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Latest Top (4) News

HHS Provides Expertise, $14 Million to Advance Development of Investigational Ebola Treatment

An investigational treatment for Ebola virus disease will receive advanced development support from the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR).

ASPR’s Biomedical Advanced Research and Development Authority (BARDA) will provide $14 million and expertise to Ridgeback Biotherapeutics of Miami to manufacture the therapeutic, mAb114, and support activities required to apply for licensure from the U.S. Food and Drug Administration (FDA).

The therapeutic is a single monoclonal antibody. Monoclonal antibodies bind to a virus protein, reducing the ability of the virus from infecting human cells.

Scientists from the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, isolated and developed the antibody from a survivor of the 1995 Ebola outbreak in the Democratic Republic of the Congo (DRC), in collaboration with the Institut National de Recherche Biomedicale, the Institute for Research in Biomedicine, and the U.S. Army Research Institute of Infectious Diseases.

“Effective Ebola therapeutics are essential in saving lives not only in the current outbreak in the DRC, but also in future outbreaks anywhere in the world and to discourage any potential use of this virus in bioterrorism,” said BARDA Director Rick Bright, Ph.D. “Combating this horrific disease requires every tool we can provide to healthcare providers and patients.”

Currently mAb114 is being offered to Ebola patients in the DRC under an expanded access protocol led by the World Health Organization and as part of an extension of a clinical trial called PALM or “Pamoja Tulinde Maisha,” which translates to “together save lives.” The trial is co-sponsored by NIAID and the National Biomedical Research Institute in the DRC, and is being carried out by an international consortium coordinated by the World Health Organization.

This product received FDA Breakthrough Therapy Designation, which helps facilitate development toward approval of critical medical products by allowing companies to submit parts of their application on a rolling basis and to work more closely with FDA officials throughout the review process.

The investigational treatment initially was manufactured in collaboration with the Defense Advanced Research Projects Agency and has been deployed to DRC as a liquid and as well as a powder that is reconstituted onsite at the Ebola treatment centers. This powder formulation does not require freezer storage, which has been helpful in the current outbreak region where freezer storage sometimes has been unreliable.

Clinical use of mAb114 within the current outbreak was the result of an extensive collaborative effort among HHS agencies, most prominently NIAID’s Vaccine Research Center and Division of Clinical Research, as well as with the Institut National de Recherche Biomedicale and the Ministry of Health in the DRC.

In addition to mAb114, BARDA is supporting advanced development of Ebola therapeutics under public-private partnerships with Regeneron Pharmaceuticals Inc. and Mapp Biopharmaceutical Inc., and is working with Merck and Janssen to develop Ebola vaccines.  BARDA also directly supports the U.S. government’s response to the outbreak in the DRC.

According to the World Health Organization, in the year since the DRC declared the current Ebola virus outbreak, the country’s health ministry has confirmed more than 3,000 cases of Ebola virus disease and more than 2,000 deaths from the illness.

About HHS, ASPR, and BARDA

HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of the Office of the Assistant Secretary for Preparedness and Response (ASPR) is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, devices, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. For more about ASPR and BARDA, visit www.phe.gov/aspr, and to learn more about partnering with BARDA, visit www.medicalcountermeasures.gov.

Fri, 20 Sep 2019 15:30:00 -0400

HHS Secretary Azar Statement on Flu Vaccine Executive Order

Upon President Trump’s signing of an executive order to modernize influenza vaccine manufacturing, Health and Human Services Secretary Alex Azar issued the following statement:

“President Trump’s executive order to modernize influenza vaccine manufacturing reflects his commitment both to America’s national security and to America’s health. Faster methods of producing influenza vaccines will help keep Americans safer both from seasonal influenza, which kills tens of thousands of Americans each year, and from the potential of pandemic influenza, which is the single greatest biodefense threat our country faces. Under this executive order, HHS will lead on coordinating and advancing work to modernize influenza vaccine production, as part of the important work we do to protect Americans from all infectious threats, whether naturally occurring, accidental, or manmade.”

Thu, 19 Sep 2019 15:45:00 -0400

HHS Releases First Federal Strategy to Increase Youth Sports Participation

Today, the U.S. Department of Health and Human Services released the National Youth Sports Strategy, the first federal roadmap that outlines steps that the Nation can take to ensure that all youth have the opportunity, motivation, and access to play sports – regardless of their race, ethnicity, sex, ability or ZIP code. The Strategy aims to achieve this goal by increasing participation in sports, increasing awareness of the benefits of sports participation, monitoring and evaluating youth sports participation, and recruiting and engaging volunteers in youth sports programming. The Strategy was announced at Fort Dupont Ice Arena with Advisor to the President Ivanka Trump, HHS Secretary Alex Azar, and members of the President’s Council on Sports, Fitness & Nutrition.

