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FDA Provides Update on Agency Response to Monkeypox Outbreak

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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

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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Community Fundraiser Hosted by CFC in Support of Infertility Awareness Week

Canadian Fertility Consulting and Fertility Matters Canada Unite for Virtual Paint Night Fundraiser

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TORONTO (Newswire.com) – Canadian Fertility Consulting is proud to announce a Virtual Paint Night Fundraiser in support of Infertility Awareness Week, scheduled for April 28, 2024. This event aims to raise awareness about infertility issues while supporting Fertility Matters Canada, a national charity dedicated to assisting those struggling with fertility challenges.

The virtual paint night will be led by the talented Jenny Hughes of Oceanside Art Studios, offering participants the opportunity to unleash their creativity while supporting a meaningful cause. Taking part is simple – join from the comfort of your home via Microsoft Teams, and we will provide all the necessary paint materials, conveniently shipped directly to your door.

“We are thrilled to host this virtual paint night fundraiser to support Infertility Awareness Week and Fertility Matters Canada,” said Janet Harbick, Administrative Specialist at Canadian Fertility Consulting. “It’s an opportunity for our community to come together, express themselves artistically, and raise vital funds for a cause that impacts so many lives.”

Participants are encouraged to register by April 12, 2024, to ensure timely delivery of the paint supplies. Registration and payment are required to secure your spot in this event.

The theme for the evening is to paint a beautiful hatching embryo, with each participant adding their own unique interpretation. No prior painting experience is necessary, as guidance will be provided throughout the virtual session.

Infertility affects one in six Canadians, leading many to explore alternative paths to parenthood. Statistics show that 40% of infertility cases are attributed to female factors, 30% to male factors, and 30% to joint infertility or remain unexplained. Additionally, various factors such as sexual orientation, genetic diseases, gynecological issues, and career considerations contribute to the complexity of infertility challenges faced by individuals and couples across every demographic and economic group.

Canadian Fertility Consulting is Canada’s largest surrogacy and egg donation agency, committed to assisting couples and individuals in their journey to parenthood. With a mission to build families with love, we provide guidance and support throughout the process of exploring alternative methods of family building.

Join us for a night of creativity and compassion as we come together to support Infertility Awareness Week and Fertility Matters Canada. Together, we can make a difference in the lives of those affected by infertility.

For more information and to register for the Virtual Paint Night Fundraiser, visit Paint Night Event Registration.

About Canadian Fertility Consulting:

Canadian Fertility Consulting is Canada’s largest surrogacy and egg donation agency, dedicated to helping couples and individuals navigate the challenges of infertility. With a focus on compassion and support, we assist in building families through surrogacy and egg donation arrangements.

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World Health Day 2020: Celebrating Nurses and Midwives in Healthcare

World Health Day: Celebrating nurses and midwives, the backbone of healthcare. #HealthcareHeroes #WorldHealthDay2020

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Today isWorld Health Day, an annual event that takes place on April 7th, organized by the World Health Organization (WHO). This day serves as a platform to highlight various health issues and set the tone for future developments in the global wellness and medical world. From mental health to insurance and everything in between, World Health Day tackles it all.

Let’s delve into the history of this significant day. The creation of the World Health Organization marked a turning point in international health efforts. In December 1945, officials from Brazil and China proposed the establishment of a comprehensive and independent international health organization. Half a year later, in July 1946, the WHO Constitution was approved in New York. On April 7, 1948, this constitution entered into force with 61 countries signing an agreement to inaugurate the NGO.

World Health Day: Celebrating nurses and midwives, the backbone of healthcare. #HealthcareHeroes #WorldHealthDay2020

Among the early initiatives of WHO was the introduction of World Health Day. Originally observed on July 22, 1949, the date was later changed to April 7, coinciding with the establishment of WHO, in order to encourage student participation. Since 1950, each World Health Day has been assigned a different theme, chosen by the WHO Director-General in consultation with member governments and staff.

World Health Day offers a globally significant opportunity to draw attention to crucial public health issues that impact communities worldwide. On this day, various promotional programs are launched that extend far beyond April 7th, raising awareness and fostering positive change.

