Q & A: Shedding light on the ‘fill and finish’ process


IN response to public query, Pharmaniaga Bhd has detailed its procedures, process of producing and distributing the Sinovac Covid-19 vaccine.

Q: How much filled and finished doses have been produced by Pharmaniaga LifeScience Sdn Bhd (PLS)?

A: As of Saturday, PLS has produced 1,889,800 doses. Some 290,480 doses have been distributed to the Health Ministry starting on May 11. About 320,000 doses are awaiting the Lot Release process by the National Pharmaceutical Regulatory Authority (NPRA) while 319,320 doses are being sent out. The remaining 960,000 doses are undergoing 12 stringent quality tests before the Lot Release process. It is expected that some 720,000 doses will be ready between May 23 and 31 for tests. A total of 2,609,800 doses will be produced by the end of May.

Q: How many doses have been handed over to the government?

A: The first batch of vaccines, involving 290,480 doses, were handed over to the Health Ministry on May 11. From the amount, 251,480 doses were distributed to the Vaccine Storage Centre and Vaccination Centres throughout the country. The remaining 39,000 doses are awaiting instructions to be sent out.

Q: How many vaccines are obtained in bulk and in finished products by Pharmaniaga or PLS?

A: PLS has received 1.4 million finished products from China and 3,400 litres of bulk vaccine for fill and finish production. Of the 1.4 million doses, 400,000 doses have been distributed to storage centres and vaccination centres in the country while the remaining one million doses will be distributed next week after getting the Lot Release process by the NPRA.

Q: How much doses can be bottled by PLS every week or month?

A: PLS’s plant can produce 500,000 doses every week or two million every month. The capacity will be increased to one million a week and four million a month starting in August.

Q: How many doses are supplied by Pharmaniaga to the National Covid-19 Immunisation Programme?

A: Pharmaniaga supplies 12.4 million doses of the Sinovac vaccine to the programme.

Q: Can companies or individuals buy the Sinovac vaccine directly from the manufacturer in Beijing, China?

A: According to the Control of Drugs and Cosmetics Regulations, only one party is allowed to register for a drug or vaccine brand. At the same time, Sinovac Life Sciences in Beijing has appointed Pharmaniaga LifeScience Sdn Bhd as its exclusive distributor in Malaysia for its finished and filled and finished vaccines through a Technology Transfer Agreement. This means that each purchase for the Sinovac vaccine in Malaysia can only be made through Pharmaniaga.

Q: Is it true that Pharmaniaga monopolises the purchasing of vaccines?

A: Pharmaniaga is not involved with the procurement of other vaccines like Pfizer and AstraZeneca. Allegations that Pharmaniaga monopolises the procurement and trade of Covid-19 vaccines is baseless.

Q: How much is a dose?

A: No country in the world will reveal the prices of the vaccines they bought from manufacturers as it is subject to an agreement between the respective countries and the manufacturer.

Q: Is it true that Pharmaniaga sells vaccines to state governments or private sector?

A: As of now, Pharmaniaga only supplies the vaccines to the Health Ministry. Pharmaniaga is allowed to supply the vaccines to state governments and private firms after fulfilling its agreement with the government.

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