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Pfizer Asks FDA to Approve Omicron-Explicit Booster Shot

News Picture: Pfizer Asks FDA to Approve Omicron-Specific Booster Shot

MONDAY, Aug. 22, 2022 (HealthDay Information)

Pfizer Inc. mentioned Monday that it has requested the U.S. Meals and Drug Management to approve the emergency use of an up to date booster shot that objectives a number of variations of the Omicron variant.

Animal research display that the brand new mRNA vaccine produces an immune reaction towards each BA.4 and BA.5 subvariants, with medical trials set to start this month, the corporate mentioned in a information unencumber saying the applying.

“The agility of the mRNA platform, at the side of in depth medical revel in with the Pfizer-BioNTech COVID-19 Vaccine, has allowed us to increase, take a look at and manufacture up to date, top of the range vaccines that align to circulating lines with unheard of pace,” mentioned Pfizer Chairman and CEO Albert Bourla.

“Having hastily scaled up manufacturing, we’re located to in an instant start distribution of the bivalent Omicron BA.4/BA.5 boosters, if licensed, to assist give protection to people and households as we get ready for attainable fall and iciness surges,” he mentioned within the unencumber.

The BA.5 subvariant accounts for almost 90% of latest U.S. COVID instances, in step with the U.S. Facilities for Illness Keep watch over and Prevention.

The FDA plans to check the information in September. If licensed, the vaccine can also be disbursed in an instant, NBC Information reported.

Harvard epidemiologist Invoice Hanage informed NBC Information that the turnaround time for this new vaccine was once “remarkably fast.” It normally takes years for vaccines to be evolved and disbursed, and the newest Omicron subvariants handiest started spreading in the USA extensively in early June.

The brand new vaccine can be “essential,” particularly for folks liable to serious infections, such because the aged, Hanage mentioned.

The brand new pictures are anticipated to be to be had ahead of an anticipated iciness surge of COVID instances, White Area COVID coordinator Dr. Ashish Jha mentioned remaining week.

The FDA is permitting Pfizer to post much less information at the shot than it has for different COVID vaccines, as a result of changed vaccines that concentrate on rising lines of COVID can also be authorized with out long medical trials, NBC Information reported.

Additional information

Consult with the U.S. Facilities for Illness Keep watch over and Prevention for extra on COVID vaccines.

SOURCES: Pfizer, information unencumber, Aug. 22, 2022; NBC Information

 

By way of Steven Reinberg HealthDay Reporter

MedicalNews

Copyright © 2021 HealthDay. All rights reserved.

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Taking a Shot at Ache Aid After Knee Alternative

News Picture: Taking a Shot at Pain Relief After Knee ReplacementThrough Amy Norton HealthDay Reporter

THURSDAY, Aug. 18, 2022 (HealthDay Information)

Researchers can have discovered a brand new strategy to assist ease the ache of knee alternative surgical procedure: infusing morphine at once into the shin bone.

The findings come from a up to date find out about of 48 sufferers present process general knee alternative. The investigators discovered that giving a morphine injection into the shin bone all over the operation managed sufferers’ post-surgery ache higher than usual remedy on my own.

It additionally lessened their reliance on probably addictive opioid ache drugs.

For now, the method is simplest being finished at a restricted selection of scientific facilities. So other people having their knees changed within the close to long term are not likely to have it as an possibility.

However there’s no reason why the way may just now not be extensively followed, in keeping with senior researcher Dr. Kwan “Kevin” Park, an orthopedic surgeon at Houston Methodist Health center.

Overall knee alternative, which is typically finished to regard serious arthritis, is a not unusual process, Park famous. A few many years in the past, sufferers would spend days within the medical institution in a while, receiving high-dose opioids to regulate the ache.

Issues have modified since then, Park stated: Ache regulate has progressed, with the assistance of drugs which are injected ahead of and all over surgical procedure, for instance. And sufferers now are frequently discharged at the similar day as surgical procedure.

However there is nonetheless room for development, he famous.

One function is to cut back the desire for opioid painkillers, reminiscent of oxycodone and hydrocodone, within the days to weeks after surgical procedure. But even so their addictive attainable, the medication could have uncomfortable side effects like nausea and constipation.

