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Pfizer begins Phase 2/3 study for COVID-19 oral antiviral in exposed adults

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Pfizer initiated a Phase 2/3 study of an investigational oral antiviral with a low dose of ritonavir to prevent COVID-19 illness, the company announced Monday. The treatment is aimed to slow viral replication after exposure to tamp down symptomatic disease and infection onset in others.
“With the continued impact of COVID-19 around the world, we believe that tackling the virus will require effective treatments for people who contract, or have been exposed to, the virus, complementing the impact that vaccines have had in helping quell infections,” Dr. Mikael Dolsten, PhD., chief scientific officer and president, worldwide research, development and medical of Pfizer, said in a news release posted Monday. “If successful, we believe this therapy could help stop the virus early – before it has had a chance to replicate extensively – potentially preventing symptomatic disease in those who have been exposed and inhibiting the onset of infection in others.”
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The Phase 2/3 study called EPIC-PEP, (Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis), is a randomized, double-blind, placebo-controlled trial, set to enroll up to 2,660 healthy adults ages 18 and older living with a household member with a confirmed symptomatic COVID-19 infection. Study participants will be randomly assigned to receive PF-07321332/ritonavir or a placebo twice each day for five or 10 days, per the news release. The treatment is designed to be administered early (such as the first sign or infection or awareness of exposure) while ritonavir is intended to slow the metabolism of the PF-07321332 antiviral to help fight the virus for a longer period of time.
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“Given the continued emergence and evolution of SARS-CoV-2 variants and their immense impact, we continue to work diligently to develop and study new ways that our investigational oral antiviral candidate could potentially lower the impact of COVID-19, not only on patients’ lives, but also the lives of their families and household members,” Dolsten said.
The company intends to evaluate the candidate's safety and efficacy in preventing confirmed SARS-CoV-2 infection and symptoms through two weeks, Pfizer said, noting that an early stage trial suggested the oral antiviral was safe and well tolerated. The global program involves other ongoing studies, like COVID-infected patients at high-risk of poor outcomes while another trial includes patients at a standard risk, which began in July and August, respectively.

Quitting smoking leads to eating more junk food, weight gain, study finds

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Put down the pack and pick up a snack.
A new study from the University of Minnesota found that quitting smoking leads to a poor diet, potentially leading to weight gain.
The new study found that the opioid system — the brain functions responsible for addiction and appetite regulation — may cause former smokers suffering from nicotine withdrawal to prefer fatty, sugary foods to fill the void.
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The study was led by Dr. Mustafa al’Absi, a licensed psychologist and professor in the Department of Family Medicine and Biobehavioral Health at the University of Minnesota Medical School, Duluth Campus, who published his findings in the Journal of Drug and Alcohol Dependence.
“We looked at whether or not acute nicotine withdrawal increases the intake of junk food — high in salt, fat and sugar — and how the stress-relieving receptors of the opioid system are involved,” al’Absi said in a press release from the university. “Mitigating these challenges during the treatment process will help patients quit smoking while understanding their eating habits and encourage healthier decisions.”
The study analyzed a group of smoking and non-smoking participants between the ages of 19 and 75. All subjects were asked to stop using nicotine for 24 hours and received either a placebo or 50 mg of naltrexone, a drug commonly used to treat patients with substance addiction problems.
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At the end of the two sessions before and after temporarily quitting, participants were offered a variety of snacks that differed in high to low energy density and dimensions of salty, sweet and fat.
The study found that those who were experiencing nicotine withdrawals consumed more calories. Those who’d taken the naltrexone were less likely to choose a high-calorie food.
“The study’s findings may be related to the use of food, especially those high in calories, to cope with the negative affect and distress that characterizes the feelings people experience during smoking withdrawal,” al’Absi said. “Results from preclinical and clinical research support this and demonstrate that stress increases proclivity for high-fat and high-sugar foods.”
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Weight gain or fear of weight gain after quitting, al’Absi believes, may be a factor in causing some smokers to relapse.
“These findings extend earlier studies that indicate the impact of tobacco use on appetite and help identify the influence of an important biological link, the brain opioid system, on craving during nicotine withdrawal,” al’Absi said. “The fear of weight gain is a major concern among smokers who think about quitting. The key to removing these barriers is to better understand the factors that increase the urge for high-caloric foods.”

