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TGA provisionally approves Moderna as COVID-19 booster


Anastasia Tsirtsakis


8/12/2021 4:45:37 PM

Australia’s medicine and therapeutic regulator has given the green light for a second vaccine to be used as a booster in adults.

A box of Moderna COVID-19 vaccine vials.
Pending approval from the ATAGI, Australians will be eligible to receive Moderna as a booster six months after receiving their second dose.

Moderna’s COVID-19 vaccine has received provisional approval from the Therapeutic Goods Administration (TGA) for use as a booster for Australians aged 18 and over.
 
Confirming the move on Wednesday, the regulator said that as with Pfizer, adults will become eligible to receive their third dose six months after receiving their second dose of a primary vaccination course.
 
The TGA said its decision followed ‘careful evaluation of the available data supporting safety and efficacy’.
 
‘The TGA’s decision was also informed by expert advice from the Advisory Committee on Vaccines, an independent committee with scientific, clinical and consumer representation,’ the regulator said.
 
Federal Health Minister Greg Hunt said the Australian Technical Advisory Group on Immunisation (ATAGI) is now considering whether to follow the TGA’s lead and approve Moderna’s use as a booster.
 
‘So in addition to the Pfizer booster, subject to final approval [by ATAGI] … Australians will have two options for boosters very, very shortly,’ he said.
 
Pending approval from ATAGI, the TGA advised that people could receive Moderna as a booster regardless of the COVID-19 vaccine received as part of their primary dosing schedule, provided it is a vaccine registered for use in Australia.
 
Part of Australia’s 25 million-dose agreement with the company includes access to 15 million doses of ‘variant-specific versions’ to address longer-term immunity and viral variants, which should be available in the first half of 2022.
 
The emergence of the Omicron variant has led to requests for ATAGI to consider reducing the booster timeframe, but the expert group has so far resisted these calls, other than announcing that a reduction from six months to five months is possible in certain circumstances.
 
Moderna has also said it plans to ‘rapidly advance’ an Omicron-specific booster candidate (mRNA-1273.529), that could be available for clinical testing in the next 60–90 days.
 
In the meantime, Minister Hunt said that ATAGI is also considering the approval of Pfizer for children aged 5–11, after the TGA gave its provisional approval on Sunday.
 
He said he expects a ‘positive announcement’ in the coming week.
 
Further information on the rollout of Moderna as a booster dose is expected to be published on the Department of Health’s website soon.
 
More than 500,000 Australians have now received a third shot of a COVID-19 vaccine, although official figures do not distinguish between vaccines given to the immunocompromised and those given as a booster.
 
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