KUALA LUMPUR: Children under 12 will be the focus in phase three of vaccine clinical trials for Sinovac (Covid-19 vaccine) which will begin at the end of this month, Deputy Health Minister II Datuk Aaron Ago Dagang said today.
He said Malaysia has been selected as one of the locations for the clinical trials which will be conducted in 10 locations, including eight facilities under the Ministry of Health (MoH), University Malaya (UM) and Universiti Teknologi Mara (UiTM).
He said the study would be coordinated by Clinical Research Malaysia (CRM) with the involvement of the Clinical Research Institute.
“Several discussion sessions were held by MoH with the Covid-19 vaccine manufacturing companies to obtain the current status and data related to the effectiveness and safety of the vaccine use for children under 12 years old,“ he said in the Dewan Rakyat.
He was replying to a question by Wong Kah Woh (PH-Ipoh Timur) whether the vaccine is suitable and effective to be provided to this age group.
Although MoH has yet to receive the required data from these manufacturing companies, Dagang said the Covid-19 Vaccine Candidate Selection Committee (JKPVC) is already examining the effectiveness and safety of the vaccine to the targeted population based on scientific evidence through clinical studies or Real World Data.
He said that several clinical studies are currently being conducted or have been conducted globally where Pfizer-BioNTech has already released the findings of a Phase three clinical study for children aged five to 12 years on Sept 20 this year.
Based on the findings released by Pfizer-BioNTech, he said the vaccine was found to be safe, well tolerated and showed a strong neutralising antibody response.
“Furthermore, based on a press release from Pfizer and BionTech on Oct 15, the clinical study data was submitted to the Food and Drug Administration (FDA) and European Medicines Agency (EMA),“ he added.
In addition, he said, China has approved two Covid-19 vaccines produced by Sinovac Biotech Ltd. and Sinopharm for emergency use for those aged three to 17 years where the Phase one and two of its clinical studies found that the vaccine was safe and able to stimulate a strong immune response in children and adolescents.
