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COVID-19 vaccine: News and updates

16 April 2021

Read the latest COVID-19 vaccine news and other updates from the Therapeutic Goods Administration (TGA).

AstraZeneca ChAdOx1-S COVID-19 vaccine
16 April 2021
Third Australian case of thrombosis with thrombocytopenia likely linked to vaccine

TGA grants provisional determination to Glaxo SmithKline Australia Pty Ltd for COVID-19 monoclonal antibody treatment - SOTROVIMAB
14 April 2021
The granting of a provisional determination means that the TGA has made a decision that GSK is now eligible to apply for provisional registration for the treatment in the Australian Register of Therapeutic Goods (ARTG).

Batch release assessment of COVID-19 vaccines
14 April 2021
COVID-19 vaccine batch release information is now available

AstraZeneca ChAdOx1-S COVID-19 vaccine
13 April 2021
Second case of thrombosis with thrombocytopenia

AstraZeneca ChAdOx1-S COVID-19 vaccine
8 April 2021
Updated safety advisory - rare and unusual blood clotting syndrome (thrombosis with thrombocytopaenia)

Wider storage and transportation conditions for the Pfizer COVID-19 vaccine now approved
8 April 2021
TGA has recently approved wider storage and transportation conditions for the Pfizer COVID-19 vaccine in Australia

Specific clotting condition reported after COVID-19 vaccination
2 April 2021
Some rare cases of thrombosis associated with thrombocytopenia have been reported overseas following the administration of COVID-19 Vaccine AstraZeneca.

Statement by Acting Australian Government Chief Medical Officer, Professor Michael Kidd and Head of the Therapeutic Goods Administration Adjunct Professor John Skerritt
2 April 2021
Australia’s vaccine safety and regulatory process is world class and people can be confident that vaccines approved for use are safe and effective

COVID-19 vaccine weekly safety report - 31-03-2021
31 March 2021
Information about the TGA's safety monitoring of COVID-19 vaccines.

COVID-19 vaccine weekly safety report - 24-03-2021
24 March 2021
Information about the TGA's safety monitoring of COVID-19 vaccines.

Melbourne-made COVID-19 vaccine now available
23 March 2021
The Melbourne-manufactured AstraZeneca vaccine is now available for Australians, with the TGA this evening approving the release of the first four batches.

TGA approves CSL - Seqirus to manufacture AstraZeneca COVID-19 vaccine in Australia.
21 March 2021
TGA has approved manufacture of the AstraZeneca COVID-19 Vaccine (ChAdOx1-S) in Australia.

AstraZeneca ChAdOx1-S COVID-19 vaccine
19 March 2021
Update - European and UK reviews find no proven link with blood clots

AstraZeneca ChAdOx1-S COVID-19 vaccine
19 March 2021
Update - Expert review finds no evidence of increased risk of anaphylaxis

COVID-19 vaccine weekly safety report - 17-03-2021.
17 March 2021
Information about the TGA's safety monitoring of COVID-19 vaccines

Approval of updated storage conditions for the Pfizer COVID-19 vaccine
13 March 2021
A storage condition of 20±5°C for up to 2 weeks within the 6 month shelf life when stored at -90 to -60°C is now approved.

COVID-19 vaccine weekly safety report - 10-03-2021
10 March 2021
Information about the TGA's safety monitoring of COVID-19 vaccines.

COVID-19 vaccines - safety and effectiveness in older adults
10 March 2021
Data on real-world use of COVID-19 vaccines approved in Australia provides reassurance about their safety in older people.

TGA adopts Access Consortium guidance for fast-tracking authorisations of modified COVID-19 vaccines for variants
5 March 2021
Access Consortium guidance for strain changes to COVID-19 vaccines.

COVID-19 vaccine weekly safety report #1 - 03-03-2021
3 March 2021
Information about the TGA's safety monitoring of COVID-19 vaccines.

TGA collecting COVID-19 vaccine side effect reports
1 March 2021
The TGA will publish weekly updates on the number of COVID-19 vaccine adverse event reports received beginning Wednesday, 3 March 2021.

Advertising COVID-19 vaccines to the Australian public
22 February 2021
Important information on how to lawfully advertise COVID-19 vaccines in Australia.

TGA provisionally approves AstraZeneca's COVID-19 vaccine
16 February 2021
The TGA has granted provisional approval to AstraZeneca Pty Ltd for its COVID-19 vaccine, making it the second COVID-19 vaccine to receive regulatory approval in Australia.

COVID-19 vaccine safety monitoring and reporting
9 February 2021
Learn how the TGA continues to monitor the safety of vaccines after they are registered in Australia so that we can detect and respond to any safety concerns.

TGA one of only five non-European regulators invited to participate on European committees on COVID-19 vaccines and therapeutics
8 February 2021
Australia, through the TGA, is one of only five non-European Union regulators formally invited to participate by the European Medicines Agency (EMA).

Investigation reveals no specific risk of COVID-19 vaccinations in elderly patients
2 February 2021
The TGA has concluded that there is no specific risk of vaccination with the Pfizer-BioNTech COVID-19 vaccine in elderly patients.

TGA provisionally approves Pfizer COVID-19 vaccine
25 January 2021
The TGA has granted provisional approval to Pfizer Australia Pty Ltd for its COVID-19 vaccine, COMIRNATY, making it the first COVID-19 vaccine to receive regulatory approval in Australia.

ICMRA statement for healthcare professionals: How COVID-19 vaccines will be regulated for safety and effectiveness
22 January 2021
Healthcare professionals and public health authorities will have a central role in discussing vaccination against COVID-19 with their patients.

TGA grants additional provisional determination for a COVID-19 vaccine
20 January 2021
The TGA has granted a provisional determination to Biocelect Pty Ltd (on behalf of Novavax Inc.) in relation to the COVID-19 Vaccine, NVX-CoV2373.

Norwegian investigation of COVID-19 vaccination risks for elderly, very frail patients
17 January 2021
In recent days the TGA has received reports of about 30 deaths in over 40,000 elderly individuals in Norway vaccinated with the Pfizer BioNTech vaccine.

Access Consortium statement on COVID-19 vaccines evidence
4 December 2020
The medicine regulators from Australia, Canada, Singapore, Switzerland and the United Kingdom have discussed the regulatory evidence requirements for COVID-19 vaccine approvals and considerations for post-market pharmacovigilance.

TGA statement on UK government emergency use authorisation related to the COVID-19 vaccine BNT162b2 supplied by Pfizer and BioNTech
2 December 2020
The TGA notes the emergency use authorisation related to the COVID-19 vaccine BNT162b2 supplied by Pfizer and BioNTech.

COVID-19 vaccines undergoing evaluation
2 December 2020
The TGA has received applications and is assessing preliminary data for three COVID-19 vaccines using the provisional pathway and rolling review procedures.

COVID-19 vaccine provisional determinations
18 November 2020
The TGA has granted a number of provisional determinations in relation to COVID-19 vaccines.

TGA grants third provisional determination for a COVID-19 vaccine
18 November 2020
On 16 November 2020 the TGA granted a provisional determination to Janssen in relation to its COVID-19 vaccine, Ad26.COV2.S.

TGA grants second provisional determination for a COVID-19 vaccine
14 October 2020
The TGA has granted a provisional determination to Pfizer Australia Pty Ltd in relation to its COVID-19 Vaccine, BNT162b2 [mRNA].

TGA grants provisional determination for COVID-19 vaccine
9 October 2020
The TGA has granted a provisional determination to AstraZeneca Pty Ltd in relation to its COVID-19 Vaccine, ChAd0x1-S [recombinant].