Introducing new vaccines into a national immunisation program (Session duration: 2 hours)
Learning objectives: 1. Understand the principles and key considerations for formulating population vaccination policies and assessing vaccines for use in population-based immunisation programs
2. Appreciate the complexity and uncertainties that such deliberations may involve
3. Understand the mechanisms and process of decisions for introducing a new vaccine into the Australian National Immunisation Program
Timetable for this session: 10 min Adding vaccines to the National Immunisation Program – Clayton Chiu 30 min Economic assessment - Tony Newall Case study 1: Considering introducing a new vaccine into the National Immunisation Program 10 min Introduction to the case study – Peter McIntyre 60 min Group tutorial & discussions – Peter McIntyre/ Kristine Macartney/ Clayton Chiu 10 min Group wrap up of case study – Peter McIntyre/ Kristine Macartney/ Clayton Chiu
Case study (hypothetical): Considering introducing a meningococcal B vaccine into the National Immunisation Program
Assumed background knowledge (covered by prior lectures): 1. Epidemiology of vaccine preventable diseases and principles of disease burden assessment 2. Characteristics of vaccines 3. Issues with vaccination program delivery
Background pre-reading: NNDSS Annual Report Writing Group. Section on Meningococcal disease (invasive) in Australia’s notifiable disease status, 2014: Annual report of the National Notifiable Diseases Surveillance System. Communicable Diseases Intelligence (2016) 40(1): E12-E133 http://www.health.gov.au/internet/main/publishing.nsf/Content/cda-cdi4001-pdf-cnt.htm/ $FILE/cdi4001e.pdf – This section provides some key background information of epidemiology of invasive meningococcal disease in Australia
1. Erickson LJ, De Wals P, Farand L. An analytical framework for immunization programs in Canada. Vaccine 2005;23:2470-6 – This article highlights a useful framework for the consideration of introducing a vaccine into a population immunisation program.
2. Drysdale SB, Pollard AJ. Group B meningococcal vaccine science and policy. Journal of Infection 2015;71 (S1):S15-S20 – This article summarises very briefly evidence supporting the licensure of a meningococcal serogroup B vaccine and considerations for its use in a population program in the UK (note that the proposed schedule is different from what would be considered in our case study). References: 1. WHO. Principles and considerations for adding a vaccine to a national immunization programme: from decision to implementation and monitoring. WHO, Geneva: 2014. http://apps.who.int/iris/bitstream/10665/111548/1/9789241506892_eng.pdf – This is a document recently published by WHO to provide guidance to countries on making decisions about and planning for the introduction of a vaccine into a national immunisation programme. It draws from the experiences of many countries that have introduced new vaccines. This document takes into considerations the differing needs, settings and constraints of countries of with differing level of resources, in the context of overall improvement and protection of health globally.
2. Nolan TM. The Australian model of immunization advice and vaccine funding. Vaccine 2010;28S:A76-A83 – This article briefly describes the model of the decision process of introducing a new vaccine into the Australian National Immunisation Program, including the roles and activities of various key statutory advisory committees involved in this process.
3. Duclos P. National Immunization Technical Advisory Groups (NITAGs): Guidance for their establishment and strengthening. Vaccine 2010;28S:A18-A25 – This article highlights the nature, roles, potential values and functions of national immunisation technical advisory groups, especially their contributions in evidence-based decision-making process for immunisation policies and programs. – This same supplement issue of Vaccine, titled “The Role of National Advisory Committees in Supporting Evidence-Based Decision Making for National Immunisation Programs”, contains a number of related articles that would be of particularly interest around this topic area from the global perspective.
4. Pharmaceutical Benefits Advisory Committee. Public Summary Documents: a. Multicomponent Meningococcal Group B Vaccine, 0.5mL, injection, prefilled syringe, Bexsero® - November 2013. http://www.pbs.gov.au/info/industry/listing/elements/pbac- meetings/psd/2013-11/meningococcal-vaccine b. Multicomponent Meningococcal Group B Vaccine, injection, 0.5mL, Bexsero® - July 2015. http://www.pbs.gov.au/industry/listing/elements/pbac-meetings/psd/2015-07/files/mulit- component-meningococcal-group-b-vaccine-psd-july-2015.pdf – These 2 public documents summarised the key considerations undertaken by the Pharmaceutical Benefits Advisory Committee regarding introducing the multicomponent meningococcal B vaccine to the Australian National Immunisation Program, and the evidence and rationale that underpins its decision.
5. Oviedo-Orta E, Ahmed S, Rappuoli R, Black S. Prevention and control of meningococcal outbreaks: The emerging role of serogroup B meningococcal vaccines. Vaccine 2015;33:3628- 3635 – This review article provides some background information on the historical development and published global experience of population use of several strain-specific Meningococcal B vaccines, in particular the strain-specific MenB vaccines, for control of large community- based epidemics/outbreaks of invasive meningococcal disease due to serogroup B.