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Monkeypox vaccine authorization expanded by FDA to increase dose supply

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Monkeypox vaccine authorization expanded by FDA to increase dose supply

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The Meals and Drug Administration (FDA) expanded its emergency use authorization (EUA) of the Jynneos monkeypox vaccine on Tuesday. 

The transfer permits well being care suppliers to make use of the vaccine with a shallower intradermal injection for people 18 years of age and older who’re decided to be at excessive threat for an infection from the virus. 

The company stated that the replace will improve the overall variety of doses out there to be used by as much as five-fold as a result of intradermal administration requires a smaller dose.

As well as, the FDA’s EUA additionally permits to be used of the vaccine – administered by subcutaneous injection, or injection beneath the pores and skin – in people youthful than 18 years of age who’re decided to be at excessive threat of an infection.

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MONKEYPOX IN AMERICA: WHO’S AT RISK AND WHY?

“In current weeks the monkeypox virus has continued to unfold at a fee that has made it clear our present vaccine provide won’t meet the present demand,” FDA Commissioner Dr. Robert M. Califf stated in a launch. “The FDA rapidly explored different scientifically applicable choices to facilitate entry to the vaccine for all impacted people. By rising the variety of out there doses, extra people who wish to be vaccinated towards monkeypox will now have the chance to take action.” 

FILE – A registered nurse prepares a dose of a monkeypox vaccine on the Salt Lake County Well being Division Thursday, July 28, 2022, in Salt Lake Metropolis. U.S. well being officers on Tuesday, Aug. 9, 2022, approved a brand new monkeypox vaccination technique designed to stretch restricted provides by permitting well being professionals to vaccinate as much as 5 folks — as an alternative of 1 — with every vial. 
(AP Photograph/Rick Bowmer, File)

To this point, the pictures have been really useful for individuals who have already been uncovered to monkeypox or are more likely to get it on account of current sexual contact in areas the place the virus is spreading.

The virus can unfold to anybody by shut, private and infrequently skin-to-skin contact, together with direct contact with objects and surfaces which were utilized by somebody with monkeypox. 

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A pregnant individual can unfold the virus to their fetus by the placenta.

The vaccine is given in two doses 4 weeks aside. Those that acquired their first dose subcutaneously can obtain their second dose both intradermally or subcutaneously. There is no such thing as a information out there to point that one dose of the vaccine will present long-lasting safety.

A staff member of the Westchester Medical Center applies a monkeypox vaccine to a person in a drive-through monkeypox vaccination point at the Westchester Medical Center in Valhalla, New York, U.S., July 28, 2022. 

A workers member of the Westchester Medical Middle applies a monkeypox vaccine to an individual in a drive-through monkeypox vaccination level on the Westchester Medical Middle in Valhalla, New York, U.S., July 28, 2022. 
(REUTERS/Eduardo Munoz)

MONKEYPOX VACCINE CAMPAIGN ROLLS OUT IN ITALY

Officers on the company additionally pressured the significance of receiving two doses of the vaccine.

“We really feel fairly strongly that the 2 doses are mandatory as a result of, partially, we don’t have any proof that three, six, eight months later folks can be adequately protected by a single dose,” Dr. Peter Marks, the FDA’s vaccine chief, stated in a press release.

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The FDA’s motion comes after a 564 willpower issued by Well being and Human Companies (HHS) Secretary Xavier Becerra. 

Syringes used for the monkeypox vaccine are seen inside of a bucket in a drive-through monkeypox vaccination point at the Westchester Medical Center in Valhalla, New York, U.S., July 28, 2022. 

Syringes used for the monkeypox vaccine are seen within a bucket in a drive-through monkeypox vaccination level on the Westchester Medical Middle in Valhalla, New York, U.S., July 28, 2022. 
(Reuters/Eduardo Munoz)

HHS stated that, as of Tuesday, it had made greater than 1.1 million monkeypox vaccine doses out there to order. The Biden administration stated it had distributed greater than 670,000 vaccines to states and jurisdictions from the Strategic Nationwide Stockpile (SNS).

The SNS is getting ready to distribute roughly 400,000 further vials to states and jurisdictions as a part of the subsequent section of the nationwide vaccine technique. 

“As a way to rapidly and successfully implement this strategy to extend Jynneos vaccine dose provide five-fold, the Biden-Harris Administration is launching a strong effort to coach well being care employees and suppliers on tips on how to administer the Jynneos vaccine intradermally,” the White Home famous.

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The administration famous the coverage would multiply the 440,000 vials presently out there as full doses into greater than 2 million smaller doses.

The White Home declared monkeypox to be a public well being emergency final week. There are almost 9,500 confirmed monkeypox and orthopoxvirus instances within the U.S.

The Related Press contributed to this report.

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How The Great British Bake Off Host Alison Hammond Lost 150 Lbs Naturally

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How The Great British Bake Off Host Alison Hammond Lost 150 Lbs Naturally


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Alison Hammond’s Weight Loss: How She Shed 150 Lbs | Woman’s World




















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One state leads country in human bird flu with nearly 40 confirmed cases

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One state leads country in human bird flu with nearly 40 confirmed cases

A child in California is presumed to have H5N1 bird flu, according to the San Francisco Department of Public Health (SFDPH).

As of Dec. 23, there had been 36 confirmed human cases of bird flu in the state, according to the California Department of Public Health (CDPH).

