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Latest Top (4) News


HHS, Janssen Collaborate To Develop Coronavirus Therapeutics

As part of the rapid global response to the 2019 novel coronavirus (SARS-CoV-2), the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response (ASPR) will use an existing partnership with Janssen Research & Development, part of Johnson & Johnson, to help develop treatments for coronavirus infections.

The Biomedical Advanced Research and Development Authority (BARDA), part of ASPR, will collaborate with Janssen to identify medicines that might be used safely and effectively to reduce the severity of illness and treat coronavirus infections. The company also will identify compounds that have antiviral activity against SARS-CoV-2 as an initial step in developing new treatments. Currently, there are no vaccines or therapeutics approved by the U.S. Food and Drug Administration (FDA) to treat or prevent novel coronavirus infections.

"This is the third coronavirus to emerge and cause severe respiratory disease in humans within 18 years, and there are still no proven therapies to treat this disease," said BARDA Director Rick A. Bright, Ph.D. "In partnering with Janssen, BARDA is breaking this barrier to protect against this, as well as the next, coronavirus outbreak. This partnership may accelerate discovery and development of a new potentially lifesaving medicines for people with coronavirus infections."

This library to be screened consists of approved therapeutics as well as investigational therapeutics that have completed some clinical trials so that basic safety and pharmacology data are available for these compounds. If screening is promising, candidates then could be considered for further development, including assessment in additional clinical studies.

To screen compounds, Janssen will work with the Rega Institute for Medical Research (KU Leuven) in Belgium. The arrangement couples the Institute's infrastructure, high throughput screening experience, and capabilities for studying special pathogens with Janssen's drug development resources and antiviral expertise.

BARDA is also working with Janssen to develop a novel coronavirus vaccine. BARDA has collaborated with the company to develop treatments and vaccines to protect against multiple infectious diseases, such as Ebola and novel influenza viruses with pandemic potential.

In addition to expanded collaboration with Janssen, BARDA is working with counterparts across the government, including within HHS and with the Department of Defense. The team is reviewing potential vaccines, treatments, and diagnostics from across the public and private sectors to identify promising candidates that could be developed to detect, protect against or treat people with coronavirus infections.

These products include those in development to treat and prevent Middle East Respiratory Syndrome (MERS) or Severe Acute Respiratory Syndrome (SARS), which are caused by coronaviruses related to SARS-CoV-2.

To obtain information about any potential products in development in the private sector that could be used in responding to the novel coronavirus outbreak, this task force launched a single point-of-entry website for innovators and product developers to submit brief descriptions of their relevant diagnostics, therapeutics, vaccines, and other products or technologies. The task force is particularly interested in identifying products and technologies that have progressed into or beyond non-clinical studies, have established large-scale commercial Good Manufacturing Practices (cGMP) manufacturing capability, and/or utilize an FDA-cleared diagnostic platform.

To further support the novel coronavirus response, BARDA also opened an easy broad agency announcement, an EZ-BAA, specific to diagnostics that utilize FDA-cleared platforms, with a viable plan to meet requirements for the FDA to consider issuing an Emergency Use Authorization within 12 weeks of an award.

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 innovation, the 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, 54 BARDA-supported products have achieved regulatory approval, licensure or clearance. BARDA DRIVe brings together the best ideas from the medical and scientific communities, together with government and venture capital investment, to drive innovation that will strengthen our nation's health security. To learn more about preparing for and responding to public health emergencies, from new infectious diseases to natural disasters and bioterrorism, by visiting the HHS public health emergency website, www.phe.gov. For more information on partnering with BARDA on developing medical countermeasures, visit www.medicalcountermeasures.gov, and for more on DRIVe, visit drive.hhs.gov.



Tue, 18 Feb 2020 11:45:00 -0500


HHS Engages Sanofi’s Recombinant Technology for 2019 Novel Coronavirus Vaccine

Racing to develop a vaccine against the 2019 novel coronavirus, the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response has engaged Sanofi Pasteur, the vaccines global business unit of Sanofi.

The Biomedical Advanced Research and Development Authority (BARDA), a component of ASPR, will provide expertise and reallocated funds to support the vaccine’s development. Sanofi will use its egg-free, recombinant DNA platform to produce a recombinant 2019 novel coronavirus vaccine candidate.

The technology produces an exact genetic match to proteins of the virus. The protein’s DNA will be combined with DNA from a virus harmless to humans, and used to rapidly produce large quantities of antigen which stimulate the immune system to protect against the virus. The antigens will be separated and collected from these cells and purified to create working stocks of vaccine for advanced development.

