PHARMANIAGA Bhd (Pharmaniaga) is on track to meet its contractual obligation to the Federal Government ahead of the agreed delivery schedule by supplying both filled and finished as wells as finished Sinovac COVID-19 vaccine.
Confident that it will be able to supply a total of 8.6 million doses by end of June 2021, Pharmaniaga’s wholly-owned subsidiary Pharmaniaga LifeScience Sdn Bhd (PLS) is also ready to ramp up production from two million to four doses a month in order to help the Government expedite the vaccination programme and achieve herd immunity.
“Up to May 23, PLS’s high-tech plant has completed fill & finish manufacturing a total of 1.89 doses of Sinovac COVID-19 doses,” Pharmaniaga’s group managing director Datuk Zulkarnain Md Eusope said.
“From the total completed doses, the EU certified plant has rolled out a total of 290,480 doses to the Ministry of Health Malaysia (MOH) on May 11, which was from the 200L of bulk vaccine received in February for process validation.”
Zulkarnain shared that 320,000 doses are awaiting approval from the National Pharmaceutical Regulatory Authority (NPRA) before it is ready to be distributed and administered for use of Rakyat. This stringent process for every batch of vaccine production is required for an approval called Lot Release by the NPRA.
Meanwhile, the remaining 960,000 doses are undergoing 12 quality control tests before the Lot Release process for NPRA approval which is expected to be completed by the end of this month, according to Zulkarnain.
“The plant is expected to fill and finish 720,000 doses which it has carried out since last Sunday and to be completed by May 31, then will undergo through 12 quality control tests. Accumulatively, PLS will have 2,609,800 doses of vaccine by end of May 2021,” Zulkarnain commented.
In tandem, Pharmaniaga has also received one million doses of finished vaccine from Sinovac in Beijing, China which has been approved its Lot Release by the NPRA. Altogether, the combination of finished vaccine from China and filled and finished finish vaccine in May alone has reached a total of more than 3.6 million.
Whereas, in June, PLS is expecting to complete another two million doses of fill and finish vaccine, as well as receive three million doses of finished vaccine from Sinovac in China. Thus, the total number of doses for June is expected to reach five million.
In the meantime, Pharmaniaga is awaiting approval by the China Food and Drug Administration (CFDA) for the Sinovac COVID-19 vaccine for children aged 3 to 17 years and manufacturing of two doses per vial before submitting it to NPRA for variation process. The production capacity is expected to increase by four million per month once the two-dose vial is approved.
The evaluation process will take about two to three weeks upon submission to NPRA, followed by running another stability test for 2 dose per vial. All these requirements are standards practice in the vaccine industry to ensure the vaccine is safe prior to distribution to the public.
“Nevertheless, looking at the critical current COVID-19 situation in Malaysia, we have proposed to the Government that we supply both finished vaccine as well as filled and finished vaccine in order to help the Government expedite the completion of NIP and at the same time review our contract obligation, thus shortened the supply period,” Zulkarnain pointed out.
“Upon completion of our obligation to the Government, we can start offering Sinovac COVID-19 vaccine to the private sector.”
Zulkarnain added that Pharmaniaga intends to import 10 million doses of Sinovac COVID-19 finished vaccine from China.
Zulkarnain opined that there could be possibility of vaccine supply shortage in Malaysia, taking into consideration the current geopolitics and supply issues around the world.
“World Health Organisation is expected to approve Sinovac COVID-19 vaccine very soon and we foresee that once it happens, the global demand for Sinovac will spike and we may not be able to obtain it easily like now,” he remarked.
“Thus, we plan to place the order now before that occurs.” – May 26, 2021
Photo credit: Malay Mail
