Thailand’s FDA doesn’t approve Russia’s Sputnik V vaccine, cites missing data

[Thaiger]

Today, Thailand’s Food and Drug Administration says Russia’s Sputnik V Covid-19 vaccine isn’t approved as crucial data is still missing. TFDA Secretary General Dr Paisal Dunkhum says the information, sent last week by KinGen Biotech, the pharmaceutical company representing the vaccine manufacturer, is the same unfinished date that was already sent to the TFDA. The missing data is: GMP PIC/S certification or equivalent Essential drug data Details of the manufacturers’ analytical process and safety studies (which is imperative for the TFDA’s calculation of the vaccine’s safety, efficacy, and quality The TFDA has asked for the absent data from the company […]

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[King Cotton]

1 hour ago, Thaiger said:

The missing data is: GMP PIC/S certification or equivalent Essential drug data Details of the manufacturers’ analytical process and safety studies (which is imperative for the TFDA’s calculation of the vaccine’s safety, efficacy, and quality The TFDA has asked for the absent data from the company

Yeah, we all know all that issue-clouding stuff. What we really, really want to know is why it's taken a full month to sort this data glitch out. Why are you TFDA people so slow at everything you do?

I could think of another, more appropriate meaning for TFDA, but I'd probably get banned from T-T.