“Flexibility and scalability are cornerstones of rapid response to an emerging infectious disease,” said BARDA Director Rick A. Bright, Ph.D. “Using this proven technology, we can pivot immediately to address this new global health threat. Our goal is a licensed vaccine to provide long-term health security against this latest virus and prevent future coronavirus outbreaks.”

BARDA has worked with Sanofi since 2004 and in 2009 began collaborating with Protein Sciences of Meridian, Connecticut, now owned by Sanofi, to develop a recombinant technology with the flexibility to make millions of doses of vaccine quickly in an influenza pandemic. In 2016, BARDA added this vaccine to the U.S. National Pre-pandemic Influenza Vaccine Stockpile. When Sanofi purchased the company and its technology in 2017, BARDA continued working with Sanofi on pandemic vaccine development, and in December 2019 the partners began focusing on increasing manufacturing capacity for recombinant influenza vaccine in the United States, in accordance with a presidential executive order to enhance national security and the public health by modernizing influenza vaccines and technologies.

This expanded collaboration with Sanofi is BARDA’s second program to focus on developing a novel coronavirus vaccine candidate in the past few weeks. There is currently no approved vaccine, treatment, or diagnostic for novel coronavirus infections; however, the U.S. Food and Drug Administration has issued an emergency use authorization (EUA) to enable emergency use of a diagnostic test developed by the Centers for Disease Control and Prevention.

BARDA also is working with counterparts across the government, including within HHS and with the Department of Defense. The team is reviewing potential vaccines, treatments and diagnostics from across the public and private sectors, particularly products in development for Middle East Respiratory Syndrome (MERS) or Severe Acute Respiratory Syndrome (SARS), to identify promising candidates for development and licensure to detect, protect against or treat novel coronavirus infections.

To obtain information about any potential products in development in the private sector that could be used in responding to the novel coronavirus outbreak, the U.S. government launched a single point-of-entry website for innovators and product developers to submit brief descriptions of their diagnostics, therapeutics, vaccines, and other products or technologies relevant to this new virus.

Federal agencies are particularly interested in identifying products and technologies that have progressed into or beyond non-clinical studies, have established large-scale commercial Good Manufacturing Practices (cGMP) manufacturing capability, and/or have utilized a platform already approved by the U.S. Food and Drug Administration (FDA).

BARDA also opened an easy broad agency announcement, an EZ-BAA, specific to diagnostics that utilize platforms already cleared by the FDA, with a viable plan to meet requirements for the FDA to consider Emergency Use Authorization (EUA) within 12 weeks of an award.

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 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, 54 BARDA-supported products have achieved regulatory approval, licensure or clearance. BARDA DRIVe brings together the best ideas from the medical and scientific communities, together with government and venture capital investment, to drive innovation that will strengthen our nation’s health security. To learn more about preparing for and responding to public health emergencies, from new infectious diseases to natural disasters and bioterrorism, by visiting the HHS public health emergency website, www.phe.gov. For more information on partnering with BARDA on developing medical countermeasures, visit www.medicalcountermeasures.gov, and for more on DRIVe, visit drive.hhs.gov



Tue, 18 Feb 2020 10:00:00 -0500


Largest Study of Sepsis Cases among Medicare Beneficiaries Finds Significant Burden

U.S. hospitals saw a 40 percent increase in the rate of Medicare beneficiaries hospitalized with sepsis over the past seven years, and in just 2018 had an estimated cost to Medicare of more than $41.5 billion according to an unprecedented study by researchers from the U.S. Department of Health and Human Services.

Sepsis is a life-threatening condition caused by the body’s extreme response to an infection. The research team analyzed data from all Medicare beneficiaries from 2012 through 2018. The study included more than 9.5 million inpatient hospital admissions, making this the largest sepsis study based on contemporary Medicare data to be published in the United States. Research team members included the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), the Centers for Medicare & Medicaid Services (CMS), and collaborators from Acumen LLC of Burlingame, California. The study appears in the journal Critical Care Medicine

Researchers determined that the increase in sepsis was not due to the growing number of American seniors enrolling in Medicare. From 2012 through 2018, the U.S. saw a 22 percent increase in the Medicare enrollment rates but a 40 percent increase in the rate of sepsis-related hospital admissions among beneficiaries.

“Sepsis is a lethal and costly health threat affecting Americans’ lives and our economy, yet many Americans may have never heard of it,” said HHS Assistant Secretary for Preparedness and Response Dr. Robert Kadlec. “Any infection can lead to sepsis, including infections caused by influenza or emerging diseases like coronaviruses, which makes sepsis a significant concern in public health emergencies.”

