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F.D.A. Allows Second Coronavirus Boosters for Everyone 50 and Older

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F.D.A. Allows Second Coronavirus Boosters for Everyone 50 and Older

WASHINGTON — Federal regulators licensed second booster pictures of the Pfizer-BioNTech and Moderna coronavirus vaccines on Tuesday for everybody 50 and older, describing the transfer as an effort to bolster waning immunity in opposition to extreme illness in case the virus sweeps the nation once more within the coming months.

The Meals and Drug Administration mentioned folks within the age group may get the extra shot a minimum of 4 months after their first booster. The company additionally licensed a second booster for folks 12 and older with sure immune deficiencies.

The choice implies that tens of thousands and thousands of People at the moment are eligible for what could be their fourth shot. And despite the fact that the general public could also be tiring of repeated doses, the transfer is almost definitely an interim one: Federal well being officers say it’s fairly potential that People of all ages may have one other shot within the fall to organize for any winter surge. The hope is that by then, scientists may have reconfigured the prevailing vaccines to work higher and last more in opposition to the variants which have emerged since November.

Federal well being officers initially thought-about limiting second boosters to these a minimum of 60 or 65 years previous. However at a information briefing, Dr. Peter Marks, who oversees the F.D.A.’s vaccine division, mentioned a decrease age restrict made extra sense as a result of so many People over 50 have power medical situations that put them in danger.

Whereas a single booster dose continues to guard most People from hospitalization and demise because of Covid-19, he mentioned, these 50 or older who acquired their first booster greater than 4 months in the past “ought to significantly take into account getting one other.”

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The Facilities for Illness Management and Prevention was a bit extra circumspect. Within the fall, when the primary spherical of boosters was licensed, the company cited a transparent profit from an added shot.

On Tuesday, in distinction, the C.D.C. up to date its vaccine steering to notice that second boosters have been now allowed. Dr. Rochelle P. Walensky, the company’s director, mentioned the choice of one other dose was “particularly necessary for these 65 and older and people 50 and older with underlying medical situations that improve their danger for extreme illness from Covid-19 as they’re the almost definitely to learn from receiving an extra booster dose right now.” About one-third of individuals aged 50 to 65 have important medical situations, officers mentioned.

The F.D.A. made the choice with very restricted information, largely from Israel. Consultants mentioned there was pretty strong information displaying a necessity for stronger safety now that variants have reduce into the vaccines’ efficiency. There may be considerably much less information on whether or not a second booster will present that safety, and for the way lengthy. Regulators mentioned one other dose posed no new security issues.

The concept that simply six months after federal regulators licensed the primary spherical of boosters, one other booster is already essential may add to public fatigue with Covid vaccines. The proof now means that the federal government’s determination final fall to authorize a primary booster — the topic of a lot scientific debate on the time — saved lives over the winter. Whereas the Omicron variant surged, those that have been boosted have been 21 instances much less prone to die from Covid and 7 instances much less prone to be hospitalized than those that have been unvaccinated, in response to the C.D.C.

However at this level, “every further dose is providing marginal worth,” mentioned Dr. Eric Rubin, an infectious illnesses knowledgeable on the Harvard T.H. Chan Faculty of Public Well being. At an occasion hosted by Columbia College this week, Dr. Kate O’Brien, the director of the vaccines division on the World Well being Group, mentioned, “We’re in a comparatively weak place on the type of coverage entrance round precisely what the info are which can be compelling choices about fourth doses.”

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The strongest information in help of a second booster got here from a newly launched Israeli research that has not but been peer reviewed. Throughout a 40-day interval this 12 months, the researchers studied Covid demise charges amongst greater than half one million adults 60 to 100 years previous who had obtained a minimum of one booster.

Among the many 234,868 who had just one booster, 232 folks died of Covid. Among the many 328,597 individuals who acquired a second booster, 92 died of Covid. The mortality fee “was considerably decrease amongst those that had obtained an extra booster,” the researchers mentioned.

Federal officers additionally studied statistical fashions that prompt that if the virus surged once more in late spring or summer season, a second booster may save 1000’s of lives and stop tens of 1000’s of hospitalizations.

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The C.D.C. singled out Johnson & Johnson recipients for particular remedy. The company has already really useful Moderna’s and Pfizer’s vaccines over Johnson & Johnson’s for security causes.

On Tuesday, it mentioned adults who acquired an preliminary dose plus a booster of Johnson & Johnson’s vaccine a minimum of 4 months in the past — a gaggle that would embrace greater than 1.4 million folks — have been eligible for a second booster with one of many mRNA vaccines. The company cited new information that confirmed Johnson & Johnson’s vaccine was much less efficient than the opposite two.

Each Pfizer and Moderna have argued for a second booster. Pfizer and BioNTech have mentioned information collected in the course of the Omicron wave confirmed that the efficiency of their preliminary booster wanes inside three to 6 months in opposition to each symptomatic an infection and extreme illness. Knowledge from Israel suggests a second booster restores safety, however researchers haven’t tracked the recipients of these boosters for lengthy.

