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Latest Top (4) News

HHS Invests in Diagnostic Labs to Expand COVID-19 Testing Capacity in the United States

Today, the U.S. Department of Health and Human Services announced combined investments of $6.5 million in two commercial diagnostic laboratories to expand capacity to conduct up to 4 million additional SARS-CoV-2 per month. SARS-CoV-2 is the virus that causes COVID-19. The investments in Aegis Sciences Corporation and in Sonic Healthcare USA will provide critical laboratory equipment supplied by Beckman Coulter Life Sciences and Thermo Fisher Scientific and increase staffing and infrastructure to allow the U.S. to perform an additional 1 million tests each week by early October.

"We are committed to leveraging every possible opportunity to expand the nation's SARS-CoV-2 testing capacity over the next several months," said Assistant Secretary for Health ADM Brett Giroir, M.D. "For this opportunity, we were able to match available instrumentation and reagents with commercial labs that were ready to immediately expand their services. We are honored to work with these labs and life sciences tools companies to ensure increased access to testing as may be needed this fall."

Aegis Sciences Corporation

In response to HHS investment, Aegis will rapidly expand its laboratory workforce and begin construction on new laboratory space at its testing facilities in Nashville, Tennessee, to meet its goal of processing more than 60,000 test samples per day beginning in September. With its expanded daily testing capacity, Aegis has agreed to partner with the Office of the Assistant Secretary for Health to perform testing of samples from select locations with vulnerable populations. These tests will return results in under 48 hours.

Sonic Healthcare USA

Sonic Healthcare USA is collaborating closely with HHS to expeditiously ramp up their testing capacity at eight SARS-CoV-2 testing facilities. HHS will provide access to instrumentation and supplies necessary to rapidly expand the scope and expedite the timeline of their ongoing capacity expansion plans. The new testing capacity will significantly enhance patient access to SARS-CoV-2 diagnostic testing across the country.

Beckman Coulter Life Sciences

Beckman Coulter Life Sciences will provide equipment that will enable laboratories to optimize their workflow, thereby increasing SARS-CoV-2 testing by up to 10,000 tests each day at 10 separate sites totaling an increase of 100,000 per day across the country.

Thermo Fisher Scientific

Thermo Fisher Scientific is supplying HHS with 56 KingFisher Flex extraction and purification systems and 40 QuantStudio 7 Flex Real-time polymerise chain reaction (PCR) tests. Each PCR test can run 384 samples at a time. These 96 systems – capable of running more than 140,000 samples per day, in total – will be placed at Aegis Sciences Corporation laboratories in Nashville, Tennessee, and at Sonic Healthcare USA labs around the country.

Thu, 13 Aug 2020 13:00:00 -0400

HHS Announces Investments for Health Information Exchanges to Strengthen their Ability to Support State and Local Public Health Agencies

The U.S. Department of Health and Human Services (HHS) today issued a Notice of Funding Opportunity to expand and accelerate innovative uses of electronic health information via health information exchanges (HIEs) to support state and local public health agencies. Strengthening health data exchange and use between HIEs and state and local public health agencies will help communities to better prevent, respond to, and recover from public health emergencies, including disasters and pandemics such as COVID-19.

With $2.5 million in funding from the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) signed by President Trump on March 27, 2020, the HHS Office of the National Coordinator for Health Information Technology (ONC) will award up to five (5) cooperative agreements under the Strengthening the Technical Advancement and Readiness of Public Health Agencies via Health Information Exchange (STAR HIE) Program.

Award recipients will focus on improving HIE services (such as last-mile connectivity and data services) in support of state and local public health agencies. The STAR HIE Program aims to strengthen existing state and local HIE infrastructure so that public health agencies are able to better access, share, and use health information as well as support communities that have been disproportionately impacted by the COVID-19 pandemic.

“State and local HIEs play a unique role in their communities by uniting health information from many different sites of service, including providers, hospitals, nursing homes, clinical laboratories, and public health departments, making them a natural fit to deliver innovative, local ‘last mile’ approaches to strengthen our overall public health response,” said Don Rucker, M.D., national coordinator for health information technology. “The funding opportunity we announced today will invest in infrastructure and data services for HIEs that provide critical real-time information to communities at the frontlines of responding to the COVID-19 pandemic.”

Award recipients will be required to deploy services that can enable, enhance, or increase the use of health information exchange at the state and local levels among relevant entities, and be inclusive of a diverse set of participating providers, including those who care for vulnerable or at-risk populations. They also will be required to engage in activities that address communities disproportionately impacted by the COVID-19 pandemic, considering factors such as age, race, ethnicity, disability, and sex.

The funding opportunity can be accessed here.

Wed, 12 Aug 2020 10:00:00 -0400

Trump Administration collaborates with Moderna to produce 100 million doses of COVID-19 investigational vaccine

Under the leadership of President Trump, the U.S. Department of Health and Human Services (HHS) and Department of Defense (DoD) today announced an agreement with Moderna, Inc. to manufacture and deliver 100 million doses of the company’s COVID-19 vaccine candidate. The federal government will own these vaccine doses.

