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Australia’s vaccination experts from the Australian Technical Advisory Group on Immunisation (ATAGI) recommend that children aged 6 months to under 5 years get vaccinated against COVID-19 if they have certain health conditions or disabilities which increase their risk of getting very sick from COVID-19.

The Spikevax (Moderna) vaccine is approved for children aged 6 months to under 5 years 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 third 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
  • complex congenital cardiac disease
  • structural airway anomalies or chronic lung disease
  • Type 1 diabetes mellitus
  • chronic neurological or neuromuscular conditions, or
  • a disability that requires frequent assistance with activities of daily living, such as severe cerebral palsy or Down Syndrome (Trisomy 21).

Read the full ATAGI statement on vaccination for children aged 6 months to under 5 years here.

It is recommended eligible children have 2 doses of the COVID-19 vaccine, given 8 weeks apart. For children who are severely immunocompromised, it is recommended they have a third dose 8 weeks after their second dose. A third dose will increase the protection of these very vulnerable children.

If children have been infected with COVID-19, it is recommended that they wait 3 months before receiving their next COVID-19 vaccine dose. Waiting 3 months between infection and vaccination is likely to provide more protection from the virus for longer.

Moderna Bivalent provisionally approved

On 29 August 2022, the Therapeutic Goods Administration of Australia granted provisional registration for the Moderna Spikevax Bivalent Original/Omicron BA.1 (subsequently referred to as Moderna bivalent) vaccine for use as a booster dose in people aged 18 years and older.

Recommendations

  • The Moderna bivalent vaccine can be used as an alternative vaccine for any booster dose in people aged 18 years or older, according to the current ATAGI recommendations for booster doses.
  • ATAGI have made no changes to the current booster recommendations and is not advising any extra booster doses beyond the second booster dose (fourth dose) in selected populations.
  • Booster doses of the COVID-19 vaccine should be given at least 3 months after the most recent COVID-19 vaccine dose or previous SARS-CoV-2 infection.
  • Eligible individuals can receive Moderna bivalent or the original vaccines (various brands) whichever is available to them. Both bivalent and original vaccines result in an improvement in the immune response against BA.1 and BA.4/BA.5 Omicron subvariants, with the Moderna bivalent vaccine showing a small incremental benefit over the original vaccine for Omicron neutralisation.
  • Coadministration of Moderna bivalent vaccine with other non-COVID vaccines is acceptable, per current ATAGI clinical guidance.
  • The Moderna bivalent vaccine is not recommended for the primary course of vaccination (first two doses in most people or first three doses in severely immunocompromised people).
  • ATAGI does not currently recommend using the Moderna bivalent vaccine as a booster in anyone under 18 years as it is not registered for this age group.

Considerations

  • As of 28 August 2022, 71.7% of the eligible population have received a 3rd dose (first booster for most people) and 54.4% of eligible people aged 50 years or older have received a second booster dose (fourth dose for most people) which suggests that many people are overdue for a booster dose.1
  • ATAGI considers receiving all recommended doses more important in obtaining optimal protection against severe COVID-19 than the variant contained within the dose.2
  • While booster vaccination with a variant-containing vaccine may not necessarily 'match' the circulating variant, it is anticipated to induce a broad immune response to current SARS-CoV- 2 variants.3-5
  • The Moderna bivalent vaccine is only registered for use as a booster vaccine. It contains 50mcg of mRNA, comprising equal quantities encoding the spike protein from the original SARS-CoV-2 virus and Omicron BA.1 variant. The Moderna primary course requires 100mcg doses, and therefore the Moderna bivalent vaccine is not considered suitable for primary vaccination. There are no data as yet on the immunogenicity of this bivalent vaccine in a primary series.
  • COVID-19 case numbers due to BA.4 and BA.5 Omicron subvariants have peaked in Australia and are expected to reduce and plateau. There is uncertainty about the timing of any future increase in cases due to the current or new variants and the characteristics of these variants (transmissibility/virulence).
  • An assessment of potential benefits, risks and timing of second booster doses, in light of current epidemiology, should be considered in those adults in whom the benefits appear less certain, such as adults aged 30-49 years without other risk factors for severe COVID-19.

Vaccine presentation

  • The Moderna bivalent vaccine is presented as a blue-capped multi-dose vial (100 mcg/mL) containing either five 0.5mL doses or ten 0.5mL doses. The vaccine does not require dilution.
  • Each dose should be administered intramuscularly, preferably in the deltoid.
  • To minimise the risk of administration errors, providers should preferably prepare and store doses of the Moderna bivalent vaccine separately from other vaccines due to the use of similar coloured vaccine vial caps (such as the Moderna paediatric vaccine 6 months to 5 years formulation). Doses withdrawn in advance of administration should be clearly labelled.

This advice may change

ATAGI continues to monitor evidence on vaccine effectiveness, the epidemiology of SARS-CoV-2 (including its seasonality and emerging subvariants), and other bivalent COVID-19 vaccines (including BA.4/BA.5 subvariant vaccines). ATAGI will add to its recommendation as further evidence on the bivalent vaccine(s) and knowledge about other uncertainties accumulates.

More information

Fourth COVID-19 Dose Fact Sheet

ATAGI recommends the COVID-19 vaccination for some children aged 6 months to under 5 years.

ATAGI statement on the use of the Moderna bivalent Original/Omicron vaccine

Australian Department of Health - Information for people with disability on COVID-19 vaccines