TGA approves Moderna vaccine for 12 to 17-year-olds

The Australian Government has welcomed today’s decision by Australia’s medicines regulator, the Therapeutic Goods Administration (TGA), to provisionally approve the use of the Moderna (Spikevax) COVID-19 vaccine for adolescents aged 12 to 17 years.
The approval by the TGA to allow the 12 to 17-year-old age group to be vaccinated with the Moderna COVID-19 vaccine follows the approval last month of its use in adults aged 18 years and older.
Australia has an advance purchase agreement with Moderna to secure 25 million doses of the vaccine – 10 million this year and 15 million of booster vaccines in 2022, with the first doses arriving later this month.
The Government will now await the advice of the independent Australian Technical Advisory Group on Immunisation (ATAGI) on how the approval of the Moderna vaccine for 12 to 17-year-olds should be incorporated into Australia’s vaccine rollout program. This advice is expected in the coming week.
The TGA’s approval of the Moderna vaccine for 12 to 17-year-olds was based on a detailed evaluation of available data to support its safety and efficacy – and is an important step in the Government’s program to vaccinate children.
It follows the Government accepting ATAGI’s advice that the Pfizer vaccine be administered in adolescents aged 12 to 15 years. Bookings for this age group open on 13 September.
Significant preparatory work has been undertaken by Operation COVID Shield on how the rollout will be expanded by including the Moderna vaccine and the first doses of the Moderna vaccine will be available through community pharmacies and workplace vaccination clinics.
Through increased supply and additional vaccination sites coming on board, we are setting vaccination records on an almost daily basis. Almost 2 million vaccines were administered last week and more than 20 million have now been administered across the country.
The Government is absolutely committed to vaccinating children as part of the rollout program – and it is expected everyone aged 12 to 18 years of age will have access to a vaccine during 2021.