DCA approves conditional registration for China's CoronaVac vaccine

DCA approves conditional registration for China's CoronaVac vaccine
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KUALA LUMPUR (April 23): The 356th Drug Control Authority (DCA) meeting today agreed to approve the conditional registration for the CoronaVac Suspension for Injection Covid-19 Vaccine (Vero Cell), Inactivated’ for use during disasters.

Health director-general Tan Sri Dr Noor Hisham Abdullah said this was the first time that the product, produced by Pharmaniaga LifeScience Sdn Bhd (PLS) through ‘fill-and-finish’ manufacturing, is being implemented in the country.

He said the product is the second source of registered CoronaVac product from the manufacturer, Sinovac Life Sciences Co Ltd, China

“The fill-and-finish manufacturing of the CoronoVac product by PLS is a new achievement by Malaysia, which has so far depended on imported vaccine products and plasma. It is hoped that the latest development can drive the growth of the local pharmaceutical industry in producing such products.

“The Ministry of Health (MOH) wants to clarify that the conditional approval requires the company holding the product registration, namely Pharmaniaga LifeScience, to present additional and latest data on the vaccine product from time to time.

“This is to ensure its effectiveness and safety is always updated and the benefit over risk comparison of the vaccine remains positive,” he said in a statement today.

He said the MOH would always improve the level of public health in the war against Covid-19 through the acquisition of vaccine supplies that had been evaluated from the aspects of quality, safety and effectiveness by the National Pharmaceutical Regulatory Agency (NPRA) and approved by the DCA.

Dr Noor Hisham said the government was also committed to ensuring adults in Malaysia achieved herd immunity in line with the target of the National Covid-19 Immunisation Programme.