WHO to revive probe into COVID-19 origins, officials warn time is running out

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The World Health Organization is developing a team of about 20 scientists who will be tasked with uncovering the origins of the COVID-19 outbreak– and officials warned that time could be running out, according to a report.
The Wall Street Journal reported Sunday that officials from the U.N.’s public-health arm have warned that the world may never know the virus’ origins.
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Lawrence Gostin, faculty director of the O’Neill Institute for National and Global Health Law at Georgetown University, told the paper that it is unclear if the team’s mandate will be enough to actually make progress in the investigation.
“China still holds all the cards, the WHO lacks power and it’s inconceivable to me that a new committee will be able to negotiate access to China…This is building a beautiful committee with nowhere to go,” he said.
The outbreak has also created additional tension between the U.S. and China. The Journal’s report said the Biden administration has been pressing WHO's director Tedros Adhanom Ghebreyesus to renew the inquiry. The WHO did not immediately respond to a late email from Fox News.
An unidentified WHO spokesman told the paper that the team’s priority “needs to be data and access in the country where the first reports were identified.”
The U.S. intelligence community earlier this month failed to conclusively identify the origin of the coronavirus following a 90-day investigation ordered by President Biden and experts are divided on why. A report by the Office of the Director of National Intelligence (ODNI) found that officials were unable to rule whether the virus escaped from a lab or spread to humans through an infected animal.
Klon Kitchen, a former intelligence officer with the ODNI, told Fox News it is in China's interest to continue to bar access to uncovering the origin of the virus.
“China is highly incentivized and capable of denying us this information,” Kitchen said. “They're incentivized to deny us this information because no matter what it is – whether it was a wet market or a biological facility as its origin – it's embarrassing to the Chinese Communist Party.”
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The Journal’s report pointed out that Chinese President Xi Jinping addressed the UN General Assembly last week and said his country will “continue to support and engage in global science-based origins tracing and stands firmly opposed to political maneuvering in whatever form.”

Diet rich in dairy may be linked to lower risk of heart disease: report

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A diet rich in dairy fat may be linked to a lower risk of cardiovascular disease, researchers say.
In a new Swedish cohort study published in the journal Plos Medicine, international experts challenged the view that full-fat dairy options should be avoided due to saturated fat.
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Looking at the dairy fat intake in 4,150 Swedish adults – the majority of whom were female, with a median age of 60.5 years – over a period of 16.6 years, the group measured the blood concentration of certain levels of fatty acids.
They recorded 578 incident cardiovascular disease events and 676 deaths, noting that cardiovascular disease risk was lower among those with higher intakes of dairy fat than compared with low intakes and that higher intakes were not associated with an increased risk of death.
Dairy intake in Sweden is among the highest in the world.
“Many studies have relied on people being able to remember and record the amounts and types of dairy foods they’ve eaten, which is especially difficult given that dairy is commonly used in a variety of foods. Instead, we measured blood levels of certain fatty acids, or fat ‘building blocks,’ that are found in dairy foods, which gives a more objective measure of dairy fat intake that doesn’t rely on memory or the quality of food databases,” Dr. Matti Marklund, of the Australia-based George Institute for Global Health, Johns Hopkins Bloomberg School of Public Health and Uppsala University, explained in a release.
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Then, in a meta-analysis, the researchers combined the result of the Swedish study with 17 similar studies in other countries, involving nearly 43,000 participants in the U.S., U.K. and Denmark.
The broader analysis also linked higher dairy fat consumption to a lower risk of cardiovascular disease, creating what the George Institute deemed the “most comprehensive evidence to date on the relationship between this more objective measure of dairy fat consumption, risk of cardiovascular disease and death.”
“Increasing evidence suggests that the health impact of dairy foods may be more dependent on the type – such as cheese, yogurt, milk, and butter – rather than the fat content, which has raised doubts if avoidance of dairy fats overall is beneficial for cardiovascular health,” lead author Dr. Kathy Trieu said in a statement.
VideoHowever, the study notes that it has limitations, including the inability of biomarkers to determine different types of dairy foods and that most studies in meta-analysis assessed biomarkers at the baseline which “may increase the risk of misclassification of exposure levels.”
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The researchers called for further clinical and experimental studies to “elucidate the causality of these relationships and relevant biological mechanisms.”
“It is important to remember that although dairy foods can be rich in saturated fat, they are also rich in many other nutrients and can be a part of a healthy diet. However, other fats like those found in seafood, nuts, and non-tropical vegetable oils can have greater health benefits than dairy fats,” Trieu added.

