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

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Thailand’s FDA doesn’t approve Russia’s Sputnik V vaccine, cites missing data
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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 (for the 3rd time).

Currently, the TFDA has already approved 5 vaccines for emergency use in Thailand: Sinovac, Sinopharm, AstraZeneca, Johnson & Johnson, and Moderna.

The Sputnik V has been authorised for emergency use in 67 countries worldwide as of June 2021.

2 months ago, Russia had agreed to sell Thailand the Sputnik V vaccine.

SOURCE: Thai PBS

 

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