Novavax's COVID-19 vaccine gets drug regulator's green light

Novavax's COVID-19 vaccine gets drug regulator's green light

A COVID-19 vaccine made by pharmaceutical company Novavax has been granted provisional approval today by the Therapeutic Goods Administration (TGA), with the first shipment of the jabs expected to arrive in the coming month.

The provisional approval will allow Australians aged 18 years and older to receive two doses of the vaccine administered three weeks apart as soon as the Australian Technical Advisory Group on Immunisation (ATAGI) grants its approval too.

Novavax’s NUVAXOVID is the first protein-based COVID-19 vaccine to receive regulatory approval in Australia.

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.

This approach differs from the vaccines developed by Pfizer and Moderna which are both messenger RNA (mRNA) vaccines, and AstraZeneca’s jab which is a vector vaccine.

Unlike Pfizer and Moderna’s jabs, NUVAXOVID is only approved for primary vaccination only as studies for the use of Novavax’s jab as a booster are ongoing.

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.

“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,” the TGA said.

“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 AdvisoryCommittee on Vaccines (ACV), an independent committee with expertise in scientific, medical and clinical fields including consumer representation.”

Novavax and the Australian government announced an advance purchase agreement for 51 million doses NUVAXOVID in January 2021. The first shipment to Australia of the Novavax vaccine is expected in the coming month.

“Obviously we have a first dose national vaccination rate of 95.2 per cent, and we know that some people have waited for Novavax. Although we’ve encouraged everybody to proceed, we recognise that that’s a fact,” Federal Health Minister Greg Hunt said.

“So hopefully this will encourage those in that less than last 5 per cent to come forward. We want to have as many people come forward to be vaccinated.”

Updated at 10.45am AEDT on 20 January 2022.

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