Moderna Australia has clarified that the decision to remove their paediatric COVID-19 vaccine from Australia was due to stock shortages. The Therapeutic Goods Administration had provisionally approved the vaccine for children under six years old, but the supply was exhausted. The company stated that they are currently focused on supplying updated and targeted booster vaccines for individuals aged 12 and older, in accordance with the current guidelines set by the Australian Technical Advisory Group on Immunisation (ATAGI).
In response to Moderna’s decision, health authorities in Australia quietly removed both options of Moderna’s paediatric COVID-19 vaccine for children aged five and under. This was in line with ATAGI’s recent decision to no longer recommend COVID-19 vaccines for healthy individuals under five years old, unless they have specific high-risk medical conditions that could make them more susceptible to severe COVID-19.
ATAGI highlighted seven specific high-risk medical conditions that could place children in heightened-risk categories for severe COVID-19. These conditions include severe primary or secondary immunodeficiency, undergoing cancer treatment or immunosuppressive treatments, bone marrow or stem cell transplant, 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.
The advisory body explained that children aged six months to less than five years who do not fall under these high-risk categories have a very low likelihood of severe illness from COVID-19. They emphasized that hospitalization or death due to COVID-19 in this age group is rare, and underlying medical conditions or immunocompromise are usually present among those affected. Additionally, the rate of paediatric inflammatory multisystem syndrome following COVID-19 is relatively low in this age group, and it even declined further with the Omicron variant compared to previous strains of the virus.
ATAGI also mentioned that a clinical trial involving 5,500 children aged six months to five years showed that Moderna’s COVID-19 vaccine offered only modest protection against infection. Furthermore, the trial reported patterns of vaccine-related adverse events, with up to one in four children in this age group experiencing fever after vaccination. They noted that fever in young children can lead to medical review or investigations and occasionally trigger a febrile convulsion, highlighting the importance of considering the side effect profile in the risk-benefit discussion.
In addition to the changes regarding the paediatric vaccine, health authorities also revised their advice on COVID-19 booster shots for individuals aged 18 and under. They now recommend that children and adolescents without any risk factors for severe COVID-19 should not receive a booster shot.
Moderna Australia assured that their vaccine formula is still widely available in Australia, despite the removal of the paediatric vaccine. The company stated that they will continue to engage with vaccine advisory bodies regarding vaccine recommendations for Australians.
In summary, Moderna’s decision to remove their paediatric COVID-19 vaccine from Australia was influenced by stock shortages. Health authorities in Australia made the decision to no longer recommend the vaccine for healthy children under five years old, aligning with ATAGI’s guidelines. The advisory body stressed the low risk of severe illness from COVID-19 in this age group and highlighted the vaccine’s modest protection and potential adverse events. The health authorities also updated their advice on COVID-19 booster shots for individuals aged 18 and under. Moderna Australia remains committed to supplying updated booster vaccines for individuals aged 12 and older and will continue to engage with vaccine advisory bodies for future recommendations.
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