Medicines

Revised: 18 October 2018

Influenza Vaccine Composition

The recommended influenza vaccine composition for New Zealand in 2019 is:

Trivalent vaccines:

Quadrivalent vaccines:

Vaccine strains that are recommended as suitable are those listed on the World Health Organization (WHO) Influenza vaccine viruses and reagents web pages (see http://www.who.int/influenza/vaccines/virus/candidates_reagents/2019_south/en/) for H1N1, H3N2 and B viruses.

The recommended composition is based on the outcome of:

Stage 1: A CMN (Form B - Labelling Grade 2) to update labelling and literature. This CMN must include a commitment to not distribute affected product until a relevant CMN (see Stage 2 below) to update the formulation has been consented.

Sponsors wanting to introduce seasonal composition updates for registered influenza vaccines are encouraged to notify the associated changes in two discrete stages:

Stage 2: A CMN (Form B - Formulation Grade 2) for approval of the updated formulation. This CMN to update the vaccine formulation (with regards to virus strains) should include the following:

Further guidance regarding the information requirements referred to in the above points can be found in EMA/CHMP/BWP/310834/2012 Guideline on Influenza Vaccines – Quality Module (see https://www.ema.europa.eu/documents/scientific-guideline/guideline-influenza-vaccines-quality-module_en.pdf).