“Indispensable manufacturing process for the Sinovac vaccine”


Senior Minister (Security Cluster) Datuk Seri Ismail Sabri Yaakob (front, second from right) receives a package containing Sinovic vaccines from Chinese Ambassador to Malaysia Ouyang Yujing at KLIA. Also present are Khairy (front, left) and Foreign Minister Datuk Seri Hishamuddin Tun Hussein (front, right). – Photo by Bernama

KUALA LUMPUR: The Chinese Sinovac Covid-19 vaccine received by Malaysia must first go through a manufacturing process by the pharmaceutical company Pharmaniaga, to be evaluated and approved by the regulatory agency.

The Coordinating Minister of the National Covid-19 Vaccination Program, Khairy Jamaluddin, said the manufacturing process was one of the criteria that would be assessed by the National Drug Regulatory Agency (NPRA) before making recommendations to the Drug Control Authority (PBKD) for approval.

“Many ask why we are getting a vaccine that has not yet been approved by regulations today. This is because the regulatory approval process needs to consider how this vaccine is bottled before it can be approved. “

He said this was aimed, among other things, at providing registration request data and performing a validation process as well as reviewing plant stability data.

Khairy, who is the Minister of Science, Technology and Innovation, said this at a press conference held after witnessing the arrival of the 200 liters of Sinovac vaccine, developed by the Chinese pharmaceutical company. , at Kuala Lumpur International Airport (KLIA) from Beijing. , China, yesterday morning.

The minister stressed that the evaluation process was aimed at ensuring that the vaccine bottled at the Pharmaniaga plant would be similar, in terms of quality and potential, to those made in China.

“This will allow data from human clinical trials conducted with products made by manufacturers in China to be used by Pharmaniaga to support their products to be safe and effective,” he said.

He also explained that the vaccine had been received in advance by Malaysia even though it had not yet been approved by the national regulatory body due to the limited supply of the global Covid-19 vaccine.

Khairy said, for example, that Singapore had also received the vaccine as a finished product, although it had not yet received approval from the country’s regulatory body.

“We want to make sure that even if regulatory approval has not been given, we give permission to import (Sinovac vaccine) so that the stability tests can be tested at the plant.

“Once it gets approved by the NPRA and the PBKD, the vaccine is already here, so it will be easy for us to continue,” he said.

“I was informed that Pharmaniaga could produce two million doses (of Sinovac) each month at its factory in Puchong, which means that we would have a steady supply of Pharmaniaga,” he said.

Asked to comment on the approval date of the Sinovac vaccine, Khairy said it would be owned by Malaysia’s Ministry of Health (MoH) and NPRA.

“I don’t know and I can’t know because the NPRA works independently and neutrally, and I can’t ask when they would approve it.

“They have to be allowed to do the job.

“Of course we want them to approve it safely and as quickly as possible, but there is no shortcut,” he said.

As to whether Sinovac vaccine registration approval needs to be made every time the vaccine bundle is received from China, Khairy said it would only be implemented once.

“If the NPRA is happy with the vaccine that we received today (yesterday) as well as the manufacturing process and also the stability tests carried out (by Pharmaniaga), then it would be approved and would be registered, maybe,” with conditional registration, similar to Pfizer.

On media reports that the United States Food and Drug Administration (FDA) approved the storage of the Covid-19 Pfizer vaccine at -20 ° C from -70 ° C to -80 ° C previously, Khairy confirmed the ‘case.

“What Pfizer will have to do now is submit to the NPRA the new data that shows the vaccine is stable for two weeks at -20ºC for NPRA approval. Although we agree with the FDA, we have to approve it here, ”he said.

Regarding the status of the acquisition of the vaccine from Johnson & Johnson, Khairy said the Department of Health is refining the company’s condition sheet and has requested that it be signed by the Minister of Health Datuk Seri Dr Adham Baba in the near future.

Meanwhile, Khairy said a total of 1.183 million records to receive the vaccine were recorded on the MySejahtera app, and a total of 3,580 people had received the vaccine as of 7 a.m. yesterday. – Bernama


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