Thai FDA waits for final results on tot jab
published : 14 Sep 2021 at 18:56
writer: Apinya Wipatayotin
The Food and Drug Administration (FDA) is now waiting for the results of the Phase 3 trial of the Sinopharm Covid-19 vaccine on young children before it approves the vaccine for use on children as young as three years old.
Biogenetech Co, the importer of the Sinopharm vaccine, has already submitted the results from the first and second phases of a study on the safety of administering the vaccine to children, said Dr Paisarn Dunkum, secretary-general of the FDA, on Tuesday.
Currently, the vaccine is approved for use on people aged 18 and over and the company has requested approval that it be used on children from the ages of 3 and over, he said.
''The FDA last Friday discussed the company's request yet since the results from the final phase trial of the vaccine have yet to be submitted, the FDA still can't decide on the request," he said.
The FDA has therefore asked the company to submit the required results as soon as possible, he said.
The Phase 3 trial results are required because the FDA will need to know certain facts such as the exact doseage that is safe and effective for children as young as three years old and the proper time interval between the first and second shots of the vaccination, he said.
The Government Pharmaceutical Organisation (GPO) is also requesting for the FDA’s approval for administering the Sinovac Covid-19 vaccine to children aged 3 and over, he said.
The GPO is now following up on the Phase 3 trial of the vaccine on children being conducted in South Africa, he said.
The Sinopharm vaccine is currently allowed to be used by the Chulabhorn Royal Academy (CRA) on young children after a study that has already been approved by the CRA’s research ethics committee for this specific purpose, he said.