ATAGI statement on the use of Novavax Covid-19 vax

Novavax COVID-19 vaccine, also known as Nuvaxovid has been provisionally approved by the Therapeutic Goods Administration (TGA) for use in a primary course of vaccination in people aged 18 years and older. Novavax COVID-19 vaccine is a spike protein-based vaccine. Each 0.5mL dose contains 5 micrograms of the of SARS-CoV-2 spike protein and 50 micrograms of Matrix-M as an adjuvant. Novavax COVID-19 vaccine has been demonstrated to be highly effective in preventing symptomatic COVID-19 in adults in a primary schedule, based on phase II-III clinical trials involving over 45,000 participants.

Novavax COVID-19 vaccine is not currently registered by the TGA for use as a COVID-19 booster vaccine.

ATAGI recommendations

• ATAGI recommends that Novavax COVID-19 vaccine can be used for the primary course of COVID-19 vaccination in people aged 18 or older.
• The recommended schedule for administration is 2 doses, a minimum of 3 weeks apart.
• Contraindications to vaccination are anaphylaxis to a previous dose of Novavax COVID-19 vaccine or to a component of the vaccine (e.g. polysorbate 80).
• There are no specific precautions for the use of Novavax COVID-19 vaccine.
• Novavax COVID-19 vaccine can be administered to pregnant and breastfeeding women. ATAGI notes that unlike the Pfizer and Moderna vaccines for which there are substantial data on their safe use in pregnancy and with breastfeeding, there are no immunogenicity or safety data for these groups with the Novavax COVID-19 vaccine. However, there are no theoretical safety concerns relating to use in pregnancy, since the Novavax COVID-19 vaccine, similarly to other COVID-19 vaccines, is not a live vaccine.
• Novavax COVID-19 vaccine can be administered to people with a prior history of SARS-CoV-2 infection, in line with recommendations for other COVID-19 vaccines.
• People with severe immunocompromise are recommended to receive 3 primary doses of COVID-19 vaccine, and Novavax COVID-19 vaccine can be used for this purpose. Refer to the ATAGI statement on the use of a 3rd primary dose which is recommended at an interval of 2 months after the 2nd dose.
• Novavax COVID-19 vaccine can be administered as part of a heterologous (mixed) primary schedule to people who have received one or more doses of another COVID-19 vaccine, including as a third dose for people with severe immunocompromise.
• Novavax COVID-19 vaccine is not currently recommended for use as a booster vaccine.
• Novavax COVID-19 vaccine can be co-administered with other vaccines if required.

Australian Government Department of Health