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2.
Ann N Y Acad Sci ; 1511(1): 59-86, 2022 05.
Article in English | MEDLINE | ID: covidwho-1625044

ABSTRACT

The rapid development of COVID-19 vaccines was the result of decades of research to establish flexible vaccine platforms and understand pathogens with pandemic potential, as well as several novel changes to the vaccine discovery and development processes that partnered industry and governments. And while vaccines offer the potential to drastically improve global health, low-and-middle-income countries around the world often experience reduced access to vaccines and reduced vaccine efficacy. Addressing these issues will require novel vaccine approaches and platforms, deeper insight how vaccines mediate protection, and innovative trial designs and models. On June 28-30, 2021, experts in vaccine research, development, manufacturing, and deployment met virtually for the Keystone eSymposium "Innovative Vaccine Approaches" to discuss advances in vaccine research and development.


Subject(s)
COVID-19 , Influenza Vaccines , Vaccines , COVID-19/prevention & control , COVID-19 Vaccines/therapeutic use , Global Health , Humans , Pandemics/prevention & control , Vaccines/therapeutic use
3.
Biology (Basel) ; 10(11)2021 Nov 15.
Article in English | MEDLINE | ID: covidwho-1523859

ABSTRACT

Recommendations for prioritizing COVID-19 vaccination have focused on the elderly at higher risk for severe disease. Existing models for identifying higher-risk individuals lack the needed integration of socio-demographic and clinical risk factors. Using multivariate logistic regression and random forest modeling, we developed a predictive model of severe COVID-19 using clinical data from Medicare claims for 16 million Medicare beneficiaries and socio-economic data from the CDC Social Vulnerability Index. Predicted individual probabilities of COVID-19 hospitalization were then calculated for population risk stratification and vaccine prioritization and mapping. The leading COVID-19 hospitalization risk factors were non-white ethnicity, end-stage renal disease, advanced age, prior hospitalization, leukemia, morbid obesity, chronic kidney disease, lung cancer, chronic liver disease, pulmonary fibrosis or pulmonary hypertension, and chemotherapy. However, previously reported risk factors such as chronic obstructive pulmonary disease and diabetes conferred modest hospitalization risk. Among all social vulnerability factors, residence in a low-income zip code was the only risk factor independently predicting hospitalization. This multifactor risk model and its population risk dashboard can be used to optimize COVID-19 vaccine allocation in the higher-risk Medicare population.

4.
Vaccine ; 39(51): 7357-7362, 2021 12 17.
Article in English | MEDLINE | ID: covidwho-1525978

ABSTRACT

Infectious diseases may cause serious morbidity and mortality in pregnant women, their foetuses, and infants; the risk associated with any newly emerging infectious disease (EID) is likely unknown at the time of its emergence. While the ongoing SARS-CoV-2 pandemic shows that the development of vaccines against new pathogens can be considerably accelerated, the immunization of pregnant women generally lags behind the general population. Guided by the priority pathogen list for WHO's R&D Blueprint for Action to Prevent Epidemics, this workshop sought to define the evidence needed for use of vaccines against EIDs in pregnant and lactating women, using Lassa fever as a model. Close to 60 maternal immunization (MI) and vaccine safety experts, regulators, vaccine developers, Lassa fever experts, and investigators from Lassa-affected countries examined the critical steps for vaccine development and immunization decisions for pregnant and lactating women. This paper reports on key themes and recommendations from the workshop. Current practice still assumes the exclusion of pregnant women from early vaccine trials. A shift in paradigm is needed to progress towards initial inclusion of pregnant women in Phase 2 and 3 trials. Several practical avenues were delineated. Participants agreed that vaccine platforms should be assessed early for their suitability for maternal immunization. It was noted that, in some cases, nonclinical data derived from assessing a given platform using other antigens may be adequate evidence to proceed to a first clinical evaluation and that concurrence from regulators may be sought with supporting rationale. For clinical trials, essential prerequisites such as documenting the disease burden in pregnant women, study site infrastructure, capabilities, and staff experience were noted. Early and sustained communication with the local community was considered paramount in any program for the conduct of MI trials and planned vaccine introduction.


Subject(s)
COVID-19 , Communicable Diseases, Emerging , Vaccines , Communicable Diseases, Emerging/epidemiology , Communicable Diseases, Emerging/prevention & control , Female , Humans , Lactation , London , Pregnancy , Referral and Consultation , SARS-CoV-2 , Vaccine Development
6.
Ann N Y Acad Sci ; 1489(1): 17-29, 2021 04.
Article in English | MEDLINE | ID: covidwho-1280366

ABSTRACT

For years, experts have warned that a global pandemic was only a matter of time. Indeed, over the past two decades, several outbreaks and pandemics, from SARS to Ebola, have tested our ability to respond to a disease threat and provided the opportunity to refine our preparedness systems. However, when a novel coronavirus with human-to-human transmissibility emerged in China in 2019, many of these systems were found lacking. From international disputes over data and resources to individual disagreements over the effectiveness of facemasks, the COVID-19 pandemic has revealed several vulnerabilities. As of early November 2020, the WHO has confirmed over 46 million cases and 1.2 million deaths worldwide. While the world will likely be reeling from the effects of COVID-19 for months, and perhaps years, to come, one key question must be asked, How can we do better next time? This report summarizes views of experts from around the world on how lessons from past pandemics have shaped our current disease preparedness and response efforts, and how the COVID-19 pandemic may offer an opportunity to reinvent public health and healthcare systems to be more robust the next time a major challenge appears.


