TGA APPROVES ASTRAZENECA COVID-19 VACCINE

 The Therapeutic Goods Administration (TGA) has today approved the AstraZeneca COVID-19 vaccine for use in Australia following a full and thorough assessment process.

The vaccine has met the required standards for safety, quality and efficacy and will be provided free to Australians.

This means Australia now has two safe and effective COVID-19 vaccines available.

Initial supply into Australia will be imported

from overseas. In the coming months, the AstraZeneca vaccine will be manufactured in Australia. Australia is one of a small number of countries in the world that can manufacture its own COVID-19 vaccine.

The AstraZeneca COVID-19 vaccine is provisionally approved in Australia for active immunisation to prevent coronavirus disease 2019 (COVID-19), caused by SARS-CoV-2, in individuals 18 years of age and older.

Prime Minister Scott Morrison welcomed the announcement.

“The TGA has found the AstraZeneca COVID-19 vaccine to be safe and effective and I welcome their thorough assessment process,” the Prime Minister said. 

“Safety is our number one priority and our own medical experts have carefully made their assessments before giving approval of the vaccine.”

The TGA has reviewed all of the available evidence and determined that two doses of the AstraZeneca vaccine can be safely administered to an individual 4-12 weeks apart.

Drawing from the advice of the TGA and also from the implementation of the program internationally, the Australian Technical Advisory Group on Immunisation has determined that to create the very best immune response, ensure the most effective clinical protection and maximise broader community coverage, the two doses of the vaccine should be administered 12 weeks apart.

However, if this preferred interval is not possible, for example because of imminent travel, cancer chemotherapy, or major elective surgery, a minimum interval of 4 weeks between doses can be used.

The AstraZeneca vaccine can be handled and stored like most other vaccines. For a large country like Australia, this provides some distinct benefits in relation to distribution and storage, particularly in rural and remote areas, including Indigenous communities.

Today’s announcement follows a rigorous and independent assessment of the vaccine’s safety, quality and efficacy by the TGA. The approval is subject to certain strict conditions, such as the requirement for AstraZeneca to continue providing information to the TGA on the safety, efficacy and quality of the vaccine.

Minister for Health and Aged Care Greg Hunt said the AstraZeneca vaccine will help save lives and protect lives.

“Data from clinical trials tells us that the AstraZeneca vaccine will stop people becoming seriously unwell with COVID-19. This is – and must – be our first priority. It would be irresponsible of us to put anything ahead of this,” Minister Hunt said.

“The global evidence is of overwhelming protection against serious illness, hospitalisation and loss of life.”

Overnight the World Health Organization said, “This regimen was shown in clinical trials to be safe and effective in preventing symptomatic COVID-19, with no severe cases and no hospitalisations more than 14 days after the second dose.”

On the 3 February 2021 the Lancet Journal said, “COVID-19 Vaccine AstraZeneca confirms 100% protection against severe disease, hospitalisation and death in the primary analysis of Phase III trials.”

Minister Hunt said, “Importantly the TGA has conducted a full and thorough, and world class assessment process.”

“As the rollout begins, the people in priority groups who need the most protection will receive a vaccine first. This includes aged care and disability care residents and workers, frontline healthcare workers, and quarantine and border workers.”

The Australian Government has secured 53.8 million doses of the AstraZeneca vaccine, with 50 million doses being manufactured here in Australia.

Every safety and regulatory box has been ticked for provisional approval – and further ones will now be ticked in the lead up to March.

The Pfizer vaccine remains on track to be rolled out from 22 February 2021.

Further details are available at aus.gov.au