SAFETY ASSURED
Khairy says he will get inoculated with the next vaccine NPRA approves as safe and effective
ACKNOWLEDGING that there is selective Covid-19 vaccine hesitancy among Malaysians who perceive one type to be better than others, Khairy Jamaluddin stresses that all approved vaccines are effective and pledges to be inoculated with the next brand authorised after Pfizer-BioNTech.
SCIENCE, Technology and Innovation Minister Khairy Jamaluddin pledged that he would get inoculated with the next vaccine that gets the stamp of approval from the National Pharmaceutical Regulatory Agency (NPRA).
“I will take whatever the NPRA approves as safe and effective as a demonstration of my confidence in the vaccine and NPRA.”
He said this after witnessing the delivery of CoronaVac, the Covid-19 vaccine manufactured by China-based Sinovac Life Sciences Co Ltd, at Kuala Lumpur International Airport (KLIA) here.
He said he would not get the Pfizer-BioNTech vaccine despite rising public confidence in the vaccine made by Germany and the US following the inoculation of Prime Minister Tan Sri Muhyiddin Yassin and Health director-general Tan Sri Dr Noor Hisham Abdullah on Wednesday.
“This is not because Pfizer is not good, but let’s allow ministers to set an example by getting the vaccine that is approved next.”
He said he would get the next vaccine that NPRA approved, be it Sputnik, Sinovac or AstraZeneca.
Khairy said there was “selective vaccine” hesitancy among Malaysians who were keen to get vaccines made by certain brands and rejected others.
“The logistics will be complicated if people are allowed a choice.”
A temperature-controlled container, known as an envirotainer, containing 200 litres of the CoronaVac vaccine arrived at KLIA at 9am yesterday. The batch flew in from Beijing on Malaysia Airlines Flight MH319 — an Airbus 330300 aircraft bearing the Jalur Gemilang livery.
Present were Foreign Minister Datuk Seri Hishammuddin Hussein, Senior Minister (Security Cluster) Datuk Seri Ismail Sabri Yaakob and Transport Minister Datuk Seri Dr Wee Ka Siong.
Present were Chinese ambassador to Malaysia Ouyang Yujing and Pharmaniaga Group managing director Datuk Zulkarnain Md Eusope.
Khairy, the coordinating minister for the National Covid-19 Immunisation Programme, said the bulk CoronaVac shipment would be packaged into 300,000 doses by Pharmaniaga.
CoronaVac was secured through a supply agreement involving 14 million doses inked between Pharmaniaga and Sinovac. The shipment will add to the 312,390 doses of Pfizer-BioNTech vaccine Malaysia received on Feb 21.
Khairy said if the NPRA approved the CoronaVac vaccine, it would become part of Malaysia’s vaccination portfolio.
On its approval status, he said he did not know when the NPRA would approve the vaccine.
“I don’t know and I cannot know. I can’t ask them when they (the NPRA) or the Drug Control Authority will approve it. They are free and independent. They must be allowed to do the work. Of course, we want them to approve safe vaccines as quickly as possible, but there is no shortcut.”
He was responding to a question on why Malaysia agreed to receive a vaccine that had yet to be approved by the regulatory body.
He said approvals for this vaccine were divided into two phases.
“One is the approval for the vaccine and the other is the approval for the filling and finishing, or bottling process, by Pharmaniaga at their Puchong factory.”
He said the regulatory process also depended on the NPRA’s review of the bottling process.
This is to prepare the application data for registration and validation for the execution of the finished product’s certification, besides looking at the stability data from the plant.
“This has to be explained carefully, while the vaccine is under the NPRA’s assessment. To give Pharmaniaga approval for fill and finish, the NPRA has to evaluate the factory, but this cannot be done without the vaccine itself.
“They have to study the stability report and do an assessment of the manufacturing before making a recommendation to the Drug Control Authority for it to decide on the approval.”
He said CoronaVac vaccine’s fill and finish approval would be given when the agency was satisfied and a conditional registration approval could be issued, as with the case of the Pfizer-BioNTech jab.
He said Singapore had received the CoronaVac vaccine even though its regulatory body had yet to approve it, adding that other countries were doing the same due to limited supply of the vaccine.
He said if the CoronaVac vaccine was approved, it would ensure a steady supply of vaccines in Malaysia during global shortages.
He said Pharmaniga told him that it could make two million doses a month once approval was given.
The data from Pharmaniaga was crucial to ensure that standards of safety and efficacy were consistent with those of China’s vaccine production plants, he said.
He said the vaccine’s efficacy rate was between 50.4 per cent and 91.2 per cent, with the World Health Organisation requiring a minimum 50 per cent.
He said Brazil’s clinical data for the vaccine showed an efficacy rate of more than 50 per cent because those involved in clinical trials were frontliners who volunteered for it, while Turkey reporting an efficacy rate of 90 per cent.
“The NPRA is very strict and will not approve vaccines that are
not safe or effective for use in Malaysia.”
He said Indonesian President Joko Widodo was one of the early recipients of the CoronaVac vaccine.
He said some medical practitioners preferred the vaccine as it was using a tried-and-tested approach of “inactivated” viruses.
Khairy said that up to 7am yesterday, 1,183,779 people had registered to get vaccinated, with 3,580 inoculated up to Friday.
The CoronaVac vaccine that arrived has been transported to Pharmaniaga LifeScience Sdn Bhd’s pharmaceutical plant in Taman Perindustrian Puchong Utama in Puchong.
Two Pharmaniaga trucks carrying the vaccine arrived at the plant under heavy police escort — six patrol vehicles, a van and four high-powered motorcycles — after leaving KLIA at 9.30am.
Selangor deputy police chief Datuk Arjunaidi Mohamed confirmed to Bernama that the vaccine reached the plant’s storage facility at 10.22am.
“Police will monitor and maintain security at the storage facility of Pharmaniaga LifeScience Sdn Bhd as long as the vaccine is kept there,” he said.