Science, Technology and Innovation Minister Khairy Jamaluddin refuted claims that the Sinovac Covid-19 vaccine doses completed by Pharmaniaga Berhad with the fill and finish process were inferior to the Sinovac doses manufactured in Beijing.
He said it took 10 weeks to distribute the fill-and-finished vaccine doses from Pharmaniaga because it underwent rigorous and thorough review by the National Pharmaceutical Regulatory Agency (NPRA).
“Why did it take from February until May to distribute the fill-finished product? That is because there was a need by the NPRA to undertake product process validation and stability testing. That was used for final approval.
“That process took about 10 weeks to complete, where it had to pass multiple tests, submission of data and reports that were needed by NPRA,” Khairy said.
He was speaking at a joint press conference today with Health Minister Dr Adham Baba on the National Covid-19 Immunisation Program (NIP) updates, which was held in Putrajaya and broadcasted online via livestream and video conference.
Khairy said this addresses the claim that has been circulated on social media questioning the quality of the fill-and-finished product from Pharmaniaga’s factory.
“Because of the stringent process validation that was required by NPRA, and because of the continuous quality control testing as well as lot release inspection that are done by NPRA, this means that the fill-finished product that comes out of Pharmaniaga’s factory in Puchong is of the same quality as the Sinovac vaccine that we receive from the Sinovac factory in Beijing, China,” he said.
Describing the claim as “most irresponsible”, Khairy said the full force of the law will come down on the person who originated the claim if the person was found.
Meanwhile, Khairy reiterated the ministry has come up with new standard operating procedures (SOPs) to prevent incidents of under-dosed vaccine shots.
“We have issued with immediate effect after the incident to identify a new SOP which is that the vaccinator will have to show the person that is being vaccinated the syringe, and show the person who’s being vaccinated that the syringe has been filled to the required quantity based on the vaccine.
“After the recipient is happy that the syringe is dosed up, then and only then can they vaccinate the person,” he said.
He was responding to a question about the “underdosing” issue which first arose when marketer Anoogrehan Manoharan reviewed a video of his AstraZeneca vaccination process at the World Trade Centre Kuala Lumpur (WTCKL) and claimed he did not receive the full dose of the vaccine.
However, Khairy did not offer an explanation on how the underdosing incident occurred in the first place. - Mkini
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