The Health Sciences Authority (HSA) in Singapore has extended the authorisation of Comirnaty COVID-19 vaccine by Pfizer-BioNTech for use in children of ages 5 to 11 years.

The vaccination regimen is to be administered as a two-dose primary series, 21 days apart, but given at a lower dose (10 micrograms) than that used for individuals aged 12 years and above (30 micrograms). This is the first COVID-19 vaccine authorised in Singapore for use in the 5 to 11 age group.

HSA had reviewed the clinical data for this subgroup which showed that 10 micrograms of the Comirnaty vaccine induced a robust immune response that was comparable to that with 30 micrograms observed in individuals aged 16 to 25 years. The vaccine efficacy was estimated to be 90.7% based on an ongoing Phase 2/3 study in children aged 5 to 11 years. 

HSA has required Pfizer-BioNTech to continue to provide information on the safety and efficacy of the vaccine in this younger age group.