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FDA authorizes bivalent COVID-19 booster shots for children under 5

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The U.S. Meals and Drug Administration (FDA) introduced Thursday that Omicron-targeting bivalent COVID-19 vaccines have been approved to be used in youngsters as younger as 6 months outdated.

“At the moment, the U.S. Meals and Drug Administration amended the emergency use authorizations (EUAs) of the up to date (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines to incorporate use in youngsters down to six months of age,” the company stated in an announcement. 

The company stated youngsters ages 6 months by means of 5 years who’ve acquired the unique Moderna COVID-19 vaccine at the moment are eligible to obtain the up to date booster shot which particularly targets the Omicron variant of the virus. 

Kids who haven’t but begun the three-dose collection of the Pfizer-BioNTech vaccine or haven’t but acquired a 3rd dose, will now be given the bivalent booster as their third shot following two doses of the unique Pfizer COVID-19 vaccine. 

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Deborah Sampson, left, a nurse at a College of Washington Medical Middle clinic in Seattle, offers a Pfizer COVID-19 vaccine shot to a 20-month-old little one, June 21, 2022, in Seattle.
(AP Photograph/Ted S. Warren, file)

Children ages 6 months by means of 4 years who’ve already accomplished their three-dose Pfizer collection usually are not eligible for the up to date booster shot, the FDA stated. 

The choice comes three days after Pfizer and BioNTech submitted an utility to the FDA for an emergency use authorization for his or her Omicron BA.4/BA.5-Tailored Bivalent COVID-19 vaccine. 

“Extra youngsters now have the chance to replace their safety towards COVID-19 with a bivalent COVID-19 vaccine, and we encourage mother and father and caregivers of these eligible to think about doing so – particularly as we head into the vacations and winter months the place extra time shall be spent indoors,” stated FDA Commissioner Robert M. Califf, M.D., in an announcement. 

“As this virus has modified, and immunity from earlier COVID-19 vaccination wanes, the extra individuals who hold updated on COVID-19 vaccinations, the extra profit there shall be for people, households and public well being by serving to stop extreme diseases, hospitalizations, and deaths,” Califf added.

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Sign is seen outside the Food and Drug Administration headquarters in White Oak, Maryland, Aug. 29, 2020.

Signal is seen outdoors the Meals and Drug Administration headquarters in White Oak, Maryland, Aug. 29, 2020.
(Reuters/Andrew Kelly/File Photograph)

The U.S. Facilities for Illness Management and Prevention is predicted to observe go well with and advocate the bivalent boosters for younger youngsters. 

Simply 3% of kids below 2 and almost 5% of these between the ages of two to 4 have gotten their main doses to date, in keeping with the CDC.

“Vaccines stay one of the best protection towards essentially the most devastating penalties of illness brought on by the at present circulating omicron variant,” FDA vaccine chief Dr. Peter Marks stated in an announcement.

The up to date vaccines from Moderna and Pfizer are mixture pictures, containing half the unique vaccine and half tweaked to match the BA.4 and BA.5 Omicron strains that till lately have been dominant. Now, BA.5 descendants are chargeable for most COVID-19 instances.

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ARMY IS ONLY SERVICE BRANCH BOOTING TROOPS OVER COVID VACCINE MANDATE IN FULL FORCE

This August 2022 photo provided by Pfizer shows vials of the company's updated COVID-19 vaccine during production in Kalamazoo, Michigan

This August 2022 photograph supplied by Pfizer exhibits vials of the corporate’s up to date COVID-19 vaccine throughout manufacturing in Kalamazoo, Michigan
(Pfizer by way of AP)

The CDC final month launched the primary real-world information displaying that an up to date booster, utilizing both firm’s model, does provide added safety to adults. The evaluation discovered the best profit was in individuals who had by no means had a previous booster, simply two doses of the unique COVID-19 vaccine — however that even those that had a summer-time dose have been extra protected than if they’d skipped the latest shot.

Pfizer and Moderna executives thanked the FDA for increasing the authorization for his or her vaccines. 

“With the FDA’s determination, youngsters and adolescents of all age teams within the U.S. will now be eligible for our up to date bivalent COVID-19 booster, offering households with an vital protecting device as we proceed by means of the winter months,” stated Stéphane Bancel, CEO of Moderna. “We recognize the FDA’s well timed assessment.”

