AstraZeneca’s COVID-19 vaccine has been granted emergency use listing (EUL) by the World Health Organization (WHO) and provisional approval by Australia’s Therapeutic Goods Administration (TGA), the national pharmaceutical regulatory agency in Australia, in individuals 18 years of age and older.

The EUL from WHO allows for two doses of the vaccine to be administered at a four- to 12-week interval. This regimen was shown in clinical trials to be safe and effective in preventing symptomatic COVID-19, with no severe cases and no hospitalizations more than 14 days after the second dose. The WHO’s Strategic Advisory Group of Experts on Immunization recommended a dosing interval of eight to 12 weeks. In addition, they also recommended use of the vaccine in countries where new variants, including the South African variant, are prevalent.

AstraZeneca and the Serum Institute of India will work with the COVAX facility, a global initiative aimed at equitable access to COVID-19 vaccines, to begin supplying the vaccine globally, with the majority going to low- and middle-income countries. In the first half of 2021, the companies say they hope that more than 300 million doses of the vaccine will be made available to 145 countries through COVAX, pending supply and operational challenges.

Provisional approval in Australia and supply update

In Australia, AstraZeneca’s COVID-19 vaccine was provisionally approved and included in the Australian Register of Therapeutic Goods for the active immunization of individuals 18 years and older for the prevention of COVID-19 caused by SARS-CoV-2. The approval is subject to certain conditions, such as the requirement for AstraZeneca to continue providing information to the TGA on longer-term efficacy and safety from ongoing clinical trials and post-market assessment.

Initial supply of the vaccine will be imported into Australia from overseas; however, it is anticipated that ongoing supply will be manufactured in Australia. Prior to the supply of the vaccine manufactured onshore, AstraZeneca will submit further information and data to the TGA to confirm that onshore manufacturing will meet strict quality standards.

The Australian pharmaceutical company, CSL, and a manufacturing partner for the vaccine, has confirmed that the final stages of manufacturing of the vaccine for Australia are planned to begin later in February (as reported on February 12, 2021), with the first doses on track for release toward the end of March (March 2021), subject to approval by the TGA.

Also, later in February (February 2021), the final manufacturing phase will commence at CSL’s Seqirus facility in Parkville, Victoria, Australia. The vaccine is formulated to a precise concentration, before being repeatedly filtered and filled into vials ahead of labelling and packing. At the same time, each batch of finished vaccine will undergo a quality check process by CSL, AstraZeneca, and the TGA.

CSL says fill–finish at the Seqirus facility will continue to run with expected release of two million doses at the end of March (March 2021), and then one million doses per week thereafter.

Source: World Health Organization, AstraZeneca, CSL, and Australia’s Therapeutic Goods Administration