Dr. Paul Burton, Moderna’s chief medical officer, advised CNN on Monday that the virus’s mutations had weakened the vaccines’ protect. “The one method that we’re going to get to a interval of stability and finally to an endemic illness is to maintain folks protected, hold their antibody ranges up, and I’m afraid meaning common boosting,” he mentioned.

Each Pfizer and Moderna have an apparent monetary incentive to advertise extra pictures: They’re projecting tens of billions of {dollars} in Covid vaccine gross sales this 12 months alone.

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Neither the F.D.A. nor the C.D.C. convened its outdoors committee of consultants to debate the brand new coverage, sparking criticism. Dr. Rubin, an F.D.A. panel member, referred to as that call cheap however mentioned it was essential for the company to make public any information it relied upon for others to scrutinize. The company’s determination memo is predicted to be posted on-line quickly.

Like different consultants, Dr. Rubin mentioned what is basically wanted now’s a vaccine that works higher than the prevailing ones in opposition to the brand new variants. Many research at the moment are underway to seek out it, however the earliest outcomes are usually not anticipated till later this spring.

“It’s not really clear but what the optimum booster needs to be,” Dr. Marks mentioned.

The F.D.A. panel is scheduled to satisfy on April 6 to debate what the nation’s booster technique needs to be transferring ahead. Federal well being officers have prompt that pictures within the fall could possibly be wanted, simply as they’re for the flu. “Sooner or later,” Dr. Marks mentioned, “we’re going to have to appreciate that this can be a virus that’s going to be with us and that we’ve got to come back to grips with coping with it frequently.”

One other main determination looms, probably subsequent month, when the F.D.A. could rule on whether or not to authorize a vaccine for the nation’s youngest kids — the one group nonetheless ineligible for pictures. Moderna plans to submit information within the coming weeks from what it has described as a profitable medical trial of a two-dose routine for kids beneath 6. Pfizer and BioNTech have mentioned they count on outcomes from their three-dose trial subsequent month for kids beneath 5.

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Dr. Marks mentioned on Tuesday that the F.D.A. would search enter from its advisory committee earlier than making choices on pictures for the youngest kids.

For lots of the roughly 3 p.c of People with immune deficiencies, Tuesday’s determination authorizes what would primarily be a fifth dose. These 12 and older can get Pfizer’s shot, whereas these adults can decide between Pfizer’s and Moderna’s.

How a lot public demand there’s for an additional booster is unclear. With the pandemic in a lull, the nation’s enthusiasm for pictures has been flagging. New reported infections have been falling because the third week in January, when the Omicron wave peaked.

In keeping with C.D.C. estimates on Tuesday, an much more contagious subvariant of Omicron, generally known as BA.2, is now dominant amongst new U.S. circumstances. The subvariant has led to a surge of latest circumstances in Europe. However some consultants assume the US could escape the brunt of its influence, partly as a result of the Omicron variant contaminated so many People.

Cheryl Shell, a 71-year-old retiree within the city of Spring Arbor in southern Michigan, mentioned she was not ready round to seek out out. She acquired her first booster in November, she mentioned, and she or he is keen to get a second as a result of she is anxious about waning efficiency. “I’ve acquired to go for any safety I can get,” she mentioned.

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Kate Bedingfield, the White Home communications director, mentioned the brand new authorization “is an effective factor and it’s a simple factor.” She mentioned the federal government had loads of provide to supply second boosters to these now eligible.

However she reiterated some extent the White Home has made repeatedly in latest weeks: If booster pictures are really useful for the overall inhabitants, she mentioned, Congress must present more cash to pay for them.

Noah Weiland and Adeel Hassan contributed reporting.

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Johnny Depp visits children’s hospital dressed as Captain Jack Sparrow in ‘magical moment’

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Johnny Depp visits children’s hospital dressed as Captain Jack Sparrow in ‘magical moment’

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An impromptu visit from Captain Jack Sparrow was a surprise treasure for some young cancer patients.

Actor Johnny Depp, who was in Spain for the San Sebastian Film Festival, dressed as the famous character from the popular “Pirates of the Caribbean” film series and dropped into the Osakidetza Donostia University Hospital.

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Depp visited the pediatric and oncology wards, where he interacted with the delighted children and their families.

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A spokesperson from the hospital described the actor’s visit as “exciting, endearing and unforgettable.”

Depp visited the pediatric and oncology wards, where he interacted with the delighted children and their families. (Osakidetza Donostia University Hospital /TMX)

“Both the children admitted to the hospital and their families and professionals who were working at that time welcomed him with great enthusiasm and affection,” the spokesperson said. 

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“In a situation of illness, anyone, but especially children, greatly appreciates a distraction of this magnitude. It was a breath of fresh air, a magical moment in which they forgot about their illness and were transported to the magical world of pirates.”

