TGA approves second COVID-19 vaccine for youngest children

Jolyon Attwooll

29/09/2022 4:10:20 PM

The Pfizer vaccine is now approved for use in children aged six months to five years, with Moderna already available to the age group.

Little girl being vaccinated
Two vaccines now have provisional regulatory approval for the youngest age group.

A second COVID-19 vaccine is likely to become available for children aged six months to five years, after the Therapeutic Goods Administration (TGA) provisionally approved the use of Pfizer for the age group.
In an announcement on Thursday, the TGA confirmed regulatory approval of the vaccine, which follows a little more than two months after a similar decision for Moderna.
The TGA said the decision to add Pfizer to the list of approved vaccines involved careful consideration of data from an ongoing clinical study in the United States.
‘The study, which included over 4500 participants aged six months to five years, demonstrated that the immune response to the vaccine was similar to that seen in children aged 5–12 years,’ the TGA stated.
The TGA also said the data suggested the safety profile of the vaccine for the age group is similar to that of adults, with ‘mild’ observed side effects.
Pending advice from the Australian Technical Advisory Group on Immunisation (ATAGI), it is set to join the Moderna paediatric vaccine, which became available in Australia this month.
ATAGI currently recommends the Moderna vaccine only for the most at-risk children aged from six months to four years, including those with severe immunocompromise, disability, and with complex health conditions which increase the risk of severe COVID-19.
That includes children with the following:

  • Severe primary or secondary immunodeficiency
  • Bone marrow or stem cell transplant, or chimeric antigen T-cell (CAR-T) therapy
  • Complex congenital cardiac disease
  • Structural airway anomalies or chronic lung disease
  • Type 1 diabetes mellitus
  • Chronic neurological or neuromuscular conditions
  • A disability that requires frequent assistance with daily activities, such as severe cerebral palsy or Down Syndrome 
A primary course of the Moderna vaccine for the age group is two doses with a gap of eight weeks, apart from those with severe immunocompromise, who need three doses as part of a primary course.
General practices were invited to express their interest in providing the Moderna vaccine to this youngest cohort in late July, with take-up much lower than for the rollout in the adult population.
A primary vaccination course for the Pfizer vaccine is due to consist of three doses, with details of the recommended gaps – and the target group – likely to be confirmed by ATAGI in the coming weeks.
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