Idaho woman loses baby after coronavirus battle: report

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A pregnant Idaho woman’s baby did not survive after she went into labor earlier this month while in a medically induced coma because of the coronavirus, according to a report.
The baby was expected to be the third child for Kimberly Rangel of Meridian, a Boise suburb, KTVB-TV of Boise reported.
After Rangel was brought out of the coma and told about the baby’s death, she experienced “severe anxiety and heavy breathing,” her sister Anne Rangel told the station.
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That prompted doctors to return Kimberly Rangel to a comatose state, the report said.
Kimberly Rangel was not vaccinated, so the family wanted to share their story in an effort to urge other pregnant women to get their shots. The Centers for Disease Control and Prevention (CDC) claims that pregnant women who are not vaccinated risk severe illness and pregnancy complications if they become infected while pregnant, KTVB reported.
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The vaccine does not increase the risk of miscarriage and has not been shown to be harmful to a fetus, the report said.

CDC director denies defying agency panel over COVID-19 booster recommendations

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U.S. Centers for Disease Control and Prevention (CDC) Director Dr. Rochelle Walensky denied overruling an agency advisory committee that had reportedly refused to endorse Pfizer-BioNTech booster shots during a White House briefing Friday afternoon.
“I want to be very clear that I did not overrule an advisory committee,” Walensky said while speaking in a briefing alongside President Joe Biden's chief medical adviser, Dr. Anthony Fauci, U.S. Surgeon General Dr. Vivek Murthy and White House COVID-19 Response Coordinator Jeff Zients.
Walensky noted that she had listened intently to both the U.S. Food and Drug Administration (FDA) advisory committee as well as to the “exceptional group of scientists” who had deliberated for an hour over very difficult questions and “where the science was.”
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“I listened to the comments on the votes and this was a scientific close call,” she said. “And, I think you could tell by the duration of the meeting and the discussions that this was a scientific close call.”
In that situation, Walensky said, it was her call to make.
“If I had been in the room, I would have voted ‘yes,’ and that was … how my recommendations came out after listening to all of their scientific deliberations. To the extent that people are concerned about confidence, I would say they should listen to the deliberations themselves. We did it publicly, we did it transparently and we did it with some of the best scientists in the country,” she added.
Centers for Disease Control and Prevention Director Dr. Rochelle Walensky testifies during a Senate Health, Education, Labor and Pensions Committee hearing to examine an update from federal officials on efforts to combat COVID-19 on Tuesday, May 11, 2021, on Capitol Hill, in Washington. (Greg Nash/Pool via AP)
On Thursday, the CDC endorsed booster shots for millions of older or otherwise vulnerable Americans, including President Biden, who joked Friday that it was “hard to acknowledge” he was over 65 years old.
“All kidding aside, I’ll be getting my booster shot as soon as I can get it done,” Biden told reporters from the White House.
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Those eligible for the Pfizer-BioNTech boosters starting on Friday include people 65 years or older, adults 18 or older with underlying health conditions and those who are at increased risk of exposure, including people in prisons, grocery store workers, health care workers and teachers.
With health care systems once again at maximum capacity, Walensky said it was her job to recognize where actions can have the greatest impact and that the booster recommendations were made with the “intention to do the greatest good, even in an uncertain environment.”
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She said that she must do what she can to preserve the health of the country, and Murthy assured that the health of recipients of Moderna and Johnson & Johnson vaccines matters “just as much as other vaccine recipients” with the goal of making booster recommendations for them a high priority in coming weeks.
Fox News' Brooke Singman contributed to this report.

