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
https://stmdailynews.com/category/lifestyle/health-and-wellness
health and wellness
Heat waves can leave homes dangerously hot – even for young, healthy adults
Heat waves can turn homes into dangerous heat traps—especially during blackouts or in houses without AC—pushing indoor temperatures and humidity into lethal territory even for young, healthy adults, not just the elderly.
Heat waves can leave homes dangerously hot – even for young, healthy adults
Zoltan Nagy, Eindhoven University of Technology
Most people know that heat waves can be dangerous, but what they may not realize is that the heat indoors can be much worse than outdoors.
When the power goes out and air conditioning stops, or in homes without cooling, a house starts to function like a greenhouse during a heat wave. Heat enters through windows and walls and has nowhere to go. Air stagnates.
Within hours, indoor temperatures can climb well above what the thermometer shows outside, especially on upper floors and in rooms with south-facing windows. Over longer periods, especially if temperatures don’t cool off overnight, conditions can become lethal.
Most heat-related deaths occur indoors. When a heat dome sent temperatures soaring in the Pacific Northwest in 2021, 98% of the more than 600 deaths in British Columbia happened inside homes. Washington and Oregon also saw high numbers of deaths in homes that lacked air conditioning.
In Europe, where only 1 in 10 households have air conditioning, heat waves killed an estimated 60,000 people in 2022 and 47,000 in 2023, largely inside buildings never designed for these temperatures.
People of all ages are at risk in heat waves like these. I spent eight years at the University of Texas at Austin studying how buildings respond to extreme heat. In a recent study, my team assessed the heat risk in every single-family home in Austin.
We found that even younger, healthy adults face far more risk than they realize.
How hot is too hot for a human body?
Your body maintains a core temperature of about 98.6 degrees Fahrenheit (37 degrees Celsius). To cool down, it pushes blood to the skin and sweats. But when air temperature is high, that convective cooling weakens. When humidity is also high, sweat cannot evaporate.
If the body has no way to release heat, core temperature rises. If the core temperature increases past about 104 F (40 C), the body’s thermoregulation starts to fail. Past 109 F (42.8 C), death becomes likely.
What makes indoor heat especially dangerous is that it does not let up at night in homes that lack air conditioning. Outdoor temperatures typically drop after sunset, and someone outside can get a few hours of recovery. But a poorly insulated home that has been absorbing heat all day releases that heat slowly, keeping indoor temperatures elevated through the night. A person inside the home never gets a break.
After two or three nights of this, even healthy people start to be at serious risk for heat-related illnesses.
Why homes heat up more than people expect
People tend to underestimate indoor heat for a few reasons.
One is that the thermostat typically sits on one wall in one room. It does not tell what the temperature is in an upstairs bedroom or near a sun-facing window. In older, underinsulated homes, the actual felt temperature can exceed 90 F (32.2 C) even when a thermostat reads 75 F (23.9 C). The hot walls, ceilings and windows can radiate heat directly onto your body.
Another reason is that people assume all homes respond to heat the same way. However, a newer home with double-pane windows and good insulation acts like a thermos, keeping heat out for a longer time. An older home with single-pane windows and cracks in the walls heats up fast.
Two houses on the same street, exposed to the same outdoor conditions, can have completely different temperatures inside. And in a blackout, where neither home has cooling, those differences can become a matter of life and death.
What we found in Austin
Our study combined two datasets. From Austin’s tax appraisal records, we pulled basic property information, such as the year the home was built, the size and the number of stories for each of the city’s 213,000 single-family homes. We then matched each home to the most similar energy simulation models in a U.S. Department of Energy database that contains thousands of detailed, physics-based building energy models representing the U.S. residential building stock.
Using those models, we simulated each building’s indoor temperatures over time during a three-day heat wave and power outage with outdoor temperatures above 110 F (43 C).
We found that 85% of homes got hot enough to pose a significant risk of death for an elderly occupant. But what surprised us was the risk to younger people.
Under today’s climate conditions in Austin, about 15% of homes already have the potential to get hot enough without air conditioning to pose serious heat risks to healthy adults. Under future warming scenarios, that number jumps to as high as 65% if average summer highs reach 104 F (40 C). Further, climate projections for Austin show that heat waves will double in frequency by the end of the century.
We found three types of buildings and accompanying risks:
- Resilient homes, which are newer and well insulated, tended to have temperature and humidity conditions that would be survivable for an elderly occupant throughout the simulated heat wave with blackout.
- Critical-risk buildings, which are mostly older homes, became dangerous almost immediately.
- And then there was the middle group – homes where temperatures rose slowly during the simulated blackout, day by day, possibly giving occupants a false sense of security until it was too late.
