Meeting the Challenges of Sepsis in Severe Coronavirus Disease 2019: A Call to Arms.

Sepsis is a life-threatening organ dysfunction that is caused by a dysregulated host response to infection. Sepsis may be caused by bacterial, fungal, or viral pathogens. The clinical manifestations exhibited by patients with severe coronavirus disease 2019 (COVID-19)-related sepsis overlap with those exhibited by patients with sepsis from secondary bacterial or fungal infections and can include an altered mental status, dyspnea, reduced urine output, tachycardia, and hypotension.

Seasonal influenza vaccination is associated with reduced risk of death among Medicare beneficiaries.

Background: Influenza causes substantial mortality, especially among older persons. Influenza vaccines are rarely more than 50% effective and rarely reach more than half of the US Medicare population, which is primarily an aged population. We wished to estimate the association between vaccination and mortality reduction.

Adjuvanted recombinant hemagglutinin H7 vaccine to highly pathogenic influenza A(H7N9) elicits high and sustained antibody responses in healthy adults.

An unprecedented number of human infections with avian influenza A(H7N9) in the fifth epidemic wave during the winter of 2016-2017 in China and their antigenic divergence from the viruses that emerged in 2013 prompted development of updated vaccines for pandemic preparedness. We report on the findings of a clinical study in healthy adults designed to evaluate the safety and immunogenicity of three dose levels of recombinant influenza vaccine derived from highly pathogenic A/Guangdong/17SF003/2016 (H7N9) virus adjuvanted with AS03 or MF59 oil-in water emulsions. Most of the six study groups meet the FDA CBER-specified vaccine licensure criterion of 70% seroprotection rate (SPR) for hemagglutination inhibition antibodies to the homologous virus.

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

Objective: To evaluate the impact of sepsis, age, and comorbidities on death following an acute inpatient admission and to model and forecast inpatient and skilled nursing facility costs for Medicare beneficiaries during and subsequent to an acute inpatient sepsis admission.

Design: Analysis of paid Medicare claims via the Centers for Medicare & Medicaid Services DataLink Project (CMS) and leveraging the CMS-Hierarchical Condition Category risk adjustment model.

Setting: All U.

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

Objectives: To distinguish characteristics of Medicare beneficiaries who will have an acute inpatient admission for sepsis from those who have an inpatient admission without sepsis, and to describe their further trajectories during and subsequent to those inpatient admissions.

Design: Analysis of paid Medicare claims via the Centers for Medicare and Medicaid Services DataLink Project.

Setting: All U.

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

Objectives: To provide contemporary estimates of the burdens (costs and mortality) associated with acute inpatient Medicare beneficiary admissions for sepsis.

Design: Analysis of paid Medicare claims via the Centers for Medicare & Medicaid Services DataLink Project.

Setting: All U.

Clinical Development of Therapeutic Agents for Hospitalized Patients With Influenza: Challenges and Innovations.

Background: Since 1999, the US Food and Drug Administration approved neuraminidase and endonuclease inhibitors to treat uncomplicated outpatient influenza but not severe hospitalized influenza. After the 2009 pandemic, several influenza hospital-based clinical therapeutic trials were unsuccessful, possibly due to certain study factors. Therefore, in 2014, the US Health and Human Services agencies formed a Working Group (WG) to address related clinical challenges.

Safety and immunogenicity of influenza A(H5N1) vaccine stored up to twelve years in the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS).

Background: As part of the U.S. Department of Health and Human Services (HHS) Pandemic Influenza Plan preparedness and response strategy, the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS) program was established by the Biomedical Advanced Research and Development Authority (BARDA) in 2005 with the goal of building and maintaining a stockpile of vaccines for influenza viruses with pandemic potential to vaccinate 20 million people in the critical workforce in the event of a pandemic.

Vaccines as a tool to estimate the burden of severe influenza in children of low-resourced areas (November 30-December 1, 2012, Les Pensieres, Veyrier-du-Lac, France).

There is an increasing focus on influenza in low-resourced areas as a vaccine-preventable cause of severe lower respiratory disease in young children, especially among those under two years of age. The extent of the disease burden is unclear: current etiologic studies may underestimate the impact of influenza if recognized or unrecognized infection occurs some time before severe disease manifestations prompt specimen collection for diagnosis. Because of various methodological challenges, a vaccine probe approach was used to estimate vaccine preventable disease incidence (VPDI) for Streptococcus pneumoniae and Haemophilus influenzae type b, particularly for pneumonia outcomes among young children.

Antivirals in seasonal and pandemic influenza--future perspectives.

Antiviral drugs continue to be an important option for the treatment of influenza disease and will likely be the only option during the early phases of pandemic. However, the limited number of drug classes licensed for treatment of influenza raises several issues, particularly in the face of drug resistance. Two classes of drugs are presently licensed for treatment of influenza, M2 and neuraminidase inhibitors.

PATH Influenza Vaccine Project: accelerating the development of new influenza vaccines for low-resource countries.

The 2009 influenza A/H1N1 pandemic demonstrated that a pandemic influenza virus has the potential to spread more rapidly in today's highly interconnected world than in the past. While pandemic morbidity and mortality are likely to be greatest in low-resource countries, manufacturing capacity and access to influenza vaccines predominantly exist in countries with greater resources and infrastructure. Even with recently expanded manufacturing capacity, the number of doses available within a 6-month timeframe would be inadequate to fully immunize the global population if the decision to implement a global vaccination program were made today.

United States of America Department of Health and Human Services support for advancing influenza vaccine manufacturing in the developing world.

Since 2005, the Government of the United States of America has provided more than US$ 50 million to advance influenza vaccine development in low-resourced countries. This programme has provided a unique opportunity for the US Government to develop a comprehensive view of, and to understand better the challenges and future needs for influenza vaccines in the developing world. The funding for this programme has been primarily through a cooperative agreement with the World Health Organization (WHO) to support directly its capacity-building grants to government-owned or -supported vaccine manufacturers in developing countries.