Thailand waits for Russia’s Sputnik V to submit more data before approval

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The missing data, which includes GMP PIC/S certification or equivalent, essential drug data, details of the manufacturers’ analytical process and safety studies, is essential for TFDA’s consideration of the vaccine’s safety, efficacy and quality, said Dr. Paisal Dunkhum.

Russia’s Sputnik V COVID-19 vaccine is yet to be approved by Thailand’s Food and Drug Administration (TFDA), as vital data remains missing, the organisation said Wednesday.

The latest information, sent last week by KinGen Biotech, the pharmaceutical company that represents the vaccine’s manufacturer in Thailand, was the same set of incomplete data already sent to the TFDA, said TFDA Secretary-General Dr. Paisal Dunkhum.



The missing data, which includes GMP PIC/S certification or equivalent, essential drug data, details of the manufacturers’ analytical process and safety studies, is essential for TFDA’s consideration of the vaccine’s safety, efficacy and quality.

The TFDA has, therefore, requested the missing data from the company for the third time.



The TFDA has already approved five vaccine brands for emergency use in the country, namely Sinovac, Sinopharm, AstraZeneca, Johnson & Johnson and Moderna.

Sputnik V was authorized for emergency use in 67 countries worldwide as of June 2021. (NNT)