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07 Nov 2022

18th May 2021

       The Expert Committee on COVID-19 Vaccination endorses the extension of the interim authorisation of the Pfizer-BioNTech COVID-19 vaccine by the Health Sciences Authority (HSA), for use in Singapore in individuals aged 12 years to 15 years to prevent COVID-19 disease. 

2.     In December 2020, the Expert Committee endorsed the interim authorisation under the Pandemic Special Access Route (PSAR) of the Pfizer-BioNTech COVID-19 vaccine by HSA, for use in individuals aged 16 years and above in Singapore. More data from further studies in the age group of 12 to 15 years old was subsequently submitted by Pfizer-BioNTech. 

3.     The Expert Committee has independently reviewed the vaccine’s safety and efficacy data submitted for this age group. We have also been briefed by HSA on its full range of considerations in the extension of the interim authorisation.In assessing the vaccine, the Expert Committee took into consideration the safety, efficacy and tolerability of the vaccine, and study design for this age group.

4.     The Pfizer-BioNTech COVID-19 vaccine demonstrated a high vaccine efficacy consistent with that observed in the adult population. Its safety profile is also consistent with the known safety profile in the adult population and the standards set for other registered vaccines used in the immunisation against other diseases. Overall, the committee is satisfied with the safety and efficacy profile of the Pfizer-BioNTech COVID-19 vaccine for this age group. 

Dosing Interval 

5.     Additionally, the Expert Committee also considered the emerging scientific evidence and is of the view that extending the maximum dosing interval to six to eight weeks, so as to maximise first-dose vaccine coverage, is a reasonable strategy where there is a compelling need. EC19V noted that vaccination with the HSA PSAR approved mRNA vaccines is already considered valid in situations where the second dose is administered up to six weeks after the first dose. An extension to six weeks, but not longer than eight weeks, would not materially impact the eventual overall immune response, as long as the second dose is eventually administered. Please refer to the Annex for further details of the Expert Committee’s considerations.

6.     The Expert Committee will continue to monitor and review the use of COVID-19 vaccines in Singapore as more data becomes available over time. Singapore remains at risk of a surge in cases and it is therefore important that we achieve as comprehensive a coverage of COVID-19 vaccination as possible across the entire population. We strongly encourage all persons who are medically eligible to be vaccinated when the vaccine is made available to them.

18 MAY 2021