The development of an effective vaccine for COVID-19 has been a global public health challenge. The race continues to manufacture and distribute vaccines that are effective and safe, and readily available to billions of people.
On 16 February 2021, the Therapeutic Goods Administration (TGA) announced it had granted provisional approval to AstraZeneca Pty Ltd for its COVID-19 vaccine, ChAdOx1-S. This is the second COVID-19 vaccine to receive regulatory approval in Australia.
Provisional approval means that the vaccine has met the high standards of safety, effectiveness and quality required for use in Australia. This allows for temporary registration and inclusion in the Australian Register of Therapeutic Goods (ARTG) for up to two years with an option to extend provisional registration beyond this initial period.