in further discussions with manufacturers and suppliers regarding additional supply to ensure there's adequate infant formula available wherever and whenever parents and caregivers need it.

The FDA issued guidance on May 16 that outlined a process by which the agency would not object to the importation of certain infant formula products intended for a foreign market or distribution in the U.S. of products manufactured here for export to foreign countries. This guidance also may provide flexibilities to those who manufacture infant formula products domestically and may be able to increase further the quantity of domestically produced product for the U.S. market. The agency has posted a webpage that will be updated with information about additional products headed to the U.S.

https://www.live5news.com/prnewswire/2022/06/15/fda-infant-formula-update-june-15-2022/

About 1 in 5 US Pregnancies Ended in Abortion in 2020

 The number and rate of U.S. abortions increased between 2017 and 2020 after a 30-year decline, according to a new report from the Guttmacher Institute.

More than 930,000 abortions took place in the U.S. in 2020, up 8% from 862,000 abortions in 2017. About 1 in 5 pregnancies ended in abortion in 2020, the report said.

The Guttmacher Institute, a research organization that supports abortion rights, said the trend shows a rising need for abortion care as the Supreme Court is poised to overturn the Roe v. Wade decision in coming weeks.

National abortion numbers reached the lowest point in 2017 since the landmark 1973 ruling that legalized the procedure. In the years following the ruling, abortion numbers rose above 1.5 million annually throughout the 1980s and then began declining in the 1990s, though they remained above 1 million annually through the early 2010s. 

The latest data shows that the abortion rate increased from 13.5 abortions per 1,000 women between ages 15 to 44 in 2017 to 14.4 abortions per 1,000 women in 2020, marking a 7% increase.

Similarly, the abortion ratio — or the number of abortions per 100 pregnancies — increased from 18.4% in 2017 to 20.6% in 2020, marking a 12% increase.

The increase in abortions was accompanied by a 6% decline in births between 2017 and 2020, the Guttmacher Institute said.

"Because there were many more births (3.6 million) than abortions (930,000) in 2020, these patterns mean that fewer people were getting pregnant and, among those who did, a larger proportion chose to have an abortion," the institute wrote.

Medication-related abortions accounted for 54% of U.S. abortions in 2020, according to the report, which was the first time they made up more than half of abortions.

The number of abortions increased in every region of the country between 2017 and 2020, the report shows. The increases were largest in the West (12%) and Midwest (10%), followed by 8% in the South and 2% in the Northeast.

In some states — Illinois,  Mississippi, and Oklahoma — there were substantial increases in the number of abortions, the institute said. In others — such as Missouri, Oregon, and North Dakota — there were substantially fewer abortions in 2020 compared with 2017.

The COVID-19 pandemic may have led to a decline in some states. In New York, abortions increased 5% from 2017 to 2019 and then fell 6% between 2019 and 2020. About 10% of clinics in New York paused or stopped abortion care in 2020 when the pandemic started.

New laws likely affected the numbers as well. Texas had a 7% increase between 2017 and 2019, followed by a 2% decrease between 2019 and 2020, which overlapped with restrictions that deemed abortions "nonessential" health care at the beginning of the pandemic.

In contrast, some numbers may have increased due to expanded Medicaid funding. Illinois began allowing state Medicaid funds to pay for abortions in January 2018, and abortions increased 25% between 2017 and 2020.

In Missouri, abortions decreased substantially from 4,710 in 2017 to 170 in 2020, the report shows, but the number of Missouri residents who traveled to Illinois for abortions increased to more than 6,500.

Every 3 years, the Guttmacher Institute contacts U.S. facilities that provide abortions to collect information about services, including the total number of abortions. The most recent count was completed in May, representing 1,687 health care facilities that provided abortions in 2019 or 2020. A full summary of the data will be published later this year in a peer-reviewed journal article.

Source:

Guttmacher Institute: "Long-Term Decline in US Abortions Reverses, Showing Rising Need for Abortion as Supreme Court Is Poised to Overturn Roe v. Wade."

https://www.medscape.com/viewarticle/975677

Biden Administration Sued Over Records On Withholding COVID-19 Treatment From Florida

 by Zachary Stieber via The Epoch Times (emphasis ours),

A watchdog seeking records from President Joe Biden’s administration on the rationing of a key COVID-19 treatment is suing the government for not providing the records in a timely manner.

The Functional Government Initiative (FGI) is seeking records that will shed light on why the administration cut shipments of monoclonal antibodies to Florida and other states in 2021 into 2022.

But the Department of Health and Human Services and two subagencies—the National Institutes of Health (NIH) and the National Institute of Allergy and Infectious Diseases (NIAID—have not complied with legal requirements outlined in the Freedom of Information Act, the watchdog says, prompting a lawsuit in federal court.

“The only way we’re going to be able to obtain these documents is through a lawsuit and that’s why we are suing HHS, NIH, and NIAID,” Peter McGinnis, a spokesman for FGI, told The Epoch Times.

Monoclonal antibodies were one of the most successful treatments of COVID-19 that have been authorized or approved by U.S. regulators, particularly against strains of SARS-CoV-2 that were circulating in 2021.

Florida was one of the first states to promote the drug, which prevents mild or moderate cases of COVID-19 from becoming more severe, thus leading to fewer hospitalizations.

The federal government monopolized the supply. It handed out doses for free to states, but the arrangement largely left states unable to order any doses themselves when the Biden administration started rationing in the fall of 2021, hitting states like Florida and Texas.

At the same time, other states saw no change or an increase in allocation.

The rationing decision was “potentially motivated by politics,” McGinnis said, noting that top Biden administration officials and Florida Gov. Ron DeSantis, a Republican, traded barbs over the move in public.

That makes it important to see emails and other records concerning the decision, according to the watchdog.

“Hopefully it’s not. I would hate to live in a world that no, we have a pandemic on our hands and the White House is restricting essential medical supplies over, ‘we don’t like this governor in the way that he attacks us, we’re not going to let him have this,'” McGinnis said.

DeSantis’s office declined to comment on the suit. HHS, NIH, and NIAID did not respond to requests for comment.

According to the filing, FGI filed the requests for information in February. The HHS acknowledged the request but has not given any other updates. That violates the law, which says that agencies must, within 20 days, notify the person making a request whether they’ll comply and the right of seeking assistance from the FOIA public liaison for the agency.

The NIH, in addition to an automatic acknowledgement, had an employee reach out for clarification but did so after the 20-day limit outlined in the law. In addition, after FGI responded to the questions, the NIH did not give any other updates.

NIAID told FGI on May 10 that its requests were under review and said the estimated time was 6 months. It wasn’t clear whether a search was underway or whether a review merely referred to deciding whether to process the requests.

Absent the lawsuit, FGI told the court that it will not receive the information it seeks due to the agencies flouting the law.

The watchdog asked the court to order the agencies to produce all records within 10 days, or such other time as deemed appropriate.

https://www.zerohedge.com/covid-19/biden-administration-sued-over-records-withholding-covid-19-treatment-florida