FDA passes on using Sinopharm vaccine for children over 3 years old

Thailand’s Food and Drug Administration has denied Sinopharm’s request to administer Covid vaccinations to children over 3 years old. The FDA cited a lack of data on the safety and efficacy of the vaccine.

Dr Paisan Dankhum, the Deputy Secretary General of the FDA, says the FDA committee and experts across many agencies had discussed the safety and effectiveness of the Sinopharm vaccine last week following Biogenie Tech, a distributor of Sinopharm in Thailand, filing a request to widen the age group for Sinopharm to include Children over 3 years old, earlier this month. They would ultimately reject the request due to insufficient data related to the drug’s safety as well as questions of its effectiveness in the 3 to 17 year old group.

The FDA has notified Biogenie Tech of the rejection and has asked the company to send more information pertaining to the safety and efficacy from the emergency use in children in countries, like China, the UAE, and others, as soon as they can, says the Deputy Secretary General.

For older children, government spokeswoman Traisulee Traisoranakul says the Pfizer vaccinations for children between the ages of 12 and 17 are still voluntary and ultimately the parents’ decision. She adds that students will not be forced to get vaccinated before going back to school in 2 months. She adds that parents will be given more information to make an informed decision prior to parents giving their consent for their kids to get vaccinated.

SOURCE: The Pattaya News