KUALA LUMPUR, February 27 – The Chinese Sinovac Covid-19 vaccine received by Malaysia today must first go through a manufacturing process by pharmaceutical company Pharmaniaga, to be evaluated and approved by the regulatory agency.
National Covid-19 Vaccination Program Coordinating Minister 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.
âMany ask why we are receiving a vaccine that has not yet been approved by the regulatory agency today. This is because the 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 also Minister of Science, Technology and Innovation, said this at a press conference after witnessing the arrival of the 200 liters of Sinovac vaccine developed by the Chinese pharmaceutical company to the Kuala Lumpur International Airport (KLIA), from Beijing, China, this morning.
Khairy stressed that the evaluation process was aimed at ensuring that the vaccine bottled at the Pharmaniaga plant is similar in 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 vaccine against Covid-19. .
Khairy said, for example, that Singapore has also received the vaccine as a finished product, although it has yet to receive approval from the country’s regulatory body.
âWe 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 factory. Once it is approved by the NPRA and the PBKD, the vaccine is already there, so it will be easy for us to continue, âhe said.
âI have been informed that Pharmaniaga can produce two million doses (of Sinovac) every month at its factory in Puchong, which means that we will have a steady supply of Pharmaniaga,â he said.
Asked to comment on the approval date of the Sinovac vaccine, Khairy said it was owned by Malaysia’s Ministry of Health (MoH) and NPRA.
âI don’t know and I can’t know because the NPRA works independently and neutrally and I can’t ask when they will approve it. They must 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, âhe 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 have received today as well as the manufacturing process and also the stability tests carried out (by Pharmaniaga), then it will be approved and registered, perhaps, with the registration. conditional, 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 degrees Celsius from -70 to -80 degrees Celsius previously, Khairy confirmed the case .
âWhat Pfizer will have to do now is submit to the NPRA the new data that shows the vaccine is stable for two weeks at -20 degrees Celsius for NPRA approval. Although we agree with the FDA, we have to approve it here, âhe 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 had been recorded on the MySejahtera app and a total of 3,580 people had received the vaccine as of 7 a.m. today. . Bernama