This year, World Health Day shines a spotlight on the exceptional contributions made by nurses and midwives to the healthcare industry. Nurses and midwives are the devoted and restless workforce that has transformed healthcare as we know it. Their tireless efforts, compassion, and expertise make them the backbone of the healthcare system, providing invaluable care and support to individuals and communities across the globe.

World Health Day 2020 celebrates nurses and midwives by organizing advocacy events worldwide. One of the highlights is the launch of the first-ever State of the World’s Nursing Report. This groundbreaking report will provide critical insights and recommendations to optimize the contributions of the nursing workforce. In 2021, a similar report focusing on the midwifery workforce will follow.

On this World Health Day, let us all join hands in acknowledging and appreciating the vital role played by nurses and midwives in providing healthcare. We owe them our gratitude and support. Take a moment to thank a nurse or midwife who has made a difference in your life or participate in events and discussions that promote their recognition.

Remember, every day is an opportunity to prioritize our health and well-being. Let World Health Day serve as a reminder to embrace healthy living, support those who care for us, and work towards a healthier future.

Stay joyful, stay healthy, and happy World Health Day!

https://nationaltoday.com/world-health-day/

https://stmdailynews.com/category/lifestyle/

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Walk Your Way to Better Health

A walk is not just good for your body, it’s also good for your soul. Physical activity, like walking, is one of the best ways to reduce stress and boost your mood for better health.

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(Family Features) A walk is not just good for your body, it’s also good for your soul. Physical activity, like walking, is one of the best ways to reduce stress and boost your mood. However, reports show walking rates are declining steadily in the United States.

On average, 1 out of every 4 U.S. adults sits for longer than eight hours each day, per research from the Centers of Disease Control and Prevention, which can have negative consequences on physical and mental health. Regular exercise improves mood, boosts energy and can even help you sleep better. Staying active is one of the best ways to keep your mind and body healthy.

Consider this advice from the American Heart Association, which has worked for decades to promote policies and strategies that make it easier for communities to get and stay active. One example is National Walking Day on April 3, established by the organization to encourage people to move more throughout the day so they can feel, think, sleep and live better.

Indeed, adding more movement can benefit your body and mind in numerous ways, such as:

Lowering disease risk. Getting the recommended amount of physical activity (at least 150 minutes of moderate, 75 minutes of vigorous or a combination of those activities per week) is linked to lower risk of diseases, stronger bones and muscles, improved mental health and cognitive function and lower risk of depression, according to the U.S Department of Health and Human Services.

Increasing sunlight exposure. Outdoor exercise is an easy way to get moving and take in the sunlight, which can improve mood, boost immunity and help you get some vitamin D. Spending time outdoors is a no-cost option and has been shown to reduce stress, promote a sense of belonging and improve mood.

Improving cognitive and mental function. Physical activity keeps your mind sharp now and later. Studies show higher fitness levels are linked to better attention, learning, working memory and problem solving. What’s more, a study published in the “British Journal of Sports Medicine” shows people who get the recommended amount of physical activity are less likely to develop depression.

Living longer. Healthy life expectancy can be positively impacted by increasing activity. According to research published in the “American Journal of Epidemiology,” swapping just 30 minutes of sitting with low-intensity physical activity reduced risk of death by 17%.

Get moving to reduce your stress and step into better health. Learn more at heart.org/movemore.

Get Inspired to Get Moving

A little creativity can go a long way to make your walk more fun. You might think of walking as a solo activity, but a companion makes it even more enjoyable. Ask colleagues, friends or family to join you.

A walk is a perfect excuse to take a break from a long day at your desk. If you work remotely, take a conference call on the go or plan your walk as a reward for completing a project.

Use your walk as a guilt-free opportunity to listen to a new audiobook or create a walking soundtrack of your favorite upbeat music.

Mix up your scenery. Taking new routes keeps your walks interesting and helps prevent boredom from traveling the same predictable path.

If you need an extra nudge to get moving, a pet may help you get fit. Dog parents are more likely to reach their fitness goals than those without canine companions. In fact, according to the “Journal of Physical Activity & Health,” dog parents are 34% more likely to fit in 150 minutes of walking a week than non-dog owners. Pets can also help lower stress, blood pressure, cholesterol and blood sugar and boost your overall happiness and well-being.

Photos courtesy of Shutterstock


SOURCE:
American Heart Association

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

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