Vaccine efficacy claim guidelines

Background

Submissions are invited from those interested in new guidance for efficacy claims for immunobiological products. All claims for the efficacy of immunobiologicals should be fully supported by data from laboratory trials and field studies. However, until now the structure, standard text and wording of such efficacy claims has not been published. The new guidance aims to provide clear and consistent advice on the intention of use of the immunobiological in a standard format.

Consultation information

The APVMA is seeking feedback in relation to guidance for efficacy claims for immunobiological products. This is new guidance based on the European approach for describing the claims for immunobiological products. The claim(s) of the product is included on the label based on standard text, including the onset and duration of immunity using the data generated in the pen/laboratory and field trials.

Making a submission

The consultation period is open until close of business on 28 February 2020.

Note that all submissions received are subject to legislation, including the Freedom of Information Act 1982, the Privacy Act 1988 and the Agvet Codes. In providing your submission to the APVMA, you agree to the APVMA publicly disclosing your submission in whole or summary form.

Electronic submissions are preferred, and may be sent to:

Registration Management
Martin.Ilott@apvma.gov.au
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001