Singapore Extends the Use of Moderna Vaccine to Younger Population

Singapore’s Health Sciences Authority (HSA) has extended the authorisation of Moderna’s Spikevax¹ COVID-19 vaccine via the Pandemic Special Access Route (PSAR) on 24 August 2022, for the prevention of Coronavirus Disease 2019 (COVID-19) in individuals of the following age groups:

a) 6 months to 5 years; administered as a course of two 25 microgram doses;
b) 6 to 11 years; administered as a course of two 50 microgram doses; and
c) 12 to 17 years; administered as a course of two 100 microgram doses.

HSA has carefully considered the data from two clinical studies in children and adolescents, and assessed that the benefits outweighed the risks for use of Spikevax in individuals aged 6 months and above. In making this regulatory decision, HSA also consulted expert advice from the Medicines Advisory Committee and Panel of Infectious Diseases Experts.

Evaluation of available safety and efficacy data in adolescents and children

The clinical data was based on two ongoing Phase 2/3 studies conducted by Moderna, comprising more than 3,700 adolescents aged 12 to 17 years and 6,000 children aged 6 months to 11 years, respectively. The results showed that the antibody levels following two doses of Spikevax administered 28 days apart as primary vaccination were comparable to those seen in adults (18 to 25 years old) in whom vaccine efficacy had been demonstrated. Hence, it can be inferred that the vaccine may provide similar level of protection in the younger populations.

Locally, real-world evidence in adults has shown reduced vaccine effectiveness, which was estimated to be around 40%, against the Omicron subvariants. Similarly in the clinical study, results in young children aged 6 months to 5 years old have shown that the vaccine was 37% to 50% effective in preventing COVID-19. Nonetheless, the data in adults continued to show that the vaccine confers high protection of 80% against severe disease. Hence, it is reasonably expected that the vaccine would similarly protect children from severe outcomes of COVID-19 such as multisystem inflammatory syndrome in children (MIS-C) and other potential complications.

Safety data from the clinical studies also showed that adverse events in adolescents and children were similar to those reported in adults. The adverse events were mild-to-moderate and commonly reported with childhood vaccination, such as injection site pain, fever, fatigue and headache. These symptoms are reactions generally associated with vaccinations and expected as part of the body’s natural response to build immunity against COVID-19. These symptoms generally resolve on their own within a few days.


¹The Spikevax vaccine has been known as the Moderna COVID-19 vaccine when it was granted PSAR interim authorisation for individuals aged 18 years and above in February 2021.

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