ATAGI rules on Novavax

The Australian Technical Advisory Group on Immunisation (ATAGI) has recommended that Novavax’s COVID-19 vaccine be made available as a primary course for people aged 18 or older.
 
The statement follows the Therapeutic Goods Administration (TGA) issuing its own approval of the long-awaited candidate, paving the way for general practices, pharmacies, state vaccination hubs, and Aboriginal Community Controlled Health Services to start offering the protein-based vaccine from next month.
 
However, RACGP President Dr Karen Price has warned participating general practices will need more assistance in the coming months, with boosters and the childhood vaccination program both continuing at pace.
 
‘General practices participating in the vaccine rollout are doing a tremendous job, but we are under enormous pressure … [and] are also struggling to absorb the cost of taking part in the rollout,’ she said.
 
‘General practice teams did not sign up to make money but at the end of the day they must make ends meet and that is proving very difficult.’
 
Last year, the RACGP welcomed an additional $10 for practices delivering booster vaccines; however, since then Dr Price says the scale of the task has only grown.
 
‘We need the Federal Government to step up and provide greater assistance to our hardworking general practice teams,’ she said.
 
‘That will enable us to run more after-hours and weekend vaccinations and speed up the pace of the rollout as Omicron cases surge across Australia.’
 
With nearly 93% of Australians aged 16 and over already considered fully vaccinated, it is not known how many of the 51 million Novavax doses will be required in 2022. However, more than half of respondents to a newsGP weekly poll conducted in October last year indicated that they encountered patients ‘daily’ who were ‘waiting for Novavax’.
 
Regardless of the reason behind a person receiving the Novavax vaccine, Dr Price said the most important thing is that ‘people get vaccinated’ against COVID.
 
‘All of the vaccines, including Novavax, are extremely safe and effective and will significantly reduce the incidence of people suffering severe effects from the virus, including hospitalisation or worse,’ she said.
 
‘Novavax will be particularly beneficial for those who have contraindications to other COVID-19 vaccines, including serious reactions to previous doses.
 
‘Whatever the reason someone will be receiving the Novavax COVID-19 vaccine, as with every other vaccine dose administered, I congratulate them for doing their bit in protecting themselves and their communities.’
 
ATAGI’s advice indicates that the newly available vaccine can be used to protect people aged 18 and over, with the only contraindications being anaphylaxis to a previous dose of a Novavax COVID-19 vaccine or to a component of the vaccine, such as polysorbate 80.
 
‘There are no specific precautions for the use of [the] Novavax COVID-19 vaccine,’ ATAGI states.
 
While the guidance states that the vaccine can also be administered to pregnant and breastfeeding women, ATAGI notes that unlike both Pfizer and Moderna, for which there are substantial data on their safe use in these cohorts, ‘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,’ ATAGI states.
 
The advisory group has also indicated that the vaccine can be administered to people with a prior history of SARS-CoV-2 infection, in line with recommendations for other COVID-19 vaccines, and as part of a heterologous (mixed) primary schedule, including as a third dose for people with severe immunocompromise.
 
Novavax is not, however, currently recommended for use as a booster vaccine.
 
As well as calling for additional funding to better facilitate general practices’ efforts, the RACGP has also pointed to ongoing issues with the rollout of paediatric and booster doses that still need to be resolved.
 
‘Term one of school starts next week, yet just one in four children aged 5–11 have had their first Pfizer vaccine dose and the vast majority of kids must wait eight weeks before receiving their second,’ Dr Price said.
 
‘Although there are plenty of children’s vaccine doses in Australia, the challenge is getting those supplies into practice fridges and then into arms.’

Dr Price said GPs are still reporting doses not arriving on time or insufficient stock being delivered. Based on the back to school timeline, she said the current delivery schedule of 100 or 200 paediatric vaccines a week per practice is not enough, especially as some practices have ‘well over 1500 children’ in that cohort on their books.
 
‘So general practice teams then have the unenviable task of ringing families and telling them that their child’s appointment must be cancelled,’ Dr Price said.
 
‘This is causing a lot of stress and anxiety and, unfortunately, some people are once again taking their frustration out on exhausted nurses and receptionists.
 
‘We are the backbone of the vaccine rollout but we are only human and given that so many pharmacies have opted out of delivering COVID-19 vaccines, general practices are shouldering an increased load.
 
‘GPs and their teams will carry on and get as many doses into arms as possible, but we need more help and that needs to happen right now.’
 
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ATAGI COVID-19 Novavax Omicron