Australia gives provisional approval to Pfizer Covid-19 vaccine

Sydney, Jan 25:  Australia’s medical regulator granted provisional approval to Pfizer’s Covid-19 vaccine, making it the first Covid vaccine to receive regulatory approval in Australia.

The first doses of the vaccine are expected to be administered in late February.

“The TGA (Therapeutic Goods Administration) has today provisionally approved the Pfizer/BioNTech #COVID19 vaccine for use in Australia. This is an important step in our fight against this terrible virus,” Prime Minister Scott Morrison tweeted.

The TGA provisional approval is for individuals 16 years of age and older.

Provisional approval of this vaccine is valid for two years and means it can now be legally supplied in Australia.

The approval is subject to certain strict conditions, such as the requirement for Pfizer to continue providing information to the TGA on longer term efficacy and safety from ongoing clinical trials and post-market assessment.

The vaccine has been shown to prevent Covid-19 however it is not yet known whether it prevents transmission or asymptomatic disease, the TGA said in a statement.

“Australians should take confidence in the thorough and careful approach taken by our world-class safety regulator,” Morrison said in a statement.

“Our priority has always been to keep Australians safe and protect lives and livelihoods. Today’s approval is another big step forward for our community, particularly in the protection of our most vulnerable people.”

In Australia the vaccine will be rolled out in five phases over the coming months and, over time, will involve more than 1,000 vaccination administration sites.