FDA approves Sinovac, Sinopharm jabs for kids aged 6 up
The Thai Food and Drug Administration (FDA) announced on Friday that it has approved the use of Sinovac and Sinopharm Covid-19 vaccines in children aged six and above without adjustments to the dose.
“Previously, two vaccines were approved for use in adults aged 18 and above at 0.5cc per recipient. Now children aged six and above can also get them at the same quantity,” FDA secretary-general Dr Paisan Dankhum said on Friday.
The Sinovac vaccine will be imported by the Government Pharmaceutical Organisation (GPO), while Sinopharm by Biogenetech Ltd.
“The two companies submitted documents to the FDA to expand the range of those covered by both vaccines to the ages of three to 17. The FDA committee considered the current data and agreed that the vaccines can be safely used in children as young as six,” said Paisan. “More information is needed before the committee can approve the use of two vaccines in children aged three to five, and the FDA has notified the two importers to submit necessary documents as soon as possible.”
Before Friday, the Thai FDA had only approved Pfizer’s mRNA paediatric formulation in orange-cap vials for children above the age of five.