Biocelect Pty Ltd (Novavax) COVID-19 vaccine, NUVAXOVID, for use in individuals aged 12-17 years

The Therapeutic Goods Administration (TGA) has provisionally approved the Biocelect Pty Ltd (on behalf of Novavax Inc.) 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 9 June 2022 the NUVAXOVID booster dose for use in adults.

As with adults, the vaccine should be administered in adolescents intramuscularly as a course of 2 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, randomised, observer-blinded, placebo-controlled study, which was conducted in United States and included over 2200 participants aged 12-17 years. This study showed that the safety profile and efficacy in adolescents is similar to that seen in adults.

The decision to provisionally approve the vaccine was also informed by expert advice from the Advisory Committee on Vaccines (ACV), an independent committee with expertise in scientific, medical and clinical fields including consumer representation. The TGA will publish the Australian Public Assessment Report relating to this provisional approval in the coming days.

Provisional approval of this vaccine for individuals 12 years and older is subject to certain strict conditions, such as the requirement for Biocelect Pty Ltd (on behalf of Novavax Inc.) to continue providing information to the TGA on longer term efficacy and safety. As an extra check, the TGA laboratories will undertake batch assessment of each batch of the vaccine before it can be supplied in Australia.

Further information relating to dosing, eligibility for booster doses and interchangeability between vaccines can be found in the Product Information (PI) document, available on the TGA website.

The potential use of this vaccine in the national COVID-19 vaccination program in this age group will be considered by the Australian Technical Advisory Group on Immunisation (ATAGI) who will provide advice to the Government in the coming weeks.

Protein vaccines

NUVAXOVID is a protein subunit vaccine and is the first protein COVID-19 vaccine to receive regulatory approval in Australia. Protein vaccines use a non-infectious component found on the surface of the coronavirus and manufactured in cells in a laboratory. After vaccination, immune cells recognise the vaccine protein as foreign and launch an immune response against it.

Supporting regulatory documents

The provisional approval pathway provides a formal and transparent mechanism for registration of promising new medicines with preliminary clinical data.

The following regulatory documents are made available as part of this process:

• Product information (PI)
• Consumer Medicine Information (CMI)

• NUVAXOVID Decision Summary

  The decision summary provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the ARTG.

• AusPAR: NUVAXOVID

  An Australian Public Assessment Report (AusPAR) provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve a prescription medicine submission.

• AusPAR: NUVAXOVID homologous booster - Booster dose for individuals aged 18 years and older
• AusPAR: NUVAXOVID heterologous booster - Booster dose for individuals aged 18 years and older
• AusPAR: NUVAXOVID – Extension of indication, use in individuals 12 years and older
• AusPAR: NUVAXOVID – Transition to full registration
• Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine - Novavax) (Biocelect Pty Ltd) Labelling Exemption 2022