Thai FDA delays Sputnik V approval after importer duplicates registration data
The Thai Food and Drug Administration (FDA) has postponed approval of the Sputnik V Covid-19 vaccine after discovering that the importer failed to supply registration details as requested.
Paisarn Dankum, secretary-general of the FDA, revealed that a second dossier of data was sent by Kingen Biotech Co on June 9, but was found to contain the same data previously submitted.
The data still lacks important information used to determine safety, quality and evidence of manufacturing standards, he said. As a result, 50 per cent of the information needed for registration, including data on active ingredients and product safety education, was still missing.
The FDA has asked Kingen Biotech Co to deliver the missing data for urgent consideration.
Meanwhile, the registration application for BioNTech-Pfizer vaccine is currently under consideration, the agency revealed last week.
So far, the FDA has approved five Covid-19 vaccine brands: AstraZeneca, Sinovac, Johnson & Johnson, Moderna and Sinopharm.
