SINGAPORE: The Health Sciences Authority (HSA) has authorised Pfizer’s Comirnaty COVID-19 vaccine for use in children aged six months through four years.
The vaccination regimen for the primary series in this age group consists of three 3-microgram doses.
The first two doses should be administered three weeks apart, followed by a third dose to be administered at least eight weeks after the second dose, HSA said in a press release on Thursday (Sep 29).
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 (MOH) when ready, the authority added.
HSA said it has carefully considered the clinical data and assessed that the benefits outweighed the risks for use of the Comirnaty vaccine in children aged six months to four years.
In making this regulatory decision, HSA said it also consulted experts from its Medicines Advisory Committee and Panel of Infectious Diseases Experts.
The authority said its clinical data was based on an ongoing trial conducted by Pfizer, involving about 1,800 participants aged six months to four years.
“The results showed that the immune response in young children with a three-dose primary series was comparable to that in adults aged 16 to 25 years who received two higher doses of 30 micrograms as the primary series vaccine,” said HSA.
“Hence, it can be inferred that three doses of the vaccine may provide a similar level of protection in young children as that of two doses in adults.”
While there were no cases of serious adverse events reported in the clinical study with Comirnaty, HSA said it recommends that caregivers of young children monitor for signs and symptoms of myocarditis such as chest pain and breathing difficulty, as well as take precautions to minimise rigorous physical activity following vaccination.
HSA said it will continue to actively monitor the safety of the vaccine and require Pfizer to submit data from the ongoing clinical study, to ensure that the benefits of the vaccine continue to outweigh the risks.