By S BIRRUNTHA / Pic by AFP
The Health Ministry (MoH) agrees to give conditional approval for the use of the CoronaVac vaccine produced by Sinovac Life Sciences Co. Ltd., China and Pharmaniaga Lifesciences Sdn Bhd, Malaysia, to teenagers aged 12 and above in the country.
Health DG Tan Sri Dr Noor Hisham Abdullah said the decision was made through the 364th Meeting of the Drug Control Authority (DCA) which convened today.
He added that the MoH had previously approved the conditional registration of CoronaVac for the use among individuals aged 18 and above.
He said this is the second conditional approval of the Covid-19 vaccine for use in adolescents after the same approval was given to the Cominarty vaccine, a Pfizer-BioNTech product in June 2021.
“However, the DCA recommends that the use of Sinovac vaccine among adolescents aged 12 to 17 years is currently given priority to adolescents without comorbidities and those with allergies or are not suitable to receive the Pfizer vaccine.
“Evaluation for the use of Sinovac among adolescents with comorbidities will continue once sufficient data are submitted,” he said in a statement today.
According to Dr Noor Hisham, the conditional registration approval 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.
He said it was to ensure that the benefit over risk comparison for the vaccine remained positive.
“The 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,” he added.