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“This authorization presents a chance for fogeys to assist higher shield their younger youngsters towards COVID-19, together with illness brought on by Omicron sublineages,” stated Pfizer CEO Albert Bourla. “Almost 40 million People have acquired a booster dose of an up to date vaccine. It’s important that all of us proceed to do our half to assist shield ourselves by staying updated with COVID-19 vaccinations, as really useful by public well being authorities, particularly now as we plan to collect for the vacations and head into the winter season.”

The Related Press contributed to this report.

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Are you an intermittent faster? If so, binge eating could be in your future, new study suggests

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Intermittent fasting (IF) has change into a preferred weight-loss technique over the previous decade.

But a brand new research from Texas A&M College revealed within the journal Urge for food means that it may increase the danger of binge-eating and different meals issues.

Writer Jordan Schueler, M.S., a PhD candidate within the Division of Psychological and Mind Sciences at Texas A&M, began growing the brand new research in 2019. 

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“There wasn’t a lot details about the psychological results of intermittent fasting — solely its affect on medical outcomes like weight and ldl cholesterol,” she advised Fox Information Digital in an electronic mail.

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“I used to be interested by seeing whether or not this particular type of time-restricted weight-reduction plan, the place individuals could ignore their starvation cues for prolonged intervals of time, may additionally induce binge-eating.”

A number of forms of fasting

There are a number of forms of intermittent fasting — however all of them observe the identical idea of alternating between fasting and consuming. 

“There wasn’t a lot details about the psychological results of intermittent fasting,” mentioned the writer of a brand new research on fasting — “solely its affect on medical outcomes like weight and ldl cholesterol.”
(iStock)

With a time-restricted strategy, the dieter solely eats throughout a sure window. For instance, with the 16/8 technique, the individual fasts for 16 hours after which can eat inside an eight-hour span, between 10 a.m. and 6 p.m. 

Different variations contain fasting for a full 24 hours a couple of times per week — or solely consuming restricted energy on fasting days.

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Those that had achieved intermittent fasting previously, the research discovered, have been extra more likely to interact in binge-eating than those that had by no means fasted. 

The researchers concerned within the new research checked out a pattern of almost 300 undergraduate school college students. 

INTERMITTENT FASTING ‘NO MAGIC BULLET’ FOR WEIGHT LOSS, RESEARCHERS SAY

Schueler mentioned they used “a recruitment technique that optimized the variety of contributors in our pattern who have been at present participating in intermittent fasting, as these have been the individuals we have been most interested by.” 

She added, “We additionally included individuals within the pattern who beforehand engaged in IF — and those that by no means had earlier than.”

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For a new study, people were asked to complete questionnaires about their intermittent fasting status, impulsivity, intuitive eating, disordered eating behaviors and mindful eating.

For a brand new research, individuals have been requested to finish questionnaires about their intermittent fasting standing, impulsivity, intuitive consuming, disordered consuming behaviors and aware consuming.
(iStock)

Among the many contributors, 23.5% have been at present taking part in intermittent fasting, 16% had tried it previously and 61% had by no means engaged in it. 

They have been requested to finish questionnaires about their intermittent fasting standing, impulsivity, intuitive consuming, disordered consuming behaviors and aware consuming.

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Those that had achieved intermittent fasting previously, the research discovered, have been extra more likely to interact in binge-eating than those that had by no means fasted. 

“Something that forces the physique into an irregular consuming sample holds the potential for disordered consuming.”

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This went towards the researchers’ expectations that present fasters can be extra more likely to binge.

“One rationalization is that those that are actively participating in IF should still be ‘efficiently’ participating in rigidity and self-control round their consuming behaviors,” Schueler mentioned. 

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“Nonetheless, it’s common to expertise a rebound impact following extreme caloric restriction, throughout which binge-eating happens. Our discovering means that though IF doesn’t seem like a danger issue for binge-eating whereas one is actively engaged within the weight loss program, it could have lasting results on one’s relationship with meals.”

The research additionally discovered that intermittent fasters have been much less more likely to tune into their inside starvation and fullness cues — and tended to offer themselves much less permission to eat. 

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"If you’re starving at 11 a.m. but feel you have to wait until 12:00 until your ‘eating window’ opens up, that’s kind of ridiculous," said one registered dietician nutritionist. 

“When you’re ravenous at 11 a.m. however really feel it’s a must to wait till 12:00 till your ‘consuming window’ opens up, that’s sort of ridiculous,” mentioned one registered dietician nutritionist. 
(iStock)

“In different phrases, intermittent fasters are removed from intuitive eaters,” mentioned Schueler. “Relatively than counting on their physique’s inherent knowledge, their consumption is decided by exterior guidelines.”

