Pharmaniaga Bhd managing director Zulkarnain Md Eusope said they were awaiting approval by the China Food and Drug Administration (CFDA) for manufacturing two doses per vial before submitting it to the National Pharmaceutical Regulatory Agency (NPRA).
“The production capacity is expected to increase by four million per month once the two-dose vial is approved.
“We expect it will take about two to three weeks of evaluation upon submission to NPRA, followed by running another stability test for two doses per vial.
“All these requirements are standard practices in the vaccine industry to ensure the vaccine is safe prior to distribution to the public,” he said in a press conference here today.
He said up to May 23, PLS had completed the fill-and-finish manufacturing process for a total of 1,889,800 doses of the Sinovac vaccine.
Zulkarnain said of the total completed doses, the PLS plant rolled out 290,480 doses to the health ministry on May 11, which was from the 200-litre bulk vaccine received in February, for process validation.
“A total of 320,000 doses are awaiting approval from NPRA before being distributed to the rakyat. Some 319,320 doses are in the process of delivery, while the remaining 960,000 doses are undergoing 12 quality control tests before the release process for NPRA approval which is expected to be completed by the end of this month,” he said.
He said the plant is also expected to fill and finish another 720,000 doses, which it has carried out since last Sunday, to be completed by May 31, before undergoing the 12 quality control tests.
PLS expects to complete another two million doses of fill-and-finish vaccine in June, as well as receive three million doses of finished Covid-19 vaccines from Sinovac in China, bringing the total number of doses for June to about five million.
He said the company is also awaiting approval by CFDA for the Sinovac vaccine for children aged three to 17 years old and hopes it can be implemented in the third or fourth quarter of this year, subject to approval.
Meanwhile, Zulkarnain asserted that PLS is the sole distributor of the Sinovac vaccine in Malaysia and all parties should go through PLS if they want to donate the vaccine.
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