PETALING JAYA: The “fill and finish” Sinovac vaccine by Pharmaniaga LifeScience Sdn Bhd has received conditional approval from the National Pharmaceutical Regulatory Agency (NPRA).
In a statement, health director-general Dr Noor Hisham Abdullah said this was the first “fill and finish” product manufactured in the country.
“This product is the second source of CoronaVac registered under Sinovac Life Science Co Ltd China.”
It is understood that the conditional approval will help boost Malaysia’s vaccine supply.
Noor Hisham said the development of a “fill and finish” vaccine was an achievement for Malaysia, which has been relying on imported vaccines and plasma.
“It is hoped this development will catalyse the growth of the local pharmaceutical industry to produce such products.”
As part of the conditional approval, Pharmaniaga is required to provide additional data on the vaccines from time to time to ensure the effectiveness and safety of the vaccine is up to date and the benefit-over-risk remains positive.
It was previously reported that Malaysia had bought 14 million doses of “fill and finish” Sinovac vaccines.
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