Subject(s)
COVID-19/epidemiology , COVID-19/therapy , Delivery of Health Care , Pandemics , Public Health , Congresses as Topic , Humans
7.
Lancet ; 397(10280): 1229-1236, 2021 03 27.
Article in English | MEDLINE | ID: covidwho-1131911

ABSTRACT

The research and development (R&D) ecosystem has evolved over the past decade to include pandemic infectious diseases, building on experience from multiple recent outbreaks. Outcomes of this evolution have been particularly evident during the COVID-19 pandemic with accelerated development of vaccines and monoclonal antibodies, as well as novel clinical trial designs. These products were developed, trialled, manufactured, and authorised for use in several countries within a year of the pandemic's onset. Many gaps remain, however, that must be bridged to establish a truly efficient and effective end-to-end R&D preparedness and response ecosystem. Foremost among them is a global financing system. In addition, important changes are required for multiple aspects of enabling sciences and product development. For each of these elements we identify priorities for improved and faster functionality. There will be no better time than now to seriously address these needs, however difficult, as the ravages of COVID-19 continue to accelerate with devastating health, social, and economic consequences for the entire community of nations.


Subject(s)
Global Health , International Cooperation , Pandemics/prevention & control , Research/economics , Research/organization & administration , Humans , Models, Organizational
9.
13.
J Addict Med ; 14(5): e139-e141, 2020.
Article in English | MEDLINE | ID: covidwho-724342

ABSTRACT

: The COVID-19 pandemic has created an urgent need to expand access to substance use disorder (SUD) treatment through telehealth. A more permanent adoption of tele-SUD treatment options could positively alter the future of SUD treatment. We identify four steps that will help to ensure a broader transition to telehealth will be successful in improving the health outcomes of patients with SUDs. These steps are: (1) investing in telehealth infrastructure to enable health care providers and patients to use telehealth; (2) training and equipping providers to provide SUD treatment through telehealth; (3) providing patients with the financial and social support, hardware, and training necessary to use telehealth; (4) making temporary changes to telehealth law and regulation permanent. We believe these 4 steps will be critical to initiating SUD treatment for many persons that have yet to receive it, and for preserving SUD treatment continuity for millions of other patients both during and after the pandemic.


Subject(s)
Coronavirus Infections , Pandemics , Pneumonia, Viral , Program Development/methods , Substance-Related Disorders/therapy , Telemedicine , Betacoronavirus , COVID-19 , Coronavirus Infections/epidemiology , Humans , Pneumonia, Viral/epidemiology , SARS-CoV-2
14.
JAMA ; 2020 Jul 06.
Article in English | MEDLINE | ID: covidwho-633292
17.
Vaccine ; 38(9): 2144-2148, 2020 02 24.
Article in English | MEDLINE | ID: covidwho-1835

ABSTRACT

Launched at Davos in January 2017 with funding from sovereign investors and philanthropic institutions, the Coalition for Epidemic Preparedness Innovations (CEPI) is an innovative partnership between public, private, philanthropic, and civil organisations whose mission is to stimulate, finance and co-ordinate vaccine development against diseases with epidemic potential in cases where market incentives fail. As of December 2019, CEPI has committed to investing up to $706 million in vaccine development. This includes 19 vaccine candidates against its priority pathogens (Lassa fever virus, Middle East respiratory syndrome coronavirus, Nipah virus, Chikungunya, Rift Valley fever) and three vaccine platforms to develop vaccines against Disease X, a novel or unanticipated pathogen. As an entity largely supported by public funds, ensuring equitable access to vaccines whose development it supports in low- and middle-income countries is CEPI's primary focus. CEPI developed an initial equitable access policy shortly after its formation, with key stakeholders expressing strong views about its content and prescriptive nature. The CEPI board instructed that it be revisited after a year. This paper describes the process of revising the policy, and how key issues were resolved. CEPI will continue to take an iterative, rather than prescriptive, approach to its policy-one that reflects the needs of multiple stakeholders and ensures it can meet its equitable access goals.


Subject(s)
Disease Outbreaks/prevention & control , Drug Development , Viral Vaccines , Drug Development/economics , Humans , International Cooperation , Organizations
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