health and wellness

FDA Provides Update on Agency Response to Monkeypox Outbreak

Published

2 years ago

July 29, 2022

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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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. View all posts

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Family

Tips for a Safe and Festive Holiday Season

Published

1 day ago

December 20, 2024

Daily News Staff

(Family Features) As people prepare to gather with family and friends this holiday season, it’s important to think about health and safety.

“With the holidays just around the corner, now is the perfect time to think about how you can help protect yourself from serious illness from flu, COVID-19 and RSV – and support your loved ones in doing the same,” said Dr. Rachel Levine, assistant secretary for health at the U.S. Department of Health and Human Services (HHS). “Vaccination is an important step in having a happy and healthy celebration.”

While preparing for holiday festivities, keep these recommendations in mind to help protect yourself from severe flu, COVID-19 and RSV.

Flu: Flu season usually peaks during the winter months, so now is a great time to get the 2024-25 flu vaccine. It’s recommended for people 6 months and older to lower their risk of infection or serious illness from the flu. In fact, people who skipped their flu shot last year were twice as likely to need medical help for the flu. The best time to get vaccinated is at least a couple of weeks before a holiday gathering. But getting vaccinated later in the season can still help. Encourage your family and friends to get the flu vaccine, too. Together you can create safer holiday celebrations.

COVID-19: Getting vaccinated against COVID-19 is also important for everyone ages 6 months and older. The updated COVID-19 vaccines offer the best protection against serious illness from the virus, especially for those at higher risk. This includes people with certain health conditions or older adults, which may include parents, grandparents and great aunts or uncles. By getting vaccinated, people of all ages can lower their risk of getting severely sick. In fact, young adults are at higher risk of developing Long COVID than older adults. However, staying up to date on your COVID-19 vaccines lowers your risk of Long COVID, too.

RSV: RSV can be especially risky for older adults and babies. That’s why everyone 75 and older, people 60-74 with certain health conditions or who live in a nursing home and pregnant people should get the RSV vaccine. Pregnant people should get the RSV vaccine at 32-36 weeks of pregnancy to help protect their newborns from severe RSV during their first six months of life.

As you prepare for the holidays, remember that prevention is the best way to keep from getting seriously sick from flu, COVID-19 and RSV. By getting vaccinated now, you can enjoy the holiday season with greater confidence and less risk of missing time together. Being vaccinated helps keep your symptoms milder if you get infected after vaccination so you can do the things you want to do with less risk of spreading infection.

Talk with your doctor about which vaccines are right for you as well as for any loved ones you help care for. Visit cdc.gov/RiskLessDoMore for more information on vaccines, or visit vaccines.gov to get started.

The Effects of Flu, COVID-19 and RSV on Different Populations

People who are Black, Hispanic or who live in rural areas may be at higher risk of severe illness from flu, COVID-19 and RSV than others. Getting vaccinated is the best protection from getting seriously sick from these viruses. According to the Centers for Disease Control and Prevention (CDC):

Last flu season, Black adults were more than twice as likely as white adults to be hospitalized for flu.
Last flu season, Hispanic adults were more likely than white adults to be hospitalized for flu.
One in 3 adults living in rural areas have never been vaccinated against COVID-19. For people living in rural areas, health services may be far away. That can mean it takes some planning to get vaccinated. But being far from medical care also means it’s even more important to lower your risk of serious illness by getting vaccinated.

Photos courtesy of Shutterstock

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SOURCE:
United States Department of Health and Human Services

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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health and wellness

8 maneras de vivir de manera más saludable en 2025

Published

4 days ago

December 18, 2024

Daily News Staff

Tome medidas para limitar el riesgo de enfermedad cardiovascular

(Family Features) En la última década se ha producido un aumento de factores de riesgo cardiovascular, como la hipertensión arterial no controlada, la diabetes y la obesidad, cada uno de los cuales aumenta el riesgo de desarrollar enfermedades cardíacas y accidentes cerebrovasculares. Estas tendencias están llevando a los investigadores a concluir que la prevalencia de las enfermedades cardiovasculares (ECV) seguirá aumentando.

