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 are 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 theAdvisory Committee on Vaccines(ACV), an independent committee with expertise in scientific, medical and clinical fields including consumer representation.
https://www.tga.gov.au/media-release/tga-provisionally-approves-novavax-biocelect-pty-ltds-covid-19-vaccine-nuvaxovidno mention of your understanding in the official advice from the TGA.... its well known that those who reject the science of vaccines build in to the fear porn all manner of aspersions, disinformation, distortions and outright lies. Teena Mc as no stranger to this strategy.