DCA approves Pharmaniaga-produced Sinovac vaccine

 

The Drug Control Authority (DCA) has approved the Sinovac vaccine that has been "filled-and-finished" by local drugmaker Pharmaniaga LifeScience Sdn Bhd (PLS).

This is the second source of Sinovac’s CononaVac vaccine to receive conditional approval for use in Malaysia, the other being finished doses produced by Sinovac itself in China.

“PLS’ fill-and-finish of CoronaVac is a new achievement for Malaysia that has long depended on the imported vaccine and plasma products,” Health Ministry director-general Dr Noor Hisham Abdullah said today.

He noted that this is the first time a vaccine has been filled and finished locally in Malaysia.

“It is hoped that this development would drive growth in the local pharmaceutical industry in producing such products,” he said.

As with all other Covid-19 vaccines approved by the DCA to date, the conditional approval requires vaccine registration holders to provide the latest additional data on their products from time to time.

This is to ensure that the benefits of the vaccine always outweigh its risk.

The partnership between Sinovac and PLS is one of several tie-ups between local manufacturers and foreign vaccine developers as part of a government plan to develop local capacity to produce Malaysia’s own vaccines in the future.

PLS is importing 14 million CoronaVac doses in bulk to bottle and package it into the finished product at its facilities in Puchong, Selangor, which requires stringent controls to ensure the final product is safe and free from contaminants.

The CoranaVac doses currently used in Malaysia’s National Covid-19 Immunisation Programme were procured directly from Sinovac itself from its facilities in China.

The government is procuring a total of 12 million doses of the CoronaVac vaccine. This is enough to cover 18.75 percent of Malaysia’s population.

Other tie-ups are between China’s CanSino Biologics and Solution Biologics Sdn Bhd, as well as between Russia’s Gamaleya Institute and Malaysia’s Duopharma Sdn Bhd. Both of those vaccines and the local partners have yet to receive DCA approval. - Mkini