FluMist Quadrivalent gains tentative approval

Intranasal flu vaccines. Source: US Air Force/Shen-Chia Chu

TGA approves registration of nasal spray which it says could boost uptake of influenza vaccine

While AstraZeneca’s FluMist Quadrivalent influenza virus vaccine nasal spray applicator has been registered on the ARTG since 18 October last year, the medicine has been beset with doubts about its effectiveness—especially compared to the injection.

In fact, in July 2016 AstraZeneca confirmed the Centers for Disease Control and Prevention (CDC) had provided its interim recommendation that the FluMist Quadrivalent Live Attenuated Influenza Vaccine was not to be used in the US for the 2016-17 season.

Data from the 2013 to 2014 season indicated there was an issue with the effectiveness of the H1N1 strain for FluMist Quadrivalent in the US, although data from Canada indicated the vaccine was effective and data from the UK also suggested it had a positive impact on the immunisation program that year.

In Australia, following a review of the intranasal spray’s quality, safety and efficacy—the findings of which were published in an Australian Public Assessment Report released this week—the TGA has approved the registration of FluMist Quadrivalent for the prevention of influenza in children and adolescents from 24 months to less than 18 years of age.

Supply of the prescription-only spray in Australia is still not permitted until the following conditions are met by the sponsor:

  • Implementation of the FluMist Quadrivalent influenza virus vaccine nasal spray Risk Management Plan (RMP). This includes a commitment to report on annual vaccine effectiveness studies.
  • Batch release testing by the TGA: It is a condition of registration that all independent batches of Flumist Quadrivalent (Q/LAIV) imported into Australia are not released into the Australian market for sale until samples and/or the manufacturer’s release data have been assessed and endorsed for release by the TGA.
  • Potency FFA assay development: The requested samples and reagents should be provided to facilitate assay development at least 12 months prior to the receipt of any consignments of the vaccine.
  • Development of an assay control for the FFA: During the evaluation phase, the sponsor was asked to develop a FFA assay control in collaboration with the TGA. The Sponsor should submit a work plan, review availability and nominate material for the development of such a standard in collaboration with the TGA at least 12 months prior to the supply of the vaccine in Australia.

According to the TGA review, the evaluator concluded that the non-clinical data provided were satisfactory and that there were no non-clinical objections to registration.

In the paediatric population, FluMist demonstrated a high degree of absolute efficacy (that is, reduction in culture-confirmed influenza cases compared to background rates) in seven placebo controlled studies.

The safety and immunogenicity of FluMist Quadrivalent were supported by data from one pivotal paediatric (2 to 17 years of age) study and one pivotal adult (18 to 49 years of age) study.

“The worldwide cumulative exposure (including FluMist and FluMist Quadrivalent) is estimated to be greater than 98 million doses since the first approval. The sponsor states that the safety profile is consistent with the current labelling, with no unexpected safety signals emerging,” said the TGA.

“As FluMist Quadrivalent does not require an injection, it is likely to be more acceptable to patients with the potential for uptake by patient groups who have not previously received an influenza vaccine and those outside the age range specified in the vaccine indications.”

Read the full TGA report here

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