Más del 60 % de los adultos estadounidenses tendrán algún tipo de ECV para 2050, según las proyecciones previstas de la American Heart Association, que celebra 100 años de servicio salvando vidas como la principal organización mundial sin fines de lucro dedicada a la salud del corazón y el cerebro de todos. Además, se espera que los costos totales relacionados con las ECV casi se tripliquen en ese período hasta alcanzar más de 1.8 trillones de dólares.

El aumento será impulsado por una población más anciana y diversa, pero estos factores de riesgo están aumentando incluso entre niños y adultos.

“Reconocemos que el panorama de la salud cardiovascular cambiará en las próximas tres décadas debido al tsunami que se avecina de aumentos en los costos de la atención médica, una población de mayor edad que vive más tiempo y un número cada vez mayor de personas de poblaciones de pocos recursos”, dijo la voluntaria de la American Heart Association, Karen E. Joynt Maddox, M.D., M.P.H., FAHA. “Aun así, estas siguen siendo las principales causas de muerte y discapacidad en Estados Unidos”.

Si bien se necesitan cambios sistemáticos continuos en la ciencia, las políticas y la atención de salud, la mayoría de las ECV se pueden prevenir a nivel individual. Usted puede ayudar a cambiar el rumbo de las terribles perspectivas de la ECV y, al mismo tiempo, mejorar su propia salud siguiendo y alentando a otros a seguir los “Life’s Essential 8” de la American Heart Association.

Coma mejor. Intente seguir un patrón de alimentación saludable en general que incluya alimentos integrales, frutas y verduras, proteínas magras, frutos secos, semillas y cocinar con aceite de oliva y de canola.

Manténgase activo. Los adultos deben realizar 2 horas y media de actividad física moderada o 75 minutos de actividad física vigorosa por semana. Los niños deben tener 60 minutos cada día, incluidos juegos y actividades estructuradas.

Deje el tabaco. El uso de productos que suministran nicotina por inhalación, que incluyen cigarrillos tradicionales, cigarrillos electrónicos y vaporizadores, es la principal causa de muerte evitable en los EE. UU.

Duerma bien. La mayoría de los adultos necesitan dormir entre 7 y 9 horas cada noche. Los niños de 5 años o menos necesitan entre 10 y 16 horas, incluidas las siestas; de 9 y 12 horas, en niños de 6 y 12 años, y entre 8 y 10 horas, entre los 13 y 18 años.

Controle el peso. Lograr y mantener un peso saludable tiene muchos beneficios. El índice de masa corporal es un indicador útil. El IMC óptimo es menor de 25, pero menor de 18.5 se considera bajo peso. Puede calcularlo en línea o consultar a un profesional de la salud.

Controle el colesterol. Los niveles altos de colesterol no HDL, o “malo”, pueden provocar enfermedades cardíacas. Su profesional de atención médica puede considerar el colesterol no HDL como el número preferido para monitorear, en lugar del colesterol total, porque se puede medir sin ayuno previo y se calcula de manera confiable entre todas las personas.

Controle el nivel de azúcar en sangre. La mayor parte de los alimentos que consume se convierten en glucosa (o azúcar en sangre) que su cuerpo utiliza como energía. Con el tiempo, los niveles altos de azúcar en sangre pueden dañar el corazón, los riñones, los ojos y los nervios.

Controle la presión arterial. Mantener su presión arterial dentro de rangos aceptables puede ayudarle a mantenerse saludable por más tiempo. Los niveles inferiores a 120/80 mmHg son óptimos. La presión arterial alta se define como una presión sistólica de 130 a 139 mm Hg (el número superior en una lectura) o una presión diastólica de 80 a 89 mm Hg (el número inferior).

Encuentre más formas de cuidar su salud en el nuevo año y más allá en heart.org.

