The Deputy Health Minister II, Datuk Aaron Ago Dagang has informed the Dewan Rakyat that Malaysia has been selected to be part of the Phase 3 clinical trials of the Sinovac Covid-19 vaccine for children aged 12 and under.
He was quoted saying by Astro Awani, adding that the study will begin at the end of this month and will be conducted in 10 locations, including 8 facilities under the health ministry, as well as Universiti Malaya and Universiti Teknologi Mara (UiTM).
Aaron Ago also said they study will be conducted by the Clinical Studies Malaysia (CRM) with the involvement of the Clinical Research Institute.
“Several discussion sessions were held by the Ministry of Health (KKM) with COVID-19 vaccine manufacturing companies to obtain the current status and data related to the effectiveness and safety of vaccine use for children under 12 years of age.”
“Although it has not yet received the required data from COVID-19 vaccine manufacturing companies so far, the Vaccine Candidate Selection Committee (JKPCV), KKM is examining the effectiveness and safety of the vaccine on the population based on scientific evidence through clinical studies or Real World Data.” he said.
Aaron Ago said this in response to a question raised by Ipoh Timur Member of Parliament, Wong Kah Woh on the suitability and effectiveness of using vaccines for children aged 12 and under.
In addition, he said that several several clinical studies are being and have been conducted globally.
“On September 20, 2021 Pfizer-BioNTech released the findings of a Phase 3 clinical study for children aged 5 to 12 year-old.”
“The vaccine was found to be safe and showed a strong neutralizing antibody response. Furthermore, based on a press release from Pfizer and BionTech on 15 October, the clinical study data was submitted to the US and European Food and Drug Administration (FDA) and European Medicines Agency (EMA).” he explained.
In addition, he said, China has approved two COVID-19 vaccines produced by Sinovac Biotech Ltd. and Sinopharm for emergency use for those aged 3 to 17 years.
Aaron Ago also said the Phase 1 and 2 clinical studies conducted by these companies found that the vaccine was safe and able to stimulate a strong immune response in children and adolescents against the virus.
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