Opioids, Park stated, “nonetheless have a task. However we wish to decrease their use, and get sufferers off of them once imaginable.”

For the brand new find out about, Park’s staff used a method referred to as intraosseous infusion, wherein medicine is at once injected into bone marrow. The researchers had already studied the infusions so that you can ship antibiotics to the shin bone all over general knee alternative; the purpose there was once to cut back the chance of an infection — an extraordinary however severe complication, Park stated.

It labored. So the researchers sought after to look whether or not including morphine to the infusion may just assist regulate sufferers’ post-surgery ache.

Within the find out about, 48 sufferers had been randomly assigned to one in all two teams. In a single, sufferers won usual ache regulate and an antibiotic infusion into the shin bone; the opposite workforce was once given the similar, however morphine was once added to the bone infusion.

All the sufferers won common anesthesia plus regional nerve blocks, which assist with post-surgery ache. They had been additionally prescribed painkillers to make use of after surgical procedure — both acetaminophen (Tylenol) for milder ache, or opioids for extra serious ache.

On reasonable, the find out about discovered, sufferers given the morphine infusion reported much less ache within the two days after surgical procedure: Their ache scores on a normal scale had been 40% to 49% decrease — a distinction that waned a bit of however continued via day 9. The sufferers extensively utilized fewer opioids within the two weeks after surgical procedure.

An orthopedic surgeon who was once now not concerned within the find out about stated the effects sound “probably promising.”

“It is at all times thrilling to look new research popping out about controlling post-op ache after general knee alternative,” stated Dr. Cynthia Kahlenberg, a hip and knee surgeon on the Health center for Particular Surgical procedure in New York Town.

Like Park, she stated that regardless of strides made in ache regulate, “many sufferers enjoy extra ache than we would like after knee alternative surgical procedure.”

Kahlenberg stated greater research are had to see if the present findings will also be replicated. She additionally stated that many hospitals, together with her personal, have begun the use of an extra regional nerve block all over surgical procedure — one who was once now not hired on this find out about.

“I am not certain how a lot of a distinction this new method would make if the (researchers) had been incorporating either one of the regularly used regional anesthesia blocks slightly than only one,” Kahlenberg stated.

Park stated additional research are deliberate.

For now, it isn’t utterly transparent why a unmarried bone infusion of morphine, which has fast however transient results, is helping regulate post-surgery ache for days. However Park stated his staff believes the blunting of the preliminary ache is essential.




QUESTION


What joints are maximum frequently suffering from osteoarthritis?

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Adjustments in Menstrual Cycle Can Come After COVID Shot

Newest Ladies’s Well being Information

News Picture: Changes in Menstrual Cycle Can Come After COVID ShotBy means of Ellie Quinlan Houghtaling HealthDay Reporter

MONDAY, July 18, 2022 (HealthDay Information)

Many have skilled unwanted side effects upon getting a COVID vaccine — tiredness, fever, headache and soreness are the most typical. However a brand new find out about confirms that individuals who have classes might revel in lesser identified problems — heavier classes or leap forward bleeding.

Researchers discovered sure other folks had been much more likely to revel in one or the opposite upon getting a shot: Those that known as non-white or who had been older, in conjunction with those that additionally reported fever or fatigue as unwanted side effects. Individuals who had endometriosis, heavy bleeding, fibroids or different reproductive issues additionally reported heavier menstrual go with the flow following a shot.

However the find out about authors stated those adjustments don’t seem to be unhealthy. And different professionals say the advantages of vaccination a long way outweigh the conceivable unwanted side effects.

“The affect of vaccine hesitancy can’t be underestimated in public well being,” stated Dr. Alison Edelman, a member of the American School of Obstetricians and Gynecologists’ Medical Record Evaluate Panel-Gynecology and a professional on COVID-19 and menstruation adjustments.

“We’ve a protracted historical past of protected vaccine building and we all know so much about vaccines — no longer all unwanted side effects with a vaccine are destructive like feeling quickly fatigued, having a sore arm, or getting a fever,” Edelman stated. “But when we did not suggest people on what to anticipate, then the ones experiencing that aspect impact would had been in point of fact involved and that fuels worry and distrust.”

