First Omicron-specific vaccine gets TGA tick
The vaccine, which targets the ancestal strain of SARS-CoV-2 plus the BA.1 Omicron variant, is approved for patients aged 18 or older, the TGA said in a statement on Tuesday.
Compared with the original Moderna vaccine, the bivalent version triggered a superior immune response against Omicron BA.1, while early data suggested it also generated a higher immune response against sub-variants BA.4 and BA.5.
An ongoing study showed the new bivalent vaccine had a similar safety and reactogenicity profile to the original Spikevax booster, when given as a second booster dose, the regulator added.