COVID-19

TGA’s final decision on Novavax expected in the next 10 days

It was reported that the TGA is expected to reach its final decision on Australia’s 51M promised supply of Novavax vaccine in the coming 10 days.

The approval for Australia’s 51 million promised supply of protein-based vaccine, Novavax, may be approved by the Therapeutic Goods Administration (TGA) in the following days.

The vaccine, developed by US pharmaceutical company Novavax, was expected to hit Australian shores in 2021, however, it experienced unprecedented delays in its approval due to supply issues. The initial data was provided to the TGA in January of last year.

Discussing the intended fourth vaccine at a press conference this morning, Chief Medical Officer Paul Kelly said a decision on its use is expected to be reached in the “coming 10 days.”

“We are seeing good progress on Novavax with recent fresh data and there are 51 million doses of Novavax if the regulator were to approve that and that decision is expected in the coming 10 days,” said Kelly.

As Australia continues to see a surge in cases, Mr Kelly further stated that the nation is approaching the peak of the Omicron wave.

Australia has surpassed a 95 per cent vaccination rate for those 16 and over receiving their first jab, with over 1 million vaccines had been delivered nationwide in a record three-day period.

As has been reported in South Australia, an overrepresentation of hospitalisations and ICU cases are from unvaccinated Australians.

“We are seeing an epidemic of the unvaccinated in young people, we are seeing it in intensive care admissions, so anyone of any age should be lining up to have that primary course of vaccination,” said Kelly.

“The curve is peaking, it is not time to stop our other public health and social measures…but there are signs of hope today,” said Kelly.

The Novavax vaccine was recently approved for use in individuals 16 and over across the EU by the European Commission on December 21, following the tick of approval for medical experts.

Further discussing the Novavax late last year, Federal Minister for Health Greg Hunt said the vaccine could be available for use in Australia in January 2022. Clinical trials show that the Novavax has a 90 per cent efficacy rate against those with a symptomatic infection, and a 100 per cent efficacy at preventing severe COVID-19 cases.

f you have any COVID-19 symptoms, no matter how mild, please seek testing as soon as possible.

Find your nearest testing site at www.sahealth.sa.gov.au/COVIDtesting.

More information is available at www.sahealth.sa.gov.au/COVIDcontacttracing.

For more information visit https://www.covid-19.sa.gov.au/ or call the SA COVID-19 Information Line on 1800 253 787.

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