Earlier research have discovered that essentially the most frequently reported aspect impact reported via other folks experiencing adjustments to their menstrual cycles had been heavy classes that “briefly reversed” in a question of cycles. However how the vaccine is in a position to affect the uterus is every other tale.

“The uterus is an immune organ,” stated find out about creator Kathryn Clancy, a professor of anthropology on the College of Illinois Urbana-Champaign. “Folks have fatigue and sore hands which might be responses to the vaccine, so it is not a stretch to consider that an immune organ just like the uterus, that adjustments and clots and most of these issues which might be associated with the immune gadget, would not be affected.”

Different immunizations also are identified to affect the uterus and menstrual go with the flow, however the researchers lamented that those don’t seem to be problems which were studied smartly.

“Thus far, there is some proof that there are some menstrual irregularities with different vaccines, just like the HPV vaccine, however the issue is there have not been numerous research that glance to this for any vaccine. Maximum research most effective focal point on fertility, just like the flu vaccine,” Clancy stated.

“That issues to every other drawback. We care about fertility, we care in regards to the well being of the fetus, however we do not care in regards to the on a regular basis stories of menstruating other folks,” she stated.

The survey, revealed July 15 within the magazine Science Advances, analyzed responses from over 35,000 other folks within the two weeks when they gained the vaccine.

Simplest those that had no longer been identified with COVID-19 had been incorporated within the research, because the sickness itself can every so often cause adjustments in menstrual go with the flow. The researchers additionally incorporated postmenopausal ladies and other folks on hormone remedies (equivalent to transgender males), a bunch that will be particularly stunned to search out leap forward bleeding.

The research discovered that simply over 42% of menstruating survey respondents reported a heavier go with the flow after receiving the vaccine, both within the first seven days or 8 to fourteen days after preliminary vaccination. Greater than 70% of respondents the usage of long-acting reversible birth control (IUDs and hormone implants) reported leap forward bleeding, as did 38.5% of other folks present process gender-affirming hormone therapies.

Nonetheless, the researchers wired that you should not simply chalk up leap forward bleeding to the vaccine. As a substitute, they inspire somebody experiencing leap forward bleeding to get checked via a physician, including that you have to rule out different reasons. Kind of 10% of the time, it can be a signal of most cancers, Clancy added.

“I feel the necessary factor to understand is that that is one thing that is going on and can most definitely proceed to occur to such an efficient vaccine, and we aren’t the one find out about up so far that is proven there are adjustments to classes as a result of this vaccine,” stated lead creator Katharine Lee. She’s a postdoctoral

General Article

May just the Flu Shot Assist Save you Alzheimer’s?

Could the Flu Shot Help Prevent Alzheimer's?By way of Steven Reinberg HealthDay Reporter

A every year flu shot might do greater than offer protection to you from an uncongenial bout of influenza: New analysis suggests it’ll lend a hand guard towards Alzheimer’s illness as neatly.

Individuals who have been vaccinated at least one time over 4 years have been 40% much less more likely to broaden Alzheimer’s throughout that length, the learn about discovered.

“It could be that by way of combating the an infection or decreasing the severity of an infection, we are mitigating the wear and tear that influenza may cause within the mind, particularly in the ones 65 and older,” stated lead writer Dr. Avram Bukhbinder, a resident within the Department of Kid Neurology at Massachusetts Basic Clinic in Boston.

“A captivating piece of this puzzle is that it isn’t simply the influenza vaccine that turns out to have this protecting impact on Alzheimer’s and different dementias,” he stated. “Different vaccines that adults generally obtain, like tetanus, diphtheria, pneumococcus and shingles, are also related to a discounted possibility of Alzheimer’s. It isn’t slightly as robust as the person who we discovered on this learn about.”

After all, this learn about does not end up that the flu vaccine itself protects the mind from Alzheimer’s. However Bukhbinder stated the massive choice of members — just about 1 million — is as as regards to proving the vaccine’s protecting impact as science can get.

Different components, reminiscent of a wholesome way of life, might play a task, however researchers tried to get rid of the impact of those components.

Bukhbinder suspects the flu vaccine alters the immune machine so it is in a position to assault proteins related to Alzheimer’s that building up within the mind and kill nerve cells (neurons) round them.