This represents more than half of the human cases in the country.

LOUISIANA REPORTS FIRST BIRD FLU-RELATED HUMAN DEATH IN US

The latest pediatric patient, who lives in San Francisco, experienced fever and conjunctivitis (pink eye) as a result of the infection.

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The unnamed patient was not hospitalized and has fully recovered, according to the SFDPH.

A child in California is presumed to have H5N1 bird flu, according to the San Francisco Department of Public Health. (iStock)

The child tested positive for bird flu at the SFDPH Public Health Laboratory. The U.S. Centers for Disease Control and Prevention (CDC) will perform additional tests to confirm the result.

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It is not yet known how the child was exposed to the virus and an investigation is ongoing.

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“I want to assure everyone in our city that the risk to the general public is low, and there is no current evidence that the virus can be transmitted between people,” said Dr. Grant Colfax, director of health, in the press release. 

BIRD FLU PATIENT HAD VIRUS MUTATIONS, SPARKING CONCERN ABOUT HUMAN SPREAD

“We will continue to investigate this presumptive case, and I am urging all San Franciscans to avoid direct contact with sick or dead birds, especially wild birds and poultry. Also, please avoid unpasteurized dairy products.” 

Samuel Scarpino, director of AI and life sciences and professor of health sciences at Northeastern University in Boston, is calling for “decisive action” to protect individuals who may be in contact with infected livestock and also to alert the public about the risks associated with wild birds and infected backyard flocks. 

Chick bird flu test

An infectious diseases expert called for “decisive action” to alert the public about the risks associated with wild birds and infected backyard flocks.  (iStock)

“While I agree that the risk to the broader public remains low, we continue to see signs of escalating risk associated with this outbreak,” he told Fox News Digital.

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Experts have warned that the possibility of mutations in the virus could enable person-to-person transmission.

     

“While the H5N1 virus is currently thought to only transmit from animals to humans, multiple mutations that can enhance human-to-human transmission have been observed in the severely sick American,” Dr. Jacob Glanville, CEO of Centivax, a San Francisco biotechnology company, told Fox News Digital.

Split image of cows and bird flu vial

As of Jan. 10, there have been a total of 707 infected cattle in California, per reports from the California Department of Food and Agriculture. (iStock)

“This highlights the requirement for vigilance and preparation in the event that additional mutations create a human-transmissible pandemic strain.”

As of Jan. 10, there have been a total of 707 infected cattle in California, per reports from the California Department of Food and Agriculture (CDFA).

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In the last 30 days alone, the virus has been confirmed in 84 dairy farms in the state.

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Chronic Pain Afflicts Billions of People. It’s Time for a Revolution.

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Chronic Pain Afflicts Billions of People. It’s Time for a Revolution.

“In the beginning, everyone thought they were going to find this one breakthrough pain drug that would replace opioids,” Gereau said. Increasingly, though, it’s looking like chronic pain, like cancer, could end up having a range of genetic and cellular drivers that vary both by condition and by the particular makeup of the person experiencing it. “What we’re learning is that pain is not just one thing,” Gereau added. “It’s a thousand different things, all called ‘pain.’”

For patients, too, the landscape of chronic pain is wildly varied. Some people endure a miserable year of low-back pain, only to have it vanish for no clear reason. Others aren’t so lucky. A friend of a friend spent five years with extreme pain in his arm and face after roughhousing with his son. He had to stop working, couldn’t drive, couldn’t even ride in a car without a neck brace. His doctors prescribed endless medications: the maximum dose of gabapentin, plus duloxetine and others. At one point, he admitted himself to a psychiatric ward, because his pain was so bad that he’d become suicidal. There, he met other people who also became suicidal after years of living with terrible pain day in and day out.

The thing that makes chronic pain so awful is that it’s chronic: a grinding distress that never ends. For those with extreme pain, that’s easy to understand. But even less severe cases can be miserable. A pain rating of 3 or 4 out of 10 sounds mild, but having it almost all the time is grueling — and limiting. Unlike a broken arm, which gets better, or tendinitis, which hurts mostly in response to overuse, chronic pain makes your whole world shrink. It’s harder to work, and to exercise, and even to do the many smaller things that make life rewarding and rich.

It’s also lonely. When my arms first went crazy, I could barely function. But even after the worst had passed, I saw friends rarely; I still couldn’t drive more than a few minutes, or sit comfortably in a chair, and I felt guilty inviting people over when there wasn’t anything to do. As Christin Veasley, director and co-founder of the Chronic Pain Research Alliance, puts it: “With acute pain, medications, if you take them, they get you over a hump, and you go on your way. What people don’t realize is that when you have chronic pain, even if you’re also taking meds, you rarely feel like you were before. At best, they can reduce your pain, but usually don’t eliminate it.”

A cruel Catch-22 around chronic pain is that it often leads to anxiety and depression, both of which can make pain worse. That’s partly because focusing on a thing can reinforce it, but also because emotional states have physical effects. Both anxiety and depression are known to increase inflammation, which can also worsen pain. As a result, pain management often includes cognitive behavioral therapy, meditation practice or other coping skills. But while those tools are vital, it’s notoriously hard to reprogram our reactions. Our minds and bodies have evolved both to anticipate pain and to remember it, making it hard not to worry. And because chronic pain is so uncomfortable and isolating, it’s also depressing.

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