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FDA Provides Update on Agency Response to Monkeypox Outbreak

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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.

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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

https://stmdailynews.com/category/lifestyle/health-and-wellness

Author

  • Rod Washington

    Rod: A creative force, blending words, images, and flavors. Blogger, writer, filmmaker, and photographer. Cooking enthusiast with a sci-fi vision. Passionate about his upcoming series and dedicated to TNC Network. Partnered with Rebecca Washington for a shared journey of love and art.

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Rod: A creative force, blending words, images, and flavors. Blogger, writer, filmmaker, and photographer. Cooking enthusiast with a sci-fi vision. Passionate about his upcoming series and dedicated to TNC Network. Partnered with Rebecca Washington for a shared journey of love and art.

recipes

Fuel Growing Families with Breakfasts that Deliver Nutrition and Flavor

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Fuel Growing Families with Breakfasts that Deliver Nutrition and Flavor

(Feature Impact) Whether you’re enjoying a leisurely weekend morning with the family or savoring those last few moments before rushing out the door, a filling, healthy breakfast is a perfect way to begin the day. Easy recipes that take less than 30 minutes (and can even be prepared the night before) make busy mornings a breeze.

Sheet Pan Pancakes are simple to whip up any day of the week – no flipping required – while Healthy Sausage Breakfast Muffins let you put protein on the menu in a kid-friendly package. When shopping for these delicious breakfasts, look for the Healthy Family Project and Produce for Kids logos to choose healthier foods and make a difference locally.

“Breakfast doesn’t have to be complicated to be powerful – a quick, balanced meal can help kids stay full, focused and energized for the day ahead,” said Tony Castillo, contributing registered dietitian at Healthy Family Project. “For growing kids, a protein-rich breakfast can help support energy, satiety and the building blocks they need as they develop. The best breakfast is one that’s simple, satisfying and realistic for busy mornings because consistency matters more than perfection.”

The versatility of these pancakes allows for endless customization and experimentation with different toppings, from fresh fruit and nuts to savory options like cheese and spinach, making them an ideal fit for the whole family. They also freeze well, so you can pop them in the toaster to have breakfast ready in a flash when hectic schedules interfere with your morning routine.

For another on-the-go solution, these breakfast muffins are made with just five ingredients, including protein pancake mix to help fuel the day. The savory combination of turkey sausage and cheddar cheese is complemented by the sweetness of onion, giving them the flavor your family desires.

To find more ways to put a nutritious breakfast on the family table, visit HealthyFamilyProject.com.

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Sheet Pan Pancakes

Recipe courtesy of the Healthy Family Project

Prep time: 10 minutes

Cook time: 5 minutes

Servings: 6

  •             Nonstick cooking spray
  • 1 1/2    cups all-purpose flour
  • 3 1/2    teaspoons baking powder
  • 1          tablespoon sugar
  • 1          teaspoon salt
  • 1 1/4    cups milk
  • 1          large egg
  • 2          tablespoons unsalted butter, melted
  • 1/2       cup sliced strawberries
  • 1/4       cup blueberries
  • 1/4       cup mini chocolate chips
  1. Preheat oven to 425 F. Cover baking sheet with parchment paper and spray with nonstick cooking spray. Set aside.
  2. In large bowl, mix flour, baking powder, sugar and salt. Add milk, egg and melted butter; mix until smooth.
  3. Pour batter onto prepared baking sheet and smooth into even layer that covers pan. Top with strawberries, blueberries and chocolate chips.
  4. Bake 5-7 minutes, or until cooked and golden brown. Let cool slightly before cutting into squares.
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Healthy Sausage Breakfast Muffins

Recipe courtesy of the Healthy Family Project

Prep time: 3 minutes

Cook time: 23 minutes

Servings: 12

  •             Nonstick cooking spray
  • 1          onion, diced
  • 1          pound turkey sausage
  • 4          eggs
  • 1/2       cup shredded cheddar cheese
  • 1          cup protein pancake mix
  1. Preheat oven to 350 F.
  2. Spray 12-cup muffin pan with nonstick cooking spray; set aside.
  3. Spray large skillet with nonstick cooking spray.
  4. In prepared skillet over medium heat, cook onion until translucent. Add turkey sausage and cook until no longer pink. Remove from heat.
  5. In large mixing bowl, lightly beat eggs. Add shredded cheese, pancake mix and sausage and onion mixture; mix well.
  6. Fill prepared muffin cups about 3/4 full with mixture.
  7. Bake 18-20 minutes, or until golden brown on top.
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SOURCE:

Healthy Family Project

At our core, we at STM Daily News, strive to keep you informed and inspired with the freshest content on all things food and beverage. From mouthwatering recipes to intriguing articles, we’re here to satisfy your appetite for culinary knowledge.

