27 February 2021
Science, Technology and Innovation Minister Khairy Jamaluddin has pledged to be inoculated with the next vaccine that gets the National Pharmaceutical Regulatory Agency’s (NPRA) green light.
The minister said he will be the first to take the next vaccine that crosses the line, be it Sputnik V, Sinovac (CoronaVac) or AstraZeneca.
“I will take whatever the NPRA approves as being safe and is efficacious as a demonstration of my confidence in the vaccine and NPRA,” he said.
Khairy said he would not take the Pfizer-BioNTech vaccine despite rising public confidence attributed to the US/Germany-manufactured vaccine following the inoculation of Prime Minister Tan Sri Muhyiddin Yassin and Health director-general Tan Sri Dr Noor Hisham Abdullah on Wednesday in conjunction with Malaysia’s Covid-19 Immunisation Programme kick off.
“This is not because Pfizer is not good, but let there be those among the ministers who will set an example by taking any vaccine which is approved next.”
Khairy acknowledged that there is selective vaccine hesitancy among Malaysians who seem keen to be vaccinated with certain brands while rejecting others.
“At the moment (however) the logistics system would be complicated if people are allowed a choice.”
Khairy said this after witnessing the delivery of CoronaVac, the Covid-19 vaccine manufactured by China-based Sinovac Life Sciences Co Ltd, here at the Kuala Lumpur International Airport (KLIA).
The envirotainer – a temperature-controlled container – with 200 litres of the vaccine arrived at 9am at KLIA from Beijing in a Malaysia Airlines Airbus 330-300 aircraft, Flight MH319, bearing the livery of the Jalur Gemilang (national flag).
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.
Also present were China’s Ambassador to Malaysia, Ouyang Yujing, and Pharmaniaga Group managing director Datuk Zulkarnain Md Eusope.
Khairy, who is also the Coordinating Minister for the National Covid-19 Immunisation Programme, said the bulk of the CoronaVac vaccine would be packaged into 300,000 doses of vaccine by Pharmaniaga.
CoronaVac was secured through a supply agreement involving 14 million doses inked between Pharmaniaga and Sinovac.
The vaccine joins the 312,390 doses of the Pfizer-BioNTech vaccine received so far.
Khairy also said that if CoronaVac is approved by NPRA, it would be a part of Malaysia’s vaccination portfolio with the immunisation aim of 80 per cent of the population.
On its approval status, Khairy said that he does not know when NPRA will approve the vaccine for inoculation.
“I don’t know and I can’t know. I can’t ask them when they (NPRA) or the Drug Control Authority will be approving 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. Do not force NPRA to make a decision or push them. Malaysians will only be satisfied when there are no pressures on the regulatory authority.”
The minister was responding to questions on why Malaysia was receiving a vaccine that is not yet approved by the regulatory body.
Khairy explained that the approval process for CoronaVac is divided into two phases.
“One is the approval for the vaccine itself and the other is the approval to the filling and finishing or bottling process by Pharmaniaga (Bhd) in their Puchong factory”.
He said the regulatory process also hinges on NPRA’s review of the bottling process – only then can it be approved.
This is to prepare application data for registration, 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 still in NPRA’s assessment. However, for us to give Pharmaniaga approval for fill and finish, the NPRA has to evaluate the factory, but the process cannot be done without the vaccine itself. They have to study the stability report and do an assessment of the manufacturing – only then can they make a recommendation to the Drug Control Authority for it to decide on the approval.”
He added that CoronaVac’s fill and finish approval would be given when the agency is satisfied. It may be issuing a conditional registration approval, as given to Pfizer-BioNTech, but it would, however, be doing ‘lot-release inspections’ for every batch that is churched out to ensure safety and efficacy.
Khairy said Singapore had received CoronaVac even though the republic’s regulatory body had not approved it, and countries are doing so because the supply of the vaccine is limited.
The minister said if CoronaVac is approved, it would contribute to a steady supply of vaccines for Malaysia during global shortages.
He said that Pharmaniga had informed him that it can produce 2 million doses a month once approval is given.
He said that the data produced by Pharmaniaga is crucial to ensure that standards of safety and efficacy are consistent with China’s vaccine production plants’ data.
Khairy further said the vaccine’s efficacy rate is between 50.4 per cent and 91.2 per cent. The minimal World Health Organisation’s requirement is 50 per cent.
He also said that Brazil’s clinical data shows the efficacy rate is more than 50 per cent because those involved in the clinical trials were volunteers from the front lines, however, in Turkey, the efficacy rate was 90 per cent.
“Our NPRA is very strict and they will not approve vaccines that are not safe or efficacious for use in Malaysia,” said Khairy, while reminding the public that Indonesian president Joko Widodo was one of the recipients of the vaccine.
He said that some medical practitioners even show a preference for the vaccine as it uses a tried and tested approach of inactivated viruses.
“We will, however, be monitoring this and listening to all views (in terms of which kind of vaccine mRNA (Messenger ribonucleuc acid) or ortherwise is most effective.”
Khairy also said that Malaysia is not planning to fast-track regulatory approvals of vaccines by enforcing emergency use as it does not want to cut corners in the process.
Ouyang said the remaining vaccine supplies from Sinovac would arrive in March onwards.
The Minister also announced that as of 7am today, 1,183,779 people have registered to be vaccinated; while 3,580 have been inoculated as of Friday.
Source: nst.com.my
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