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(CNN)The Biden administration has declared the monkeypox outbreak in the US to be a public health emergency.

"We're prepared to take our response to the next level in addressing this virus, and we urge every American to take this virus seriously and to take responsibility to help us tackle this virus," US Department of Health and Human Services Secretary Xavier Becerra said.
Gay men are lining up as early as 2 a.m. for monkeypox vaccines. Many leave empty-handedMonkeypox is a poxvirus, related to smallpox and cowpox. It generally causes pimple- or blister-like lesions and flu-like symptoms such as fever, according to the US Centers for Disease Control and Prevention.
    The lesions typically concentrate on the arms and legs, but in this outbreak, they're showing up more frequently on the genital and perianal area.
      "Classically, it presents like many other viral illnesses with what's called a viral prodrome, and symptoms like fevers, chills, swollen lymph nodes, fatigue and muscle aches are common. Within five days of the prodrome starting, patients develop a rash that can look like pimples or blisters," said Dr. Jason Zucker, an infectious diseases specialist at NewYork-Presbyterian/Columbia University Irving Medical Center. Read MoreHow is monkeypox spread?Monkeypox spreads through close contact, according to the CDC. That includes direct physical contact with lesions as well as "respiratory secretions" shared through face-to-face interaction and touching objects that have been contaminated by monkeypox lesions or fluids. The virus may also pass to a fetus through the placenta.
        Many of the cases in the outbreak appear to be connected to sexual contact, often during sex. The CDC says research is ongoing on whether monkeypox can spread through semen or vaginal fluids, or whether the virus can spread asymptomatically. Who is at risk of monkeypox?Anyone who has had contact with someone with a monkeypox-like rash, or who has had contact with someone who has a probable or confirmed case of monkeypox, is at high risk for infection. However, a large number of cases in this outbreak have been in men who have sex with men, including gay and bisexual men, and public health officials are focusing their prevention efforts in this group. The virus is not unique to this community, but the nature of its close-contact spread has led to a disproportionate impact.Now should I worry about monkeypox? Our medical analyst explains"The vast majority of those who have been diagnosed to date with human monkeypox virus are self-identifying men who have sex with men," Zucker said."This is likely due to shared sexual networks. So what we're seeing is, they're seeing it first and experiencing the majority of cases. Just like other diseases, there's no reason it can't spread to other communities via sexual or other close contact," he said.According to the CDC, those at higher risk during this outbreak include people who "had skin-to-skin contact with someone in a social network experiencing monkeypox activity," including men who have sex with men who meet partners online, through an app or at a social event.People with conditions involving a weakened immune system like HIV and eczema, and children under 8 may also be at higher risk of severe illness if infected, according to the CDC. What should I do if I have monkeypox symptoms?If you notice a new rash or other monkeypox symptoms, avoid any close contact with other people until you have seen a doctor and gotten tested. "When you see a healthcare provider, wear a mask, and remind them that the virus is circulating in the area," the CDC says.If you're diagnosed with monkeypox, the agency recommends isolation at home and away from family members until the rash or lesions are gone. What's the treatment for monkeypox?According to the CDC, there is no approved treatment specific for monkeypox. But because it's genetically similar to smallpox, doctors can use similar treatments, such as antiviral medications. Access to experimental monkeypox treatment remains uneven, doctors sayThe CDC is making doses of tecovirimat, an antiviral medication also known as Tpoxx, available for monkeypox patients at risk of severe disease. This may include those whose infection has advanced into the severe stage and people with weakened immune systems. The National Institute of Allergy and Infectious Diseases has also announced a study of Tpoxx as a monkeypox treatment.Treatment for monkeypox should also include efforts to manage symptoms and complications, according to the World Health Organization. Is there a monkeypox vaccine?Two vaccines are available in the US to prevent monkeypox, but not everyone is eligible to get one.The US has "ample supply" of the smallpox vaccine ACAM2000, which can also be used to prevent monkeypox. However, it shouldn't be used in people with certain health conditions, according to the CDC. Change in monkeypox vaccine injection method could mean more doses but may not be easy, experts say"We have 100 million doses of ACAM2000," National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci said in late June, but its side effects mean that it "in my mind as a public health person, would not be worth giving it widely throughout the general population."Another vaccine, Jynneos, is specifically intended for monkeypox, but it's in short supply. Federal stock is being distributed to municipalities based on the number of cases and the population at risk in a given area. According to the US Department of Health and Human Services, more than 600,000 doses of Jynneos have been distributed from the Strategic National Stockpile and another 150,000 doses are expected to arrive in September. The CDC has estimated at least 1.5 million people in the US are eligible for monkeypox vaccination. The federal government has proposed changing how vaccines are physically given, which may mean the current supply could stretch further.Jynneos is a two-dose vaccine, with a four-week gap between doses. But in light of the shortages, some experts have called for a single-dose regimen until supply improves.Monkeypox vaccination can be used as pre-exposure prophylaxis (PrEP), post-exposure prophylaxis (PEP) and outbreak response PEP (PEP++), according to the CDC. Some lab techs refuse to take blood from possible monkeypox patients, raising concerns about stigma and testing delaysPrEP refers to vaccinations given to members of high-risk communities, such as lab or health care workers, before they may come into contact with the virus. PEP means vaccinating people after a known exposure to prevent disease or help ease symptoms. For prevention, the CDC recommends that the vaccine be given up to four days after exposure. PEP given four to 14 days after exposure may result in milder disease. PEP++ is the CDC approach for people with unconfirmed exposure to the virus but with risk factors that may make them more likely to get it. "When coupled with self-isolation and other prevention measures when symptoms first occur, PEP++ may help slow the spread of the disease in areas with large numbers of monkeypox cases," the CDC says. Can I get a vaccine?Monkeypox vaccine demand is high, but supply shortages and eligibility restrictions mean it can be difficult to find at this point. Testing is crucial to getting monkeypox under control, but theres a shocking lack of demand Eligibility for the vaccines remains somewhat strict. People who are known, confirmed contacts of people with monkeypox are eligible to be vaccinated. Also eligible are presumed contacts who had a sex partner in the past 14 days diagnosed with monkeypox, those who had multiple sex partners in the past 14 days in an area where monkeypox is spreading, and those whose jobs may expose them to monkeypox, according to the CDC. If you think you meet one of these criteria and want to find out about your eligibility, contact your doctor or your local health department.How do I keep myself safe?The CDC recommends avoiding close contact or shared objects with someone with monkeypox. Frequent hand-washing is also recommended. For social gatherings including parties, raves, clubs and festivals, the CDC says to stick to events with more clothing, where skin-to-skin contact may be less frequent. Get CNN Healths weekly newsletter

