On 29 September 2022 the Therapeutic Goods Administration (TGA) provisionally approved Comirnaty (Pfizer) COVID-19 vaccine for use in children aged 6 months to 4 years.
ATAGI has evaluated data on immunogenicity, efficacy, and safety to consider the use of the Pfizer 6 months to 4 years COVID-19 vaccine in this age group.
The COVID-19 Moderna already been recommended by ATAGI on 3 August 2022 in this age group, for high-risk children (as identified below). There is no preference for either the Moderna
ATAGI does not currently recommend vaccination for children aged 6 months to not in the below risk categories for severe COVID-19. Further information regarding the low risk of severe COVID-19 in healthy children aged
6 months to this statement.
ATAGI recommends the Pfizer 6 month to 4 years COVID-19 vaccine as a primary course of vaccination against SARS-CoV-2 for children aged 6 months to 4 years with severe immunocompromise, complex or multiple health conditions, or disability with significant or complex health needs.
This includes children with the following or similar conditions:
- Severe primary or secondary immunodeficiency, including those undergoing treatment for cancer, or on immunosuppressive treatments as listed in the ATAGI advice on 3rd primary doses of COVID-19 vaccine in individuals who are severely immunocompromised;
- Bone marrow or stem cell transplant, or chimeric antigen T-cell (CAR-T) therapy recipients;
- Complex congenital cardiac disease;
- Structural airway anomalies or chronic lung disease;
- Type 1 diabetes mellitus;
- Chronic neurological or neuromuscular conditions; or
- A disability with significant or complex health needs, such as severe cerebral palsy or Down Syndrome (Trisomy 21).
The Pfizer 6 months to 4 years vaccine requires 3 primary doses, each containing 3mcg of mRNA. ATAGI recommends an interval of 8 weeks between each dose. Children with severe immunocompromise are also recommended to receive
3 primary doses. ATAGI will update this recommendation if future evidence demonstrates a need for additional doses.
ATAGI currently recommends the administration of COVID-19 vaccines be deferred for 3 months after a confirmed SARS-CoV-2 infection. Vaccination after this interval is likely to provide a better immunological response and optimise the duration of protection.
The Pfizer vaccine for 6 months to 4 year old children (Pfizer 6 month to 4 years vaccine) is an mRNA vaccine. Each 0.2mL dose contains 3 micrograms of mRNA. Results of a recent clinical trial demonstrate the Pfizer 6 month to 4 years vaccine is effective at protecting against COVID-19 disease in children who have not yet been infected with SARS-CoV-2, and most side effects are short-term. However, there are little data available regarding the impact of COVID-19 vaccines on routine immunisations recommended in this age group. Furthermore, severe COVID-19 in this cohort is very rare.
The recommended primary course dosing schedule is 3 doses, 8 weeks apart. Whilst this differs from the interval used in the clinical trial conducted by Pfizer, research suggests a longer dose interval may improve vaccine effectiveness and reduce the risk of rare side effects, including myocarditis or pericarditis.
Recent safety data from the United States, indicates that the Pfizer 6 month to 4 years vaccine has a good safety profile. As at 1 September 2022, over 890,000 doses have been administered with only a small number of adverse events following immunisation reported.
ATAGI will continue to evaluate further data on the safety and efficacy of vaccinations against COVID-19 in this age group and provide updated recommendations as required.