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COVID-19 vaccine: News and updates

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

COVID-19 vaccine weekly safety report - 23-09-2021
23 September 2021
Information about the TGA's safety monitoring of COVID-19 vaccines.

COVID-19 vaccine weekly safety report - 16-09-2021
16 September 2021
Information about the TGA's safety monitoring of COVID-19 vaccines.

TGA's lawyers allege UAP breach of copyright and demand distribution of alleged misleading adverse event reports stop
15 September 2021
Lawyers for the TGA have written to United Australia Party leader, Mr Craig Kelly MP, alleging it has breached copyright and demanding that it stop distributing incomplete extracts of adverse event reports relating to COVID-19 vaccines which the TGA believes could be seriously misleading.

COVID-19 vaccine weekly safety report - 09-09-2021
9 September 2021
Information about the TGA's safety monitoring of COVID-19 vaccines.

TGA Provisional Approval of Moderna COVID-19 vaccine to include 12-17 years age group
4 September 2021
The TGA has granted provisional approval to Moderna Australia Pty Ltd in relation to the COVID-19 vaccine, Spikevax (elasomeran), for individuals aged 12 years and over.

COVID-19 vaccine weekly safety report - 02-09-2021
2 September 2021
Information about the TGA's safety monitoring of COVID-19 vaccines.

COVID-19 vaccine weekly safety report - 26-08-2021
26 August 2021
Information about the TGA's safety monitoring of COVID-19 vaccines.

COVID-19 vaccine weekly safety report - 19-08-2021
19 August 2021
Information about the TGA's safety monitoring of COVID-19 vaccines.

TGA batch release of Pfizer vaccine purchased from the Government of Poland
16 August 2021
The TGA has today approved for release doses of the Pfizer/BioNTech vaccine that arrived in Australia late last night from the Republic of Poland.

COVID-19 vaccine weekly safety report - 12-08-2021
12 August 2021
Information about the TGA's safety monitoring of COVID-19 vaccines.

Batch release assessment of COVID-19 vaccines
12 August 2021
Information about the batch release assessment process for COVID-19 vaccines

TGA grants provisional determination to Merck Sharp & Dohme's antiviral COVID-19 treatment Molnupiravir
10 August 2021
On 9 August 2021 the TGA granted provisional determination to Merck Sharp & Dohme (Australia) Pty Ltd (MSD) in relation to Molnupiravir.

COVID-19 vaccine weekly safety report - 05-08-2021
5 August 2021
Information about the TGA's safety monitoring of COVID-19 vaccines.

COVID-19 vaccine weekly safety report - 29-07-2021
29 July 2021
Information about the TGA's safety monitoring of COVID-19 vaccines.

Canberra individual fined $2,664 for alleged unlawful advertising of a homoeopathic medicine in relation to COVID-19
23 July 2021
The TGA has issued an infringement notice for $2,664 to an individual from Canberra, for a breach of the Therapeutic Goods Act 1989 in relation to the alleged unlawful advertising of a homoeopathic medicine with COVID-19 claims.

TGA Provisional Approval of Pfizer-BioNTech COVID-19 vaccine to include 12-15 years age group
23 July 2021
The TGA has provisionally approved the use of the Pfizer BNT162b2 COVID-19 vaccine (COMIRNATY) in individuals 12 years and older.

COVID-19 vaccine weekly safety report - 22-07-2021
22 July 2021
Information about the TGA's safety monitoring of COVID-19 vaccines.

COVID-19 vaccine weekly safety report - 15-07-2021
15 July 2021
Information about the TGA's safety monitoring of COVID-19 vaccines

Communicating about COVID-19 vaccines
9 July 2021
Guidance that explains how any party can lawfully provide communications about COVID-19 vaccines to support the Government's COVID-19 vaccine roll-out.

Therapeutic Goods (Restricted Representations - COVID-19 Vaccines) Permission (No. 2) 2021
9 July 2021
This instrument is made under section 42DK of the Therapeutic Goods Act 1989.

COVID-19 vaccine weekly safety report - 8-07-2021
8 July 2021
Information about the TGA's safety monitoring of COVID-19 vaccines

COVID-19 vaccines undergoing evaluation
6 July 2021
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: Information for consumers and health professionals
6 July 2021
Answers to the common types of questions you may have about how the TGA assesses and monitors a vaccine for safety, quality and effectiveness.