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          Avoid sex or close physical intimacy if any person involved has monkeypox. The CDC recommends specifically to avoid touching any rash that may be on a partner's body. To help prevent the spread of monkeypox while sexually active, maintaining 6 feet of distance, keeping clothes on during sex, and using condoms and/or gloves can lower chances of exposure."However, condoms alone may not prevent all exposures to monkeypox, since the rash can occur on other parts of the body," the CDC says.

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          Letter obtained by CNN shows FDA defended new monkeypox vaccine strategy to vaccine maker

          (CNN)The US Food and Drug Administration defended the federal government's recent decision to stretch out its limited supply of the Jynneos monkeypox vaccine by giving individuals smaller doses using a different method of injection, pointing out in a letter to the company that manufactures the vaccine that a 2015 clinical study showed "a very similar immune response" to the new method as well as the previously used one.

          In a letter Friday to Bavarian Nordic CEO Paul Chaplin, two top FDA officials responded to concerns Chaplin had raised earlier this week. They wrote that the agency recently determined that the benefits of stretching its limited supply of the two-dose Jynneos vaccine by giving individuals smaller doses outweighed the known possible risks. The decision came after the FDA ruled out -- at least for now -- the use of alternative vaccines, as well as the option of delaying the second vaccine dose by three to six months, the agency said.
            The FDA's letter, obtained by CNN Saturday, was signed by FDA Commissioner Dr. Robert Califf and Dr. Peter Marks, the director of the FDA's Center for Biologics and Evaluation Research.
              The letter cited a 2015 clinical study, which Chaplin co-authored, in which "individuals who received the vaccine intradermally received a lower volume (one fifth) than individuals who received the vaccine subcutaneously."Read More"The results of this study demonstrated that intradermal administration produced a very similar immune response to subcutaneous (SC) administration," the letter said. While the intradermal injection method "did result in more redness, firmness, itchiness and swelling at the injection site, but less pain," the letter continued, "these side effects were manageable."What is monkeypox? Symptoms, risk factors, treatment and how the virus is spreadThe FDA also detailed other options that the agency had considered. But the use of alternative vaccines to prevent monkeypox "was determined to be either impractical or inadvisable at this time," according to the letter. Specifically, the ACAM2000 vaccine, which is FDA approved for prevention of smallpox, "may not be appropriate now for a potentially immunocompromised population," the letter said.
                The FDA also looked into the option of delaying the second vaccine doses by three to six months, rather than giving the second dose the recommended 28 days after the first. But the agency ultimately determined that there was not any data to demonstrate that this method would provide sufficient protection, and that delaying the second dose could also give people "a false sense of reassurance that they were protected against monkeypox when the actual level of protection would be unknown and quite possibly inadequate," the letter said.The federal government's announcement this week authorizing health care providers to give smaller doses of Jynneos came in an attempt to better meet the high demand for the vaccine. Top Biden administration health officials have made clear in recent days that given the speed of the spread of monkeypox -- which it earlier this month declared a public health emergency -- the US did not have enough vaccine supply to meet demand. This week's decision to stretch out the available Jynneos vaccines was aimed at addressing the limited supply. Dr. Marks of the FDA said Thursday that there were an estimated 1.6 million to 1.7 million people in the US who are now eligible for the two-dose Jynneos vaccine. According to the US Department of Health and Human Services, around 634,213 vials have been sent to jurisdictions as of Friday.The low-dose intradermal strategy immediately prompted concern among some public health experts, including about the limited amount of research surrounding the new method."This approach raises red flag after red flag, and appears to be rushed ahead without data on efficacy, safety, or alternative dosing strategies," David Harvey, executive director of the National Coalition of STD Directors, said in a statement this week.
                  Chaplin, the CEO of Bavarian Nordic, also raised concerns. CNN reported that Chaplin wrote in a letter Tuesday to Califf and HHS Secretary Xavier Becerra that he had concerns about the "very limited safety data available" on the newly announced vaccination strategy, and that a relatively high percentage of people in the clinical study -- 20% -- did not get their second shot."While we have certain reservations, we are trying to find the best way to support the [emergency use authorization] by collecting additional data and aligning on the responses to assist state officials in the rollout," Chaplin wrote. "We are also investing in expanding the manufacturing capacity at both BN and external facilities, with likely more announcements soon to come."

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