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JYNNEOS vaccine:

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    (CNN)In an effort to stretch the limited supply of the Jynneos monkeypox vaccine, federal health officials this week authorized giving smaller doses using a different method of injection.With more than 10,000 monkeypox cases in the United States and vaccine demand remaining high, Jynneos has been in short supply for weeks. The new injection strategy allows health-care providers to give shallow injections intradermally, in between layers of the skin, with one-fifth the standard dose size instead of subcutaneously, into the fatty layer below the skin, with the larger dose. FDA authorizes change in how monkeypox vaccine is given, stretching supply amid high demandYet the specific efficacy data for the vaccine is not clear, and some experts argue that not enough is known about how the low-dose intradermal strategy might affect the protection it provides in the real world.Even at the original dosage size, "there is no traditional assessment of this vaccine," Dr. Robert Califf, commissioner of the US Food and Drug Administration, said Tuesday. It's approved for emergency purposes based on studies of immune responses, not clinical outcomes, because there haven't...
    (CNN)The US government is considering a change to how physicians give monkeypox vaccines so it can make the most of the supply on hand, US Food and Drug Administration Commissioner Dr. Robert Califf said Thursday. As part of the Biden administration's declaration of the monkeypox outbreak in the US as a public health emergency, it's looking into administering Jynneos vaccine shots intradermally instead of subcutaneously.Biden administration declares the monkeypox outbreak a public health emergency"We're considering an approach for the current doses of Jynneos that would allow health-care providers to use an existing one-dose vial of the vaccine to administer a total of up to five separate doses," Califf said.The monkeypox vaccine is now given subcutaneously, meaning delivered below the skin. But with an intradermal vaccination, "basically, you're staying in the skin; you're not going through the skin," said Dr. Daniel Griffin, an infectious disease specialist at Columbia University.New method could extend vaccine supplyRead MoreUsing a smaller dose with intradermal injection has been done with vaccines for flu and rabies, epidemiologist Dr. Jay Varma told CNN in an email. "The skin...
    Monkeypox isn’t going to be the next COVID-19. But with the outbreak having bloomed to thousands of infections, with cases in nearly every state, on Aug. 4, 2022, the U.S. declared monkeypox a national public health emergency. One reason health experts did not expect monkeypox to become so widespread is that the U.S. had previously approved two vaccines for the virus. Maureen Ferran, a virologist at Rochester Institute of Technology, has been keeping tabs on the two vaccines that can protect against monkeypox.1. What are the available monkeypox vaccines?Two vaccines are currently approved in the U.S. that can provide protection against monkeypox, the Jynneos vaccine – known as Imvamune/Imvanex in Europe – and ACAM2000, an older smallpox vaccine. The Jynneos vaccine is produced by Bavarian Nordic, a small company in Denmark. The vaccine is for the prevention of smallpox and monkeypox disease in adults ages 18 and older who are at high risk for infection with either virus. It was approved in Europe in 2013 and by the U.S. Food and Drug Administration in 2019. The Jynneos vaccine is...
    Less than a decade ago, the United States had some 20 million doses of a new smallpox vaccine — also effective against monkeypox — sitting in freezers in a national stockpile. Such vast quantities of the vaccine, known today as Jynneos, could have slowed the spread of monkeypox after it first emerged in the United States more than two months ago. Instead, the supply, known as the Strategic National Stockpile, had only some 2,400 usable doses left in it in mid-May, enough to fully vaccinate just 1,200 people. The rest of the doses had expired. Now, some 10 weeks into the outbreak, people at high risk who want to get vaccinated have been unable to find a dose and may not be able to find one for months. The chain of events that led the stockpile of a now-critical vaccine to dwindle to near nothing in the United States is only now emerging. At several points federal officials chose not to quickly replenish doses as they expired, instead pouring money into developing a freeze-dried version of the vaccine that would...
    A person arrives to receive a monkeypox vaccination at the Northwell Health Immediate Care Center at Fire Island-Cherry Grove, in New York, U.S., July 15, 2022. Eduardo Munoz | Reuters The Centers for Disease Control and Prevention has confirmed more than 1,400 monkeypox infections across 44 states and territories in the U.S. and said it expects the outbreak to grow. CDC Director Dr. Rochelle Walensky said the demand for monkeypox vaccines is outstripping the available supply, which has led to long lines in places such as New York City — an epicenter of the outbreak. "We know that this is frustrating," Walensky said in a call with reporters Friday. The Health and Human Services Department is working to increase supply, she added. Walensky said the agency expects cases to increase through July and August since symptoms of the virus usually start within three weeks of exposure. People who don't yet know they're infected will likely seek medical attention and get tested in the coming weeks. The U.S. now has the capacity to conduct 70,000 tests per week after recruiting several commercial...
    The Biden administration announced Thursday that it would distribute 144,000 additional doses of the Jynneos vaccine, which is approved to treat monkeypox and smallpox. The Department of Health and Human Services said it would begin shipping vaccine doses from the Strategic National Stockpile to states and cities across the United States starting Monday, as the country ramps up its response to the current outbreak. FIRST ROUND OF MONKEYPOX VACCINE APPOINTMENTS IN DC SNATCHED UP IN DAYS "We are using every tool we have to increase and accelerate JYNNEOS vaccine availability in jurisdictions that need them the most," Steve Adams, director of the Strategic National Stockpile, said in a statement. "In less than ten days, we've made available 200,000 JYNNEOS vaccine doses in communities where transmission has been the highest and with high-risk populations, and significantly scaled testing availability and convenience. Together, these are critical components of our overall effort to combat this virus." The vaccine doses are in addition to 56,000 doses that were shipped last month. The Centers for Disease Control and Prevention said...
