TGA green lights Nuvaxovid for 12–17-year-olds

Morgan Liotta

27/07/2022 2:00:34 PM

But while provisional approval has been granted, inclusion in the national program for this age group is yet to be confirmed.

Teenage boy receiving vaccination
The Novavax vaccine joins Pfizer and Moderna as the third registered COVID-19 vaccine for use in ages 12–17.

The Therapeutic Goods Administration (TGA) has given provisional approval for Nuvaxovid to be administered to adolescents aged 12–17 years.
Prior to the decision, Pfizer and Moderna’s mRNA vaccines were the only two registered for use in people aged 12–17.
According to the TGA, provisional approval of Nuvaxovid was informed by expert advice and clinical trials, including from the Advisory Committee on Vaccines, for which an Australian Public Assessment Report relating to the decision will shortly be published.
‘In making this decision, the TGA [also] considered data from a Phase 3, randomised, observer-blinded, placebo-controlled study, which was conducted in United States and included over 2200 participants aged 12–17 years,’ a release from the regulator states.
‘This study showed that the safety profile and efficacy in adolescents is similar to that seen in adults.’
As Australia’s first protein-based vaccine for protection against COVID-19, Nuvaxovid has helped boost vaccination coverage in people who did not want to receive Pfizer, Moderna or AstraZeneca. Since being added to the national rollout program in January, more than 167,800 doses have been administered.
Last month, the TGA also granted approval for the vaccine as a booster in people aged 18 and over. However, the Australian Technical Advisory Group on Immunisation (ATAGI) recommends mRNA vaccines – Pfizer and Moderna – remain the preferred COVID-19 vaccines for booster doses in this age group.
Federal Government data as of 25 July confirms that more than 95% of people 16 and over have received two doses, although the figure for 12–15-year-olds is lower, at 79.53%.
Use of the Nuvaxovid vaccine in the national COVID-19 vaccination program for 12–17-year-olds is still yet to be considered by ATAGI, which is expected to provide advice to the Government in the coming weeks.
Provisional approval of the vaccine for people aged 12 years and older is ‘subject to certain strict conditions’, the TGA states, including the requirement for Novavax to provide continuous information to the TGA on longer term efficacy and safety.
Nuvaxovid should be administered in adolescents as a course of two doses 21 days apart – the same as the adult dosage rules – the TGA recommends. The vaccine contains the same ingredients as for people aged 18 years and older. Further information relating to ingredients, dosing, eligibility and interchangeability between vaccines is available on the Product Information document.
The TGA has confirmed its laboratories will also perform assessments of each batch of the vaccine before it can be supplied in Australia as an additional safety measure.
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