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FDA authorizes updated COVID-19 booster shots targeting omicron variant

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FDA authorizes updated COVID-19 booster shots targeting omicron variant

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The U.S. Meals and Drug Administration (FDA) introduced Wednesday that it has licensed up to date coronavirus booster photographs focusing on the highly-contagious omicron variant.

“As we speak, the U.S. Meals and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize bivalent formulations of the vaccines to be used as a single booster dose at the least two months following major or booster vaccination,” it stated in an announcement.

The brand new photographs, which the FDA is referring to as “up to date boosters,” comprise “two messenger RNA (mRNA) elements of SARS-CoV-2 virus, one of many authentic pressure of SARS-CoV-2 and the opposite one in widespread between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2.”

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Lucas Kittikamron-Mora, 13, holds an indication in help of COVID-19 vaccinations as he receives his first Pfizer vaccination on the Cook dinner County Public Well being Division on Might 13 in Des Plaines, Ailing. 
(AP/Shafkat Anowar)

“The COVID-19 vaccines, together with boosters, proceed to save lots of numerous lives and forestall essentially the most severe outcomes (hospitalization and demise) of COVID-19,” FDA Commissioner Robert Califf stated in an announcement. “As we head into fall and start to spend extra time indoors, we strongly encourage anybody who’s eligible to contemplate receiving a booster dose with a bivalent COVID-19 vaccine to supply higher safety in opposition to presently circulating variants.”

The FDA says the up to date Moderna single dosage boosters are licensed for people 18 years or older, whereas the Pfizer-BioNTech one is for people 12 years or older.

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Dr. Manjul Shukla transfers Pfizer COVID-19 vaccine into a syringe in December 2021 at a mobile vaccination clinic in Worcester, Mass. 

Dr. Manjul Shukla transfers Pfizer COVID-19 vaccine right into a syringe in December 2021 at a cellular vaccination clinic in Worcester, Mass. 
(AP Photograph/Steven Senne)

Each sorts of booster photographs will present “higher safety in opposition to COVID-19 brought on by the omicron variant,” it added.

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“The BA.4 and BA.5 lineages of the omicron variant are presently inflicting most instances of COVID-19 within the U.S. and are predicted to flow into this fall and winter,” the FDA stated.

 

The FDA additionally introduced that it “will work shortly to guage future information and submissions to help authorization of bivalent COVID-19 boosters for extra age teams as we obtain them.”

The FDA says the updated coronavirus booster shots will offer better protection against the omicron variant.

The FDA says the up to date coronavirus booster photographs will provide higher safety in opposition to the omicron variant.
(iStock)

“The FDA has been planning for the likelihood that the composition of the COVID-19 vaccines would should be modified to handle circulating variants,” stated Peter Marks, director of the FDA’s Middle for Biologics Analysis and Analysis. “We sought enter from our outdoors specialists on the inclusion of an omicron element in COVID-19 boosters to supply higher safety in opposition to COVID-19. We now have labored carefully with the vaccine producers to make sure the event of those up to date boosters was carried out safely and effectively.”

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Death Toll in Gaza Likely 40 Percent Higher Than Reported, Researchers Say

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Death Toll in Gaza Likely 40 Percent Higher Than Reported, Researchers Say

Deaths from bombs and other traumatic injuries during the first nine months of the war in Gaza may have been underestimated by more than 40 percent, according to a new analysis published in The Lancet.

The peer-reviewed statistical analysis, led by epidemiologists at the London School of Hygiene and Tropical Medicine, used modeling in an effort to provide an objective third-party estimate of casualties. The United Nations has relied on the figure from the Hamas-led Ministry of Health, which it says has been largely accurate, but which Israel criticizes as inflated.

But the new analysis suggests the Hamas health ministry tally is a significant undercount. The researchers concluded that the death toll from Israel’s aerial bombardment and military ground operation in Gaza between October 2023 and the end of June 2024 was about 64,300, rather than the 37,900 reported by the Palestinian Ministry of Health.

The estimate in the analysis corresponds to 2.9 percent of Gaza’s prewar population having been killed by traumatic injury, or one in 35 inhabitants. The analysis did not account for other war-related casualties such as deaths from malnutrition, water-borne illness or the breakdown of the health system as the conflict progressed.

The study found that 59 percent of the dead were women, children and people over the age of 65. It did not establish what share of the reported dead were combatants.