    The Biden administration is ramping up efforts to slow the spread of monkeypox by distributing tens of thousands of vaccine doses, after facing criticism over its early response to a US outbreak primarily affecting gay men.  The plan, announced on Tuesday, involves rapidly expanding access to doses of Bavarian Nordic's Jynneos vaccine - which has so far been limited - to prevent monkeypox in areas with the highest transmission and need.  The announcement came just hours after advocates sent a letter to the White House slamming the administration's monkeypox response, saying that 1 million doses of the Jynneos vaccine already owned by the US are stuck in limbo in Denmark awaiting a facility inspection.  Although the vaccine itself has been approved for use by US regulators, the doses in Denmark were produced on a manufacturing line that is still awaiting Food and Drug Administration (FDA) approval, officials said earlier this month.   The letter from PrEP4ALL and Partners for Health said in part: 'We must not allow the same failures of vaccine production and distribution that hampered the global COVID-19 response...
    Mock-up vials labeled "Monkeypox vaccine" are seen in this illustration taken, May 25, 2022. Dado Ruvic | Reuters The U.S. will deploy nearly 300,000 monekypox vaccine doses in the coming weeks in an effort to stamp out an outbreak of the virus that continues to grow. The Centers for Disease Control and Prevention is recommending that people who have had confirmed or presumed monkeypox exposures get vaccinated against the virus. Vaccination should occur within two weeks of exposure to the virus but the sooner the better, according to the CDC. The U.S. is immediately releasing 56,000 doses of the Jynneos vaccine from the strategic national stockpile, followed by 240,000 doses in the coming weeks. A total of 1.6 million doses of Jynneos will be available in the fall, according to the Health and Human Services Department. Jynneos is a two-dose vaccine approved by the Food and Drug Administration for adults ages 18 and older who are high risk of exposure to smallpox or monkeypox. HHS is prioritizing allocation of the Jynneos doses to communities with the highest number of...
    NEW YORK (AP) — The U.S. government is buying more monkeypox vaccine as a surprising international outbreak continues to grow, health officials said Friday. As of Friday, the U.S. had identified 45 cases in 15 states and the District of Columbia. More than 1,300 cases have been found in about 30 other countries outside the areas of Africa where the virus is endemic. Officials say the risk to the American public is low, but they are taking steps to assure people that medical measures are in place to deal with the growing problem. A two-dose vaccine, Jynneos, is approved for monkeypox in the U.S. The U.S. government has 72,000 Jynneos doses, and will get 300,000 more doses from its manufacturer, Bavarian Nordic, over the next several weeks, said Dawn O’Connell, who oversees the government’s stockpile of emergency vaccines and treatments. On Friday, the government announced it had ordered 500,000 more Jynneos doses from Bavarian Nordic to be delivered late this year. The company also is holding other doses owned by the U.S. government, she said. “We have the vaccines and...
    Mock-up vials labeled "Monkeypox vaccine" are seen in this illustration taken, May 25, 2022.Dado Ruvic | Reuters The United States has more than 36,000 doses of the Jynneos monkeypox vaccine immediately available in the strategic national stockpile, according to the Health and Human Services Department. The Centers for Disease Control and Prevention is sending the vaccine to people who have had high risk exposures to the virus in an effort to stop the disease from spreading further. The U.S. has identified 25 confirmed or presumed cases of monkeypox cases across 12 states as of Friday. The U.S. told Bavarian Nordic, a Danish biotech company, to ship an additional 36,000 doses of Jynneos in the near future, an HHS spokesperson said. Bavarian Nordic is holding more than 1 million doses owned by the U.S. and can fill 16.4 million more doses upon request by the federal government, the spokesperson said. The global monkeypox outbreak is the largest ever outside of Africa. Nearly 800 confirmed cases of monkeypox across 27 countries have been reported to the World Health Organization. Most of the...
    Test tubes labelled "Monkeypox virus positive and negative" are seen in this illustration taken May 23, 2022. Dado Ruvic | Reuters The Biden administration has distributed 1,200 monkeypox vaccine doses for people who have had high-risk exposures to the virus, part of a nationwide public health response to stamp out the disease before it causes a major outbreak. U.S. health officials, worried the virus is spreading faster than previously thought, have said the global outbreak of monkeypox is the largest ever. The World Health Organization said Wednesday that there are now more than 550 cases across 30 countries. In the U.S., at least 20 confirmed or suspected cases have been reported in 11 states, including California, Colorado, Florida, Georgia, Illinois, Massachusetts, New York, Pennsylvania, Virginia, Utah and Washington state, according to the Centers for Disease Control and Prevention. "A monkeypox outbreak of this scale and scope across the world, it has not been seen before," Dr. Raj Panjabi, who leads the White House pandemic preparedness office, told reporters on a call last week. However, CDC officials have sought to reassure the...
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