HHS developed the National Youth Sports Strategy in response to President Donald Trump’s Executive Order 13824, which called for a national strategy to increase youth sports participation. According to the Physical Activity Guidelines for Americans, youth need at least 60 minutes a day of moderate-to-vigorous physical activity to stay healthy. Playing sports is one way youth can get the physical activity they need.

“We know that when youth are engaged in sports, their life outcomes are more positive and bright: They have increased graduation rates, higher wages, greater self-confidence and are better at working with others,” said Advisor to the President Ivanka Trump. “Yet, over the past decade youth participation in sports has declined. The Trump Administration is committed to reversing that trend and has implemented the first-ever national strategy. The work of the President’s Council is critical to increasing youth sports participation, regardless of age, gender, ZIP code or financial status.”

Not all youth have the same opportunity to participate in sports. For example, children from low income families, children with disabilities, and girls are less likely to participate. As part of the National Youth Sports Strategy, the HHS Office of Minority Health and the Office on Women’s Health announced $6.7 million in grants to 18 communities to promote youth sports participation. The two-year Youth Engagement in Sports: Collaboration to Improve Adolescent Physical Activity and Nutrition (YES) grants, will support local partnerships that offer youth sports and nutrition activities for racial and ethnic minorities, girls, and disadvantaged youth, particularly in areas where few youth programs exist. A full list of grant recipients is available at Minorityhealth.hhs.gov.

 “With this first-ever federal strategy to promote access to youth sports, President Trump is demonstrating his commitment to strengthening our communities and helping all Americans achieve better physical and mental health,” said Secretary Azar. “The National Youth Sports Strategy and the new YES grants will help expand sports opportunities for all youth, especially those less likely to have access to youth sports today, including girls, racial and ethnic minorities, kids from low-income neighborhoods, and kids with disabilities.”

Sports participation provides numerous benefits in addition to helping youth be more physically active. Benefits can include higher levels of perceived competence, confidence, and self-esteem; improved life skills, such as goal setting, time management, and work ethic; reduced risk of suicide and suicidal thoughts and tendencies; the opportunity to develop social and interpersonal skills, such as teamwork, leadership, and relationship building; and improved concentration, memory, school attendance, and academic performance. The National Youth Sports Strategy outlines actions steps for everyone from coaches and parents, to communities and local organizations to make youth sports safe, fun, and accessible by all.

Read the entire National Youth Sports Strategy

Thu, 19 Sep 2019 11:00:00 -0400

HHS Awards over $85 Million to Help Health Centers Expand Access to Oral Health Care

Today, the U.S. Department of Health and Human Services’ (HHS), Health Resources and Services Administration (HRSA) awarded over $85 million to 298 health centers to expand their oral health service capacity through new infrastructure enhancements. These investments are the first by HRSA to solely focus on oral health infrastructure and will enable HRSA-funded health centers to provide new, or enhance existing, oral health services.

“Health centers play a key role in providing access to a comprehensive range of services Americans need to stay healthy, and that includes high-quality oral health care,” said HHS Secretary Alex Azar. “Early detection of oral diseases can prevent much more costly health challenges and improve Americans’ health, which is the ultimate goal of President Trump’s vision for our healthcare system. These are the first awards HRSA has ever made solely for health centers’ oral healthcare infrastructure, and they will support better access to oral health services in communities across the country, including underserved urban and rural areas.”

The awards of up to $300,000 each will support physical and organizational infrastructure investments for health centers, such as minor alteration and renovation to modernize existing facilities, purchase and installation of dental and radiology equipment, training and consultation to increase oral health integration, and purchase of mobile dental units to increase access to oral health care in hard-to-reach parts of communities.

“Access to high-quality, integrated oral health care is essential to the early detection of oral diseases, which are critical to preventing future, often costly, health issues,” said Acting HRSA Administrator Tom Engels. “These awards, which are the first of their kind, will help health centers tackle limitations in infrastructure, such as outdated equipment and insufficient space, and improve access to integrated, oral health services in primary care settings in communities across the country.”

In 2018, HRSA-funded health centers served more than 6.4 m illion dental patients, a 13 percent increase from 2016, and provided more than 16.5 million dental visits.

For more than 50 years, health centers have delivered affordable, accessible, quality, and cost-effective primary health care services to patients. Today, nearly 1,400 health centers operate approximately 12,000 service delivery sites nationwide.

To see a list of award recipients, visit: https://bphc.hrsa.gov/program-opportunities/funding-opportunities/oral-health/fy19awards

To learn more about HRSA’s Health Center Program, visit: http://bphc.hrsa.gov/about

To locate a HRSA-funded health center, visit: http://findahealthcenter.hrsa.gov

Wed, 18 Sep 2019 08:15:00 -0400