The research’s findings didn’t shock Lauren Harris-Pincus, a registered dietitian nutritionist who has been training for greater than 25 years within the New York/New Jersey space. 

She agreed that intermittent fasting may promote unhealthy habits by suppressing inside starvation cues.

“Something that forces the physique into an irregular consuming sample holds the potential for disordered consuming,” she advised Fox Information Digital in an interview. 

Some consultants don’t discover intermittent fasting to have a lot further long-term weight-loss profit over commonplace calorie restriction. 

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“When you’re ravenous at 11 a.m. however really feel it’s a must to wait till 12:00 till your ‘consuming window’ opens up, that’s sort of ridiculous. It’s merely not logical or efficacious to disregard your physique’s alerts for the sake of one thing that’s fairly faddish.”

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For individuals who have already got a poor physique picture, intermittent fasting may fairly simply set off disordered consuming, warned Tanya Freirich, a registered dietitian nutritionist. She practices as The Lupus Dietitian and serves individuals with autoimmune illnesses. 

“If somebody already has a poor physique picture, has issue tuning into their physique’s starvation and fullness cues, or tends to make use of meals as a coping mechanism, intermittent fasting can additional deteriorate the power for that individual to intuitively eat,” she advised Fox Information Digital in an electronic mail. 

Added Freirich, “Intermittent fasting is a set of exterior guidelines that may information individuals to pay attention much less to their physique’s cues. Disregarding the physique’s alerts could make it increasingly more tough to discern these messages sooner or later.”

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People who engage in intermittent fasting should watch out for red flags that may indicate they're veering into disordered eating territory, said one expert.

Individuals who interact in intermittent fasting ought to be careful for purple flags which will point out they’re veering into disordered consuming territory, mentioned one skilled.
(iStock)

Freirich does imagine intermittent fasting is usually a wholesome and sustainable life-style for some individuals — significantly in the event that they eat their first meal early within the day to gas their exercise and set their consuming window at eight hours or longer. 

For instance, this might imply having breakfast at 8 a.m. and dinner at 6 p.m. — an consuming window of 10 hours, with 14 hours of fasting. 

Nonetheless, she doesn’t suggest the approach for individuals who have diabetes, are vulnerable to low blood strain, are pregnant or lactating — or who’ve a historical past of disordered consuming.

Individuals who really feel unwell, weak or dizzy as a result of starvation may be susceptible to disordered consuming. 

Some consultants, together with Harris-Pincus, don’t discover intermittent fasting to have a lot further long-term weight-loss profit over commonplace calorie restriction. 

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A earlier research from April 2022 even discovered that time-restricted consuming didn’t result in a better discount in physique weight, physique fats or metabolic danger elements amongst overweight sufferers.

Warning indicators of disordered consuming

Freirich mentioned those that are participating in intermittent fasting ought to be careful for purple flags which will point out they’re veering into disordered consuming territory.

One instance is changing into overly inflexible in regards to the timing of meals. Individuals may really feel anxious, responsible or ashamed if they can not observe the time constraints. 

Some people may consume so much during the "eating window" that they "feel uncomfortably full or stuffed — which can indicate a cycle of restriction and bingeing," said Freirich.

Some individuals could eat a lot throughout the “consuming window” that they “really feel uncomfortably full or stuffed — which might point out a cycle of restriction and bingeing,” mentioned Freirich.
(iStock)

One other warning signal: Individuals could discover themselves withdrawing from essential social occasions as a result of these occasions happen outdoors the designated consuming window. 

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Or, a give attention to consuming could also be some individuals’s dominant thought all through the day. 

Individuals who really feel unwell, weak or dizzy as a result of starvation may be susceptible to disordered consuming. 

“One other signal is consuming a lot throughout the consuming window that they really feel uncomfortably full or stuffed — which might point out a cycle of restriction and bingeing,” mentioned Freirich.

The research’s limitations

The Texas A&M research does have some limitations. Schueler famous that the pattern dimension was small and never very various in regard to gender id, age, race/ethnicity, schooling or socioeconomic standing. 

The pattern dimension was small and never very various in regard to gender id, age, race/ethnicity, schooling or socioeconomic standing. 

