30 September 2022 | News
HSA authorises the use of comirnaty COVID-19 vaccine by Pfizer in young children aged 6 months through 4 years
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The Health Sciences Authority (HSA) has authorised Pfizer’s Comirnaty COVID-19 vaccine on 28 September 2022, for the prevention of Coronavirus Disease 2019 (COVID-19) in children aged 6 months through 4 years. This is the second vaccine authorised for use in Singapore by HSA for young children. HSA had also previously authorised the Comirnaty vaccine for adults and older children aged 5 years and above.
HSA has carefully considered the clinical data and assessed that the benefits outweighed the risks for use of Comirnaty in children aged 6 months through 4 years. In making this regulatory decision, HSA also consulted experts from its Medicines Advisory Committee and Panel of Infectious Diseases Experts.
The vaccination regimen for the primary series in this age group consists of three 3-microgram doses – the first two doses to be administered three weeks apart, followed by a third dose to be administered at least 8 weeks after the second dose. Official vaccination recommendations on the use of this vaccine will be issued by the Expert Committee on COVID-19 Vaccination and the Ministry of Health when ready.
While there were no cases of serious adverse events such as myocarditis/pericarditis (inflammation of the heart muscle) reported in the clinical study with Comirnaty, HSA recommends that caregivers of young children should monitor for signs and symptoms of myocarditis such as chest pain, breathing difficulty, etc., as well as take precautions to minimise rigorous physical activity following vaccination.