Regulatory Pathways That Facilitated Timely Registration of a New Group A Meningococcal Conjugate Vaccine for Africa's Meningitis Belt Countries.

BACKGROUND: Through its normative and public health leadership roles, the World Health Organization (WHO) plays a key role in the availability of vaccine products in low-and middle-income countries. The recent introduction of a new group A meningococcal conjugate vaccine, PsA-TT (MenAfriVac), in Africa exemplifies this process. WHO requires that any new vaccine to be introduced in countries for public health reasons and supplied through United Nations centralized mechanisms be licensed by the national regulatory agency (NRA) in the producing country, then prequalified and given a marketing authorization in the user countries. METHODS: PsA-TT was manufactured by the Serum Institute of India, Ltd (SIIL), which submitted a license application in April 2009 to the Drug Controller General of India (DCGI), the Indian NRA responsible for licensing vaccines. WHO encouraged the DCGI to establish a collaboration with Health Canada's Centre for Vaccine Evaluation for the review. Through this collaborative effort, registration was facilitated and in December 2009 an export license was granted to SIIL, which subsequently submitted an application for WHO prequalification. RESULTS: Given the importance of the vaccine, WHO "fast tracked" the prequalification review, and after a detailed review and site visit, WHO prequalification was granted to PsA-TT in June 2010. Country use of the new vaccine could not occur until the vaccine was a registered product in each country seeking its use. WHO facilitated country reviews by conducting regulatory training exercises (in French and English) for country NRA staff, which used the PsA-TT registration as a case study. CONCLUSIONS: PsA-TT was gradually registered in African countries as vaccine introduction proceeded. The regulatory pathway for this new group A meningococcal conjugate vaccine proved to be a useful training opportunity both in India and Africa, because the availability of the vaccine was a high African public health priority, as well as for WHO as a case study to facilitate registration of vaccines based on reliance on other regulatory bodies.

How safe is it to shop? Estimating the amount of space needed to safely social distance in various retail environments.

COVID-19 has had a devastating effect on towns and cities throughout the world. However, with the gradual easing of lockdown policies in most countries, the majority of non-essential retail businesses are trying their best to bounce back both economically and socially. Nevertheless, the efforts of retail traders are hampered by uncertainty regarding what capacity measures need to be taken, and there is an urgent need to understand how social distancing can be safely followed and implemented in these spaces. This paper draws from retail space allocation, crowd science, operational research and ergonomics/biomechanics to develop a method for identifying the minimum amount of space an individual needs to socially distance in shops, markets, shopping centres and open commercial spaces, when there are other people present. The area required per person is calculated for both static space (where people are seated, standing or queuing, for example) and dynamic space (where people need to walk freely). We propose our method as a step forward in understanding the very practical problem of capacity, which can hopefully allow retail spaces to operate safely, and minimise the risk of virus transmission.

The quality of life of elderly women who underwent radiofrequency ablation to treat breast cancer.

The purpose of this article is to explore the effects of radiofrequency ablation (RFA), an investigational treatment for breast cancer, on the quality of life of elderly women. For this descriptive phenomenological study, the authors interviewed 12 White women (aged 60-81 years) 4 months to 1 year after treatment and analyzed these interviews for common themes. They asked questions regarding the lived experience of RFA treatment and its effects on quality of life. Analyses focused on the effects of deciding to have the RFA treatment and the treatment itself. They found quality of life improved because the women felt empowered by (a) their decision to have the procedure, (b) knowing that the procedure might kill the tumor, (c) and feeling that they were contributing to cancer research. The level of support received from the medical team, family and friends, and other cancer survivors also improved participant quality of life.

Treatment of invasive breast carcinoma with ultrasound-guided radiofrequency ablation.

BACKGROUND: Radiofrequency ablation (RFA) is a minimally invasive thermal ablation technique. This study reports the safety and efficacy of RFA as a minimally invasive strategy for breast cancers <3 cm diameter in postmenopausal women. METHODS: Twenty-two postmenopausal women (aged 60 years or older) with clinical T-1N0 core biopsy proven breast cancers were studied. Thermocoagulation was undertaken using a sonographically guided RF probe under local anesthesia and sedation. The ablated tumor was resected between 1 and 2 weeks later. Endpoints were technical success, completeness of tumor kill, marginal clearance, skin damage, and patient reports of pain and procedural acceptability. RESULTS: The procedure was well tolerated and cosmesis was excellent. Pathology revealed a central ablation zone surrounded by hyperemia. Coagulative necrosis was complete in 19 of 22 patients. Disease at the ablation zone margin was found in 3 patients and 5 patients had disease distant to the ablation zone consisting of multifocal tumors (2), in-transit metastasis (1), and extensive ductal carcinoma in situ with microinvasive carcinoma (2). Ninety-five percent of patients would be willing to have RFA again. CONCLUSIONS: Radiofrequency ablation can be safely applied in an outpatient setting with acceptable patient tolerance. By itself, RFA cannot be considered effective local therapy. Trials to evaluate RFA complemented with breast irradiation are justified.

Towards saving a million bed days: reducing length of stay through an acute oncology model of care for inpatients diagnosed as having cancer.

PROBLEM: The need to develop a patient pathway for emergency admissions who have a previously undiagnosed cancer. DESIGN: The existing patient pathway was audited and process-mapped to identify delays and areas for improvement. Discussions with key stakeholders were held to identify their needs from an acute oncology service. STRATEGIES FOR CHANGE: A new patient pathway was developed, and a new online referral process was implemented. The publicity and education campaign was repeatedly aimed at referring physicians at consultant and junior level, and took the form of emails and presentations with handouts at all teaching sessions, multidisciplinary team meetings, the Consultants Committee and Junior Doctors' induction. Effects of change The new system was piloted for 6 months. 12/18 patients were referred via the new pathway. 15/18 patients were referred via the new online system. Length of stay, endoscopies, biopsies and blood tests were all statistically significantly reduced during the study period compared with the original audit. LESSONS LEARNT: The challenge was to convince the referring general physicians to use the new patient pathway and referral method. Incorporating their ideas for improvement and implementation made it more likely that they would take up the new ideas. Education and publicity were also extensive, often repeated, and at both junior and senior level. Having the Lead Cancer Clinician and Acute Medicine Consultant engage directly with consultant colleagues, as well as strong support from the Medical Director, was also crucial to the project's success.