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No FDA nod for use of Sinopharm vaccine in children aged 3 and above

The Thailand Food and Drug Administration (FDA) has yet to approve giving Sinopharm Covid-19 vaccine to children aged over three years due to inadequate information on safety and efficiency, FDA secretary-general Paisan Dankhum said on Monday.

“Sinopharm’s importer, Bio Genetech Ltd, has applied to extend the use of Sinopharm vaccine for children aged 3-17 after it had been previously approved for use in people aged 18 years and above,” he said. “However, FDA committee and experts from various agencies agreed on September 10 that there is not enough information on the safety and effectiveness of the vaccine in children aged 3-17 years, therefore the FDA did not approve the use of Sinopharm vaccine for this age group.”

Paisan added that the FDA has informed Bio Genetech to urgently submit additional documentation that support the use of the vaccine in children of that age group, including statistics from countries that have approved the use of Sinopharm in children such as China and United Arab Emirates.

The Sinopharm inactivated vaccine has been approved for use in Thailand in an emergency situation since May 28. According to statistics from Chulabhorn Royal Academy, more than 6.3 million doses of Sinopharm vaccine have been provided nationwide.

Published : September 21, 2021