TGA approves Pfizer booster for teens

Canberra pharmacist Erin Cooper MPS vaccinating a teenage patient.

Pfizer’s Comirnaty COVID-19 vaccine has been provisionally approved by the Therapeutic Goods Administration (TGA) for use as a booster in those aged 16–17 years.

Immunisers should not administer the vaccine to this age group until a recommendation is made by the Australian Technical Advisory Group on Immunisation (ATAGI).

Federal Minister for Health Greg Hunt said a decision from ATAGI was expected early next week. 

‘If that is a yes, we will make it available immediately,’ he said on Channel Seven’s Sunrise program today (Friday).

‘There are very large numbers of doses that are out with GPs and pharmacies, as well as Commonwealth and state clinics.’

Dosing for this age group is the same as those over 18, meaning a booster may be administered after two primary doses. This primary series can be any of the COVID-19 vaccines approved for use in this age group. 

The TGA announcement follows its provisional approval of Comirnaty as a booster for those 18 years and older in October, as it continues to monitor ongoing trials associated with booster doses for younger children.

New vaccine coming soon

Pharmacists already involved in the vaccine rollout will begin administering a fourth vaccine, Nuvaxovid by Novovax in February, after TGA provisional approval and at the recommendation of ATAGI.

The federal government purchased 51 million doses of the vaccine this month, with samples for batch testing due to arrive imminently. 

If the batch testing is successful, Minister Hunt said the vaccine would be available from the week of 21 February. 

Like Comirnaty and Moderna’s Spikevax mRNA vaccines, two doses of Nuvaxovid, a cell-based protein vaccine, constitutes the initial course, 3 weeks apart.

Studies are ongoing for its use in paediatric patients and as a booster.

ATAGI has advised that three doses as a primary course of vaccination can be used by people who are severely immunocompromised. 

The vaccine is expected to be available from community pharmacies, general practices, Aboriginal Community Controlled Health Services, state and territory clinics and Commonwealth vaccination centres from 21 February. The mandatory online training module for COVID-19 vaccinators should be available in the coming days.

Oral antiviral treatments approved

Additionally, the first oral antiviral COVID-19 treatments have also been provisionally approved by the TGA. The federal government has bought 300,000 treatment courses of Merck Sharp & Dohme’s Lagevrio (molnupiravir) and 500,000 courses of Pfizer’s Paxlovid (nirmatrelvir + ritonavir).

Effective in treating people with mild to moderate coronavirus with a high risk of progressing to severe disease, the prescription medicines are taken every 12 hours for 5 days, which disrupts the ability of the virus to multiply effectively.