health and wellness
FDA Provides Update on Agency Response to Monkeypox Outbreak
Today, the U.S. Food and Drug Administration is providing an update on its multipronged response to monkeypox in the United States, including its efforts in the areas of diagnostics, vaccines and therapeutics. The agency has also established a dedicated website to provide important information about the FDA’s ongoing regulatory activities related to monkeypox along with frequently asked questions. The FDA will provide updates as developments occur and will continue to work with federal public health partners and industry to ensure timely access to all available medical countermeasures.
“The FDA has been closely tracking reports of monkeypox transmissions in the United States with our federal public health partners and coordinating preparedness efforts accordingly,” said FDA Commissioner Robert M. Califf, M.D. “We understand that while we are still living with COVID-19, an emerging disease may leave people feeling concerned and uncertain, but it’s important to note that we already have medical products in place, specifically an FDA-approved vaccine for the prevention of monkeypox disease and an FDA-cleared diagnostic test. The FDA is using the full breadth of its authorities to make additional diagnostics and treatments available. We will continue to collaborate with our partners across all sectors to expand accessibility to countermeasures and bolster the tools in our arsenal as appropriate.”
The monkeypox virus is part of the same family of viruses as variola virus, the virus that causes smallpox (a virus that has been eradicated globally). Both monkeypox and smallpox fall into the category of “orthopoxviruses.” Monkeypox is generally not fatal and typically resolves on its own without treatment. The current outbreak in the U.S. usually presents as a rash on the body, face or genital area. Although there is a very low risk of dying, there have been reported complications including severe pain, at times requiring hospital admission.
Diagnostics
Since the first case of monkeypox in the U.S. was detected, the FDA has been working with commercial laboratories and manufacturers to make monkeypox tests more readily available to consumers who need them. The Centers for Disease Control and Prevention (CDC) has an FDA-cleared non-variola orthopoxvirus test that can detect monkeypox by a swab from a monkeypox lesion (rash or growth). At this time, this is the only FDA-cleared test. The FDA is not aware of clinical data supporting the use of other sample types, such as blood or saliva, for monkeypox virus testing. In July 2022, the FDA issued a safety communication advising people to use swab samples taken directly from a lesion when testing for the monkeypox virus.
The FDA-cleared monkeypox test is being offered by the CDC and throughout many laboratories that include the CDC’s public health Laboratory Response Network. In addition, federal public health authorities have worked with industry to make the test available through five large commercial laboratories. The agency is working closely with the CDC to increase production of its FDA-cleared test and the FDA has cleared the use of additional reagents and instruments to increase the throughput of the CDC test.
The FDA will continue to work with the diagnostic community to augment access to accurate testing to support the response.
Vaccines
In 2019, the FDA approved the JYNNEOS Vaccine for the prevention of smallpox and monkeypox in adults 18 years of age and older determined to be at high risk of infection. JYNNEOS is the only vaccine approved for the prevention of monkeypox in the United States. Although clinical trials and data are limited because of the small number of cases until now, the immunological response to vaccine administration is consistent with effective prevention of the disease.
Following the emerging public health crisis closely, the FDA was aware that there were close to 800,000 doses of this vaccine pending release this fall following approval of additional manufacturing capabilities at one of the plants where the vaccine is made. With this in mind, the agency worked with HHS partners and expedited the submission of the required application for the company’s manufacturing changes in order to make these doses available to those in need. After accelerating the timeline for an inspection of the plant from fall to earlier this month, the FDA has finished its evaluation of the required information to validate product quality and has determined that the vaccine meets its quality standards.
On July 26, the agency approved a supplement to the biologics license for the JYNNEOS Vaccine, to allow for additional manufacturing capabilities at the facility. Given the emerging public health need, the FDA previously facilitated the shipment of manufactured doses to the U.S. so that they would be ready to be distributed once the manufacturing changes were approved. With the supplement approval, those manufactured doses may now be further distributed and administered. Additional doses manufactured at this plant can help address the need for this vaccine moving forward.
Therapeutics
There is no FDA-approved or authorized medicine for the treatment of monkeypox disease; however, TPOXX (tecovirimat), an antiviral medication, is being made available through the CDC under an FDA authority called Expanded Access or “compassionate use.” The FDA continues to work with the CDC to streamline their Expanded Access Program for monkeypox to facilitate access.
There are currently no human data demonstrating the efficacy of TPOXX for the treatment of monkeypox, or the safety and pharmacokinetic profile (which helps us understand what the human body does to a drug). Although expanded access program is available, conducting randomized, controlled trials to assess TPOXX’s safety and efficacy in humans with monkeypox infections is essential.
