health and wellness
FDA Provides Update on Agency Response to Monkeypox Outbreak
Last Updated on June 30, 2024 by Daily News Staff
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
How Young Adults Can Build a Healthier Future
Bridging national service and public health, the initiative supports a diverse group of early career professionals working to address today’s public health challenges in a range of roles
(Family Features) Shaping the future of public health into an equitable one means ensuring all people and communities have access to the health care and resources they need to live well. The nation requires a strong, diverse public health workforce to accomplish that goal.
That’s why AmeriCorps and the Centers for Disease Control and Prevention launched Public Health AmeriCorps – to support the recruitment, training and development of early career public health workers who can serve their local communities.
Bridging national service and public health, the initiative supports a diverse group of early career professionals working to address today’s public health challenges in a range of roles, including:
- Health education and training
- Community outreach and engagement
- System navigation, referrals and linkage to care
- Research, data collection, analysis and assessment
What Members are Saying
Everyone was impacted by the COVID-19 pandemic – including Dionne Johnson, who lost a loved one to the virus.
“I had a family member die from COVID-19, and it really touched me,” Johnson said. “That gave me the passion and lit the fire under me to actually pursue a career in public health.”
Now, Johnson is realizing her dreams of transforming public health in her community. In her work, she wants to teach people in Black and brown communities how they can learn to be healthy and advocate for themselves.
Another member, Jaiden Singh, is the son of immigrants. Singh launched a promising career in public health so he can give back to the community where he grew up.
“Being a part of the organization not only has really supplemented my education that I’m working toward in public health and policy, it has also given me the opportunity to do work that I am really passionate about in a community that I have known all my life and really do love,” Singh said. “I would highly recommend being a part of this really valuable and inspiring community.”
Action That Creates Impact
The diverse work of Public Health AmeriCorps benefits not only program members but also the communities they serve. As examples of the program at work, members have:
- Provided overdose rescue education, raised awareness about opioid use disorder and harm reduction strategies and distributed overdose rescue kits containing naloxone (an overdose-reversing nasal spray).
- Held back-to-school COVID-19 testing events, distributed early childhood health education and built community gardens in underserved communities.
- Participated in a community mental health crisis intervention system to assess, stabilize and link people in crisis to follow-up care and services.
- Supported elementary schools as part of a dental hygiene program that sends out staff and volunteers to provide free teeth cleanings to students.
Learn More and Apply
If you want to start your career and make a difference in public health, consider member benefits such as:
- Education awards to apply to higher education or student loan forgiveness
- Student loan deferment and forbearance
- Living allowance
- Hands-on experience
- Training from experts
Visit AmeriCorps.gov/PublicHealth for a list of opportunities to serve and contact your desired opportunity by phone or email to learn more and apply. You can also subscribe to the newsletter to learn more about the initiative.
SOURCE:
AmeriCorps
Lifestyle
Saving a Life This Summer: Ways to Step Up Safety Practices
Regardless of where you are, summer is a reminder that emergencies like cardiac arrest can happen anywhere. Take the safety of those around you into your own hands this summer with this checklist.
(Feature Impact) The busy summer season can take you almost anywhere – baseball fields, backyard cookouts, long workdays or road trips across the country. Regardless of where you are, summer is a reminder that emergencies like cardiac arrest can happen anywhere.
More than 350,000 out-of-hospital cardiac arrests occur in the United States each year, and 90% of people will not survive, according to the American Heart Association, a nonprofit organization devoted to changing the future for a world of healthier lives for all. Sudden cardiac arrest can happen anytime, anywhere. People often hesitate to step in. In fact, nearly 2 out of 3 adults believe CPR can only be performed by medical professionals. This mistaken belief can cost lives and contributes to the low survival rate.
Ordinary people have extraordinary power. You don’t need to wear scrubs or have a medical background to save a life – you just need the courage to act.
Take the safety of those around you into your own hands this summer with this checklist.
Plan Ahead
Summer is often a time for welcome disruptions, including vacations, camps, sports and parties. Before traveling or attending events, check if your destination has a cardiac emergency response plan, which establishes specific steps to reduce death from cardiac arrest in any setting, from schools and community organizations to workplaces and sports facilities.
Learn CPR
Cardiac arrest can happen anywhere: at home, at work, in schools, at a soccer game or on vacation. When it happens, the first chance for survival often rests with the people nearby.
Anyone can be the difference before professional help arrives. The power to save a life is in your hands. CPR is a human responsibility, not just a medical skill. When friends, family or even strangers step in during cardiac emergencies, survival rates can double or even triple.
Hands-Only CPR for adults consists of two easy steps:
- Call 9-1-1 or shout for someone else to call.
- Push hard and fast in the center of the chest to the beat of a familiar song that’s 100-120 beats per minute, such as “Stayin’ Alive” by the Bee Gees.
Share Resources with Your Family and Community
Once you’ve learned simple, two-step Hands-Only CPR, share resources with your community to help expand the American Heart Association’s Nation of Lifesavers. Raising awareness with family, neighbors and colleagues can help people feel confident in the face of an emergency.
Families can watch short instructional videos that demonstrate the life-saving steps for adults as well as techniques for infants and children.
Travelers can also get trained in about 5 minutes with a Hands-Only CPR Kiosk, located in many airports and public spaces across the country.