Visit our Food & Drink section to get the latest on Foodie News and recipes, offering a delightful blend of culinary inspiration and gastronomic trends to elevate your dining experience. https://stmdailynews.com/food-and-drink/

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A Healthier, Greener Home: Eco-Friendly Cleaning Hacks

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Last Updated on May 13, 2026 by Daily News Staff

Eco-Friendly Cleaning Hacks

A Healthier, Greener Home: Eco-Friendly Cleaning Hacks

(Feature Impact) Keeping your home clean doesn’t have to mean filling your cabinets with harsh chemicals or single-use cleaning products. In fact, some of the most effective solutions may already be in your pantry.

By swapping a few everyday products for simple, eco-friendly solutions, you can clean effectively, save money and make your home a little greener. If you’re looking to reduce waste, cut back on toxins and simplify your cleaning routine, natural ingredients like vinegar, baking soda and lemon can deliver results while also being safer for your home – and the environment.

Make Your Own All-Purpose Cleaner

Instead of buying multiple cleaners for different surfaces, try a DIY solution that works in many areas of the home. In a spray bottle, combine 1 cup white vinegar, 1 cup water and 10 drops of the essential oil of your choice – such as lemon, lavender or tea tree – then use it on countertops, sinks, glass and other surfaces to curb grease and grime. Avoid using vinegar-based cleaners on natural stone like granite or marble, however, as its acidity can cause damage.

Let Baking Soda Do the Scrubbing

One of the most versatile eco-friendly cleaners around, baking soda acts as a gentle abrasive that helps lift stains without scratching surfaces. Simply sprinkle baking soda onto sinks, bathtubs, cookware, stovetops or tile grout then scrub with a damp sponge or cloth for a sparkling clean finish.

Freshen Carpets Naturally

Carpets and rugs can trap odors, but a DIY deodorizer made of 1 cup baking soda and 10-15 drops of the essential oil of your choice can replace chemical sprays and keep floor surfaces smelling fresh. Just sprinkle across the carpet, let sit for 15-20 minutes then vacuum.

Use Lemon to Cut Grease and Stains

Lemon juice is a powerful natural cleaner due to its acidity and antibacterial properties. It can leave behind a fresh scent when used to clean cutting boards, remove soap scum and water spots or deodorize garbage disposals. For stubborn grime, mix lemon juice with baking soda to create a paste that can tackle tough surface stains.

Naturally Deodorize Drains

If your kitchen sink smells unpleasant, skip the harsh chemical drain cleaners. Pour 1/2 cup baking soda down the drain then add 1/2 cup white vinegar. Let the mixture fizz a few minutes then flush with hot water to help loosen buildup while neutralizing odors.

Polish Stainless Steel with Pantry Staples

Remove grimy fingerprints and give stainless steel appliances a streak-free shine with a simple mixture of 1 tablespoon white vinegar and 1 tablespoon olive oil.

Find more DIY, eco-friendly cleaning tips and tricks at eLivingtoday.com.

Photo courtesy of Shutterstock

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eLivingtoday.com

Our Lifestyle section on STM Daily News is a hub of inspiration and practical information, offering a range of articles that touch on various aspects of daily life. From tips on family finances to guides for maintaining health and wellness, we strive to empower our readers with knowledge and resources to enhance their lifestyles. Whether you’re seeking outdoor activity ideas, fashion trends, or travel recommendations, our lifestyle section has got you covered. Visit us today at https://stmdailynews.com/category/lifestyle/ and embark on a journey of discovery and self-improvement.

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Food and Beverage

Balance Your Plate with Produce, Protein and Whole Grains

Making health-conscious decisions with your at-home menu doesn’t have to be complicated, but it does require commitment and a little more foresight at the grocery store. Simple adjustments to overall eating patterns, like building your plate around produce, powerful proteins and whole grains, can encourage better health.

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(Feature Impact) Making health-conscious decisions with your at-home menu doesn’t have to be complicated, but it does require commitment and a little more foresight at the grocery store. Simple adjustments to overall eating patterns, like building your plate around produce, powerful proteins and whole grains, can encourage better health.

Nutritious meal-planning can be easy, affordable and delicious – and it all starts with a little balance. Consider this advice from the American Heart Association’s Healthy for Good initiative, nationally sponsored by the Egg Nutrition Center, to adequately round out a healthy plate.

Fill Half Your Plate with Fruits and Veggies

Loaded with nutrients, fresh produce is a perfect place to start each plate. Fill about half your plate with combinations of bananas, strawberries, blueberries, sweet potatoes, peas, carrots and more of your favorites. To boost variety with each meal, look for fruit and veggie blends or step out of your usual routine and try something new.

