PETALING JAYA: Part of the regulatory process for the CoronaVac vaccine’s approval also involves assessing how the vaccines will be bottled by Pharmaniaga, says Khairy Jamaluddin.
The Science, Technology and Innovation Minister said this when explaining why the first batch of CoronaVac vaccines was being brought to Malaysia before it had gotten approval by the National Pharmaceutical Regulatory Agency (NPRA).
“This is a bulk delivery of the vaccine, this is not the finished product. This is different from vaccines that enter the country in the form of vials.
“The vaccines that we have received today are in bulk and will be sent to the Pharmaniaga plant in Puchong where the regulatory approval process will start, ” he said during a press conference at the Kuala Lumpur International Airport after the first batch of the vaccines arrived on Saturday (Feb 27).
He explained that there are two approval processes involved, which are evaluation of the actual vaccine itself and the bottling process by Pharmaniaga.
“Many are asking why we are receiving vaccines that have yet to obtain approval by the regulatory agency?
“This is because the regulatory process involves assessing how the vaccine will be manufactured or bottled by Pharmaniaga, after which the vaccine can be approved.
“Yes, the CoronaVac is still being evaluated by NPRA, but for us to give approval for Pharmaniaga to conduct the fill-and-finish process, NPRA has to also assess Pharmaniaga’s processes as well and that cannot be done if we don’t have the vaccine.
“They have to study the stability report and the manufacturing processes of Pharmaniaga, then only NPRA can conduct assessment and recommendation for approval, ” he said.
He compared this to other countries such as Singapore that have tight regulatory controls and who have already received the vaccines as a finished product.
He added that should the vaccine be approved, Pharmaniaga is expected to produce two million doses every month.
Earlier Saturday, the vaccines touched down at KLIA at 8.55am on flight MH319, which was operated by MASKargo.
Developed by Sinovac Life Sciences Co Ltd, the vaccines had journeyed from the plant in Beijing, China and arrived in bulk totalling 200 litres.