Innovative approaches to COVID-19 medical countermeasure development.

BACKGROUND: The COVID-19 pandemic, while unfortunately notable for immense strain and death throughout the world, has also shown great promise in the development of medical countermeasures. As the global scientific community shifted almost entirely towards vaccines, diagnostics and therapeutics, new trial designs most significantly adaptive platform trials, began to be used with greater speed and broader reach. These designs allowed for deploying and investigating new therapeutics, repurposing currently existing therapeutics and flexibly removing or adding additional medications as data appeared in real-time. Moreover, public-private sector partnering occurred at a level not seen before, contributing greatly to the rapid development and deployment of vaccines. OBJECTIVES: To provide a brief overview of the advances in preventative and therapeutic medical countermeasure development for COVID-19. METHODS: A narrative review of relevant major medical countermeasure trials was conducted using the date range February 2020-December 2022, representing the period of greatest productivity in research to investigate COVID-19. RESULTS: Among the most influential trial designs are the adaptive platform designs, which have been applied to the development of initial COVID-19 antivirals, monoclonal antibodies, repurposing of existing immunomodulatory therapy and assisted in the disproof of ineffective medical therapies. Some of the most prominent examples include the REMAP-CAP, RECOVERY and TOGETHER trials. CONCLUSIONS: Adaptive platform trial designs hold great promise for utility in future pandemics and mass casualty events. Additionally, public-private sectoring is essential for rapid medical countermeasure development and should be further enhanced for future biopreparedness.

How Infectious Disease Experts Impacted the Coronavirus Disease 2019 Response: Lessons From the Front Lines.

In this article, we summarize findings from research conducted by the Johns Hopkins Center for Health Security and the Infectious Diseases Society of America to understand infectious disease (ID) workforce contributions to the coronavirus disease 2019 (COVID-19) response and their impacts. ID experts were found to have made diverse and unique contributions that went well beyond their usual responsibilities, with many spending several hours a week on these activities without additional compensation. These efforts were thought to not only build community resilience but also augment the ongoing public health response. Respondents also reported several hospital and clinical leadership roles taken on during the pandemic, such as developing protocols and leading clinical trials. We also make several policy recommendations, such as medical student debt relief and improved compensation, that will be needed to help fortify the ID workforce for future pandemics.

Patents as a Driver of the Unprecedented Biomedical Response to COVID-19.

The response by the biotech and pharmaceutical sectors to the COVID-19 pandemic has been historically unprecedented. Vaccines based in cutting-edge technologies, such as the mRNA platform, were invented, tested, and distributed to patients in less than a year. Yet politicians and activists argue that patents and other intellectual property (IP) have impeded the development and distribution of these vaccines. In explaining why this is profoundly mistaken, this essay first describes the medical and economic uncertainties inherent in the production of vaccines, especially those made in response to an emerging infectious disease like COVID-19. This makes clear the unprecedented achievement in the mass production and distribution of COVID-19 vaccines in less than 1 year after the start of the COVID-19 pandemic. It then describes the current manufacturing and licensing landscape, which was created on the basis of a market infrastructure built by reliable and effective patent rights. There is now a glut in the global supply of vaccine doses-and billions more doses are still being produced. The essay concludes by identifying the non-IP causes impeding global vaccine distribution, such as lack of infrastructure in the developing world, as well as regulatory restrictions and trade barriers. Those concerned with global vaccine equity should focus on policies to resolve these real-world problems.

ICU preparedness in pandemics: lessons learned from the coronavirus disease-2019 outbreak.

PURPOSE OF REVIEW: The worldwide SARS-CoV-2 pandemic has taken a heavy toll on ICUs worldwide. This review expounds on lessons learned for ICU preparedness during the pandemic and for future mass casualty events. RECENT FINDINGS: In the 21st century, there have already been several outbreaks of infectious diseases that have led to mass casualties creating ICU strain, providing multiple opportunities for hospitals and hospital systems to prepare their ICUs for future events. Unfortunately, the sheer scale and rapidity of the SARS-CoV-2 pandemic led to overwhelming strain on every aspect of ICU disaster preparedness. Yet, by analyzing experiences of hospitals throughout the first 7 months of the current pandemic in the areas of infection control, equipment preparedness, staffing strategies, ICU spatial logistics as well as acute and postacute treatment, various important lessons have already emerged that will prove critical for successful future ICU preparedness. SUMMARY: Preemptive planning, beginning with the early identification of staffing resources, supply chains and alternative equipment sources, coupled with strong infection control practices that also provide for the flexibility for evolving evidence is of utmost importance. However, there is no single approach that can be applied to every health system.

Antibiotic Consumption and Stewardship at a Hospital outside of an Early Coronavirus Disease 2019 Epicenter.

There are scant data on the impact of coronavirus disease 2019 (COVID-19) on hospital antibiotic consumption, and no data from outside epicenters. At our nonepicenter hospital, antibiotic days of therapy (DOT) and bed days of care (BDOC) were reduced by 151.5/month and 285/month, respectively, for March to June 2020 compared to 2018-2019 (P = 0.001 and P < 0.001). DOT per 1,000 BDOC was increased (8.1/month; P = 0.001). COVID-19 will impact antibiotic consumption, stewardship, and resistance in ways that will likely differ temporally and by region.

Clade X: A Pandemic Exercise.

Clade X was a day-long pandemic tabletop exercise conducted by the Johns Hopkins Center for Health Security on May 15, 2018, in Washington, DC. In this report, we briefly describe the exercise development process and focus principally on the findings and recommendations that arose from this project.

Characteristics of Microbes Most Likely to Cause Pandemics and Global Catastrophes.

Predicting which pathogen will confer the highest global catastrophic biological risk (GCBR) of a pandemic is a difficult task. Many approaches are retrospective and premised on prior pandemics; however, such an approach may fail to appreciate novel threats that do not have exact historical precedent. In this paper, based on a study and project we undertook, a new paradigm for pandemic preparedness is presented. This paradigm seeks to root pandemic risk in actual attributes possessed by specific classes of microbial organisms and leads to specific recommendations to augment preparedness activities.

Infectious Diseases Physicians: Improving and Protecting the Public's Health: Why Equitable Compensation Is Critical.

Infectious diseases (ID) physicians play a crucial role in public health in a variety of settings. Unfortunately, much of this work is undercompensated despite the proven efficacy of public health interventions such as hospital acquired infection prevention, antimicrobial stewardship, disease surveillance, and outbreak response. The lack of compensation makes it difficult to attract the best and the brightest to the field of ID, threatening the future of the ID workforce. Here, we examine compensation data for ID physicians compared to their value in population and public health settings and suggest policy recommendations to address the pay disparities that exist between cognitive and procedural specialties that prevent more medical students and residents from entering the field. All ID physicians should take an active role in promoting the value of the subspecialty to policymakers and influencers as well as trainees.