Moderna will manufacture the vaccine doses while clinical trials are underway. Manufacturing in parallel with clinical trials expedites the traditional vaccine development timeline and builds toward the U.S. government’s Operation Warp Speed goal to begin delivering safe and effective vaccines to the American people by the end of the year. If the U.S. Food and Drug Administration (FDA) authorizes use as outlined in agency guidance, the vaccine doses would be distributed and used as part of a COVID-19 vaccination campaign.

“In creating a vaccine portfolio for Operation Warp Speed, the Trump Administration is increasing the likelihood that the United States will have at least one safe, effective vaccine by 2021,” said HHS Secretary Alex Azar. “Today’s investment represents the next step in supporting this vaccine candidate all the way from early development by Moderna and the National Institutes of Health, through clinical trials, and now large-scale manufacturing, with the potential to bring hundreds of millions of safe and effective doses to the American people.”

The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, collaborated with the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and Army Contracting Command to provide up to approximately $1.5 billion to manufacture and deliver the vaccine doses to government-designated locations across the country. The government also can acquire up to an additional 400 million doses of the vaccine.

The project announced today includes fill-finish manufacturing in U.S.-based facilities. This fill-finish manufacturing step ensures vaccine doses are packaged and ready to ship immediately, subject to successful clinical trials and FDA authorization.

If these doses are used in a COVID-19 vaccination campaign, the vaccine would be available to the American people at no cost. As is customary with government-purchased vaccines, healthcare professionals could charge for the cost of administering the vaccine.

The vaccine, called mRNA-1273, has been co-developed by Moderna and scientists from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. NIAID has continued to support the vaccine’s development including nonclinical studies and clinical trials.

In addition, BARDA has supported phase 2/3 clinical trials, vaccine manufacturing scale up and other development activities for this vaccine. The Phase 3 clinical trial, which began July 27, is the first government-funded Phase 3 clinical trial for a COVID-19 vaccine in the United States.

About Operation Warp Speed

OWS is a partnership among components of the Department of Health and Human Services and the Department of Defense, engaging with private firms and other federal agencies, and coordinating among existing HHS-wide efforts to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.

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 ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. To date, BARDA-supported products have achieved 55 FDA approvals, licensures or clearances. To learn more about federal support for the nationwide COVID-19 response, visit coronavirus.gov.

About the JPEO-CBRND

The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) protects the Joint Force by providing medical countermeasures and defense equipment against chemical, biological, radiological and nuclear (CBRN) threats. JPEO-CBRND’s goal is to enable the Joint Force to fight and win unencumbered by a CBRN environment. JPEO-CBRND facilitates the rapid response, advanced development, manufacturing and acquisition of medical solutions, such as vaccines, therapeutics, and diagnostics, to combat CBRN and emerging threats such as COVID-19. To learn more about JPEO-CBRND’s COVID-19 response, visit https://www.jpeocbrnd.osd.mil/coronavirus or follow JPEO-CBRND on social media at @JPEOCBRND.

Tue, 11 Aug 2020 17:30:00 -0400

Secretary Azar Highlights the Importance of Open, Transparent Global Health Leadership During Visit to Taiwan

On Tuesday, U.S. Health and Human Services Secretary Alex Azar and the U.S. delegation met with Foreign Minister Wu for a conversation on the U.S.-Taiwan friendship and Taiwan's global health leadership. Secretary Azar congratulated Minister Wu for all that Taiwan has done for global health, and stated the belief of the United States that Taiwan's accomplishments should be recognized on the world stage, and that Taiwan should be able to share these lessons and its world-class expertise in international forums, such as the World Health Assembly. Secretary Azar has made this point repeatedly to the World Health Organization, from which Taiwan has been excluded as an observer for the last four years. They also discussed how Taiwan is an important partner for economic progress and security in the Indo-Pacific Region.

Secretary Azar then met with former Vice President Chen and a group of COVID-19 response experts for a discussion on Taiwan's pandemic response and ways the United States and Taiwan can further their collaboration on disease response and other global health issues.

Taiwan Vice President Lai then hosted the U.S. delegation for a lunch, where the Secretary thanked the Vice President for the warm welcome he received in Taiwan. The delegations discussed how this visit reaffirms the United States' commitment to Taiwan as a free and open democracy in East Asia, and is a recognition of Taiwan's health leadership.

Secretary Azar delivered a major address at National Taiwan University, emphasizing that Taiwan is a democratic success story, a reliable partner, and a force for good in the world. Taiwan's success in responding to the virus not only saved lives, but allowed them to aid others around the world by sending supplies and direct technical assistance to help control their epidemics. Their response stands in stark contrast with the apparent response from the Chinese Communist Party (CCP), which, Secretary Azar said, did not live up to the binding obligations it had under the International Health Regulations, betraying the cooperative spirit needed for global health.

HHS Secretary Azar delivered remarks at National Taiwan University and met with COVID-19 experts in Taipei, Taiwan on August 11, 2020.
HHS Secretary Azar delivered remarks at National Taiwan University and met with COVID-19 experts in Taipei, Taiwan on August 11, 2020.

Tue, 11 Aug 2020 14:45:00 -0400