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TGA approves Omicron-specific vaccine


Jolyon Attwooll


31/08/2022 10:38:29 AM

The ‘bivalent’ COVID-19 vaccine, developed by Moderna, has been given the go-ahead by the Australian medicines regulator.

Person getting vaccinated against COVID-19
Initial analysis suggests the updated vaccine generates a higher immune response against all of Omicron’s known major sub-variants compared to the original candidate. (Image: AAP)

The Therapeutic Goods Administration (TGA) has given a provisional green light to Moderna’s updated COVID-19 booster vaccine, which targets both the original strain of SARS-CoV-2 as well as the Omicron variant.
 
In an announcement on Tuesday afternoon, the regulatory agency confirmed the decision, which applies to the use of the bivalent original/Omicron vaccine – also known as mRNA-1273.214 – as a booster in adults over the age of 18.
 
The TGA states that the vaccine ‘elicited a superior neutralising antibody response against Omicron BA.1 strain and a similar response against the ancestral strain’ when compared to the original vaccine.  
 
Despite the vaccine being originally developed to target BA.1, the TGA also says initial analysis suggests the updated vaccine ‘generates a higher immune response against the sub-variants BA.4 and BA.5’ than the original.
 
Of the vaccine dose, 25 micrograms of imelasomeran targets the BA.1 variant, while 25 micrograms of elasomeran is aimed at the original strain of SARSCoV-2. 
 
The regulator states that it considered data from an ongoing clinical trial, with its decision also ‘informed by expert advice from the Advisory Committee on Vaccines’.
 
The TGA also says there were no new safety signals identified.
 
‘Provisional approval of this vaccine is subject to certain strict conditions, such as the requirement for Moderna to continue providing information to the TGA on longer term benefits from ongoing clinical trials and post-market assessment,’ the TGA said.
 
The exact guidelines for administering the vaccine, which is the first to specifically target the variant, are expected to be confirmed by the Australian Technical Advisory Group on Immunisation (ATAGI) in the coming weeks.
 
Nine Newspapers is reporting that the first doses of the vaccines are expected to arrive in Australia shortly.
 
‘Following TGA’s provisional approval, the doses will arrive in the country within weeks – allowing Australia to be among the first countries in the world to have access to this next-generation COVID-19 vaccine,’ a spokesperson for the biotechnology company told the publisher.
 
However, a company spokesperson would not confirm whether Australia is likely to receive its full allotment of 15 million variant-specific doses by the end of 2022, instead directing newsGP to the Department of Health and Aged Care.
 
The UK was the first country to give provisional approval to the Omicron-specific vaccine.
 
The TGA states that it is the third major regulator to approve the updated vaccine globally.
 
Another vaccine specifically targeting the Omicron variant is being developed by Pfizer but is not currently listed by the TGA as under evaluation in Australia.
 
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