13 May 2021

COVID-19 Vaccination Information Distillation: TGA's registration process for the COVID-19 vaccine and what to consider now

By Greg Williams, Sheena McKie and Mitchell Donohue

The sponsors of the Pfizer and AstraZeneca vaccines can apply to transition the vaccines to full registration once more clinical data confirming the safety of the vaccines is available.

Australia's vaccination program for COVID-19 launched on 22 February 2021 and is being closely watched by the Australian public. Two vaccines have now received provisional registration in Australia, meaning they can now be administered to the Australian public, and a further two have received provisional determination. Along with these new vaccines comes a raft of product safety and product liability issues both for the public and private sector to monitor and possibly deal with.

How did we get here?

The Australian Government has entered four agreements to secure the supply of COVID-19 vaccines for Australian residents. Three of these agreements are for the supply of the University of Oxford/AstraZeneca, Novavax and Pfizer/BioNTech vaccines. The fourth agreement entered Australia with the COVAX Facility along with 188 other countries. The COVAX Facility has nine vaccine candidates in various clinical trial stages.

After initially being granted provisional determination in October 2020, two vaccines have received provisional registration in Australia: Provisional registration means the Australian Therapeutic Goods Administration (TGA) has decided the vaccines meet the necessary standards for use in Australia.

 

Effective date

Sponsor

Name

Type

25 January 2021

Pfizer Australia Pty Ltd

mRNA

15 February 2021

AstraZeneca Pty Ltd

Viral vector

 

Background to provisional registration

Before a vaccine is approved for public use, it must first go through a strict screening process by the TGA. Before being granted provisional registration, a new vaccine must first be granted provisional determination. The TGA may grant provisional determination to a new prescription medicine (or a new indication for an existing (approved) prescription medicine) – including a vaccine – where:

  • an indication of the medicine is the treatment, prevention or diagnosis of a life-threatening or seriously debilitating condition (in this case, COVID-19);
  • (relevantly), no other therapeutic goods intended to treat prevent or diagnose COVID-19 are included in the Australian Register of Therapeutic Goods (ARTG);
  • there is preliminary clinical data demonstrating that the medicine is likely to provide a major therapeutic advance; and
  • the applicant has provided sufficient evidence of their plan to submit comprehensive clinical data on the safety and efficacy of the medicine within 6 years of the vaccine from provisional registration on the ARTG (if granted).

Provisional determination does not mean the vaccines can begin being administered to the Australian public. First, the vaccines need to be granted provisional registration on the ARTG. For this to occur, the applicant for registration (who will usually become the Australian sponsor) must make an application, accompanied by a comprehensive dossier, including specific information about clinical and non-clinical/toxicology studies, chemistry, manufacturing, risk management and other information.

Once accepted by the TGA for evaluation, the application passes through a number of phases, which include assessment by technical experts. The process involves review of information provided in the initial application and requests for further information by the TGA. Although the TGA works collaboratively and shares information with other regulators around the world, it conducts its own assessment.

Ultimately, the TGA's role is to assess the safety, quality and effectiveness of the vaccine.

A medicine which is provisionally registered:

  • holds that provisional registration for an initial period of two years, with an option to apply for up to two extensions (maximum six years); and
  • must be the subject of a plan requiring the sponsor to submit comprehensive clinical data, stability data and other information during the period of provisional registration.

Once the decision to either approve or not approve an application has been made the TGA will release an Australian public assessment report (AusPAR), product information and consumer medicines information documents before the product is first supplied to Australians. These documents have now been published for the Pfizer and AstraZeneca vaccines and are available on the TGA's website.

What's next?

Transition to full registration

The Pfizer and AstraZeneca vaccines can now be administered to the Australian public by health professionals. The national roll-out of COVID-19 vaccines commenced on 22 February 2021.

Provisional registration will automatically lapse upon expiry for the initial period (2 years), unless one or more application/s for an extension is granted or if the sponsors have applied for full registration of the vaccines and this application is being considered by the TGA.

Full registration means the vaccines will be registered in the ARTG, with no end date, provided that the annual fees are paid and no suspension or cancellation of the registration occurs (eg. due to safety issues).

The sponsors of the Pfizer and AstraZeneca vaccines can apply to transition the vaccines to full registration once more clinical data confirming the safety of the vaccines is available. The application for full registration must be lodged before the end of the provisional registration period. As the provisional registration period continues while the TGA considers the application, the provisional registration period may be potentially longer than the maximum six year period mentioned above.

Ongoing monitoring

The vaccines will be monitored for safety, efficacy and quality during the period of provisional determination. All provisionally registered medicines, including the Pfizer and AstraZeneca vaccines, are subject to additional monitoring in Australia using the "Black Triangle Scheme". This scheme helps healthcare practitioners and patients identify new medicines (or those being used in different ways) and is intended to encourage the reporting of possible side effects (known as adverse events). The TGA has also indicated it will publish weekly safety reports; see the latest report here. So far the TGA has received 12,694 reports of suspected adverse events in relation to the vaccines and has administered over 1.9 million doses.

Additionally, the TGA has access to data obtained by AusVaxSafety. AusVaxSafety is a surveillance system which uses SMS and a short survey to collect data regarding adverse events following immunisation from people who have received the vaccines. AusVaxSafety shares its data with the TGA to assist with reporting and responding to adverse events.

Further vaccines being considered by the TGA

Two further COVID-19 vaccines are also the subject of provisional determination:

 

Effective date

Sponsor

Name

Type

16 November 2020

Janssen-Cilag Pty Ltd

Viral vector

19 January 2021

Biocelect Pty Ltd (on behalf of Novavax Inc.)

Protein sub-unit

 

A minefield of product safety and product liability issues

As the world watches the safety and efficacy of the worldwide vaccination programs, we flag (without suggesting we have any ready answers) a raft of product safety and product liability issues which may arise for governments, employers, retailers, travel organisations such as airlines and accommodation venues, and healthcare professionals:

  • what information should be given to individuals before they are vaccinated (given the history of use and constantly growing information base);
  • what decisions about mandating vaccines are appropriate or can be justified, particularly for countries like Australia which have been relatively successful in suppressing the virus;
  • who will be responsible for any injury, loss or damage suffered by individuals, including:
    • where those individuals have been required (either by their employer, or in order to use a service) to have a vaccine which they may not have otherwise chosen;
    • where the damage occurs from incorrect administration of the vaccine;
    • where vaccines have particular supply chain requirements (e.g. extreme cold chain storage) and may be handled by multiple different entities in the delivery of the vaccines;
  • the impact and likely consequences of the Australian Government's decision to indemnify vaccine manufacturers and healthcare workers administering the vaccine in contrast to a no-fault compensation system; and
  • how can any vaccine shortages be managed.

 

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Clayton Utz communications are intended to provide commentary and general information. They should not be relied upon as legal advice. Formal legal advice should be sought in particular transactions or on matters of interest arising from this communication. Persons listed may not be admitted in all States and Territories.