YOURSAY | ‘This is not Viagra, where you can take your own sweet time to approve it. This is an emergency.’

Noor Hisham explains 'slow' vaccine approval, hopes to deliver quickly

Dr Raman: "The first dossier for a Covid-19 vaccine was only submitted by Pfizer a week ago on Dec 15 and is the only dossier submitted to the ministry so far.”

With due respect, Dr Noor Hisham Abdullah, this statement demolishes your credibility. In medical terms, it is like a person who is critically injured and rather than calling the ambulance, he is waiting for a passing ambulance.

You know that developed countries, and those with bigger markets, are clamouring for the vaccines. They must have pre-ordered and paid for all the vaccines available and to be manufactured months ahead.

Malaysia, a tiny market, would not have figured in their radar at all. All they know is, it is some kleptocracy somewhere, perhaps a place to avoid doing any business with.

Yet you blame Pfizer for sending the dossier late. It didn't occur to you to seek out the documents. Then you lecture us on National Pharmaceutical Regulatory Agency (NPRA) approval process and its typical time period of 90 to 120 days.

Is there no coordination between the people who signed the purchase contracts and the medical experts?

The first clause would have been for the supplier to submit all documents regarding the vaccine. In fact, those details would have been vetted even before the contract is negotiated. Just too many fingers in the pie, I guess.

Biasabisa: Science, Technology and Innovation Minister Khairy Jamaluddin said in November that Pfizer coronavirus vaccine will be received by Feb 21.

Then Noor Hisham said it would take four months to study the safety data. Then, Prime Minister Muhyiddin Yassin echoed what Khairy said.

These are the uncertainties that we, taxpayers, gotten for diligently paying our dues. We are talking about lives here, right?

Hmmmmmmmm: Are Singapore and other countries using the same vaccine as us? Are you saying that they did not do their due diligence before approving the vaccines for use in their countries?

I think it would be a far more palatable excuse if you were to say that we are waiting to see if there are any adverse reactions from those who have taken the vaccines before administering the vaccines on our own citizens because you care for us.

Or perhaps you are waiting for 70 percent of the world to be vaccinated to confer us with herd immunity so that we don't even have to be vaccinated?

Neutral Point: Indeed, when the country of origin already tested, approved by internationally recognised bodies, why do we still need to do evaluation?

It’s the same like medical equipment where the products already obtained FDA, CE, TUV certification, our Medical Device Authority (MDA) body still needs the local importer to provide documents to our Sirim for evaluation before products can be approved and allowed to be imported and supplied to government hospitals.

Wira: We don't need to reinvent the wheel. By the time we get our vaccine, a few hundred million people would have already been vaccinated elsewhere in the world, many of them for a good three months. By then, if they don't die, we start to vaccinate Malaysians.

Let's be candid about Bolehland. The rule of thumb is, hundreds or even thousands may die from Covid-19 in this country, but no one should die from the vaccination.

Hrrmph: If a vaccine can be developed in one-tenth of the normal time period, surely our bureaucracy can work faster too.

But if the Health director-general is talking about the mental attitude of people, our sticking to forms over substance, our diehard clutch on how things "have always been done", well, this attitude is what has been blunting our country's competitive age.

PurpleJaguar0553: Exactly. Why can’t the NPRA be proactive considering the emergency situation? Why the need to wait for the manufacturer to submit the documents?

This is the malaise of the civil service - they only react not proact. USFDA, EU Medicines Agency, UK Medicine and Healthcare Products Regulator, Indonesia BPOM and Singapore Health Sciences Authority have approved the vaccine for use. Even India's CDSCO is evaluating it within a few weeks.

Why does the NPRA need four months? At this rate, approval will come, if at all, in April 2021 and by then at the rate of 2,000 infections per day, Malaysia will have another 258,000 people infected if the current surge does not die down not to mention the havoc the standard operating procedures (SOPs) are causing to the economic, health and education sectors.

The NPRA should have worked with its foreign counterparts, including Singapore, on the vaccine's safety aspects to speed up the approval process. Why can’t our civil servants think out of the box during emergencies? They seem to think that it’s business as usual even in an emergency and the red tape must be strictly adhered to.

This is no doubt the result of mediocrity in our civil service. A product of the government only being concerned about employing as many people as it can while not being bothered about efficiency nor quality.

Unspin: The US FDA approved the Pfizer vaccine for emergency use based on the recommendation of an advisory panel that consists of more than 20 independent scientific experts, infectious disease doctors and statisticians. The big question is whether Malaysia has such a panel of experts to review the approval process.

The Health Ministry should be mindful that (1) it is critical for our healthcare heroes to get inoculated soonest possible so that they can be protected from Covid-19, and (2) a faster approval process will inspire hope and confidence for our economy.

Enlightened Globalist: This is an unsatisfactory explanation by the Health director-general. NPRA should not re-invent the wheel. This is not Viagra, where you can take your own sweet time to approve it. For heaven’s sake, this is a medical, economic and mental health emergency.

More lives and livelihoods would be lost with this procrastination. Think about all the frontliners risking their lives every day. I would assume that NPRA members are safely guarded in their air-conditioned offices with little or no risk of contracting Covid-19.

How come Singapore approved it so quickly? They didn't wait for months.

I would like to ask Noor Hisham whether our NPRA has ever rejected any drug that was approved by UK, US, or Europe.

Cut the bureaucratic red tape of the NPRA, and 'copy and paste' the approvals from the more well-established drug authorities of Singapore, UK, Switzerland, Europe, US and Canada.

Don't allow Little Napoleons to flex their power. Every day lost means more lives lost.

Fair&Unbiased: Look, Noor Hisham, are you saying that we the citizens have to watch the figures escalate every day from the tens to the hundreds and now to the thousands, just so that the NPRA Department can pass the use of the vaccines?

Just to crunch some numbers - 2,000 for Malaysia equates to roughly 20,000 for the US. I think this is a pretty alarming figure in view of the size of our country. Are you questioning the legitimacy of the approvals by the FDA, the pharmaceutical body in the UK and Singapore?

Time is of the essence. Buck up, for goodness sake! We would like to know the real reason for the delay, please. Stop playing with the health and lives of the citizens by giving these sick and lame excuses of the need to further test the vaccine.

VioletPanda7423: Dear DG, you cannot use the same timeline to assess the vaccine as per other drugs.

Having been an external assessor for the Health Ministry for some of the new drugs, I know how tardy the process could be. Of course, each step in the process could be fast-tracked without comprising on the safety of the evaluation process and the vaccine.

You just need to sit down and work out a timeline for it and shorten the deadline for everyone involved. However, if this tardiness is due to external factors that you cannot disclose, that’s another story altogether.

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