“What we predict could be going down is the influenza vaccine could be converting the immune machine such that its reaction to Alzheimer’s proteins makes them no longer as destructive to our mind,” he stated.

The similar may also be the case for the COVID-19 vaccine however, Bukhbinder stated, that hasn’t but been proven.

A vaccine advisory panel to the U.S. Facilities for Illness Keep watch over and Prevention not too long ago beneficial that folks 65 and older get some of the stronger flu pictures designed to present older adults extra powerful coverage.

Bukhbinder praised that call.

“This additional-strength influenza vaccine, which appears to be extra protecting towards the true an infection, used to be simply formally beneficial by way of the CDC, which is unbelievable,” he stated.

He is keen to look in long term research if the stronger vaccines are much more protecting towards Alzheimer’s.

Bukhbinder’s workforce when compared the danger of Alzheimer’s amongst just about 1 million other folks seniors who had flu pictures and a equivalent quantity who did not. On the time, Bukhbinder used to be a pupil on the College of Texas in Houston.

All over 4 years of follow-up, about 5% of those that had flu vaccine advanced Alzheimer’s, in comparison to just about 9% of those that weren’t vaccinated, researchers discovered.

“I believe that is every other compelling reason why to get vaccinated towards influenza,” Bukhbinder stated. “It isn’t a be sure that it will forestall you from getting Alzheimer’s, however it truly turns out it is including to the compelling nature of the vaccine.”

Heather Snyder, vice chairman of clinical and medical members of the family on the Alzheimer’s Affiliation, reviewed the findings.

She speculated that the hyperlink researchers known would possibly come right down to way of life possible choices: Individuals who get their every year flu shot would possibly interact in different wholesome behaviors that still cut back the danger of Alzheimer’s and different dementias.

“This new learn about means that flu vaccination is also treasured for keeping up cognition and reminiscence as we age,” she stated.

However it is too quickly to inform if the flu vaccine on its own can decrease Alzheimer’s possibility, Snyder stated. Extra analysis is had to perceive the organic mechanisms at the back of those findings, she stated.




SLIDESHOW


The Levels of Dementia: Alzheimer’s Illness and Growing old Brains
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“It is usually conceivable that there are problems associated with unequal get right of entry to and/or vaccine hesitancy and that can affect the learn about inhabitants and the analysis effects,” Snyder added.

The findings, which might be very similar to earlier, smaller research, have been not too long ago printed on-line within the Magazine of Alzheimer’s Illness.

Additional information

For extra on Alzheimer’s illness, head to the Alzheimer’s Affiliation.

SOURCES: Avram Bukhbinder, MD, resident, Department of Kid Neurology, Massachusetts Basic Clinic, Boston; Heather Snyder, PhD, vice chairman, clinical and medical members of the family,

General Article

Young children, Children & the COVID Shot: An Professional Solutions Your Questions

News Picture: Babies, Toddlers & the COVID Shot: An Expert Answers Your Questions

MONDAY, June 27, 2022 – After an overly lengthy wait, young children, little toddlers and preschoolers can now get COVID-19 pictures.

Many oldsters would possibly really feel reduction, however some may additionally have questions. Dr. Jessica Ericson, a pediatric infectious illness doctor at Penn State Well being Kids’s Medical institution in Hershey, Pa., provides some solutions to lend a hand folks weigh some great benefits of vaccinating youngsters who’re 6 months of age and older.

“The vaccine provides the massive advantage of protective youngsters in opposition to critical headaches and dying from COVID, and it has the longer term advantage of coaching a kid’s immune gadget to handle COVID,” Ericson mentioned. “That is how we cross from a plague to an epidemic degree, the place COVID turns into a lot much less worrisome.”

Ericson could also be a mother to a 6-year-old, who’s vaccinated, and a 3-year-old, who’s now eligible. From a sensible perspective, Ericson famous, when her 3-year-old examined sure for COVID from an afternoon care publicity, the end result did not stay her older kid at house.

But, she’s within the minority in opting for to get her 6-year-old immunized. Handiest about 30% of fogeys have selected to get COVID pictures for his or her 5- to 11-year-olds who become eligible for the Pfizer vaccine overdue remaining fall.