The FDA has more information on TPOXX’s approval for smallpox under the “Animal Rule” regulations on its monkeypox webpage.
Source: FDA
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Health
10 Simple Changes You Can Make Today for Improved Health and Wellness
Improve your health and wellness with these simple changes to your daily routine.
Boost Your Wellbeing with These Easy Tips
Living a healthy lifestyle is important for our physical and mental well-being, but sometimes it can be overwhelming to know where to start. However, there are simple changes that we can make to our daily routines that can have a big impact on our health and wellness. Here are 10 simple changes you can make today to improve your health and wellness.
- Drink more water: Staying hydrated is key for our body’s systems to function properly. Aim for at least 8 glasses of water a day.
- Add more fruits and vegetables to your diet: Fruits and vegetables are packed with nutrients and antioxidants that can help protect against diseases. Aim for at least 5 servings a day.
- Move more: Regular exercise is important for maintaining a healthy weight, reducing stress, and improving overall health. Find activities that you enjoy and aim for at least 30 minutes of physical activity a day.
- Get enough sleep: Sleep is essential for our body to heal and regenerate. Aim for 7-9 hours of sleep each night.
- Reduce stress: Chronic stress can have negative effects on our physical and mental health. Find activities that help you relax and reduce stress, like meditation or yoga.
- Practice good hygiene: Good hygiene practices like washing your hands regularly and showering daily can help prevent the spread of germs and illnesses.
- Limit alcohol intake: Drinking too much alcohol can have negative effects on our liver and overall health. Limit your intake to no more than 1-2 drinks per day.
- Quit smoking: Smoking is a major cause of many diseases and can have negative effects on our health. Quitting smoking is one of the best things you can do for your health.
- Wear sunscreen: Protect your skin from the harmful effects of the sun by wearing sunscreen with at least SPF 30, especially when spending time outdoors.
- Connect with others: Social connections are important for our mental health and well-being. Make an effort to spend time with friends and family, or find a community group that interests you.
Making these simple changes to your daily routines can have a big impact on your health and wellness. Remember that small steps can lead to big changes. Start with one or two changes and gradually add more as you feel comfortable. With time, these habits will become a natural part of your daily routine, helping you to live a healthier and happier life.
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(Family Features) While many Americans agree Conventional CPR (cardiopulmonary resuscitation) or Hands-Only CPR (HOCPR) significantly improve a person’s chance of survival from cardiac arrest, less than half are confident they can perform either Conventional CPR or HOCPR in an emergency.
Learning CPR
Black or Hispanic adults who experience cardiac arrest outside a hospital setting are substantially less likely to receive lifesaving care from a bystander. In spite of these survey results, the American Heart Association is working to change this by empowering members of these communities to learn lifesaving CPR, and a growing segment of respondents are willing to act in an emergency.
The American Heart Association’s 2023 survey also revealed that as a result of the organization’s efforts to change attitudes about performing CPR, which can lead to lifesaving results, more than half of African Americans said they would be willing to perform CPR in an emergency compared to 37% two years ago. Additionally, Hispanic and Latino respondents are more confident in their abilities to perform CPR.
Committed to turning a nation of bystanders into lifesavers, the American Heart Association’s multiyear initiative, Nation of Lifesavers, helps teens and adults learn how to perform CPR and use an automated external defibrillator (AED); share that knowledge with friends and family; and engage employers, policymakers, philanthropists and others to create support for a nation of lifesavers.
“Each of us has the power in our own hands to respond to a sudden cardiac arrest,” said Anezi Uzendu, M.D., American Heart Association expert volunteer. “We simply need to know what to do and have the confidence to act.”
The long-term goal: to ensure that in the face of a cardiac emergency, anyone, anywhere is prepared and empowered to perform CPR and become a vital link in the chain of survival, aiming to double the survival rate of cardiac arrest victims by 2030. It takes just 90 seconds to learn how to save a life using HOCPR, which can be equally as effective as traditional CPR in the first few minutes of cardiac arrest.
Nationally supported by the Elevance Health Foundation, the American Heart Association’s HOCPR campaign is focused on chest compression-only CPR. If a teen or adult suddenly collapses due to a cardiac event, you can take two steps to save a life: immediately call emergency services and use these tips to begin performing HOCPR.
- Position yourself directly over the victim.
- Put the heel of one hand in the center of the chest and put your other hand on top of the first.
- Push hard and fast in the center of the chest at a rate of 100-120 beats per minute, which is about the same tempo as the song “Stayin’ Alive” by the Bee Gees, and at a depth of approximately 2 inches.