Johnny Depp hospital visit

A spokesperson from the hospital described the actor’s visit as “exciting, endearing and unforgettable.” (Osakidetza Donostia University Hospital /TMX)

The entire hospital team, the admitted children and their families are all “enormously grateful” for Depp’s visit, the spokesperson said. 

“It has been a pleasure and an honor to have Jack Sparrow with us, a great pirate.”

‘Meaningful impact’

Harpreet Pall, MD, chair of pediatrics at K. Hovnanian Children’s Hospital at Hackensack Meridian Jersey Shore University Medical Center, confirmed that a celebrity role model visiting a children’s hospital can have a “meaningful impact” on the patients’ emotional health.

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“Some of the psychological benefits include improved self-esteem and confidence, distraction from illness, improved optimism and a morale boost,” Pall told Fox News Digital. 

Pirates of the Caribbean

Actor Johnny Depp arrives for the world premiere of “Pirates of the Caribbean: Dead Men Tell No Tales” in Shanghai on May 11, 2017. (Getty Images)

“A celebrity visit can create excitement and decrease some of the stress of being in the hospital.”

The visit can also increase children’s engagement with their health care team, the doctor said, leading to better adherence to the treatment plan. 

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Pall added, “In addition, having a positive outlook and social interaction promotes healing for hospitalized children.”

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To reduce dementia risk, seniors should take up this outdoor activity, study suggests

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To reduce dementia risk, seniors should take up this outdoor activity, study suggests

Gardening could help aging adults stay sharp later in life, according to a recent study published in the Journal of Environmental Psychology.

Researchers at the University of Edinburgh in Scotland found that tending to gardens at an older age is associated with “small but detectable cognitive benefits.”

The long-term study tracked participants who shared details of their lifestyles and completed “frequent assessments” of their thinking skills up to age 90.

ELLEN DEGENERES HAS OSTEOPOROSIS: HERE’S WHAT TO KNOW ABOUT THE PAINFUL BONE CONDITION

The “Lothian Birth Cohort 1921” study followed people who were born in the Edinburgh area, starting at age 11. The participants regularly took an intelligence test known as the Scottish Mental Survey of 1932. 

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People who gardened frequently or occasionally showed “greater lifetime improvement in cognitive ability,” the results found. (iStock)

Hundreds of participants sat for the same exam at age 79.

Out of 467 participants, 31% had never gardened, while 43% gardened regularly.

The results revealed that the 280 who gardened frequently or occasionally showed “greater lifetime improvement in cognitive ability compared with those who never gardened or rarely did so.”

OZEMPIC PUSH FOR SENIORS? SOME DOCTORS SAY MORE PEOPLE AGE 65 AND OVER SHOULD BE ON IT

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Between the ages of 79 and 90, the participants’ cognitive ability — including memory, problem-solving and word fluency — declined in general, but the researchers found that the “earlier advantage of gardeners endured.”

Elderly woman taking care of her garden

The results revealed that the 280 who gardened frequently or occasionally showed “greater lifetime improvement in cognitive ability compared with those who never gardened or rarely did so.” (iStock)

Study co-author Dr. Janie Corley wrote in a press release how identifying behaviors that “facilitate healthy cognitive aging are of major public interest for the prevention of cognitive decline and dementia.”

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“Gardening is a key leisure activity in late adulthood,” she said. “Engaging in gardening projects, learning about plants and general garden upkeep involve complex cognitive processes, such as memory and executive function.” 

She continued, “Consistent with the ‘use it or lose it’ framework of cognitive function, more engagement in gardening may be directly associated with a lower risk of cognitive decline.”

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Dr. Azza Halim, MD, an anti-aging specialist, noted that gardening has been studied as an anti-aging activity for seniors, providing physical, mental and emotional benefits, including for longevity and cognition.

laughing couple tends to their outdoor garden

“It is important to engage in physical and social activities to maintain youthfulness,” an expert said. (iStock)

Gardening also counts as “low-impact exercise” that is beneficial for cardiac health and circulation, the physician added.

“It provides mental stimulation to reduce cognitive decline, as well as fostering mental and emotional well-being, relaxation and decreased anxiety,” she said. 

“At any age, it is important to engage in physical and social activities to maintain youthfulness — and more so in later years to stave off high blood pressure, depression, weight gain and cognitive decline.”

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“Engaging in gardening projects … involves complex cognitive processes.”

The researchers noted that their work cannot prove a direct correlation between gardening and improved cognitive ability, as factors like available greenery and social interactions could have impacted these results.

The study is supported by the Biotechnology and Biological Sciences Research Council and the Chief Scientist Office of the Scottish Executive Health Department. 

Fox News Digital reached out to the researchers for comment.

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How an Indigenous Diet Helped One Man Lose 200 Pounds + Tips for Boosting Your Health

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How an Indigenous Diet Helped One Man Lose 200 Pounds + Tips for Boosting Your Health


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Indigenous Diet: Benefits for Weight Loss and Overall Health| Woman’s World




















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