For plenty of folks, probably the most key questions is that this: Why vaccinate when few youngsters die from COVID and plenty of have most effective delicate signs.

“I believe we get distracted via specializing in dying charges,” Ericson mentioned. “There are numerous techniques a kid’s frame and existence will also be disrupted in the event that they get COVID.”

She famous that more youthful youngsters are at upper chance of headaches. For something, their respiring tubes are smaller and will extra simply get clogged with phlegm.

“More youthful youngsters’s immune techniques don’t seem to be as powerful both,” Ericson added.

It is usually no longer conceivable to understand which youngsters gets very in poor health or who gets what is referred to as lengthy COVID, risking long-term bodily and psychological well being problems, she mentioned.

Ericson emphasised that the COVID-19 vaccine is secure for young children and little toddlers.

“Vaccines paintings very in a similar way without reference to age, and those vaccines were given to hundreds of thousands of other people during the last 18 months and are somewhat secure,” she mentioned.

The hot popularity of babies was once in line with the end result of scientific trials involving this age crew, Ericson mentioned.

For folks fascinated about conceivable unintended effects, she mentioned those might be very similar to the ones after any vaccine. They come with fever, sore arm and swollen lymph nodes. Younger youngsters generally tend to have fewer vaccine unintended effects than older youngsters, Ericson added.

Some other attention is that children too can unfold the virus in the event that they pick out it up at day care or faculty.

“Kids certainly carry COVID house to the circle of relatives and unfold it once they cross out,” Ericson mentioned. “The easiest way to disrupt that chain is vaccination. If we will be able to prevent even 50% of transmissions, our case numbers will plummet.”

Even if the vaccine isn’t 100% efficient, even combating 50% of infections and just about 100% of serious sicknesses makes it profitable, Ericson mentioned.

Folks of those youngest youngsters have a option to make that isn’t to be had to folks of older youngsters: There are two authorized vaccines for this age crew, one from Pfizer and one from Moderna. Which to select is an issue of private choice, Ericson mentioned.

For youngsters underneath age 5, Pfizer is a three-shot routine. The primary two pictures are given 3 weeks aside, and the remaining, no less than two months later.

Moderna is a two-shot routine. The pictures are given about 4 weeks aside for children underneath 6. Those that are immune-compromised can get a 3rd dose no less than a month after their 2nd.

“Some folks would possibly prioritize gaining immunity sooner and select Moderna, which supplies coverage after six weeks, as opposed to about 12 weeks for Pfizer,” Ericson mentioned. “Different folks will select Pfizer as a result of unintended effects are fewer or they really feel extra at ease since Pfizer vaccines are already being utilized in youngsters as younger as 5.”

Additional info

The U.S. Facilities for Illness Keep watch over and Prevention has extra about COVID-19 vaccines.

SOURCE: Penn State Well being, information free up, June 23, 2022

By means of Cara Murez HealthDay Reporter

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CDC Panel Urges Seniors to Get New, Extra Potent Flu Shot This Fall

News Picture: CDC Panel Urges Seniors to Get New, More Potent Flu Shot This Fall

THURSDAY, June 23, 2022 (HealthDay Information)

A U.S. Facilities for Illness Keep an eye on and Prevention vaccine advisory panel on Wednesday voted to suggest that American citizens 65 and older get the brand new, stronger flu pictures for the reason that common shot does not be offering sufficient coverage.

The extra tough vaccines may additionally be offering extra or longer coverage for seniors with weakened immune programs who do not reply as smartly to standard pictures. The selections come with Fluzone Top-Dose, Fluad with an immune booster and Flublok, the Related Press reported.

The CDC typically adopts the panel’s suggestions. That is the primary time the government has subsidized a most well-liked vaccine for older adults.

The company urges all American citizens elderly 6 months and older to get a flu shot each and every season.

Flu vaccines don’t seem to be 100% efficient, and are considerably much less efficient in seniors. However the brand new pictures seem to paintings higher than the common shot, particularly in combating hospitalizations for flu.

“Those influenza vaccines are higher, however aren’t but the house run that we would really like to have,” panel member Dr. Helen Keipp Talbot, of Vanderbilt College, in Nashville, Tenn., mentioned throughout the assembly, the AP reported.

