Provisional Approval
Following a thorough and independent review of Pfizer’s submission, the TGA has decided that this vaccine meets the high safety, efficacy and quality standards required for use in Australia.
COMIRNATY is provisionally approved and included in the Australian Register of Therapeutic Goods (ARTG) for active immunization to prevent coronavirus disease 2019 (COVID-19), caused by SARS-CoV-2, in 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. COMIRNATY has been shown to prevent COVID-19, however, it is not yet known whether it prevents transmission or asymptomatic disease.
Australians can be confident that the TGA’s review process of this vaccine was rigorous and of the highest standard.
The decision to provisionally approve the vaccine was also informed by expert advice from the Advisory Committee on Vaccines (ACV), an independent committee with expertise in scientific, medical and clinical fields including consumer representation.
The TGA will continue to actively monitor the safety of the Pfizer vaccine both in Australia and overseas and will not hesitate to take action if safety concerns are identified. As an extra check, the TGA laboratories will undertake a batch assessment of each batch of the vaccine before it can be supplied in Australia.
The TGA has published a series of regulatory documents that relate to this decision, including the Australian Public Assessment Report (AusPAR) and the decision summary, which provide details about the evidence that the TGA reviewed to support the provisional approval of the vaccine. The Product Information, FAQs, and information on labelling and batch testing are also available on the COVID-19 vaccines hub.
Further information on the COVID-19 vaccine rollout is available on the Department of Health website
Rollout details
Health Minister Greg Hunt said the rollout would start with 80,000 jabs per week, “if not more”.
The Government was expecting to be briefed by Pfizer on supply beyond March in mid-February.
Health Department Secretary Brendan Murphy said Australia faced “major logistics issues” vaccinating the entire Australian population.
The Pfizer vaccine needs to be stored at minus-70 degrees Celsius.
Dr Murphy added, that while the vaccine was approved for people aged 16 and above, “a cautious clinical decision” will need to be made about whether it will be given to those who are old and frail.
“The risks versus the benefits of the vaccination need to be considered,” he said.
Norway reported some deaths among very old recipients of the vaccine last week.
The vaccine was designed to reduce the negative health impacts of COVID-19, but Dr Murphy warned that it was not clear yet whether the vaccine would reduce transmission rates.
“We don’t yet know how effective they are at preventing the transmission of the virus,” he said, though noted it “stands to reason” that vaccines will also reduce the spread.
WE CAN HELP YOU
If you are thinking of staying longer, a better option would be a student visa. As currently, most of our schools are offering discounts, special instalment plans, or other forms of help.
At Go Study, we have expert counselors able to support you step by step and guide you through this delicate journey. Before you make any decision, which may affect your current visa or situation. Please contact us and seek advice, our support is free of charge!
WHAT DOES THIS MEAN FOR INTERNATIONAL STUDENTS IN AUSTRALIA
The good news is, most people on temporary visas inside Australia will get the vaccine for free.
It’s also the first step to a reopening of the borders so international students and working holidaymakers can re-enter Australia. As yet, there is no timeline set out by the Australian Government – but Go Study expects that as vaccines get administered globally, policy changes will move quickly. We see this as the first vital stage needed to begin considering how to safely let students come back to study in Australia.
What we do know is that the first students to be allowed back into Australia will be those who are returning students or who have a confirmation of enrollment. If you are looking to study in Australia, contact us as Go Study, so we can get your application started and secure you a Confirmation of Enrollment (COE) which will help you get priority consideration for entry into Australia.
