MONDAY, April 29, 2024
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FDA rejects claim by private hospital on registration of Covid-19 vaccine

FDA rejects claim by private hospital on registration of Covid-19 vaccine

The Food and Drug Administration (FDA) has denied a private hospital's claim that the state agency was taking three months to register Sinovac Covid-19 inactivated vaccine.

FDA secretary-general Dr Paisan Dankhum said that there is a registration for Sinovac by Government Pharmaceutical Organization (GPO), not from the hospital. The FDA also had never been contacted by the private hospital, except registration for approval of vaccine reservation on January 11.

The FDA is responsible for reviewing the vaccines that will be used in Thailand, which must be evaluated before use. To be suitable for Thai people, the vaccine will be evaluated for quality, safety and effectiveness. A person who wants to register must show documentary information to assess the qualifications of the vaccine in all three areas, after which the FDA is ready to fully facilitate registration.

The secretary-general added that the FDA was aware of the current situation regarding the Covid-19 epidemic and had adjusted operating guidelines to allow all types of health products to meet the needs of people during the period, including offering advice or answer questions all the time.

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