About 80% of the ones on Medicare get the high-dose vaccines each and every 12 months, officers mentioned. The brand new vaccines value 3 times greater than usual flu pictures, however they’re coated by way of insurance coverage, in step with the AP.

All over final wintry weather’s flu season, the vaccine used to be most effective 35% efficient in adults and 44% efficient in youngsters in combating signs critical sufficient to peer a physician, the AP reported.

Additional info

Discuss with the U.S. Facilities for Illness Keep an eye on and Prevention for extra on flu vaccines.

SOURCE: Related Press

Via Steven Reinberg HealthDay Reporter

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FDA Advisors Again Moderna Shot for Older Youngsters, Teenagers

News Picture: FDA Advisors Back Moderna Shot for Older Children, Teens

WEDNESDAY, June 15, 2022 (HealthDay Information)

The U.S. Meals and Drug Management’s vaccine advisory panel voted unanimously on Tuesday to counsel the company approve the emergency use of Moderna’s COVID-19 vaccine in youngsters elderly 6 to 17.

Regardless of the unanimous toughen, some panel participants apprehensive that trials of the vaccine have been carried out sooner than the emergence of the Omicron variant. They famous the vaccine would most probably lend a hand save you critical sickness however now not be as excellent at blockading delicate infections, The Washington Submit reported.

“We crossed a line,” when Omicron and its subvariants surfaced as a result of now a 3rd dose is wanted for complete coverage, mentioned panel member Paul Offit, a professor of pediatrics at Youngsters’s Sanatorium of Philadelphia. He supported authorization — so long as a 3rd Moderna dose is at the method.

“We are at a distinct section on this pandemic,” Offit mentioned. “I feel the advantages obviously outweigh the dangers, however I say that with the relaxation being only if there will likely be a 3rd dose.”

Moderna instructed the panel it’s checking out a booster shot for the 6-through-17 age teams and may search FDA authorization as early as July.

Pfizer’s COVID-19 vaccine has already been authorized for this age staff, so having a 2d possibility may now not spice up vaccinations a lot, no less than within the 6-to-11-year-old age staff. Best 29 p.c of youngsters in that age staff have won the two-shot routine of Pfizer’s pictures, in step with the Submit.

In coming to its resolution, the FDA panel analyzed Moderna’s two-dose vaccine for kids elderly 6 to 11 at part the energy of the grownup shot, and for adolescence elderly 12 to 17 on the grownup dose. Usually, the FDA follows the suggestions of its skilled panels. As soon as the FDA has licensed the pictures, as anticipated, skilled advisers to the U.S. Facilities for Illness Regulate and Prevention will speak about the most efficient use of the Moderna vaccine in older youngsters and youths this weekend.

Moderna first requested the FDA to approve its vaccine for teens and older teenagers closing June, a month after Pfizer received emergency authorization for its coronavirus vaccine for use in 12- to 15-year-olds. The FDA then authorized the emergency use of the Pfizer vaccine for children elderly 6 to twelve closing October.

However regulators have been apprehensive about studies of an extraordinary situation — referred to as myocarditis — that have been observed most commonly in younger males who were given the Moderna vaccine, so they selected to lengthen a choice whilst extra analysis used to be carried out. The corporate mentioned considerations about myocarditis have now subsided after additional analysis and real-world proof, the Submit reported.

In a 2d assembly on Wednesday, the similar FDA panel will weigh Moderna’s vaccine for kids underneath 6 and Pfizer’s vaccine for kids underneath 5.

There are about 18 million youngsters underneath 5 in the USA and they’re the one age staff within the nation now not but eligible for any COVID vaccines, the Submit reported.

Whilst there are considerations about whether or not there’s sufficient call for for the Moderna vaccine in more youthful age teams, Jason Schwartz, a vaccine coverage skilled on the Yale Faculty of Public Well being, mentioned any Moderna authorization may end up treasured ultimately.

“We are nonetheless studying how those vaccines carry out, each about ranges and period of coverage,” Schwartz mentioned. “We might be informed through the years that one vaccine is healthier.”

Additional info

Discuss with the U.S. Facilities for Illness Regulate and Prevention for extra on COVID vaccines for children and youths.

SOURCE: The Washington Submit

By way of Robin Foster HealthDay Reporter

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