Grocery tip: Frozen fruits and veggies are often cheaper and just as delicious as their fresh counterparts. It’s frozen right after it’s picked, locking in freshness for a longer shelf life. Just be sure to avoid products with added salt or sugar.

Carve Out a Quarter of the Plate for Powerful Proteins

Healthy food isn’t just fuel. It should be easy and nourish you, too. Look for versatile solutions that provide a protein power-up like skinless chicken breast, no-salt-added beans, low-sodium tuna, tofu or eggs.

High-quality protein from foods, along with a balanced diet and regular exercise, can help support the muscles in your body. Eggs are an example, along with lean animal protein and some plant-based proteins. According to the American Heart Association’s guidelines, healthy people can include up to one whole egg daily, and up to seven per week, as part of a heart-healthy diet. For older adults with normal cholesterol, two eggs per day is acceptable.

Eggs deliver both protein and choline, nutrients that help support growing brains and bodies, especially early in life. In fact, many Americans don’t get enough choline, a critical nutrient for supporting brain development, memory and mood.

Grocery tip: Stock up on proteins that offer both versatility and affordability, helping you cook multiple meals per week without putting a dent in your wallet. Eggs are a perfect example as they can be used at any meal, not just breakfast – try them in wraps or omelets in the morning, hard-boil them to go with a lunchtime salad or add to a frittata at dinner.

17787 B detail embed2Save a Corner for Whole Grains

Finally, fill that last quarter of the plate with ready-to-go whole grains, many of which provide dietary fiber that can support a healthy heart and healthy digestion. Conversely, most refined grains contain little or no fiber.

Examples of whole grains include barley, brown rice, corn, oatmeal, rolled or steel-cut oats, popcorn, quinoa, sorghum and wild rice, along with products labeled “whole grain” or “whole wheat” like bread or pasta.

Grocery tip: Look for whole grains that can make mealtime a cinch. Corn tortillas, instant oats and even popcorn can help you create nutritious plates and better-for-you snacks with the snap of your fingers. Try keeping packets of pre-cooked brown rice on hand to bulk up favorite dishes or toss with leftovers to round out a healthy plate.

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Visit Heart.org to discover more nutrition guidance for heart-healthy meals.

3 Tips to Complement a Healthy, Balanced Plate

Nutrition isn’t just about what’s on your plate – it’s also about what’s next to it and how much is on it. Pair a balanced meal with this advice to help take healthy eating to the next level.

Stay Hydrated
If it’s not already a habit, add a glass of water to each meal. Staying hydrated helps your heart pump blood throughout the body, get rid of waste and regulate body temperature. While water is the best source of hydration, water-rich foods like fruits and vegetables can also play a role.

Watch Portion Sizes
Pay attention to suggested servings from your favorite food groups. For example, one slice of whole-grain bread, 1/2 cup of cooked pasta and two ounces of cheese (about the size of a domino) are the suggested serving sizes for these popular foods.

You can serve and eat smaller portions by:

  • When cooking at home, offer the proper serving size to each family member then put extra food away for leftovers.
  • When dining out, skip appetizers and split your meal with a friend or partner.
  • Avoid eating while watching TV or at your computer. It may be harder to control how much you’re eating if you’re not paying full attention.
  • Mindfully measure out your snacks – even fruits and veggies – into appropriate portions before serving instead of helping yourself directly from the bag or box.

Limit Salt
While sodium supports vital functions like controlling your body’s fluid balance, excess sodium in your bloodstream pulls water into the blood vessels, increasing the amount of blood inside them and thus increasing blood pressure. More than 70% of the sodium people eat comes from packaged, prepared and restaurant foods due to salt added for flavoring, stabilizing, preserving and reducing bacterial risk, according to the American Heart Association. 

Cutting back on sodium can help reduce the rise in blood pressure that occurs as you age, even if you don’t have high blood pressure now. It may also help reduce the risk of heart attack, heart failure, kidney disease and more.

Try cooking more meals at home where you can control sodium intake, flavoring foods with herbs and spices instead of table salt and rinsing canned beans and vegetables to wash away excess sodium.

Photo courtesy of Shutterstock (family preparing meal)

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SOURCE:

American Heart Association

Our Lifestyle section on STM Daily News is a hub of inspiration and practical information, offering a range of articles that touch on various aspects of daily life. From tips on family finances to guides for maintaining health and wellness, we strive to empower our readers with knowledge and resources to enhance their lifestyles. Whether you’re seeking outdoor activity ideas, fashion trends, or travel recommendations, our lifestyle section has got you covered. Visit us today at https://stmdailynews.com/category/lifestyle/ and embark on a journey of discovery and self-improvement.

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