by SHAHEERA AZNAM SHAH / pic by TMR FILE
PHARMANIAGA Bhd has begun distributing the first batch of filled and finished Sinovac Covid-19 vaccines to vaccine storage and vaccination dispensing centres in the country.
The pharmaceutical company said about 290,480 doses of Sinovac vaccine had been transported from its production facility plant, Pharmaniaga LifeScience Sdn Bhd (PLS).
The first batch of the vaccine was handed to the Health Minister Datuk Seri Dr Adham Baba by Pharmaniaga group MD Datuk Zulkarnain Md Eusope (picture) at the Health Ministry (MoH) yesterday.
“PLS has recently obtained a lot of release approval for its filled and finished Sinovac Covid-19 vaccine from the National Pharmaceutical Regulatory Agency (NPRA), which allows the vaccines to be distributed to MoH’s designated health facilities.
“The approval is a historic event not only for PLS but also for Malaysia as this is the first-ever human vaccine produced locally,” it said in a statement yesterday.
The lot release of vaccines refers to the process of evaluating each lot of licensed product before approving its release from the manufacturing plant and onto the market, the company said.
It added the process usually takes about two weeks for it to be completed by NPRA. The first four batches released were manufactured from 200 litres of Sinovac Covid-19 bulk which arrived in Malaysia on Feb 27, for process validation batch manufacturing.
The supply was subsequently approved by the Drug Control Authority (DCA) on April 23, for commercialisation.
Pharmaniaga had submitted for registration of finished Sinovac Covid-19 vaccine since January 2021, of which the group has procured 400,000 doses of the finished vaccines directly from Beijing upon getting approval from DCA on March 2.
PLS is currently at its full production cycle capacity and able to produce two million doses per month.
As of May 10, PLS has manufactured 1.28 million doses of Covid-19 vaccine and 290,480 doses had received lot release approval.
“We are very grateful to the authorities, especially NPRA, for prioritising the vaccine evaluation and subsequent lot release approvals.
“Our appreciation also to DCA which approved the use of the vaccine.
“All vaccines produced will continue to be subject to stringent tests and evaluation by authorities, and our highly skilled technical teams will continue to adhere to it,” Zulkarnain said.
He added Pharmaniaga has put forward its best effort towards the ongoing phases of the National Covid-19 Immunisation Programme in the country.
“As of now, our focus is on the supply and distribution of Covid-19 vaccines, given new waves of the virus are expected to persist around the world.
“This is a core priority for the group and we will continue to be entrusted with this critical role in Malaysia’s fight against the pandemic,” he said.
Zulkarnain also said Pharmaniaga is currently waiting for approval by the China Food and Drug Administration for the Covid-19 vaccine for children aged three to 17 years old and manufacturing of two doses per vial.
“The production capacity is expected to increase by four million per month once the two-dose vial is approved.
“At present, the Sinovac Covid-19 vaccine has been approved in China and 44 other countries with more than 350 million doses had been administered globally.
“It is also tested to be effective against mutants reported in Brazil, the UK and South Africa,” he said.
Minister of Science, Technology and Innovation, Khairy Jamaluddin Abu Bakar said yesterday a million more doses of AstraZeneca vaccine will arrive this month.
He said the AstraZeneca opt-in vaccination programme will be expanded to other states and bookings will be made soon.