You are here
TGA provisionally approves Biocelect Pty Ltd's (on behalf of Novavax Inc) COVID-19 vaccine NUVAXOVID
The Therapeutic Goods Administration (TGA) has granted provisional approval to Biocelect Pty Ltd (on behalf of Novavax Inc) for its COVID-19 vaccine, NUVAXOVID. This is the first protein COVID-19 vaccine to receive regulatory approval in Australia.
This protein vaccine is provisionally approved and included in the Australian Register of Therapeutic Goods (ARTG) for active immunisation to prevent COVID-19 in individuals 18 years of age and older. It is recommended that the vaccine is given in 2 doses administered 3 weeks apart.
NUVAXOVID is provisionally approved for primary vaccination only. Studies for use of NUVAXOVID as a booster dose and in paediatric patients are ongoing, so the vaccine does not have regulatory approval for these purposes at this stage. The TGA will review any future application from the Sponsor as a priority.
The Novavax vaccine has received conditional marketing authorisation by the European Medicines Agency, and the World Health Organisation has issued an emergency use listing for the vaccine.
NUVAXOVID is a protein subunit vaccine. Protein vaccines use a non-infectious component found on the surface of the coronavirus and manufactured in cells in a laboratory. After vaccination, immune cells recognise the vaccine protein as foreign and launch an immune response against it.
Provisional approval of this vaccine in Australia is subject to certain strict conditions, such as the requirement for Biocelect Pty Ltd (on behalf of Novavax Inc) to continue providing information to the TGA on longer-term efficacy and safety from ongoing clinical trials and post-market assessment.
Novavax and the Australian government announced an advance purchase agreement for 51 million doses of Novavax's COVID-19 vaccine in January 2021. The first shipment to Australia of the Novavax vaccine is expected in the coming month.
Australians can be confident that the TGA's review process of NUVAXOVID was rigorous. 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.
Information about Australia's vaccine rollout can be found on the Department of Health's webpage.
Supporting regulatory documents
The provisional approval pathway provides a formal and transparent mechanism for registration of promising new medicines with preliminary clinical data.
The following regulatory documents are made available as part of this process:
- Product information (PI)
- Consumer Medicine Information (CMI)
- NUVAXOVID Decision Summary
The decision summary provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the ARTG.
- AusPAR: NUVAXOVID
An Australian Public Assessment Report (AusPAR) provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve a prescription medicine submission.
- Advisory Committee on Vaccines meeting statement, meeting 29, 7 January 2022
An independent expert committee that provides advice on an application to register a new vaccine.
- Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine - Novavax) (Biocelect Pty Ltd) Labelling Exemption 2022