Methamphetamine-involved overdose deaths spike in US, study shows

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Methamphetamine-involved overdose deaths nearly tripled from 2015 to 2019 in the United States, according to a new National Institutes of Health (NIH) study.
The deaths involving the stimulant sharply rose during that time among people ages 18 to 64, the NIH National Institute on Drug Abuse (NIDA) reported. The agency said that patterns of methamphetamine use have become riskier and diversified across the nation's population.
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While the number of people who reported using methamphetamine during this time did not increase as steeply, the analysis found that populations with methamphetamine use disorder have become more diverse.
In addition, the study – published in JAMA Psychiatry – suggests that increases in higher-risk patterns of methamphetamine use – including increases in methamphetamine use disorder, frequent use and the use of other drugs at the same time – may be contributing to the rise in overdose deaths.
Last year, data from the U.S. Centers for Disease Control and Prevention (CDC) revealed that more than 93,000 Americans died from drug overdoses, which the NIH said marked the largest one-year increase in overdose deaths ever recorded.
The surge, NIH said, has largely been driven by rising overdoses involving synthetic opioids such as fentanyl, and overdose deaths involving psychostimulants like methamphetamine have also risen sharply in recent years. Many of those deaths involved the use of an opioid at the same time.
“In addition to heroin, methamphetamine and cocaine are becoming more dangerous due to contamination with highly potent fentanyl, and increases in higher risk use patterns such as multiple substance use and regular use,” NIDA Director Dr. Nora D. Volkow, one of the authors of the study, said in a statement.
The study's authors analyzed data on overdose deaths involving psychostimulants other than cocaine sourced from cause of death files in the National Vital Statistics System from 2015 to 2019 and assessed the methamphetamine use patterns of American adults ages 18 to 64 as reported by the National Survey on Drug Use and Health.
From 2015 to 2019, the number of overdose deaths involving psychostimulant drugs other than cocaine – largely methamphetamine – rose by 180%, from 5,526 to 15,489, according to the data.
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The number of people who reported using methamphetamine increased by 43% over the same period.
The institute said its researchers also noted shifts in the populations using methamphetamine from 2015 to 2019, with American Indians and Alaska Natives with the highest prevalence of methamphetamine, as well as methamphetamine use disorder and methamphetamine injection.
“Public health approaches must be tailored to address methamphetamine use across the diverse communities at risk, and particularly for American Indian and Alaska Native communities, who have the highest risk for methamphetamine misuse and are too often underserved,” Volkow said.
Previous studies found that American Indians and Alaska Natives also had the greatest increases in methamphetamine overdose deaths in recent years.
VideoHistorically, methamphetamine has been most commonly used by middle-aged White people, the NIH said.
Furthermore, the analysis found that the prevalence of methamphetamine use disorder among those who did not inject the drug increased tenfold among Black people from 2015 to 2019 and that methamphetamine use disorder without injection quadrupled in young adults ages 18 to 23.
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The CDC says that nearly 841,000 people have died since 1999 from a drug overdose in the U.S.

