Recommendations for acceleration of vaccine development and emergency use filings for COVID-19 leveraging lessons from the novel oral polio vaccine.

A new oral polio vaccine, nOPV2, has become the first vaccine to pursue a WHO Emergency Use Listing. Many lessons were learned as part of the accelerated development plan and submission, which have been categorized under the following sections: regulatory, clinical development, chemistry manufacturing and controls, and post-deployment monitoring. Efforts were made to adapt findings from these studies to COVID-19 vaccine candidates. Specific concepts for accelerating COVID-19 vaccine development across multiple functional domains were also included. The goals of this effort were twofold: (1) to help familiarize vaccine developers with the EUL process; and (2) to provide general guidance for faster development and preparations for launch during the COVID-19 pandemic.

From policy to practice in the Affordable Care Act: Training center for New York State's health insurance programs.

BACKGROUND: The United States currently faces the large, logistical undertaking of enrolling millions of Americans into a complex Affordable Care Act (ACA) system within a short period of time. One way states have addressed this implementation challenge is through the development of consumer assistance programs. In these programs, health care professionals-known as "Assistors"-are trained in insurance enrollment services to help consumers navigate the complex application and plan selection process, with the ultimate goal of optimizing enrollment rates. ORGANIZATIONAL CONTEXT: Cicatelli Associates Inc. (CAI), a non-profit capacity building organization, has served as the Statewide Training Center for New York's Health Insurance Program Initiative since 2013, before the ACA Marketplace roll-out occurred. This article presents a narrative of CAI's experiences and promising practices related to training and developing of the Assistor workforce in New York State (NYS). SOLUTIONS IDENTIFIED THROUGH TRAINING AND DEVELOPMENT: By the end of the second enrollment period (February 2015), NYS trained and certified over 11,000 Assistors (1); CAI trained fifteen percent of this total workforce. As a result of this intensive workforce training effort, NYS observed extremely high rates of facilitated enrollment, and overall success with the roll-out process. LESSONS FROM THE FIELD: Through this initiative, CAI has garnered key insights for other organizations that engage in similar work, as well as state policymakers considering how to integrate and bolster the Assistor programs in their states. These lessons include: the necessity of ensuring that Assistors are armed with all technical concepts and messages; ensuring that Assistors are motivated to work through a change process; the constructive feedback process that can occur when these Assistors directly communicate issues to the state; and the transformation of public opinion that can occur when Assistors provide good customer service and can effectively promote statewide and federal ACA policies and benefits.

Developing children's palliative care in Africa through beacon centres: lessons learnt.

Much progress has been made in the provision of palliative care across sub-Saharan Africa, however much still remains to be done, particularly in the area of children's palliative care (CPC). The Beacon Centres programme was set up in 2009, aimed at improving access to CPC in South Africa, Uganda and Tanzania through more and better-trained health professionals and CPC clinical services of a high standard. Having identified sites in each country to develop into CPC Beacon Centres, Navigators were identified who would be the 'champions' for CPC in those sites and lead a programme of training, mentorship and support. Five navigators (2 in Uganda and Tanzania and 1 in South Africa) were trained between September and December 2009. Following this they undertook CPC needs assessments at the 3 centres and set up and delivered a six-month CPC training programme, providing mentorship and support to students to enable them to integrate CPC into their workplaces. To date, 188 participants have commenced the six-month course, with 80 having completed it. CPC has been integrated into the activities of the centres and a CPC virtual resource centre set up in South Africa. The achievements from the Beacon project have been great and the work of the navigators immense, but as in all projects it has not been without its challenges. Lessons learnt include issues around: the focus of the project; the length and nature of the training; assessment; accreditation; the choice of navigators; mentoring; administrative support; co-ordination; the choice of project sites; and the integration of CPC into services. The need for CPC is not going to go away and it is therefore important that models of scaling-up are found that are not only practical, feasible, affordable and sustainable, but that focus on the outcome of improved CPC for all those who need it. It is hoped that the lessons shared from the Beacon Project will help in developing and implementing such models.