The Influenza Vaccine Formulation process:
In February (for the NH) and September (for SH) WHO convenes a consultation involving the five major influenza centres (one here in Australia), three major regulatory authorities (including Australia’s TGA) and other experts, to review all of the available information on influenza, epidemiological, antigenic and genetic at that time and to recommend the most appropriate formulation for the coming season’s vaccine. This often results in at least one of the three component strains being updated since the previous six monthly meeting.
Shortly after the WHO recommendations regarding vaccine formulation are made (2017 SH published at: http://www.who.int/influenza/vaccines/virus/recommendations/2017_south/en/) regional or national committees are convened to ratify the recommendation as relevant to their jurisdiction (the Australian Influenza Vaccine Committee met on 13th October 2016, (last year's decision at: https://www.tga.gov.au/aivc-recommendations-composition-influenza-vaccine-australia-2017) and to then extend the recommendation, which is made based on analysis of laboratory reference strains, into one that selects actual viruses that have been derived in a way acceptable to regulatory agencies (ie viruses with a ‘clean’ pedigree and the antigenic characteristic of the reference strains). Requirements for laboratory reference reagents necessary for vaccine standardisation and quality control are also set at that time. Where new strains are incorporated into the formulation it is necessary to then improve their growth characteristics, in an approved laboratory, so that they will meet manufacturers’ requirements and for regulatory authorities to prepare the reference reagents. Once they receive the strains the manufacturers then need to fine-tune their production processes to reach adequate yields – different viruses can have different growth characteristics and processing requirements. These are all time-consuming activities, particularly when the formulation involves two new strains.
Influenza Vaccine Composition 2017 - Southern Hemisphere/Australia
The formulation of influenza vaccines for use in Australia is determined each year by the Australian Influenza Vaccine Committee (AIVC) based on information and recommendations from the World Health Organization (WHO). A meeting of the AIVC was held on 8 October 2015 where the expert committee reviewed and evaluated data related to epidemiology, antigenic and genetic characteristics of recent influenza isolates circulating in Australia and the Southern Hemisphere, serological responses to 2014-2015 vaccines, and the availability of candidate vaccines viruses and reagents. The committee recommended that the TGA should adopt the September WHO recommendations; the trivalent influenza vaccine components for the Australian 2016 influenza season should contain the following:
The influenza vaccine for the Australian 2017 influenza season contains the following three virus strains:
- A (H1N1): an A/Michigan/45/2015 (H1N1)pdm09 like virus
- A (H3N2): an A/Hong Kong/4801/2014 (H3N2) like virus*
- B: a B/Brisbane/60/2008 like virus
Quadrivalent vaccines should contain viruses listed above, plus the additional B virus:
- B/Phuket/3073/2013 like virus.
1. WHO 2017 Southern Hemisphere recommendation
2. Therapeutic Good Administration (TGA), Australian Influenza Vaccine Committee (AIVC) recommendations for influenza vaccine composition in 2017: TGA / AIVC Recommendations
Last updated: 27 October 2016