Provisional registration of COVID-19 vaccine(s) in Australia

MVEC supports the authorisation of COVID-19 vaccines that reach the regulatory requirements regarding both vaccine efficacy and safety.

There is lots of interest nationally and internationally regarding the process for regulation of vaccines and concerns that this may be happening ‘too fast’ and steps may be missed. There is also some confusion regarding how these vaccine regulatory processes may vary between countries.

The Therapeutic Goods Administration

The Therapeutic Goods Administration (TGA), is the body in Australia that reviews all the information required to license a vaccine in Australia. This includes a detailed dossier of all available trial information (preclinical and phases 1-3), as well as an extensive pharmacovigilance plan to be activated once the vaccine comes onto the market (phase 4 vaccine safety monitoring).

The TGA has established a COVID-19 hub that includes detailed information on their role and internal processes [refer to TGA: COVID-19 hub].

Provisional registration process

A number of sponsors of COVID-19 vaccines have applied to the TGA for registration using the so-called ‘provisional approval pathway’.

The provisional pathway is only one of a number of pathways that a sponsor may use to apply for the approval of a vaccine. It allows for the temporary registration of promising medicines or vaccines based on early data, where the benefits of early access, outweigh any risks. It is very important to note that the TGA evaluation process under the ‘provisional pathway’ is still a full review of the vaccine and the TGA does not have a mechanism for emergency use authorisations (EUA).

Once the TGA has approved a COVID-19 vaccine for registration, it will be included in the Australian Register of Therapeutic Goods (ARTG) as a provisionally registered medicine and available to be administered by health professionals.

Timeline: The provisional registration is for an initial period of 2-years, with the option to apply for up to two extensions, up to a maximum of 6-years. Sponsors may apply for ‘full registration’ when there is more clinical data to confirm the safety of the vaccine.

The TGA’s provisional approval pathway consists of five steps:

1. provisional determination
2. pre-market registration 
3. provisional registration period 
4. extension of provisional registration (if required), and  
5. transition to full registration. 

Emergency Use Authorisation (EUA)

This is a process for vaccine use being utilised in the United States by the FDA [refer to FDA: Emergency Use Authorization]. 

It allows the FDA to approve a vaccine in the setting of a public health emergency, such as the COVID pandemic. The FDA have outlined to vaccine sponsors the thresholds that would need to be met for a COVID-19 vaccine to be considered under this pathway, which can only be activated under specific guidance of section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 

The European Medicines Agency have also outlined their guidance for COVID-19 vaccine authorisation in Europe [refer to EMA: Guidance for medicine developers and other stakeholders on COVID-19 . 

International Coalition of Medicines Regulatory Authorities (ICMRA) 

In this MVEC page we have already mentioned three regulators (TGA, FDA and EMA) and like many issues flagged during the pandemic, there has been close collaboration between the regulators and early sharing of information related to the vaccine trials and safety data. 

The International Coalition of Medicines Regulatory Authorities (ICMRA) is acting as a forum to support strategic coordination and international cooperation among global medicine regulatory authorities. The aim of these international activities is to expedite and streamline the development, authorisation and availability of both COVID-19 treatments and vaccines worldwide. ICMRA members also work towards increasing the efficiency and effectiveness of regulatory processes and decision-making [refer to ICMRA: COVID-19].

MVEC will continue to provide news items on the regulatory processes being undertaken regarding COVID-19 vaccines, with a focus on some of the safety aspects and phase 4 surveillance activities being undertaken as part of post marketing surveillance. 

To report any adverse event following immunisation in Victoria, go to SAEFVIC.  

Resources

• MVEC: Vaccine development and safety
• MVEC: COVID19 Road to a Vaccine podcast Episode 7- The importance of regulatory bodies in the development of vaccines with Professor Norman Baylor
• MVEC: COVID19 Road to a Vaccine podcast Episode 16- COVID-19 vaccine candidates regulatory process update with Professor Norman Baylor