PUTRAJAYA OCT.1: The 364th Drug Control Authority (DCA) meeting held today has agreed to grant conditional approval for the use of CoronaVac vaccine produced by Sinovac Life Sciences Co. Ltd., China and Pharmaniaga Lifesciences Sdn. Bhd. Malaysia to those aged 12 years and above.
Director General of Health, Tan Sri Dr. Noor Hisham Abdullah said, CoronaVac has previously approved conditional registration for use among individuals 18 years of age and older.
“This is the second COVID-19 vaccine approved for use in adolescents after the same approval was given to the Cominarty vaccine, a Pfizer-BioNTech products in June 2021,” Dr. Noor Hisham said in a statement here today.
Dr. Noor Hisham added, the DCA recommends that the use of CoronaVac vaccine among adolescents aged 12 to 17 years is currently given priority to adolescents without comorbidities and who have allergies or are not suitable to receive Cominarty vaccine.
“Evaluation for the use of CoronaVac in adolescents with comorbidities will continue once sufficient data are submitted,” Dr. Noor Hisham said.
Dr. Noor Hisham added, the approval of this conditional registration requires information on the quality, safety and effectiveness of the vaccine product to be monitored and evaluated based on the latest data from time to time. It is to ensure that the benefit over risk comparison of the vaccine remains positive.
“The Ministry of Health (MOH) is also committed to improving access to COVID-19 vaccine products in Malaysia, by ensuring that they have been evaluated in terms of quality, safety and effectiveness by the National Pharmaceutical Regulatory Agency (NPRA) and approved by the DCA,” Dr. Noor Hisham said.-Malaysia World News