Seqirus (Australia) Pty Ltd is the primary manufacturer licensed by the Australian Government pursuant to the Therapeutic Goods Act 1989 to manufacture vaccines for human use. The licence requires the manufacturer to comply with the principles of Good Manufacturing Practice.
Vaccine products must be entered in the Australian Register of Therapeutic Goods (ARTG) prior to supply of the products for human use. The ARTG identifies the following vaccines as being manufactured by Seqirus (Australia) (not all of these vaccines were necessarily manufactured in 2021):
Influenza Vaccine
Q fever Vaccine
Note: In regard to Section 3, General Description of the Types of Diseases Covered, Seqirus (Australia) Pty Ltd sponsors a wide range of bacterial vaccines and viral vaccines that are manufactured overseas and imported into Australia for supply in Australia.
There are other manufacturers in Australia with a GMP licence issued by the TGA to produce biological goods – this category includes, but is not limited to, vaccines. The list of these facilities may be accessed from the TGA on-line services home page at www.tga.gov.au and by selecting the links to “Industry”, “Manufacturing therapeutic goods” followed by the Quick Link to “eBusiness Services” and then “Australian Manufacturers”.
A search of “Australian Manufacturers” identifies the following manufacturers licensed to manufacture vaccines for human use (additional to Seqirus (Australia) Pty Ltd):
- GlaxoSmithKline Australia Pty Ltd, 1061 Mountain Highway Boronia VIC has been issued with a licence (MI-15082005-LI-000773-2) that authorises the manufacture of Rotarix vaccine for pooling, filling, packaging and labelling of final bulk batches manufactured by GlaxoSmithKline Biologicals S.A Belgium.
GlaxoSmithKline Australia Pty Ltd is also listed on the ARTG as a sponsor of vaccines (i.e. responsible for the commercial supply).