Sputnik V should be approved for use in Thailand next month: FDA
The reason Russia’s Sputnik V vaccine has not been registered for use in Thailand is because the importer Kingen Biotech Ltd has not yet submitted full documentation for registration, the Food and Drug Administration (FDA) said on Friday.
Covid-19 vaccine to be used in Thailand must be registered by the FDA as per four standards: Safety, quality, efficiency, and risk management, said FDA secretary-general Dr Phaisan Dankhum.
“Vaccine importers must submit documents giving all necessary information based on the guidelines provided by the ICH [International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use],” Phaisan explained.
“So far, three brands of Covid-19 vaccines have been registered in Thailand, namely AstraZeneca, Sinovac, and Johnson & Johnson, after their importers submitted all documents necessary to get approval,” he added.
“Meanwhile, the importer of Sputnik V has submitted some documents, such as details of manufacture, and animal and human trials, but they have yet to submit key details about quality control, safety, efficiency, and their risk management plan after the vaccine is used in Thailand.”
Phaisan added that Kingen Biotech has said that they will submit the rest of the documents later this month, after which the FDA will take around 30 days to complete the approval process.