The Therapeutic Goods Administration (TGA) carries out research on all vaccines in Australia.
In Australia, vaccines and other prescription medicines are regulated by the Therapeutic Goods Administration (TGA) in accordance with the provisions of the Therapeutic Goods Act 1989 (the Act). It is a requirement of the Act that therapeutic products imported into, supplied in, or exported from Australia be included in the Australian Register of Therapeutic Goods (ARTG).
In order for a vaccine to be included in the ARTG, a sponsoring company is required to make an application which consists of data to support the quality, safety and efficacy of the product for its intended use, and which is then subject to rigorous evaluation by the TGA. TGA's data requirements are largely based on those applying in the European Union, supplemented by Australia-specific requirements where necessary. Extensive guidance is available to assist with the interpretation of the requirements, including documents relating specifically to the registration of vaccines.
The quality control aspects of an application cover the batch production processes to ensure that the medicine is produced to a consistent standard as defined by the product specification. This quality specification places controls on the purity and potency of the medicine as well as on other aspects necessary to ensure the efficacy of the product.
Recognising the important role of vaccines for public health, the pre-market quality review of vaccine submissions is supplemented by a batch release program operated by TGA in accordance with recommendations of the World Health Organization. Through this program, production and quality control data for each batch of a vaccine are assessed prior to it being supplied in Australia. The TGA also operates a batch testing program for the most widely used vaccines, including influenza vaccines, in which aspects such as the potency and sterility of the vaccine are checked.
The pre-clinical data supplied to TGA for assessment include studies designed to assess the toxicological profile of the medicine. These studies commonly include data on the safety of the product when tested in animals.
The third component of an application to include a vaccine, or other prescription medicine, in the ARTG is the submission of clinical data. This part of a submission consists of clinical trial data in humans. These data are used to support both the safety and efficacy of the product for the indications proposed by the product sponsor. The clinical data requirements vary with different products and different types of submission. In general, well-designed trials conducted in a sufficient number of subjects representing the target population and of a sufficient duration are usually required in order to demonstrate the efficacy and safety of the product for the proposed indication. The clinical evaluators assess the balance of benefits and risks based on the submitted clinical trial data and then recommend approval or rejection of the application based on that overall assessment. Each medicine and vaccine carries the risk of adverse effects in some people; the key issue in the regulatory decision is to determine that the overall balance of risks and benefits is positive in the population in whom the product is intended to be used.
As part of the evaluation process, the TGA delegate will refer an application or a new chemical entity (NCE) or major extension of indication to the Advisory Committee on Prescription Medicines (ACPM). The ACPM is a statutory committee whose members are appointed by the Minister. The Committee meets every two months and considers applications referred to it by TGA delegates, providing advice on a range of issues, but with particular emphasis on NCEs and extension of indications for already marketed prescription products.
Since April 2009, the TGA has required sponsors to submit a formal risk management plan (RMP) with each application for registration or extension of indication of a new medicine or vaccine. RMPs are intended to set out those activities and interventions that will be undertaken to identify, characterise and mitigate known or anticipated risks relating to a new medicine or vaccine, recognising that premarketing trials cannot prospectively identify all safety issues.
The decision-maker with respect to an application for marketing approval is a delegate of the Secretary of the Department of Health and Ageing, within the TGA. The delegate takes into account (but is not bound by) the views of the ACPM before making a decision to approve or reject a product. Approvals may be subject to conditions such as restrictions on the use of a product to certain patient groups, or compliance with an agreed RMP. The Product Information and the Consumer Medicines Information are made available on the TGA website to assist health professionals and consumers to better understand the benefits and risks of medicines.
http://www.tga.gov.au/safety/alerts-medicine-seasonal-flu-101008.htmI was going to dig out my daughter's baby book to see what 'more and more and more' has been added in the nearly 20 years since she was first immunised, but just taking a quick glance at the list of the definition of fully immunised, off the top of my head I can only spot one that has been added in that time (Hep B).
http://immunise.health.gov.au/internet/immunise/publishing.nsf/Content/faq-related-payments#exemptionsThere's exemptions for children that are on medication that could cause side-effects for the vaccines, as well as for parents who have a 'conscientious objection' to immunising their children. The former category would apply only for a small percentage of children, and as far as I'm concerned when it comes to the latter, if parents just don't want their little precious immunised and they would have been eligible for FTB Part A, then they should be given the choice of not wanting the benefit along with not wanting their kids immunised.
http://www.ato.gov.au/individuals/content.aspx?menuid=0&doc=/content/00174278.htm&page=7I don't know or particularly care how it all works in the US, but that's how it works here. If any parent were to trot out the 'I don't trust the government blah blah' line, I'd point out to them that if they don't trust the government they should prove that lack of trust by refusing to receive all government benefits as well...