COVID-19 vaccine approval process
6 July 2021
An overview of the vaccine approval process using the provisional approval pathway, which is the pathway being used by pharmaceutical companies to date.

COVID-19 vaccine weekly safety report - 1-07-2021
1 July 2021
Information about the TGA's safety monitoring of COVID-19 vaccines

TGA grants third provisional approval to COVID-19 vaccine: Janssen
25 June 2021
On 25 June 2021 the TGA granted provisional approval to Janssen-Cilag Pty Ltd (known as Johnson & Johnson overseas) for its COVID-19 vaccine Janssen, making it the third COVID-19 vaccine to receive regulatory approval in Australia.

COVID-19 vaccine: Janssen
25 June 2021
The TGA granted provisional approval to Janssen-Cilag Pty Ltd (known as Johnson & Johnson overseas) for its COVID-19 vaccine Janssen, making it the third COVID-19 vaccine to receive regulatory approval in Australia.

COVID-19 vaccine: Provisional registrations
25 June 2021
COVID-19 vaccines that have been provisionally approved for use in Australia.

TGA grants provisional determination for the Moderna COVID-19 vaccine, Elasomeran
24 June 2021
The TGA, part of the Department of Health, has granted provisional determination to Moderna Australia Pty Ltd in relation to the COVID-19 Vaccine, Elasomeran

COVID-19 vaccine weekly safety report - 24-06-2021
24 June 2021
Information about the TGA's safety monitoring of COVID-19 vaccines

Promotion of COVID-19 vaccinations: further information for healthcare practitioners and other advertisers
17 June 2021
Interaction between TGA and AHPRA advertising guidelines

COVID-19 vaccine weekly safety report - 17-06-2021
17 June 2021
Information about the TGA's safety monitoring of COVID-19 vaccines

Communicating about COVID-19 vaccines
16 June 2021
Updated guidance clarifying the interaction between TGA and AHPRA advertising guidelines.

Misleading radio messages about COVID-19 vaccine safety
8 June 2021
The TGA is seriously concerned about misleading information that has recently been broadcast on radio stations providing a distorted picture of the safety of COVID-19 vaccines.

New regulatory arrangements support businesses and health professionals to communicate and incentivise COVID-19 vaccination
7 June 2021
The TGA has implemented arrangements to facilitate the communication of information about approved COVID-19 vaccines

COVID-19 vaccine weekly safety report - 03-06-2021
2 June 2021
Information about the TGA's safety monitoring of COVID-19 vaccines

COVID-19 vaccine weekly safety report - 27-05-2021
27 May 2021
Information about the TGA's safety monitoring of COVID-19 vaccines

TGA approves more flexible storage conditions for Pfizer-BioNTech COVID-19 vaccine
24 May 2021
Updated storage conditions for the Pfizer COVID-19 vaccine

TGA evaluating first monocolonal antibody treatment for COVID-19, SOTROVIMAB - GlaxoSmithKline Australia Pty Ltd
21 May 2021
The TGA granted a provisional determination to GlaxoSmithKline Australia Pty Ltd in relation to the monoclonal antibody treatment, SOTROVIMAB (GSK4182136) on 14 April 2021

COVID-19 vaccine weekly safety report - 20-05-2021
20 May 2021
Information about the TGA's safety monitoring of COVID-19 vaccines

COVID-19 vaccine weekly safety report - 13-05-2021
13 May 2021
Information about the TGA's safety monitoring of COVID-19 vaccines

Provisional determination granted to Pfizer in relation to COVID 19 vaccine, COMIRNATY - for use in individuals 12 years of age and older
12 May 2021
The granting of this determination means that Pfizer is now eligible to apply to vary its provisional registration for the vaccine for use in individuals 12 years of age or older.

COVID-19 vaccine weekly safety report - 06-05-2021
6 May 2021
Information about the TGA's safety monitoring of COVID-19 vaccines

COVID-19 vaccine weekly safety report - 28-04-2021
28 April 2021
Information about the TGA's safety monitoring of COVID-19 vaccines

AstraZeneca ChAdOx1-S COVID-19 vaccine
23 April 2021
Three additional Australian cases of TTS likely linked to vaccine

COVID-19 vaccine weekly safety report - 21-04-2021
21 April 2021
Information about the TGA's safety monitoring of COVID-19 vaccines

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

COVID-19 vaccine weekly safety report - 14-04-2021
14 April 2021
Information about the TGA's safety monitoring of COVID-19 vaccines

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).

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.

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 vaccine provisional determinations18 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].