The Health Sciences Authority (HSA) in Singapore has extended the authorisation of Moderna’s Spikevax COVID-19 vaccine via the Pandemic Special Access Route (PSAR), for the prevention of COVID-19 in individuals 6 months to 5 years- administered as a course of two 25 microgram doses; 6 to 11 years- administered as a course of two 50 microgram doses; and 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.
Safety data from the clinical studies also showed that adverse events in adolescents and children were similar to those reported in adults.
Post-market surveillance data of mRNA vaccines has suggested a potential risk of myocarditis (inflammation of the heart muscle) in young adults and adolescents. While there were no cases of myocarditis reported in the clinical studies with Spikevax, the risks could not be excluded.
As of Tuesday, average daily infections over a seven-day period fell to 2,700 — down from a peak of 10,200 in mid-July.
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