KUALA LUMPUR – The by Drug Control Authority (DCA) has granted the conditional approval for the usage of CoronaVac manufactured by Sinovac Life Sciences Co. Ltd, China and Pharmaniaga LifeSciences Sdn. Bhd. Malaysia to be used on individuals aged 12 years-old and above.
Earlier, the CoronaVac was conditionally approved for the use on individuals aged 18 years and above.
Director-General of Health, Tan Sri Dr Noor Hisham Abdullah said that it is the second Covid-19 vaccine approved for the use on adolescents, after the similar approval was given to Cominarty manufactured by Pfizer-BioNTech in June 2021.
Nevertheless, the DCA recommended the administration of CoronaVac to prioritise on adolescents aged 12 to 17 without comorbidity or those who are allergic to Cominarty, or not suitable to receive Cominarty.
“Assessment on the usage of CoronaVac among adolescents with comorbidity will be made right after there is sufficient of data,” he said in a statement today.
The Ministry of Health (MOH) also said that the conditional approval requires quality, safety and efficacy information of the vaccine, and it is assessed and monitored based on the latest data from time to time, to ensure the benefit-risk comparison of the vaccine would remain positive.
He added, the MOH is always committed to increase access to the Covid-19 vaccine products in Malaysia, by ensuring that they are being evaluated from the aspects of quality, safety and efficacy by the National Pharmaceutical Regulatory Agency (NPRA) and approved by Drug Control Authority (DCA). -MalaysiaGazette