TGA approves AstraZeneca COVID-19 vaccine for use in Australia

Pharma News: COVID-19 Vaccine AstraZeneca (previously known as AZD1222) has been granted provisional approval in Australia by the Therapeutic Goods Administration (TGA) for active immunisation of individuals ≥18 years old for the prevention of coronavirus disease 2019 (COVID-19).

This approval marks an important milestone in AstraZeneca’s worldwide efforts against COVID-19, and its commitment to provide broad and equitable access globally, at no profit during the pandemic.

Liz Chatwin, Country President AstraZeneca Australia & New Zealand, said “Today is a momentous day that brings months of hard work and collaboration between government, AstraZeneca and scientific experts on vaccination to fruition for the people of Australia.

“We are very proud that, through our partnership with University of Oxford, AstraZeneca is able to provide broad and equitable access to its COVID-19 vaccine at no profit during the pandemic, and that through the agreements made with the Australian Government and manufacturing partner CSL, we can make this vaccine available for use in Australia throughout the year.”

AstraZeneca has an agreement with the Australian Government to supply 53.8 million doses of the vaccine, with the bulk of this manufactured at CSL’s Melbourne facilities. Initial supply from overseas will be available for administration in Australia as swiftly as possible, in line with the government’s strategy.

“We anticipate Australian made doses will be available from late March,” confirmed Ms Chatwin.

The approval decision was based on a submission which included results of an interim analysis of the Phase III programme conducted by the University of Oxford and published in The Lancet on 8 December 2020. The vaccine is approved as a regimen of two standard doses given between four and 12 weeks apart.

“These trials showed our vaccine was 100% effective in preventing severe disease, hospitalisations and deaths. In terms of safety in clinical trials, there were no serious events related to the vaccine,” added Ms Chatwin.

On the role of the vaccine to reduce or cease the transmission of the virus, Ms Chatwin said “We have some encouraging data showing that the AstraZeneca vaccine may have an impact on transmission but that’s about all I can say at the moment. We need to remember that we’re in a global pandemic. At the heart of the government’s vaccination strategy is to prevent severe disease, hospitalisations and deaths because these have a significant impact on our healthcare system.”

Consumer education is imperative for a high uptake of the COVID-19 vaccine. Ms Chatwin said” The Australian Government is responsible for the rollout and implementation of the vaccination strategy and they’ve already begun some excellent education campaigns to support public confidence in the vaccine.

“The number one message to consumers today is that the TGA is a world class regulatory agency and it has concluded – after a rigorous, thorough and independent review – that the AstraZeneca vaccine meets the highest safety, efficacy and quality standards for use in Australia.

“We are in a global pandemic. There is overwhelming public health advice that as many people should be vaccinated as possible to prevent the serious consequences of COVID-19 that is severe disease, hospitalisations and deaths,” she added.

In addition to the University of Oxford-led programme, AstraZeneca is conducting large Phase III clinical trials in the US and other countries as part of a global programme. In total, the University of Oxford and AstraZeneca expect to enrol more than 60,000 participants in clinical trials worldwide. Additional safety and efficacy data will continue to accumulate from ongoing clinical trials, and will be shared with TGA as well as other regulators around the world.

The vaccine can be stored, transported and handled at normal refrigerated conditions (two -eight degrees Celsius) for up to six months.

AstraZeneca continues to work closely with regulatory authorities around the world as part of ongoing rolling reviews of the vaccine data, to secure temporary use or conditional / provisional approval during this health crisis. Overnight, the World Health Organisation has granted Emergency Use Listing for the AstraZeneca vaccine, for an accelerated pathway to vaccine availability including low-to-middle-income countries. AstraZeneca continues to engage with governments and collaborators around the world to ensure broad and equitable access to the vaccine at no profit for the duration of the pandemic.