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Mike Spagat, an expert on calculating casualties of war who was not involved in this research, said the new analysis convinced him that Gaza casualties were underestimated.

“This is a good piece of evidence that the real number is higher, probably substantially higher, than the Ministry of Health’s official numbers, higher than I had been thinking over the last few months,” said Dr. Spagat, who is a professor at Royal Holloway College at the University of London.

But the presentation of precise figures, such as a 41 percent underreported mortality, is less useful, he said, since the analysis actually shows the real total could be less than, or substantially more. “Quantitatively, it’s a lot more uncertain than I think comes out in the paper,” Dr. Spagat said.

The researchers said their estimate of 64,260 deaths from traumatic injury has a “confidence interval” between 55,298 and 78,525, which means the actual number of casualties is likely in that range.

If the estimated level of underreporting of deaths through June 2024 is extrapolated out to October 2024, the total Gazan casualty figure in the first year of the war would exceed 70,000.

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“There is an importance to war injury deaths, because it speaks to the question of whether the campaign is proportional, whether it is, in fact, the case that sufficient provisions are made to to avoid civilian casualties,” said Francesco Checchi, an epidemiologist with an expertise in conflict and humanitarian crises and a professor at the London School of Hygiene and Tropical Medicine who was an author on the study. “I do think memorializing is important. There is inherent value in just trying to come up with the right number.”

The analysis uses a statistical method called capture-recapture analysis, which has been used to estimate casualties in other conflicts, including civil wars in Colombia and Sudan.

For Gaza, the researchers drew on three lists: The first is a register maintained by the Palestinian Ministry of Health, which mainly comprises the dead in hospital morgues and estimates of the number of unrecovered people buried in rubble. The second is deaths reported by family or community members through an online survey form the ministry established on Jan. 1, 2024, when the prewar death registration system had broken down. It asked Palestinians inside and outside Gaza to provide names, ages, national ID number and location of death for casualties. The third source was obituaries of people who died from injuries that were published on social media, which may not include all of the same biographical details and which the researchers compiled by hand.

The researchers analyzed these sources to look for individuals who appear on multiple lists of those killed. A high level of overlap would have suggested that few deaths were uncounted; the low amount they found suggested the opposite. The researchers used models to calculate the probability of each individual appearing on any of the three lists.

“Models enable us to actually estimate the number of people who have not been listed at all,” Dr. Checchi said. That, combined with the listed number, gave the analysts their total.

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Patrick Ball, director of research at the Human Rights Data Analysis Group, and a statistician who has conducted similar estimates of violent deaths in conflicts in other regions, said the study was strong and well reasoned. But he cautioned that the authors may have underestimated the amount of uncertainty caused by the ongoing conflict.

The authors used different variations of mathematical models in their calculations, but Dr. Ball said that rather than presenting a single figure — 64,260 deaths — as the estimate, it may have been more appropriate to present the number of deaths as a range from 47,457 to 88,332 deaths, a span that encompasses all of the estimates produced by modeling the overlap among the three lists.

“It’s really hard to do this kind of thing in the middle of a conflict,” Dr. Ball said. “It takes time, and it takes access. I think you could say the range is larger, and that would be plausible.”

While Gaza had a strong death registration process before the war, it now has only limited function after the destruction of much of the health system. Deaths are uncounted when whole families are killed simultaneously, leaving no one to report, or when an unknown number of people die in the collapse of a large building; Gazans are increasingly buried near their homes without passing through a morgue, Dr. Checchi said.

The authors of the study acknowledged that some of those assumed dead may in fact be missing, most likely taken as prisoners in Israel.

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Roni Caryn Rabin and Lauren Leatherby contributed reporting.

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Dementia risk for people 55 and older has doubled, new study finds

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Dementia risk for people 55 and older has doubled, new study finds

Dementia cases in the U.S. are expected to double by 2060, with an estimated one million people diagnosed per year, according to a new study led by Johns Hopkins University and other institutions.

Researchers found that Americans’ risk of developing dementia after age 55 is 42%, double the risk that has been identified in prior studies, a press release stated.

For those who reach 75 years of age, the lifetime risk exceeds 50%, the study found.

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Women face a 48% average risk and men have a 35% risk, with the discrepancy attributed to women living longer than men.