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“Due to this fact, we have no idea if we’d see the identical outcomes amongst people from extra various or traditionally marginalized populations,” she mentioned. 

“Extra analysis is required in an effort to generalize these findings.”

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Schueler additionally identified that people took the surveys at one cut-off date — versus throughout a span of years. 

“This implies we can not know whether or not intermittent fasting causes binge-eating or vice versa,” she mentioned.

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“What is required to find out this are extra longitudinal research that observe individuals over time to see when the binge-eating develops — and observe the various factors that contributed to it.”

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India to improve drug regulatory system with $80M after locally made cough syrup was linked to 89 child deaths

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India to enhance drug regulatory system with $80M after domestically made cough syrup was linked to 89 little one deaths

India will spend $79.6 million on strengthening its drug regulatory system, the well being minister mentioned on Friday, after the World Well being Group raised considerations about domestically produced cough syrups being linked to the demise of 89 kids in two nations.

India is named the “pharmacy of the world” and its prescription drugs exports have greater than doubled over the previous decade to $24.5 billion in 2021-22. The demise of at the least 70 kids in Gambia and 19 kids in Uzbekistan final yr have dented that picture.

Authorities knowledge shared by Well being Minister Mansukh Mandaviya on Friday confirmed that out of almost 89,000 drug samples examined in 2021-22 by states and territories, greater than 2,500 didn’t meet requirements and near 380 had been declared spurious or adulterated.

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Mandaviya mentioned the federal authorities has allotted funds to his ministry for measures together with establishing new drug testing laboratories and upgrading current ones.

“The federal government has taken numerous regulatory measures to make sure the standard of medicines within the nation,” he mentioned in a written reply to a query in parliament.

India’s Chemical substances and Fertilizers Minister Mansukh Mandaviya gestures throughout his interview at his workplace in New Delhi on July 15, 2022.
(REUTERS/Anushree Fadnavis)

It was not instantly clear when the funds can be offered nor how they’d be used. The well being ministry didn’t instantly reply to a Reuters request in search of readability.

Final month the WHO referred to as for “quick and concerted motion” to guard kids from contaminated medicines.

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The WHO, the U.S. Meals and Drug Administration and international regulatory authorities have launched an investigation into the supply of contaminated cough syrups which have killed greater than 300 kids in Africa and Asia.

The businesses whose syrups had been linked to the demise of kids have both denied that their merchandise had been contaminated or declined to remark whereas investigations are ongoing.

Within the case of Gambia, Indian authorities inspectors discovered no contamination in take a look at samples of the syrup linked to the demise of kids.

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‘My Watch Think’s I’m Dead’

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Her name middle and others have alerted Apple to the difficulty. In mid-January, the corporate despatched 4 representatives to watch Ms. Dummer and her workforce for a day; she mentioned they’d loads of examples to indicate off.

In a written assertion, Alex Kirschner, an Apple spokesman, mentioned, “We’ve got been conscious that in some particular situations these options have triggered emergency providers when a person didn’t expertise a extreme automobile crash or arduous fall.” The corporate famous that when a crash is detected, the watch buzzes and sends a loud warning alerting the person {that a} name is being positioned to 911, and it gives 10 seconds wherein to cancel the decision.

Apple additionally mentioned that updates to the software program late final 12 months had been supposed to “optimize” the know-how and cut back the variety of false calls. Mr. Kirschner added, “Crash Detection and Fall Detection are designed to get customers assist once they want it most, and it has already contributed to saving a number of lives.”

Apple maintains a set of incidents wherein the 2 applied sciences have come to the rescue. In a single case, an Apple Watch alerted the authorities after a driver in Indianapolis had crashed right into a phone pole and the machine dialed for help. In one other, a watch referred to as for assist after a New Jersey man fell down a steep cliff whereas mountain climbing.

In Colorado, name dispatchers had hassle recalling an occasion wherein a watch had saved a skier in misery. (Ms. Dummer added that her workforce had “very hardly ever” obtained false 911 calls from different corporations’ units, equivalent to Android telephones.)

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The issue extends past skiers. “My watch usually thinks I’ve had an accident,” mentioned Stacey Torman, who works for Salesforce in London and teaches spin lessons there. She may be safely on the bike, exhorting her class to ramp up the power, or waving her arms to congratulate them, when her Apple Watch senses hazard.

“I need to have a good time, however my watch actually doesn’t need me to have a good time,” she mentioned. Oh nice, she thinks, “now my watch thinks I’m useless.”

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