KUALA LUMPUR – China’s Sinovac Covid-19 vaccine received by Malaysia today must first undergo the manufacturing process by pharmaceutical company Pharmaniaga Bhd before evaluation and approval by the country’s drugs regulator.
Khairy Jamaluddin, the coordinating minister for the National Covid-19 Immunisation Programme, said the manufacturing process is among the criteria to be evaluated by the National Pharmaceutical Regulatory Agency (NPRA), before it makes recommendations to the Drug Control Authority (DCA) for approval.
“Many ask why we’ve received a vaccine that has yet to be approved by the regulator. This is because the approval process must look at how the vaccine is bottled before it can be approved,” he told a press conference after witnessing the arrival of 200l of the Sinovac vaccine from Beijing, China, at Kuala Lumpur International Airport this morning.
He said the evaluation process will ensure that the vaccine bottled at the Pharmaniaga plant is similar, in terms of quality and potential, to that undertaken in China.
“It will allow the data on clinical human trials conducted for products by manufacturers in China to be used by Pharmaniaga to support their products to be safe and effective.”
He said the vaccine was delivered in advance due to limited supply worldwide.
Singapore also received the vaccine when the jab has yet to get the green light from the republic’s regulator, he said.
“We want to make sure that even though regulatory approval has not been given, we granted permission to bring in (the vaccine) so that stability testing can be done at the factory.
“Once it is given approval by NPRA and DCA, since the vaccine is already here, it will be easy for us to continue.
“I was informed that Pharmaniaga can produce two million doses (of the Sinovac vaccine) every month at their factory in Puchong, which means we will have a steady supply from Pharmaniaga.”
Asked about the vaccine approval date, he said it is up to the Health Ministry and NPRA.
“I do not know, and I cannot know, because NPRA works independently and neutrally, and I cannot ask them when they will approve it. They must be allowed to do their work.
“Of course, we want them to approve it as quickly as possible, but there is no shortcut.”
On whether approval for vaccine registration will be done each time the doses arrive from China, he said it is a one-time process.
“If NPRA is satisfied with the vaccine we received today, as well as the manufacturing process and the stability testing (by Pharmaniaga), then it will be given approval and be registered, perhaps with conditional registration, similar to Pfizer.”
On press reports that the United States Food and Drug Administration (FDA) has approved the storage of the Pfizer jab at -20°C, from -70°C to -80°C previously, Khairy confirmed the matter.
“What Pfizer will have to do now is submit to NPRA the new data that shows the vaccine is stable for two weeks at -20°C. Although we have agreed with FDA, we have to approve it here.”
On the status of the acquisition of Johnson & Johnson’s Covid-19 vaccine, he said the Health Ministry is refining the term sheet from the company, and that he has requested that it be signed by Health Minister Datuk Seri Dr Adham Baba soon.
He added that 1.183 million registrations for vaccination have been made via the MySejahtera app, while 3,580 individuals have been inoculated, as at 7am.
On February 16, the prime minister announced that all MPs and assemblymen, regardless of political persuasion, will receive the Covid-19 vaccines in the phase 1.
Tan Sri Muhyiddin Yassin said this was agreed on by the Special Committee of Ensuring Access to Covid-19 Vaccine Supply (JKJAV), seeing that MPs and assemblymen are usually in contact with the people in the course of their work. – Bernama, February 27, 2021
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