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Dementia cases in the U.S. are expected to double by 2060, with an estimated one million people diagnosed per year. (iStock)

The study, which was published in the journal Nature Medicine on Jan. 13, analyzed data from the Atherosclerosis Risk in Communities Neurocognitive Study (ARIC-NCS), which has tracked the cognitive and vascular health of nearly 16,000 adults since 1987.

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“Our study results forecast a dramatic rise in the burden from dementia in the United States over the coming decades, with one in two Americans expected to experience cognitive difficulties after age 55,” said study senior investigator and epidemiologist Josef Coresh, MD, PhD, who serves as the founding director of the Optimal Aging Institute at NYU Langone, in the release.

Understanding risk factors

“One of the main reasons for the increase is that great medicine and tecnological advances are keeping us alive longer and age is a risk factor for dementia,” Dr. Marc Siegel, clinical professor of medicine at NYU Langone Health and Fox News senior medical analyst, told Fox News Digital.

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“Obesity is associated with inflammation, diabetes and high blood pressure, which are all independent risk factors for dementia.”

In addition to aging, other risk factors include genetics, obesity, hypertension, diabetes, unhealthy diets of ultraprocessed foods, sedentary lifestyles and mental health disorders, the release said.

“We have an obesity epidemic with over 45% adults obese in the U.S.,” Siegel noted. “Obesity is associated with inflammation, diabetes and high blood pressure, which are all independent risk factors for dementia.”

      

“And as an unhealthy population, we also have more heart disease, and atrial fibrillation is a risk factor for cognitive decline,” he added.

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Dementia risk was found to be higher among people who have a variant of the APOE4 gene, which has been linked to late-onset Alzheimer’s disease. Black adults also have a higher risk.

virtual volumetric drawing of brain in hand

Researchers found that Americans’ risk of developing dementia after age 55 is 42%, double the risk that has been identified in prior studies. (iStock)

Research has shown that the same interventions used to prevent heart disease risk could also prevent or slow down dementia, the study suggested.

“The pending population boom in dementia cases poses significant challenges for health policymakers in particular, who must refocus their efforts on strategies to minimize the severity of dementia cases, as well as plans to provide more health care services for those with dementia,” said Coresh.

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What needs to change?

Professor Adrian Owen, PhD, neuroscientist and chief scientific officer at Creyos, a Canada-based company that specializes in cognitive assessment and brain health, referred to the increase in dementia cases as a “tidal wave.”

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“This new study’s anticipated surge in dementia cases underscores the urgent need for early and accurate detection,” he told Fox News Digital.

“By catching issues early, we give people the power to make lifestyle adjustments, seek available treatments and plan their futures with clarity.”

“By identifying cognitive decline at its earliest stages, we have an opportunity to intervene before patients and families bear the full weight of the disease.”

Owen recommends conducting regular cognitive assessments as part of routine check-ups to proactively identify early signs of cognitive decline.

“By catching issues early, we give people the power to make lifestyle adjustments, seek available treatments and plan their futures with clarity,” he said.

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Man with doctor

“By identifying cognitive decline at its earliest stages, we have an opportunity to intervene before patients and families bear the full weight of the disease.” (iStock)

Maria C. Carrillo, PhD, chief science officer and medical affairs lead for the Alzheimer’s Association in Chicago, said there is an “urgent need” to address the global crisis of Alzheimer’s disease and dementia. 

To help keep the aging brain healthy, the Alzheimer’s Association published its report 10 Healthy Habits for Your Brain. Some of the tips are listed below.

For more Health articles, visit www.foxnews.com/health

– Participate in regular physical activity.

– Learn new things throughout your life and engage your brain.

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– Get proper nutrition — prioritize vegetables and leaner meats/proteins, along with foods that are less processed and lower in fat.

– Avoid head injury (protect your head).

– Have a healthy heart and cardiovascular system — control blood pressure, avoid diabetes or treat it if you have it, manage your weight and don’t smoke.

Man with Alzheimer's

Research has shown that the same interventions used to prevent heart disease risk could also prevent or slow down dementia. (iStock)

The research was funded by the National Institutes of Health.

Fox News Digital reached out to the researchers for additional comment.

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Are GLP-1 Pills the Future of Ozempic? | Woman's World

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Are GLP-1 Pills the Future of Ozempic? | Woman's World


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Are GLP-1 Pills the Future of Ozempic? | Woman’s World



























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