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Moderna Has Been Approved as a COVID-19 Booster by the TGA on a Temporary Basis

Moderna Has Been Approved as a COVID-19 Booster by the TGA on a Temporary Basis

Published By Victoria , 2 years ago

The Australian Medicines and Therapeutic Goods Administration has approved a second vaccination to be used as a booster in adults.

The Therapeutic Goods Administration (TGA) has granted provisional clearance to Moderna's COVID-19 vaccine for use as a booster for Australians aged 18 and above.

The agency confirmed the decision on Wednesday, saying that, like Pfizer, adults would be eligible for their third dosage six months after getting their second dose of the main immunisation course.

The TGA said that their decision was made after a "careful examination of the available evidence supporting safety and effectiveness."

The TGA's decision was also influenced by expert opinion from the Advisory Group on Vaccines, an independent committee composed of scientific, clinical, and consumer representatives.

According to Federal Health Minister Greg Hunt, the Australian Technical Advisory Group on Immunisation (ATAGI) is currently debating whether to follow the TGA's example and approve Moderna's use as a booster.

He added that in addition to the Pfizer booster, and subject to final clearance [by ATAGI], Australians will have two booster alternatives very, very soon.

The TGA indicated that, pending ATAGI clearance, persons might get Moderna as a booster regardless of the COVID-19 vaccine received as part of their main dosage regimen, as long as it is a vaccine licensed for use in Australia.

Part of Australia's 25 million-dose arrangement with the business includes access to 15 million doses of 'variant-specific versions' to address long-term immunity and virus variations, which are expected to be ready in the first half of 2022.

The development of the Omicron variety has prompted appeals for ATAGI to explore shortening the booster term, but the expert group has so far rejected these requests, other than saying that a decrease from six months to five months is feasible under specific conditions.

Moderna also said that it intends to 'rapidly develop' an Omicron-specific booster candidate (mRNA-1273.529), which might be ready for clinical testing within the next 60–90 days.

Meanwhile, Minister Hunt said that ATAGI is contemplating Pfizer permission for children aged 5–11, after the TGA's preliminary clearance on Sunday.

He said that he anticipates a "good announcement" in the next week.

More information on the deployment of Moderna as a booster dosage is planned to be posted shortly on the Department of Health's website.

More than 500,000 Australians have already received a third dose of the COVID-19 vaccination, albeit official numbers do not differentiate between shots given to immunocompromised people and those given as a booster.


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