“This groundbreaking study sheds new light on the sepsis-related challenges faced by patients, providers, and taxpayers alike,” said CMS Administrator Seema Verma. “It demonstrates the urgent need for an approach to address a problem that is threatening the health and lives of Medicare beneficiaries. To that end, CMS continues to clear away regulatory obstacles and financial disincentives that have long inhibited the development of life-saving antibiotics capable of treating sepsis patients. Patients suffering from sepsis deserve to see America’s full innovative potential mobilized to address this devastating condition.”

Most patients with sepsis arrived at the hospital with the condition, rather than developing sepsis in the hospital, a possible indicator of success for CMS efforts to reduce hospital-based cases of sepsis. However, two-thirds of these sepsis patients had a medical encounter in the week prior to hospitalization. This finding represents an opportunity for improved education and awareness among patients and healthcare providers, as well as the need for diagnostics to detect sepsis early.

The analysis explored the impact of sepsis severity on health outcomes for Medicare beneficiaries. Despite declining mortality overall, 10 percent of patients with non-severe forms of sepsis died while in the hospital or within a week of discharge, and 60 percent with non-severe forms of sepsis died within three years.

Outcomes were worse among patients with the most severe form of sepsis known as septic shock. Forty percent of these patients died while in the hospital or within a week of being discharged, and 75 percent died within three years. The risk of sepsis was even greater for patients who had other chronic health conditions and the risk of death in the hospital and within three years was greater among these patients if they developed sepsis.

The study also identified the high costs of treating sepsis. Although the inpatient costs of care per stay among Medicare beneficiaries decreased between 2012 and 2018, the increase in the number of patients with sepsis led to an estimated overall increase in Medicare spending from $27.7 billion in 2012 to more than $41.5 billion in 2018 for inpatient hospital admissions and subsequent skilled nursing facility care.

The research team also projected future costs by modeling the increasing number of cases and estimates for all payer costs outside the Medicare population, and concluded that overall costs rose 12-14 percent every two years. Based on that estimate, inpatient hospital and skilled nursing care for sepsis care in 2019 may exceed $62 billion.

“We were astonished by the study’s results,” said Rick Bright, Ph.D., a study author, HHS deputy assistant secretary for preparedness and response (ASPR) and director of the Biomedical Advanced Research and Development Authority (BARDA) at ASPR. “To save lives in public health emergencies, we must solve sepsis. The findings of this study have implications not only for patient care, particularly after patients are discharged, but also for investments by industry, non-government organizations and government agencies. Solving sepsis requires working together. Because of the health security implications, we are taking a holistic approach to this national threat.”

BARDA currently is partnering with industry and academia to develop and encourage adoption of new technologies to detect sepsis earlier as well as to predict and identify the severity of the infections. BARDA also is collaborating with other government agencies and non-government organizations on improved awareness, education, and training for healthcare providers.

CMS has implemented an inpatient bundled sepsis measure in its Inpatient Hospital Quality Reporting Program. This measure is a series of steps to detect and treat sepsis earlier in its course. CMS data have shown that since implementation, organizations that follow all the steps have significantly lower mortality rates for patients diagnosed with severe sepsis and septic shock. The agency is also tackling sepsis in post-acute care settings and is developing a measure for early detection and treatment of healthcare-associated infections, including sepsis in post-acute care settings.

To foster innovation in treating infections that lead to sepsis, CMS is removing barriers to developing new antimicrobial therapies to treat drug-resistant infections. In 2019, CMS finalized an expanded pathway for certain new antibiotics to more quickly receive additional Medicare payments and to increase payments for them. The agency also updated its payments to hospitals to provide them with appropriate resources to treat sick patients with drug-resistant infections. This step helps people who need these medications get access to them.

In addition, to broaden the understanding of the epidemiology of sepsis, CDC continues to assess the adult sepsis burden and identify factors that put people at higher risk for sepsis and has begun a similar effort to assess sepsis burden in children.

CDC has also developed tools for tracking sepsis in individual hospitals to help healthcare facilities assess adult sepsis incidence within their facilities and measure their prevention progress. By working with partners, including the CDC Prevention Epicenters, CDC has invested in innovative ways to improve sepsis early detection and treatment. CDC’s national educational campaign, Get Ahead of Sepsis for patients, healthcare professionals, and the general public emphasizes the importance of early recognition, timely treatment, reassessment of antibiotic needs, and prevention of infections.

The study analyzed claims made on behalf of traditional Medicare beneficiaries as well as from Medicare Advantage plans to explore the burden of sepsis in highly impacted populations including older Americans, those with end-stage renal disease, and those who depend on both Medicare and Medicaid.

