KUALA LUMPUR – The 356th Drug Control Authority (DCA) meeting today agreed to approve the conditional registration of 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 is the first time the product, produced by Pharmaniaga LifeScience Sdn Bhd (PLS) through “fill-and-finish” manufacturing, is being implemented in the country.
It is the second source of registered CoronaVac products from Chinese manufacturer Sinovac Life Sciences Co Ltd, he said in a statement today.
“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 Health Ministry wants to clarify that the conditional approval requires the company holding the product registration, namely PLS, 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 the government is committed to ensuring Malaysians achieve herd immunity in line with the targets set under the National Covid-19 Immunisation Programme. – Bernama, April 23, 2021
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