Pharmaniaga Must Fulfil Putrajaya’s ‘Entire’ Covid-19 Vaccine Order First: Khairy

Khairy Jamaluddin also says that the filled and finished Sinovac vaccine produced by Pharmaniaga is of the same quality as the finished vaccine imported from China due to NPRA’s rigorous quality control.

KUALA LUMPUR, May 25 — The federal government today put its foot down on the supply of Sinovac’s Covid-19 vaccine, telling Pharmaniaga Bhd to deliver its entire order of 12 million doses first before supplying state governments and private parties.

Vaccine Minister Khairy Jamaluddin’s instructions to Pharmaniaga — if heeded by the government-linked company (GLC) — could slow the supply of Sinovac vaccines to any state governments that have or are planning to make orders, in a bid to procure their own supply independent of Putrajaya.

“For Sinovac, the order from the federal government must be fulfilled in its totality before they can sell to private entities or state governments,” Khairy told a joint press conference today with Health Minister Dr Adham Baba.

“That is the condition that we have given Sinovac as well as Sinovac’s local product registration holder, which is Pharmaniaga. 

“The federal government’s order, in its entirety, must be fulfilled first before there is any sale to any private entities or state governments. This is because we have to prioritise the National Immunisation Programme, where we give vaccines for free to everyone who is a resident of Malaysia.” 

The federal government has appointed local pharmaceutical company Pharmaniaga as the sole manufacturer to produce Sinovac’s Covid-19 vaccine via fill-and-finish, as well as sole distributor to import the finished product from Sinovac’s manufacturing plant in Beijing, China. 

Pharmaceutical companies typically fill product orders from various customers simultaneously in a staggered manner, but Khairy has now instructed Pharmaniaga to fill the federal government’s entire Covid-19 vaccine order first before working on orders from other parties, including state governments. 

Khairy said today that Pharmaniaga is expected to deliver 320,000 doses of Sinovac’s vaccine produced via fill-and-finish, the final stage of manufacturing, this week. About 1.7 million doses have been delivered so far, including 1.4 million doses of the finished vaccines imported directly from China. That leaves another 10.3 million doses of the federal government’s order to fill.

Selangor’s state government said last week that it has booked 2.5 million doses of Covid-19 vaccines — whose brand it did not name — and that the state plans to roll out its own coronavirus vaccination programme next month.

Penang Chief Minister Chow Kon Yeow said last Friday that the state government intended to procure Covid-19 vaccines from distributors approved by the federal government or directly from vaccine manufacturers.

Only three Covid-19 vaccines have been approved by the National Pharmaceutical Regulatory Agency (NPRA) for use in Malaysia — Sinovac, Pfizer-BioNTech, and AstraZeneca-Oxford — all of which have been ordered by the federal government for the National Covid-19 Immunisation Programme (PICK).

“As far as I know, Pfizer and AstraZeneca only sell to national governments around the world,” Khairy said today.

The science, technology and innovation minister also stressed that Pharmaniaga did not have production problems and that the company’s vaccine manufacturing was progressing as planned. Pharmaniaga, he said, has a fill-and-finish production capacity of 500,000 doses per week. 

Senior Defence Minister Ismail Sabri Yaakob said Sunday that besides the 1.4 million doses of the finished Sinovac vaccine from China that have already been delivered to Malaysia, another three million doses would be imported by the end of next month. These 4.4 million doses of the finished vaccine comprise more than a third of the federal government’s order of 12 million doses.

“Pharmaniaga is bringing in additional finished products on its own initiative to help the government in expediting the national immunisation programme. And I think this additional procurement can also address the need for us to ramp up the vaccination process in the month of June,” Khairy said today.

He also explained that the reason why Pharmaniaga took three months to distribute its first batch of 290,480 doses of the filled-and-finished Sinovac vaccine this month, after receiving the unfilled vaccine in February, was because NPRA needed to undertake product process validation and stability testing for the vaccine.

“That process took about 10 weeks to complete where it had to pass multiple tests, submissions of data, and reports that were needed by NPRA,” said Khairy.

The vaccine minister refuted allegations on social media that the filled-and-finished Covid-19 vaccine from Pharmaniaga was of inferior quality to the finished product imported from China. 

“Because of the stringent process validation that was required by NPRA, and because of the continuous quality control testing as well as lot release inspections that are done by NPRA, this means that the fill-finish product that comes out of Pharmaniaga’s plant in Puchong is of the same quality as the Sinovac vaccines that we received from the Sinovac factory in Beijing, China, as the finished product.”

CodeBlue issued a statement yesterday on the circulation of a fake WhatsApp message attached to a CodeBlue article, where the message, which did not name an author, claimed that “corruption corrupted the quality of vaccine packed by Pharmaniaga”.

“This allegation is most irresponsible and if we find out who has been spreading this allegation, we will ensure the full force of the law comes down on that person,” Khairy said today.

The minister also said that the Special Committee on Ensuring Access to Covid-19 Vaccine Supply (JKJAV) would deliberate Thursday on whether to delay the second dose of coronavirus vaccines to protect more people with the first dose. 

Full dosage with the Pfizer and AstraZeneca vaccines provides full protection against new coronavirus variants like the B.1.617.2 variant first found in India and the B.1.1.7 “Kent” strain first detected in the United Kingdom. Sinovac, he said, is expected to publish data on the effectiveness of its Covid-19 vaccine against new variants.

A new Public Health England study showed that two doses of the Pfizer and AstraZeneca vaccines are 88 per cent and 60 per cent effective respectively against symptomatic disease from the B.1.617.2 variant.

However, both vaccines’ protection against symptomatic disease from the Indian variant is only 33 per cent three weeks after the first dose, lower than the World Health Organization’s (WHO) recommended 50 per cent effectiveness.

“We will certainly take into consideration emerging data that is coming out of the United Kingdom, suggesting that the full two doses are required for effective protection against the new variants,” said Khairy.

He also expressed confidence that Covid-19 vaccine supply for Malaysia would cover as many people as possible before year end, but said that herd immunity depended on the mutations of the virus and whether people who have yet to register for vaccination would come forward.

“I forecast that after September or October, we’ll have a different problem on our hands, which is that vaccination rates may plateau as we finish vaccinating everyone who has registered and we’ll have to start looking at people who have not registered to vaccinate.”

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