Sinopharm’s vaccine on track for approval after Thai importer submits documents
Complete documents to register Sinopharm’s Covilo vaccine for use against Covid-19 in Thailand have been submitted, Food and Drug Administration (FDA) secretary-general Dr Paisan Dankhum said on Monday.
Sinopharm is a state-owned company in China that manufactures the inactivated Covid-19 vaccine.
The documents were submitted by the vaccine's importer, Bio Genetech Ltd.
So far, four vaccines have been approved and registered for use in Thailand by the FDA -- AstraZeneca, imported by AstraZeneca (Thailand) Ltd and manufactured domestically by Siam Bioscience Ltd; CoronaVac or Sinovac, imported by the Government Pharmaceutical Organisation; Johnson & Johnson vaccine, imported by Janssen-Cilag Ltd; and Moderna vaccine, imported by Zuellig Pharma Ltd.
“Two more importers are in the process of vaccine registration -- Bio Genetech Ltd, and Kingen Biotech Ltd, which will import the Sputnik V vaccine,” he said.
“With complete documents submitted, the FDA will evaluate Bio Genetech’s application and complete the registration as soon as possible."
Phaisan added that it usually takes the FDA 30 days to finish the approval process after all the documents have been submitted.
“The FDA will carefully consider the quality, efficacy and safety of the Covid-19 vaccines to make sure they can be used in Thailand as soon as possible while following international standards of vaccine approval,” he said.