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- Australia’s Therapeutic Goods Administration (TGA) has this week approved the Novavax vaccine and two oral COVID treatments to reduce the chance of severe disease
- Novavax’s jab is the first protein vaccine to be approved in Australia, and Head of the TGA Professor John Skerritt says he hopes the availability of the jab will boost vaccination rates
- There is also talk of potentially using Novavax as a booster or in adolescence paediatric use, though the TGA has so far only approved the shot as a primary vaccine
- The two oral COVID treatments also approved this week by the TGA are Pfizer’s PAXLOVID and Merck Sharp & Dohme’s (MSD) LAGEVRIO treatments
- Both medicines are designed to reduce the chance of hospitalisation or severe disease rather than to prevent infection
Australia’s Therapeutic Goods Administration (TGA) has this week approved the Novavax vaccine and two oral COVID treatments to reduce the chance of severe disease.
It marks three firsts for the country: the first protein vaccine against the virus to receive approval and the first two oral treatments for vulnerable patients with COVID-19.
While the government has ordered 51 million doses of the Novavax jab, it’s now up to the Australian Technical Advisory Group on Immunisation (ATAGI) to determine exactly when and to whom the vaccine will be made available.
Hopes Novavax will increase overall jab rate
Head of the TGA Professor John Skerritt on Thursday said he knew some people were “for whatever reason” waiting to receive the Novavax jab, known as NUVAXOVID, rather than the already-available vaccines in Australia.
“This just gives them further choice,” Professor Skerritt said.
He said the protein vaccine is based on an older technology than that of the likes of Pfizer, AstraZeneca and Moderna, and so he hoped the availability of the new jab would lift the overall vaccination rate from 95 per cent to 97 or 98 per cent.
There is also talk of potentially using Novavax as a booster or in adolescence paediatric use. Professor Skerritt said as soon as enough data is available, the TGA will be able to make a decision on such a matter.
The TGA said in a media statement it recommends the vaccine is given in two doses, administered three weeks apart. The Novavax jab has received conditional marketing authorisation by the European Medicines Agency and a recommendation for emergency use by the World Health Organisation.
“Australians can be confident that the TGA’s review process of NUVAXOVID was rigorous,” the drug regulator said.
“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.”
First oral COVID treatments
The two oral COVID treatments also approved this week by the TGA are Pfizer’s PAXLOVID and Merck Sharp & Dohme’s (MSD) LAGEVRIO treatments.
The treatments are not designed to prevent infection but to reduce the chance of hospitalisation or death in patients.
“Neither product is intended to be used as a substitute for vaccination against COVID-19,” the TGA said.
Both medicines are designed to be administered as soon as possible after a COVID-19 diagnosis and within five days of the onset of symptoms. Both medicines are taken twice a day for five days.
Around 800,000 courses of the pills are expected to arrive in Australia over the coming weeks.
The TGA, however, said the medicines should not be taken when pregnant or breastfeeding children, or by people looking to conceive. Those with severe kidney or liver issues are also advised to not take the treatments.
MSD Australia Medical Director Gary Jankelowitz said the provisional approval of the LAGEVRIO drug was a “regulatory milestone in the ongoing fight against COVID-19”.
“LAGEVRIO has the potential to help address a medical need in the community,” Dr Jankelowitz said.
“MSD acknowledges the partnership and support of the Australian Government and the Minister for Health and Aged Care, Hon Greg Hunt MP, in making this treatment option available for eligible adults.”
Pfizer Australia and New Zealand’s Managing Director Anne Harris shared similar sentiments about PAXLOVID.
“This at-oral therapy, developed to reduce hospitalisations and save lives, has the potential to transform COVID-19 treatment and help lessen the devastating impact of the virus that has now taken over 5 million lives globally,” Ms Harris said.
Treatments like these will likely play a key role in keeping the Australian economy strong as states work to avoid lockdowns and tight restrictions, according to a recent Deloitte Access Economics Business Outlook report.
