Thai FDA rejects Sinopharm Covid-19 vaccine injections in children over 3 years old

National –

The Thai Food and Drug Administration (FDA) has rejected Sinopharm’s request to provide Covid-19 vaccination injections in children over 3 years old due to insufficient data on the safety and effectiveness of the vaccine.

Dr. Paisan Dankhum, the Deputy Secretary-General of the FDA, revealed today, September 21st, that the FDA committee and experts from many agencies had jointly considered the safety and efficacy of the Sinopharm Covid-19 vaccine last Friday after Biogenie Tech Co., Ltd., an authorized distributor of Sinopharm in Thailand, has requested permission to extend the legitimate age group for Sinopharm use to children over 3 years old in early September.

They mutually agreed to turn down the company’s request due to insufficient data on the safety and effectiveness of the vaccine in the prevention of disease in the age group of 3-17 years old.

“The FDA has already notified the result to the Biogenie Tech Co., Ltd., and asked the company to urgently send additional information to the FDA regarding the safety and efficacy information obtained from the emergency use in children from different countries, such as the People’s Republic of China, the United Arab Emirates, etc. for the committee to consider as soon as possible,” the Deputy Secretary-General concluded.

Meanwhile, government spokeswoman Traisulee Traisoranakul said yesterday that Pfizer injections among children aged 12-17 years old are voluntary under their parents’ decisions and considerations. They will not be forced to get shots before going to school by this November.

She stated: “To assist with decision-making, information about vaccines will be provided. Pros and cons will be clarified to both parents and students before filling out the consent whether they agree to be vaccinated before going to school.”

“Once vaccinated, the student’s information will be stored in the database of the Ministry of Public Health to continuously monitor the symptoms after the injection. Students who aren’t injected, however, will be welcome to attend school in person and we will not mandate vaccinations as a requirement to go back to school.” Traisulee stated.

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