Novavax receives COVID-19 booster approval

The Therapeutic Goods Administration (TGA) has granted provisional registration of Novavax’s Nuvaxovid COVID-19 vaccine as a booster in people aged 18 and over.
 
While the Australian Technical Advisory Group on Immunisation (ATAGI) had already advised that the vaccine could be used as a booster in limited circumstances, the new determination allows its use as a booster in any population aged 18 and over.
 
According to a company statement, provisional registration was based on data from Novavax’s Phase 2 trial conducted in Australia, from a separate Phase 2 trial conducted in South Africa, and from the UK-sponsored COV-BOOST trial.
 
As part of the Phase 2 trials, a single booster dose of Nuvaxovid was administered to healthy adult participants approximately six months after their primary two-dose course.
 
The third dose reportedly produced increased immune responses comparable to or exceeding levels associated with protection in Phase 3 clinical trials. In the COV-BOOST trial, Nuvaxovid also induced a ‘robust antibody response’ when used as a heterologous third booster dose.
 
The vaccine was the fourth candidate approved for use as part of Australia’s vaccine rollout, following Pfizer’s Comirnaty, AstraZeneca’s Vaxzevria, and Moderna’s Spikevax.
 
Comirnaty and Spikevax have been primarily used as boosters in Australia to date, with Vaxzevria typically only administered as a booster for patients who had a ‘significant adverse reaction’ following a previous mRNA vaccine dose.
 
Last week, Pfizer’s vaccine was the first to gain approval for use as a booster among immunocompromised 12–15-year-olds. Moderna’s application for Spikevax to be used a booster dose for individuals aged 12 years and over remains under evaluation.
 
As of 5 June, about 150,300 doses of Nuvaxovid had been administered in Australia, and while no adverse events have emerged that weren’t captured during clinical trials, the TGA is investigating whether there is an association between the vaccine and myocarditis and pericarditis.
 
So far, there have been three cases ‘likely to represent’ myocarditis and 11 likely to represent pericarditis in people who have received the vaccine, according to the most recent TGA COVID-19 vaccine safety report.
 
In the Novavax-sponsored trials, following the booster, local and systemic reactions were generally short-lived with a median duration of approximately two days. The incidence of Grade 3 or higher events remained relatively low.
 
Safety reporting of reactogenicity events showed an increasing incidence across all three doses of Nuvaxovid, reflecting the increased immunogenicity seen with a third dose.
 
Medically attended adverse events, potentially immune-mediated medical conditions, and severe adverse events occurred infrequently following the booster dose and were balanced between vaccine and placebo groups.
 
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