TGA provisionally approves COVID-19 vaccine, Nuvaxovid, for use in 12-17 year olds

Australia’s Therapeutic Goods Administration (TGA) has provisionally approved the Biocelect - on behalf of US biotech Novavax (Nasdaq: NVAX) - COVID-19 vaccine, Nuvaxovid, for use in individuals aged 12-17 years. The decision follows provisional approvals on 19 January 2022 for the use of Nuvaxovid in adults, on June 9, 2022, the Nuvaxovid booster dose for use in adults.

As with adults, the vaccine should be administered in adolescents intramuscularly as a course of two doses 21 days apart. The vaccine contains the same ingredients as those used in older age groups.

In making this decision, the TGA considered data from a Phase III, randomized, observer-blinded, placebo-controlled study, which was conducted in USA and included over 2,200 participants aged 12-17 years. This study showed that the safety profile and efficacy in adolescents is similar to that seen in adults.