To find more information about learning CPR, visit Heart.org/Nation.
Summer Safety Tips
In addition to learning CPR and sharing valuable resources with your family and community, consider these ways to keep yourself and loved ones safe throughout the summer months.
- Stay Hydrated: High temperatures can quickly lead to dehydration and heat-related illness. Drink water regularly throughout the day, especially during outdoor activities, and pack extra water when away from home.
- Protect Your Skin: Hats, sunglasses and lightweight clothing can protect skin from sun exposure, but it’s important to use broad-spectrum sunscreen and reapply every 2 hours.
- Swim with a Buddy: Hopping in a pool, lake or ocean is a hallmark of summer but can be dangerous without precautions. Never swim alone and ensure children are always supervised by an adult near water.
- Identify the Locations of Safety Equipment: When attending camps, heading to a sporting event or enjoying the pool or beach, identify where lifeguards, AEDs and emergency exits are located. Knowing where to find help can save valuable time when every second counts.
- Practice Grill Safety: Some of your most memorable summer moments may happen during a backyard barbecue or cookout, and it’s important to keep those gatherings safe. Use grills away from homes, decks and dry grass. Never leave them unattended while cooking, and be sure kids and pets stay at a safe distance from hot surfaces.
Saving a Life Within 1 Year of Learning CPR
On a chilly Tuesday, dawn was breaking as Matthew Lynch reached his highway exit, but traffic was backed up at a particular intersection. He waited through three cycles before finally getting close enough to see the holdup: a stalled SUV.
While most cars buzzed by, Lynch moved slowly and peered into the vehicle. He saw people inside and parked his sedan, flipped on the hazard lights and ran to the stalled SUV. As he knocked on the driver’s window, there was no response. The doors were locked. Two people – a male driver and female passenger – were unresponsive.
Lynch ran back to his own car and called 9-1-1 before managing to open the driver’s side door. He discovered the driver was not breathing normally, signaling to Lynch he’d need to start CPR – which he’d learned 10 months earlier during a training session he’d helped organize for a work-sponsored men’s group.
Knowing he had to do something, Lynch started pushing hard and fast in the center of the man’s chest. Within a minute, the man gasped for breath.
Just as Lynch leaned over to see if he could help the female passenger, first responders arrived and Lynch backed away, knowing there was nothing more he could do.
“It was just a lot to take in,” said Lynch, a member of the American Heart Association’s 2026 Nation of Lifesavers Class, a small group of volunteers, dedicated to raising awareness of CPR by sharing their own personal stories of survival or rescue. “Mostly I felt an incredible sense of gratitude that I could help someone.”
A strong admirer of the Good Samaritan parable, Lynch is always on the lookout for the opportunity to help others. He learned a lot about himself in that moment and about the importance of learning CPR, along with the confidence that comes from knowing you could be a lifesaver.
“I quickly realized the certification was way less important than the actual CPR training,” he said. “Your ability to help in any capacity is better than doing nothing. If I hadn’t done that training, I probably would not have helped.”
SOURCE:
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News
How healthy is Sodastream?
The SodaStream Sparkling Water Maker is a device that forces carbon dioxide (CO2) gas (stored under pressure in a cylinder) into water, making it sparkling (fizzy)
Sodastream machines have been gaining popularity in recent years as an alternative to store-bought soft drinks. Not only are they more environmentally friendly, but they also offer several health benefits compared to traditional sodas.
Reduced Sugar Intake
One of the most significant health benefits of using a Sodastream machine is reducing sugar intake. Traditional sodas are loaded with sugar, and excessive sugar intake can lead to weight gain, obesity, and other health problems such as Type 2 diabetes. With a Sodastream machine, you can control the amount of sugar you add to your drink, allowing you to enjoy a refreshing beverage without the harmful effects of excessive sugar consumption.
No Artificial Sweeteners
Many store-bought soft drinks contain artificial sweeteners, which can have negative health effects such as headaches and digestive problems. Sodastream machines, on the other hand, allow you to use natural sweeteners such as fruit extracts, honey or agave nectar, giving you a healthier and more natural alternative.
No Preservatives
Another advantage of using a Sodastream machine is that you can avoid preservatives commonly found in store-bought soft drinks. Preservatives such as sodium benzoate and potassium sorbate have been linked to health problems such as cancer and allergies. By making your own drinks, you can avoid these harmful additives and enjoy a healthier, preservative-free beverage.
Eco-Friendly
In addition to the health benefits, using a Sodastream machine is also environmentally friendly. Traditional soft drinks are packaged in plastic bottles or cans, which contribute to environmental pollution. With a Sodastream machine, you can reuse the same bottle multiple times, reducing waste and helping to reduce your carbon footprint.
Variety
Finally, Sodastream machines offer a wide variety of flavors and options, allowing you to customize your drink to your liking. You can mix and match different flavors or create your own unique blends, giving you a healthier and more enjoyable alternative to traditional sodas.
In conclusion, Sodastream machines offer several health benefits compared to traditional store-bought soft drinks. By reducing sugar intake, avoiding artificial sweeteners and preservatives, and being eco-friendly, they offer a healthier and more sustainable alternative to traditional soft drinks. Moreover, with a wide variety of flavors and options, you can customize your drink to your liking, making it a fun and enjoyable way to stay healthy.
