COVID-19

TGA provisionally approves Novavax vaccine as well as two oral COVID-19 treatments

Federal Health Minister Greg Hunt spoke today with the latest information on the evolving COVID-19 situation across the country.

NOVAVAX APPROVED

Hunt announced that the TGA has authorised the vaccine Novavax which is the first protein COVID-19 vaccine to receive regulatory approval in Australia.

“The Novavax vaccine will now go to ATAGI for consideration over the course of the next week but it’s a very promising development,” he said.

“The first of two green lights has been given.”

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.

Hunt said Australia has 51 million units available of the vaccine.

“We have a first dose national vaccination rate of 95.2%, and we know that some people have waited for this vaccine,” Hunt said.

“Hopefully, this will encourage those people in the less than last 5% to come forward.

“We want to have as many people come forward to be vaccinated. The next stage is the Australian Technical Advisory Group on Immunisation [ATAGI] and, subject to their approval, it will be made available over the coming weeks to be distributed through states and territories, general practices, and pharmacies that seek to order it.”

TGA Deputy Secretary Professor John Skerritt commented on the TGA’s approval of the Novavax vaccine saying it is great that it has finally been approved.

“The approval is for a primary course – the first two doses,” Skerritt said.

“I know there is interest in a booster or for children in a paediatric dose. The company has not applied for that yet.”

Skerritt said he believes the approval of Novavax will increase Australia’s vaccination rate.

“It is approved and ready to move to make use of the vaccine and is approved in two doses 21 days apart, so that will also enable rapid completion of vaccination and our dream is we maintain our 95% up to 98.99% in this country,” Skerritt said.

Skerritt compared COVID vaccines to the Olympics.

“It’s really important to realise that the medicine trials were run at different times, in different countries with different amounts of COVID, so it’s a little bit like the Olympics – you don’t know who the best athlete is until they come up head-to-head,” Skirritt said.

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.

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.

TWO NEW ORAL COVID TREATMENTS APPROVED

Hunt also announced the approval of two new oral antivirals: Paxlovid by Pfizer and Molnupiravir by MSD.

“These two new oral antivirals mean that people will be able to have a course of treatment if prescribed by a doctor and that means they won’t necessarily need to take them in hospital,” Hunt said.

He said they add to our protection and in particular focus on those that have mild to moderate symptoms but are at risk of severe disease.

“It’s elderly Australians, particularly those in aged care that these are suited to,” Hunt said.

“Between the two, there are 800,000 courses of treatment that are on order and we are expecting the first of these courses to arrive in the coming weeks and they will be made available through prescription.

“That is a really important addition in a very important sign of hope and protection for the Australian public.”

Skerritt said having multiple medicines is not unusual.

“It is common to have a selection of medicines – both medicines in the clinical trials were very effective in reducing death,” Skerritt said.

“These medicines will be rolled out in aged care, whilst we are sadly seeing younger people die it is mainly older people who are affected.”

Hunt emphasised the importance of getting vaccinated regardless of the new easier alternative of a oral pill.

“We do not want people to feel that if they can pop a pill they do not need to be vaccinated,” he said.

Hunt said that vaccinations are important for efficacy and to provide individuals with greater immunity, however does accept that the oral treatment is an excellent second choice for those who are elderly and immuno-compromised.

If 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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