Texas has already seen conditions like our case study’s – a heat wave paired with a power outage. In 2024, a derecho knocked out power for nearly 900,000 Houston households while the heat index climbed to 100 F (37.8 C). Seven weeks later, Hurricane Beryl cut power to 2.6 million homes, leaving them without power for over three days, with temperatures over 90 F (32.2 C).
What you can do to stay safe
If you can’t get cooling at home, there are steps you can take that can help.
Move to the lowest floor of your home, where it will be coolest. Close the blinds and curtains on sun-facing windows. Drink water constantly to stay hydrated, which is essential for regulating body temperature.
If you’re facing a blackout, be sure to also check on elderly neighbors, especially those living alone. You can also try to find a public cooling center; many cities now open them during heat emergencies.
Longer term, upgrades such as reflective window film, attic insulation and lighter-colored roofing can reduce how much a home heats up. After the 2021 heat dome, British Columbia’s coroner recommended updating building codes to address heat.
Our own findings point in the same direction: We propose that new homes should be required by building codes to maintain conditions in which at least light physical activity remains possible for all occupants for at least 72 hours during a power outage.
As summers get hotter with climate change and blackouts become more frequent, the risks of people suffering heat illnesses will only continue to rise.
Zoltan Nagy, Professor of Building Services, Eindhoven University of Technology
Heat waves can leave homes dangerously hot – even for young, healthy adults
This article is republished from The Conversation under a Creative Commons license. Read the original article.
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(Feature Impact) Relationships and plumbing have something in common: they can both benefit from practicing smarter bathroom habits. Whether you’re sharing a household with your family, a partner or roommates, good etiquette in these frequently shared spaces can save everyone’s sanity – just like rethinking your flushing routines can save your pipes.
From simple annoyances like leaving the toilet seat up to potentially costly mistakes like clogging your plumbing by flushing the wrong items, a new survey from the Responsible Flushing Alliance (RFA) illuminated a variety of bad habits that cause the most tension in American homes.
In addition to shedding light on these problems, the alliance outlined solutions you can implement at home to restore peace in your restroom. Plus, you can gamify the habit changes to make them more entertaining.
“Our goal is to revolutionize public education by keeping it highly engaging, memorable and fun,” RFA President Lara Wyss said. “We are challenging the public to rethink their everyday habits.”
Get started with these seven tips:
Replace the toilet roll properly
Don’t be the reason someone gets stranded with nothing but a cardboard tube in their moment of need. Keep extra rolls nearby, and when you’re down to the last square of toilet paper, make it a race against the clock to replace it.
Use the (flush) force
An unflushed toilet was listed as the biggest bathroom pet peeve by 37% of survey respondents. To make it fun for the family, introduce a new tradition: before you leave the bathroom, pretend there’s an invisible force field pushing you back to make sure you’ve flushed and are good to go.
Hunt for sink and shower hair
Leaving hair in the drain isn’t just a source of potential plumbing clogs – it’s also an irritant for 35% of respondents. After you shower or style your hair, make it a game to see how many stray strands you can capture and deliver to the trash can.
Clean it and close it
You’ve probably heard jokes about people who leave the toilet seat up, so don’t make yourself the punchline. For a completely un-mockable routine, grab the brush to give the bowl a quick swish after you flush, ensure the seat is down and use an anti-bacterial wipe to leave everything sparkling. You’ll notice cleaning wipes bear the Do Not Flush symbol, which means they go in the trash and never the toilet.
Conquer the counter
Toothpaste and water often splatter all over the place, so to be a polite bathroom roommate, wipe up the mess before it’s even had a chance to dry. Keep cleaning wipes or rags within easy reach and give yourself a 10-second deadline to leave surfaces spotless.
Practice good towel etiquette
Wet towels don’t belong on bathroom floors. If they still have a use or two left in them, banish them back to your towel rack. Otherwise, challenge yourself to a game of laundry basketball, aiming for the hamper.
Don’t flush the un-flushable
According to an RFA survey, half of Americans are still flushing things they know they shouldn’t, like paper towels, feminine hygiene products and non-flushable wipes. Since clearing a clog in your home can cost anywhere from $300-$15,000 or more, the only thing you’ll be draining with habits like these is your wallet.
“Always check wet wipes for the Do Not Flushsymbol and disposal instructions, which helps us protect not only the health of our homes and environment but our relationships, too,” Wyss said.
Visit FlushSmart.org to learn more about good bathroom etiquette, take an interactive quiz and put these tips into practice with a seven-day challenge.
Photo courtesy of Shutterstock (throwing away non-flushable wipe)
SOURCE:
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Lifestyle
Social media before bedtime wreaks havoc on our sleep − a sleep researcher explains why screens alone aren’t the main culprit
Social Media Before Bedtime? A sleep researcher explains why late-night social media disrupts sleep less because of screens and blue light, and more because of emotional engagement—doomscrolling, social comparison, habitual checking and FOMO—that keeps the brain aroused and delays rest.