- Continue compressions and use an AED, if available, until emergency help arrives.
To learn more about how you could be the difference between life and death for someone experiencing a cardiac event, visit Heart.org/nation.
Photo courtesy of Shutterstock
SOURCE:
American Heart Association
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STM Daily News is a multifaceted podcast that explores a wide range of topics, from life and consumer issues to the latest in food and beverage trends. Our discussions dive into the realms of science, covering everything from space and Earth to nature, artificial intelligence, and astronomy. We also celebrate the amateur sports scene, highlighting local athletes and events, including our special segment on senior Pickleball, where we report on the latest happenings in this exciting community. With our diverse content, STM Daily News aims to inform, entertain, and engage listeners, providing a comprehensive look at the issues that matter most in our daily lives. https://stories-this-moment.castos.com/
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How APOL1-mediated kidney disease can impact you, your kidneys and your family
(Family Features) A genetic condition that can cause kidney failure, APOL1-mediated kidney disease (AMKD) represents a group of kidney diseases associated with mutations (changes or variants) in the apolipoprotein L1 (APOL1) genes.
Typically, the APOL1 genes – of which every person has two, one from each parent – create proteins that play a role in immunity. However, some people are born with mutations in one or both genes, and having mutations in both can increase the risk of developing kidney disease and even kidney failure.
In honor of National AMKD Awareness Day on April 30, consider this information from the experts at the American Kidney Fund to better understand the disease and become APOL1 aware.
Understanding Risk Factors
Research shows Black people with kidney disease are more likely to develop kidney failure than any other racial or ethnic group. The reasons for these health disparities include social determinants of health, a higher burden of diabetes and high blood pressure in the Black community, barriers to health care access and genetics.
The APOL1 gene mutations evolved over the past 3,000-10,000 years in people who lived in western and central Africa and are associated with increased protection from a parasite carried by the tse tse fly that causes African sleeping sickness. While protecting from one disease, the mutation – if inherited in both APOL1 genes – is more likely to lead to kidney disease in those of certain African descent, including people who identify as Black, African American, Afro-Caribbean or Latina or Latino.
In fact, an estimated 13% of Black Americans have two APOL1 gene mutations, according to the American Kidney Fund. While not everyone who has two APOL1 mutations will get kidney disease, there is a 1 in 5 chance they will go on to develop AMKD.
Identifying Symptoms
If you have kidney damage, symptoms may not occur until your kidneys are close to failing. As kidney damage worsens, one or more of these symptoms may occur:
- Protein in urine
- Swelling in legs or weight gain
- Feeling weak or tired
- High blood pressure
Should these symptoms occur and you have a family history of kidney disease, talk to a doctor about getting tested for kidney disease, as testing is the only way to determine kidney function. AMKD can cause damage to parts of the kidney that filter blood or, in some cases, cause cells in the kidneys to die, which can lead to damage and scarring that may eventually lead to kidney failure.
Getting a Diagnosis
The only way to know if you have APOL1 gene mutations is to do genetic testing via a blood or saliva sample. Genetic testing may be considered if you have kidney disease and don’t know the cause or if you’re considering donating a kidney. Testing may also be considered if a family member is a carrier for the mutation. If you have questions about genetic testing, discuss your options with a doctor or ask for a referral to a genetic counselor.
Taking Steps to Prevent Kidney Disease
There are currently no treatments available for AMKD. However, there are steps you can take to protect your kidneys and promote general health. Work with your doctor to create a plan to prevent or delay the progression of kidney disease, which may include:
- Doctor visits to check how your kidneys are working through urine and blood tests
- Checking for and managing diabetes and high blood pressure
- A healthy eating plan, which may involve limiting things like sodium (salt)
- Taking prescription medications as directed
- Being active at least 30 minutes each day of the week
- Quitting smoking or using tobacco
If you have the APOL1 gene mutations, you may be able to take part in clinical trials. Trials could provide an opportunity for researchers to develop and test safe treatments for AMKD. Also speak with family members about having genetic testing done if you have the mutation as they may also have it.
Learn more and find additional resources at kidneyfund.org/APOL1aware.
Photo courtesy of Shutterstock
SOURCE:
American Kidney Fund
STM Daily News is a vibrant news blog dedicated to sharing the brighter side of human experiences. Emphasizing positive, uplifting stories, the site focuses on delivering inspiring, informative, and well-researched content. With a commitment to accurate, fair, and responsible journalism, STM Daily News aims to foster a community of readers passionate about positive change and engaged in meaningful conversations. Join the movement and explore stories that celebrate the positive impacts shaping our world.
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