Foto cortesía de Shutterstock

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SOURCE:
American Heart Association

Nuestra sección de estilo de vida en STM Daily News es un centro de inspiración e información práctica, que ofrece una variedad de artículos que tocan varios aspectos de la vida diaria. Desde consejos sobre finanzas familiares hasta guías para mantener la salud y el bienestar, nos esforzamos por empoderar a nuestros lectores con conocimientos y recursos para mejorar sus estilos de vida. Ya sea que esté buscando ideas de actividades al aire libre, tendencias de moda o recomendaciones de viaje, nuestra sección de estilo de vida lo tiene cubierto. Visítanos hoy en https://stmdailynews.com/category/lifestyle/ y embárcate en un viaje de descubrimiento y superación personal

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Lifestyle

Why winter makes you more vulnerable to colds – a public health nurse explains the science behind the season

Published

6 days ago

December 15, 2024

Daily News Staff

Libby Richards, Purdue University

You’ve probably heard “Don’t go outside in the winter with your hair wet or without a coat; you’ll catch a cold.”

That’s not exactly true. As with many things, the reality is more complicated. Here’s the distinction: Being cold isn’t why you get a cold. But it is true that cold weather makes it easier to catch respiratory viruses such as the cold and flu.

Research also shows that lower temperatures are associated with higher COVID-19 rates.

As a professor of nursing with a background in public health, I’m often asked about infectious disease spread, including the relationship between cold and catching a cold. So here’s a look at what actually happens.

Many viruses, including rhinovirus – the usual culprit for the common cold – influenza, and SARS-CoV-2, the virus that causes COVID-19, remain infectious longer and replicate faster in colder temperatures and at lower humidity levels. This, coupled with the fact that people spend more time indoors and in close contact with others during cold weather, are common reasons that germs are more likely to spread.

The flu and respiratory syncytial virus, or RSV, tend to have a defined fall and winter seasonality. However, because of the emergence of new COVID-19 variants and immunity from previous infections and vaccinations decreasing over time, COVID-19 is not the typical cold-weather respiratory virus. As a case in point, COVID-19 infection rates have surged every summer since 2020.

Virus transmission is easier when it’s cold

More specifically, cold weather can change the outer membrane of the influenza virus, making it more solid and rubbery. Scientists believe that the rubbery coating makes person-to-person transmission of the virus easier.

It’s not just cold winter air that causes a problem. Air that is dry in addition to cold has been linked to flu outbreaks. That’s because dry winter air further helps the influenza virus to remain infectious longer. Dry air, which is common in the winter, causes the water found in respiratory droplets to evaporate more quickly. This results in smaller particles, which are capable of lasting longer and traveling farther after you cough or sneeze.

How your immune system responds during cold weather also matters a great deal. Inhaling cold air may adversely affect the immune response in your respiratory tract, which makes it easier for viruses to take hold. That’s why wearing a scarf over your nose and mouth may help prevent a cold because it warms the air that you inhale. https://www.youtube.com/embed/7JQ78oLFV9A?wmode=transparent&start=0 Cold weather can affect nasal immunity.

Also, most people get less sunlight in the winter. That is a problem because the sun is a major source of vitamin D, which is essential for immune system health. Physical activity, another factor, also tends to drop during the winter. People are three times more likely to delay exercise in snowy or icy conditions.

Instead, people spend more time indoors. That usually means more close contact with others, which leads to disease spread. Respiratory viruses generally spread within a 6-foot radius of an infected person.

In addition, cold temperatures and low humidity dry out your eyes and the mucous membranes in your nose and throat. Because viruses that cause colds, flu and COVID-19 are typically inhaled, the virus can attach more easily to these impaired, dried-out passages.

What you can do

The bottom line is that being wet and cold doesn’t make you sick. That being said, there are strategies to help prevent illness all year long:

Wash your hands often.

Person's hands covered with suds under a running faucet. — Handwashing is a time-tested strategy for reducing the spread of germs at any time of year. Mike Kemp/Tetra Images via Getty Images

Avoid touching your face, something people do between nine and 23 times an hour.
Stay hydrated. Eight glasses a day of water is a good goal, but that could be more or less depending on lifestyle and the size of the person.
Eat a well-balanced diet. Dark green, leafy vegetables are rich in immune system-supporting vitamins, while eggs, fortified milk, salmon and tuna have vitamin D.
Stay physically active, even during the winter.
Get adequate sleep.
Clean hard, high-touch surfaces in your home often.
If your nose or throat gets dry in the winter, consider using a humidifier.
Get your annual flu and COVID-19 vaccine.