It comes after the CSL-manufactured vaccine was approved for use on Sunday,and follows the approval of AstraZeneca’s European-made vaccines on February 16.
“The TGA’s clearance of the vaccine for local manufacture is a major step in Australia’s response to the COVID-19 pandemic,” the regulator said in a statement.
“We will now be able to provide secure access to large numbers of doses of a domestically produced vaccine,with the Australian government having procured 50 million doses for delivery in the coming months.”
The TGA has to approve each batch of vaccines before they can be distributed,including the Pfizer vaccine being rolled out in aged care facilities across the country.
“TGA testing of the vaccine batches in our Canberra laboratories plus review of extensive manufacturing documentation,has ensured that the locally manufactured vaccine has exactly the same composition and performance as the overseas-manufactured vaccine,the same quality,and is free of contaminants,” the TGA said.
“All subsequent batches of the Melbourne-manufactured vaccine completed in the coming weeks and months will go through the same individual batch testing and release process by the TGA.”