ATAGI has recommended the Novavax vaccine be used for a primary course of COVID-19 inoculation — including as part of a mixed schedule — but not as a booster.
The first batches of the vaccine, the fourth to be approved for Australia, were expected to be available in the week beginning 21 February, federal Health Minister Greg Hunt said on Monday.
In a statement on Nuvaxovid, ATAGI recommends two doses at least three weeks apart.
The vaccine can be administered as part of a mixed primary schedule to adults over 18 who have received one or more doses of another COVID-19 vaccine.
And it can be used as a third dose for people with severe immunocompromise.
But ATAGI stresses the vaccine is not currently recommended for use as a booster.
The vaccine can be given to pregnant and breastfeeding women, with the caveat being there is no available immunogenicity or safety data, as there is for the Pfizer and Moderna mRNA vaccines, as breastfeeding and pregnant women were excluded from clinical trials.
“However, there are no theoretical safety concerns relating to use in pregnancy since the Novavax COVID-19 vaccine, similar to other COVID-19 vaccines, is not a live vaccine,” ATAGI wrote.
Data from more than 30,000 phase III trial participants showed Nuvaxovid achieved 90.4% efficacy overall and 100% efficacy against moderate-to-severe disease.
For adults aged 65 or older vaccine efficacy was 88.9%, and in adults with a comorbid medical condition, it reached about 91%, ATAGI said.
Serious adverse events were rare, with a “numerical imbalance” in the incidence of hypertension in older adults during the three days following vaccination, 1% for Novavax vaccine recipients and 0.6% for those receiving a placebo dose.
Local adverse events were reported in 58% of participants after a first dose and 79% after a second dose, with the most common being injection-site tenderness and pain.
“Local adverse events were more frequent among younger (age 18-64) participants compared with older participants.”