TGA provisionally approves Nuvaxovid vaccine and two oral COVID-19 treatments
Health & Biotech
Health & Biotech
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The Therapeutic Goods Administration (TGA) has granted provisional approval to Biocelect (on behalf of Novavax Inc) for its COVID-19 vaccine, Nuvaxovid – the first protein COVID-19 vaccine to receive regulatory approval in Australia.
A protein vaccine essentially uses a non-infectious component found on the surface of the coronavirus and is manufactured in cells in a laboratory.
After vaccination, immune cells recognise the vaccine protein as foreign and launch an immune response against it.
It’s suitable for people 18 and over, and recommended to be given in two doses, three weeks apart.
Earlier this month Novavax and the Federal Government casually announced an advance purchase agreement for 51 million doses – with the first shipment expected in the coming month.
It almost seems suspiciously fast for a Government that dragged its feet sorting out supply for the roll out of the Pfizer and AstraZeneca vaccines.
The TGA also granted provisional approval to two oral COVID-19 treatments today – neither of which is a substitute for vaccination FYI.
The first treatment, Paxlovid, by our old friends Pfizer Australia, works with a nirmatrelvir component that blocks the activity of a protease enzyme that the coronavirus needs in order to replicate.
Nirmatrelvir is administered in combination with low-dose ritonavir to maintain plasma levels of nirmatrelvir for the duration of the treatment.
But there’s a hefty list of medicines it can’t be used with (here if you’re interested and/or have severely reduced kidney or liver function).
The other treatment Molnupiravir (Lagevrio) from Merck Sharp & Dohme, works by inhibiting replication of the SARS-CoV-2 virus.
The TGA stresses that the products are for the treatment of adults with COVID-19 who do not require initiation of oxygen and who are at increased risk of progression to hospitalisation or death.
The Government has secured access to 500,000 treatment courses of Paxlovid and 300,000 courses of Lagevrio for supply during 2022 – with the first deliveries of both medicines expected in the coming weeks.
“Either medicine should be administered as soon as possible after diagnosis of COVID-19 and within five days of the start of symptoms,” the TGA says.
“Lagevrio is available as capsules, while Paxlovid comprise separate tablets of nirmatrelvir and ritonavir.
“In both cases, the medicines are taken twice a day for five days.”
Both treatments have already received conditional marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency and emergency use authorisation from the US Food and Drug Administration, and Paxlovid was authorised by Health Canada earlier this week.