Common painkiller acetaminophen could alter fetal development, researchers warn

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A group of researchers is calling for greater caution in the use of paracetamol during pregnancy.
Paracetamol, commonly known as acetaminophen or APAP, is the most common drug ingredient in America, according to The Acetaminophen Awareness Coalition.
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The organization notes that it is the active ingredient in more than 600 pain-relieving medications, including Tylenol.
Acetaminophen, an external analgesic, works as a pain reliever for mild to moderate pain and as a fever reducer.
However, in a new study and consensus statement published Thursday in the journal Nature Reviews Endocrinology, an international group of experts urged precautionary action through focused research efforts and by raising awareness.
“A new Consensus Statement summarizes human epidemiological studies and experimental research in cells and animal models, which suggest that APAP exposure during pregnancy can alter fetal development and might increase the risk of certain neurodevelopmental, reproductive and urogenital disorders. The authors make several recommendations around minimizing exposure to APAP during pregnancy and increasing awareness, and present a call for focused research,” the statement began.
However, Nature noted both that paracetamol is widely considered to be the safest option for relief of pain and fever in pregnancy and that the UK National Institute for Health and Care Excellence states that APAP use during pregnancy is not thought to be harmful. The European Medicines Agency (EMA) advises that APAP can be used during pregnancy at the lowest effective dose for the shortest possible time and at the lowest possible frequency, while the U.S. Food and Drug Administration and EMA say studies investigating a possible connection between APAP use in pregnancy and disorders in offspring were inconclusive.
The researchers pointed out that the management of chronic pain associated with pregnancy has been understudied, arguing that a balance must be struck between “potential harm to pregnant people and/or their fetuses from untreated pain and fever and the increased risks of harm to the fetus from medications.”
“As such, the recommendations by Bauer and colleagues advise that pregnant people should only use APAP if medically indicated, that they should consult with their physician or pharmacist if they are uncertain about APAP use and that they should use the lowest effective APAP dose for the shortest possible time. These recommendations might not substantially differ from current advice in some countries,” the statement carried on. “However, the authors believe APAP-specific risk communication is needed between health professionals and pregnant people owing to prevalent APAP use and a widespread perception of negligible risk.”
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In the study, “Paracetamol use during pregnancy — a call for precautionary action,” the scientists, clinicians and epidemiologists summarized evidence for concerns about the alternation of fetal development and increased risk of certain disorders by conducting reviews of animal- and human epidemiological-based research spanning more than two decades.
They used only studies that investigated APAP as an independent exposure, searching experimental and epidemiological literature in English available on PubMed, including systematic reviews using the search terms “acetaminophen” or “paracetamol,” “endocrine,” “reproduction,” “urogenital,” “neurodevelopment,” “attention deficit disorder,” “autism spectrum disorder,” “hypospadias,” “anogenital distance” and “cryptorchidism.”
In human observational studies, conclusions suggested that prenatal APAP exposure might be associated with both reproductive and neurobehavioral ab..