Brian N. Chin, Trinity College
“Avoid screens before bed” is one of the most common pieces of sleep advice. But what if the real problem isn’t screen time − it’s the way we use social media at night?
Sleep deprivation is one of the most widespread yet overlooked public health issues, especially among young adults and adolescents.
Despite needing eight to 10 hours of sleep, most adolescents fall short, while nearly two-thirds of young adults regularly get less than the recommended seven to nine hours.
Poor sleep isn’t just about feeling tired − it’s linked to worsened mental health, emotion regulation, memory, academic performance and even increased risk for chronic illness and early mortality.
At the same time, social media is nearly universal among young adults, with 84% using at least one platform daily. While research has long focused on screen time as the culprit for poor sleep, growing evidence suggests that how often people check social media − and how emotionally engaged they are − matters even more than how long they spend online.
As a social psychologist and sleep researcher, I study how social behaviors, including social media habits, affect sleep and well-being. Sleep isn’t just an individual behavior; it’s shaped by our social environments and relationships.
And one of the most common yet underestimated factors shaping modern sleep? How we engage with social media before bed.
Emotional investment in social media
Beyond simply measuring time spent on social media, researchers have started looking at how emotionally connected people feel to their social media use.
Some studies suggest that the way people emotionally engage with social media may have a greater impact on sleep quality than the total time they spend online.
In a 2024 study of 830 young adults, my colleagues and I examined how different types of social media engagement predicted sleep problems. We found that frequent social media visits and emotional investment were stronger predictors of poor sleep than total screen time. Additionally, presleep cognitive arousal and social comparison played a key role in linking social media engagement to sleep disruption, suggesting that social media’s effects on sleep extend beyond simple screen exposure.
I believe these findings suggest that cutting screen time alone may not be enough − reducing how often people check social media and how emotionally connected they feel to it may be more effective in promoting healthier sleep habits.
How social media disrupts sleep
If you’ve ever struggled to fall asleep after scrolling through social media, it’s not just the screen keeping you awake. While blue light can delay melatonin production, my team’s research and that of others suggests that the way people interact with social media may play an even bigger role in sleep disruption.
Here are some of the biggest ways social media interferes with your sleep:
- Presleep arousal: Doomscrolling and emotionally charged content on social media keeps your brain in a state of heightened alertness, making it harder to relax and fall asleep. Whether it’s political debates, distressing news or even exciting personal updates, emotionally stimulating content can trigger increased cognitive and physiological arousal that delays sleep onset.
- Social comparison: Viewing idealized social media posts before bed can lead to upward social comparison, increasing stress and making it harder to sleep. People tend to compare themselves to highly curated versions of others’ lives − vacations, fitness progress, career milestones − which can lead to feelings of inadequacy and anxiety that disrupt sleep.
- Habitual checking: Social media use after lights out is a strong predictor of poor sleep, as checking notifications and scrolling before bed can quickly become an automatic habit. Studies have shown that nighttime-specific social media use, especially after lights are out, is linked to shorter sleep duration, later bedtimes and lower sleep quality. This pattern reflects bedtime procrastination, where people delay sleep despite knowing it would be better for their health and well-being.
- Fear of missing out, or FOMO: The urge to stay connected also keeps many people scrolling long past their intended bedtime, making sleep feel secondary to staying updated. Research shows that higher FOMO levels are linked to more frequent nighttime social media use and poorer sleep quality. The anticipation of new messages, posts or updates can create a sense of social pressure to stay online and reinforce the habit of delaying sleep.
Taken together, these factors make social media more than just a passive distraction − it becomes an active barrier to restful sleep. In other words, that late-night scroll isn’t harmless − it’s quietly rewiring your sleep and well-being.
How to use social media without sleep disruption
You don’t need to quit social media, but restructuring how you engage with it at night could help. Research suggests that small behavioral changes to your bedtime routine can make a significant difference in sleep quality. I suggest trying these practical, evidence-backed strategies for improving your sleep:
- Give your brain time to wind down: Avoid emotionally charged content 30 to 60 minutes before bed to help your mind relax and prepare for sleep.
- Create separation between social media and sleep: Set your phone to “Do Not Disturb” or leave it outside the bedroom to avoid the temptation of late-night checking.
- Reduce mindless scrolling: If you catch yourself endlessly refreshing, take a small, mindful pause and ask yourself: “Do I actually want to be on this app right now?”
A brief moment of awareness can help break the habit loop.
Brian N. Chin, Assistant Professor of Psychology, Trinity College
This article is republished from The Conversation under a Creative Commons license. Read the original article.
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