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Novavax given limited approval as booster


Jolyon Attwooll


2/03/2022 3:26:47 PM

New ATAGI advice permits Novavax for third dose and encourages those who had AstraZeneca as primary course to take mRNA booster.

Novavax vial.
ATAGI has said Novavax can be used as a booster provided no other COVID-19 vaccine is suitable for that individual. (Image: AAP)

The Australian Technical Advisory Group on Immunisation (ATAGI) has stated that Novavax can be used as a COVID booster vaccine in limited circumstances.
 
The group issued the new guidance on Wednesday (2 March). It allows GPs to administer the vaccine, which was the fourth to be approved for use in Australia, as a booster for patients aged 18 and over ‘if no other COVID-19 vaccine is considered suitable for that individual’.
 
In a shift to the previous procedure, ATAGI issued its advice prior to the approval of Novavax for use as a booster by the Therapeutic Goods Administration (TGA).
 
The TGA last week said it is expecting data to support an application for Novavax’s use as a booster this month.
 
The ATAGI announcement references the application for Novavax in its latest announcement.
 
‘An application for the Novavax vaccine for use in Australia as a booster dose is expected to be provided to the TGA shortly,’ it states.
 
‘There is currently limited evidence that supports the safety and immunogenicity of Novavax used as a homologous or heterologous booster.
 
‘ATAGI considers Novavax to be acceptable for use as a booster dose in an individual aged 18 or older if no other COVID-19 vaccine is suitable for that individual.’
 
Previously Novavax had only been approved as a two-dose primary vaccine course, with many general practices deciding not to offer it as an option due to the advanced stage of the vaccine rollout in Australia.
 
As of Thursday last week, around 15,000 doses of the Novavax vaccine had been administered around the country.
 
At a recent COVID-19 webinar GPs were advised that Novavax would not currently be covered by the vaccine compensation program if used off-label as a booster.
 
The Department of Health (DoH) has been approached by newsGP to check whether that has now changed with the shift in ATAGI advice.
 
Another alteration to ATAGI’s advice surrounds AstraZeneca, which is now no longer recommended for a booster dose for patients whose primary vaccine course was two-doses of AstraZeneca.
 
It is a shift in policy that actively encourages a mixed dose schedule for those who had the adenoviral vector AstraZeneca vaccine.
 
However, it can still be administered as a booster if patients refuse to take the recommended option.
 
‘[AstraZeneca] can still be used [as a booster] if these individuals decline receiving an mRNA vaccine as a booster dose,’ the ATAGI recommendation reads.
 
‘The only scenario in which a booster dose using AstraZeneca vaccine is actively recommended is for people with medical contraindications to the Pfizer and/or Moderna vaccines [eg anaphylaxis, myocarditis].’
 
The ATAGI announcement says that while a third dose of AstraZeneca ‘provides a booster effect … and is well tolerated’, new research suggests mRNA vaccines could be more effective.
 
‘Recent immunogenicity studies show that mRNA vaccines as a booster produce significantly higher antibody levels, which suggest that they could provide better protection,’ ATAGI states.
 
‘This is particularly important with Omicron becoming the dominant circulating SARS-CoV-2 variant, where higher antibody levels after the booster dose appear important for providing protection.’
 
Australia has an agreement in place to purchase 51 million doses of the Novavax vaccine.
 
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