BANGKOK, Sept 21 (TNA) – The Food and Drug Administration has not approved the administration of the COVID-19 vaccine made by Sinopharm for children aged 3 and over on insufficient safety information and urged Biogenetech Co to give more information.
FDA secretary-general Dr. Paisarn Dunkum said Biogenetech which was the approved importer of the Sinopharm vaccine sought permission from the FDA to lower the minimum age of recipients of the Sinopharm vaccine from 18 to 3 years old.
On Sept 10 experts from the FDA and many other organizations considered information on the safety and efficacy of the vaccine and resolved not to reduce the minimum age of Sinopharm vaccine recipients to 3 years old as proposed because there was not enough information about the safety of the vaccine administration and the company did not submit any data on the efficacy of the vaccine among recipients aged 3-17 years.
The FDA already informed Biogenetch of the resolution and asked the company to present the additional information as soon as possible. The FDA especially sought information on the safety and efficacy of the vaccine administered under emergency conditions with children in the countries that approved its use such as China and the United Arab Emirates so that the FDA’s committee of vaccine experts could resume considering the company’s request right away, Dr. Paisarn said. (TNA)