Exercise and weight loss: Why working out may not help as much as you think

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A new study of how physical activity impacts the metabolism of humans suggests that increasing levels of activity may bring diminishing returns in energy expenditure.
This is due to “compensatory responses in non-activity energy expenditures,” international researchers wrote in the study, published in August in the journal Current Biology.
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For every 100 calories burned as a result of working out, the study says most people will net fewer than 72 calories burned.
“This suggestion has profound implications for both the evolution of metabolism and human health. It implies that a long-term increase in activity does not directly translate into an increase in total energy expenditure (TEE) because other components of TEE may decrease in response – energy compensation,” the study summary notes.
The group found that for 1,754 adults living “normal lives,” energy compensation averages 28% due to reduced basal energy expenditure (BEE) and that “this suggests that only 72% of the extra calories we burn from additional activity translates into extra calories burned that day.”
A young woman runs on a bridge. (Credit: iStock)
BEE is how many calories are burned simply by being alive.
The researchers subtracted numbers from TEE to understand energy expenditure from exercise and other movement and used statistical modeling to draw these conclusions.
In addition, the degree of energy compensation for different body compositions varied considerably.
The reason, the study suggests, could be due to among-individual differences in calorie compensation, with people who compensate more being more likely to accumulate body fat.
STUDY SUGGESTS MICROBIOME COULD BE KEY TO LOSING WEIGHT
Alternatively, the researchers said, the process might be within individuals – bodies compensating more strongly for calories burned during activity and making weight loss more difficult.
“Determining the causality of the relationship between energy compensation and adiposity will be key to improving public health strategies regarding obesity,” the study states.
Notably, the study did not examine food intake.
The U.S. Centers for Disease Control and Prevention (CDC) notes that adult obesity prevalence in the U.S. was 42.4% in 2017 to 2018.
VideoObesity also impacts some groups more than others, with non-Hispanic Black adults with the highest age-adjusted prevalence of obesity followed by Hispanic adults and non-Hispanic White adults.
Another study published this month in iScience points to increased physical activity and improvements in fitness levels as key to reducing the risk of obesity-related health conditions and mortality – even with the absence of weight loss.
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“We propose a weight-neutral strategy for obesity treatment on the following grounds: (1) the mortality risk associated with obesity is largely attenuated or eliminated by moderate-to-high levels of cardiorespiratory fitness (CRF) or physical activity (PA), (2) most cardiometabolic risk markers associated with obesity can be improved with exercise training independent of weight loss and by a magnitude similar to that observed with weight-loss programs, (3) weight loss, even if intentional, is not consistently associated with lower mortality risk, (4) increases in CRF or PA are consistently associated with greater reductions in mortality risk than is intentional weight loss, and (5) weight cycling is associated with numerous adverse health outcomes including increased mortality,” the University of Arizona and University of Virginia authors wrote.
“Adherence to PA may improve if health care professionals consider PA and CRF as essential vital signs and consistently emphasize to their patients the myriad benefits of PA and CRF in the absence of weight loss,” they said.

COVID-19 variant R.1 is ‘something really to watch,’ researcher says

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As the coronavirus continues to spread around the world, researchers are keeping a close eye on the R.1 variant in the United States.
The U.S. Centers for Disease Control and Prevention does not identify the R.1 variant as a variant of concern or interest.
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However, in a post detailing an outbreak at a Kentucky nursing home in March, the agency said R.1 does have “several mutations of importance,” demonstrating “evidence of increasing virus transmissibility … evidence of reduced neutralization by convalescent and post-vaccination sera” and the potential to “reduce the effectiveness of neutralizing antibodies.”
“Although vaccination was associated with decreased likelihood of infection and symptomatic illness, 25.4% of vaccinated residents and 7.1% of vaccinated (health care providers) were infected, supporting concerns about potential reduced protective immunity to R.1,” the CDC reported. “In addition, four possible reinfections were identified, providing some evidence of limited or waning natural immunity to this variant.”
During the Kentucky nursing home outbreak, 46 COVID-19 cases were identified, including 26 residents – 18 of whom were fully vaccinated – and 20 health care workers, four of whom were vaccinated.
Attack rates in unvaccinated residents were three times as high as those in vaccinated residents. In unvaccinated health care workers, attack rates were 4.1 times as high as those in vaccinated health care personnel.
Three of the nursing home’s residents died, including two who were not vaccinated.
An Outbreak.Info lineage report shows Maryland as the state with the greatest cumulative R.1 prevalence. The variant has spread to all but three states, according to the project, with more than 2,200 cases nationwide.
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In Georgia, the state Department of Public Health reports that the variant has infected fewer than 100 people, according to Atlanta's 11 Alive.
The station spoke to former Harvard Medical School professor and COVID-19 researcher William Haseltine about concerns over the variant and its potential to reduce protective immunity and overpower vaccine antibodies.
He called the R.1 variant “something really to watch” and wrote in Forbes that the variant that originated in Japan “has over 10,000 entries in the GISAID SARS-CoV-2 database.”
“That’s the first warning, that there was a virus that spreads through a fully vaccinated population,” Haseltine said.
This strain, he noted, “has a potential to get around.”
“It’s doing it mostly by making more of itself once it gets into the body, not only by evading what happens on the way in,” Haseltine said.
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“We need to know what it is that can break through our vaccines.”
Nevertheless, as Newsweek has reported, not all variants end up taking hold, and vaccinations were associated with a decreased likelihood of infection and symptomatic illness in the Kentucky outbreak.