Revised: 17 October 2019

Medicines

Influenza Vaccine Composition

The recommended influenza vaccine composition for New Zealand in 2020 is:

Trivalent vaccines:

  • A/Brisbane/02/2018 (H1N1)pdm09-like virus;
  • A/South Australia/34/2019 (H3N2)-like virus; and
  • B/Washington/02/2019-like (B/Victoria lineage) virus.

Quadrivalent vaccines:

  • A/Brisbane/02/2018 (H1N1)pdm09-like virus;
  • A/South Australia/34/2019 (H3N2)-like virus;
  • B/Washington/02/2019-like (B/Victoria lineage) virus; and
  • B/Phuket/3073/2013-like (B/Yamagata lineage) virus.

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/2020_south/en/) for H1N1, H3N2 and B viruses.

The recommended composition is based on the outcome of:

  • the meeting of the Australian Influenza Vaccine Committee, with a New Zealand representative, to consult on the influenza vaccine composition for 2020 (held on 9 October 2019)
  • information on international surveillance by the WHO Global Influenza Surveillance and Response System
  • analysis of recent data on epidemiology and strain characterisation
  • the recommendations of the WHO annual consultation on the composition of the 2020 influenza vaccine for the Southern Hemisphere.

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:

  • Summarised quality control information for Master and Working Seed Lots proposed for use in the forthcoming campaign, including strain history, and results from testing for sterility, mycoplasma, identity of haemagglutinin and neuraminidase, and egg infectivity. If results from genetic analysis are not available, an estimated date for the provision of this data should be provided.
  • An assessment of the risks of contamination of the product with extraneous agents, updated as relevant with regards to new or emerging viruses potentially present in materials or clinical isolates used to generate the new seeds.
  • Batch analysis data (including verification of HA and NA, and validation of splitting/solubilisation (as relevant) and inactivation) for three monovalent pooled harvest batches made at commercial scale using the proposed seeds. Data should be compared to relevant compendial monograph requirements. Particle size analysis for new strains should be provided for information purposes.
  • Qualification of SRD testing of HA content in drug substance and drug product using defined standard antigens and antisera. Demonstration of specificity of B-strain reagents should include evidence for a lack of cross-reactivity between the B-strain viruses from the quadrivalent product.
  • Stability data from testing of drug substances and drug product in recent years to support the proposed shelf life for the forthcoming campaign, along with a protocol to monitor stability of drug substances and drug product from the forthcoming campaign. Any stability data obtained to date from the forthcoming campaign, and a commitment to inform Medsafe of OOS results or aberrant trends that may arise, should also be provided.
  • Confirmation that the product is in full compliance with a relevant Ph. Eur. monograph for influenza vaccine (specify which monograph).
  • Data from release testing of three batches of SH finished product from the forthcoming season, or a commitment to forward this as soon as available.
  • Commitment to forward Certificates of Analysis for the first three vaccine lots intended for the New Zealand market in the forthcoming season prior to their distribution.

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-revision-1_en.pdf).

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