The publication includes detailed methods that could enable similar analyses of data from patients covered by private insurance, Veterans Affairs, Department of Defense healthcare facilities, and state Medicaid programs that could lead to an even more accurate understanding of how sepsis affects Americans.

The study will be discussed in two free webstreamed sessions at 2 p.m. EST, Feb. 16, and 3:15 p.m. EST, Feb. 17, during the Critical Care Medicine Congress 2020. The study was published in the journal as three articles:

Sepsis Among Medicare Beneficiaries: 1. The Burdens of Sepsis, 2012–2018

Sepsis Among Medicare Beneficiaries: 2. The Trajectories of Sepsis, 2012–2018

Sepsis Among Medicare Beneficiaries: 3. The Methods, Models, and Forecasts of Sepsis, 2012–2018

Learn more about sepsis and find clinical resources from the Centers for Disease Control and Prevention, and explore what BARDA is doing to solve sepsis at drive.hhs.gov/solvingsepsis.html.



Fri, 14 Feb 2020 10:00:00 -0500


HHS, Janssen Join Forces On Coronavirus Vaccine

To expedite development of vaccines that protect against the 2019 novel coronavirus, the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response (ASPR) will expand an existing partnership with New Jersey-based Janssen Research & Development, part of Johnson & Johnson.

Janssen and the Biomedical Advanced Research and Development Authority (BARDA), a component of ASPR, will share research and development costs and expertise to help accelerate Janssen's investigational novel coronavirus vaccine into clinical evaluation.

"When it comes to infectious diseases, vaccines are the backbone of the public health response," said BARDA Director Rick A. Bright, Ph.D. "With emerging infectious diseases such as COVID-19, speed is crucial to saving lives and reducing further spread of the virus. Janssen is a proven partner with a flexible, rapid, vaccine platform which gives us an edge in the race to protect people in the U.S. and worldwide from the health security threat posed by this novel coronavirus."

Janssen also will work on the scale-up of production and manufacturing capacities required to manufacture the candidate vaccine. This same approach was used to develop and manufacture Janssen's investigational Ebola vaccine with BARDA support; that vaccine is being used in the Democratic Republic of the Congo as part of the current Ebola outbreak response.

In addition to an investigational Ebola vaccine, the BARDA and Janssen partnership has supported development of other products and technologies to help save lives in public health emergencies, including a treatment for blood injuries caused by acute levels of radiation and a treatment for injuries caused by inhaled sulfur mustard. The partnership also has supported two JLABS respiratory protection technology innovation challenges and established a health security innovation zone at the new JLABS@Washington DC facility to spur breakthrough technologies needed for health security.

There is currently no approved vaccine, treatment, or diagnostic for novel coronavirus infections; however, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) to enable emergency use of a diagnostic test developed by the Centers for Disease Control and Prevention.

In addition to expanded collaboration with Janssen, BARDA is working with counterparts across the government, including within HHS and with the Department of Defense. The team is reviewing potential vaccines, treatments and diagnostics from across the public and private sectors, particularly products in development for Middle East Respiratory Syndrome (MERS) or Severe Acute Respiratory Syndrome (SARS), to identify promising candidates for development to detect, protect against or treat people with novel coronavirus infections.

To obtain information about any potential products in development in the private sector that could be used in responding to the novel coronavirus outbreak, this task force launched a single point-of-entry website for innovators and product developers to submit brief descriptions of their relevant diagnostics, therapeutics, vaccines, and other products or technologies. The task force is particularly interested in identifying products and technologies that have progressed into or beyond non-clinical studies, have established large-scale commercial Good Manufacturing Practices (cGMP) manufacturing capability, or utilize an FDA-cleared diagnostic platform.

To further support the novel coronavirus response, BARDA also opened an easy broad agency announcement, an EZ-BAA, specific to diagnostics that utilize FDA-cleared platforms, with a viable plan to meet requirements for the FDA to consider issuing an EUA within 12 weeks of an award.

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 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, 54 BARDA-supported products have achieved regulatory approval, licensure or clearance. BARDA DRIVe brings together the best ideas from the medical and scientific communities, together with government and venture capital investment, to drive innovation that will strengthen our nation's health security. To learn more about preparing for and responding to public health emergencies, from new infectious diseases to natural disasters and bioterrorism, by visiting the HHS public health emergency website, www.phe.gov. For more information on partnering with BARDA on developing medical countermeasures, visit www.medicalcountermeasures.gov, and for more on DRIVe, visit drive.hhs.gov.



Tue, 11 Feb 2020 16:30:00 -0500