A new formulation of the Pfizer COVID-19 vaccine (Comirnaty) has been provisionally approved for use in children aged 5-11 years by the Therapeutic Goods Administration. This approval is based on the results of a recent clinical trial demonstrating that the vaccine is highly effective and that most side effects are mild and transient. ATAGI notes that real-world evidence on the safety of this vaccine in children aged 5-11 years is rapidly accumulating overseas, including data on the low rate of rare adverse events following immunisation, notably myocarditis, which the clinical trial was insufficiently powered to assess.

The recommended dose for this age group is 10µg (0.2mL), a third of the recommended 30µg dose for people aged ≥12 years.

ATAGI’s recommendations take into account:

  • The direct benefits of vaccination for the child in preventing illness;
  • The indirect benefits of vaccination for the child, their family and for the broader community. To realise some of these benefits, a large proportion of the 5-11 year age group would need to be vaccinated;
  • Adequate supply of the paediatric Pfizer COVID-19 vaccine is expected to be available to vaccinate all 5-11-year-old children.

To read the recommendations in full, please click on the link below:
ATAGI recommendations on Pfizer COVID-19 vaccine use in children aged 5 to 11 years