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YOUR OPINION | ‘This is not Viagra, where you can take your time to approve it. This is an emergency.’
Noor Hisham explains ‘slow’ vaccine approval, hopes to deliver quickly
Dr. Raman: “The first file for a Covid-19 vaccine was submitted by Pfizer a week ago on December 15 and is the only file submitted to the ministry so far.”
With all due respect, Dr. Noor Hisham Abdullah, this statement destroys your credibility. In medical terms, it is like a person who is seriously injured and instead of calling the ambulance, he is waiting for an ambulance to pass.
You know that developed countries and those with larger markets cry out for vaccines. They must have pre-ordered and paid for all available vaccines and must be manufactured months in advance.
Malaysia, a tiny market, would not have been on their radar at all. All they know is that there is some kleptocracy somewhere, perhaps a place to avoid doing business with.
However, he blames Pfizer for submitting the file late. It didn’t occur to you to look for the documents. Then he lectures us on the National Drug Regulatory Agency (NPRA) approval process and its typical 90-120 day time frame.
Is there no coordination between the people who signed the purchase contracts and the medical experts?
The first clause would have been for the provider to submit all documents related to the vaccine. In fact, those details would have been examined even before the contract was negotiated. Too many fingers in the cake, I guess.
Biasabisa: Science, Technology and Innovation Minister Khairy Jamaluddin said in November that Pfizer’s coronavirus vaccine will be received by February 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 got from diligently paying our debts. We are talking about lives here, right?
Hmmmmmmmm: Are Singapore and other countries using the same vaccine as us? Are you saying they didn’t do their due diligence before approving the vaccines for use in their countries?
I think it would be a much more acceptable excuse if you said that we are waiting to see if there are any adverse reactions on the part of those who have taken the vaccines before administering the vaccines to our own citizens because they take care of us.
Or maybe you’re waiting for 70 percent of the world to be vaccinated to give us herd immunity so we don’t even have to get vaccinated?
Neutral point: In fact, when the country of origin has already been tested, approved by internationally recognized bodies, why do we still have to make an assessment?
It is the same as the medical equipment where the products already got FDA, CE, TUV certification, our Medical Device Authority (MDA) body still need the local importer to provide documents to our Sirim for evaluation before the products may be approved and allowed to be imported and supplied to government hospitals.
Hero: We don’t need to reinvent the wheel. By the time we receive our vaccine, a few hundred million people would have already been vaccinated in other parts of the world, many of them for a good three months. By then, if they don’t die, we start vaccinating Malaysians.
Let’s be honest about Bolehland. The general rule of thumb is that hundreds or even thousands can die from Covid-19 in this country, but no one should die from the vaccine.
Hrrmph: If a vaccine can be developed in one-tenth of the normal time frame, surely our bureaucracy can run faster too.
But if the General Director of Health is talking about people’s mental attitude, our attachment to forms over substance, our unconditional attachment to how things “have always been done”, well, this attitude is the that has been hindering the competitive era of our country.
PurpleJaguar0553: Exactly. Why can’t NPRA be proactive in considering the emergency situation? Why the need to wait for the manufacturer to send the documents?
This is the malaise of the public administration: they only react, they do not act. The USFDA, the EU Medicines Agency, the UK Medicines and Health Products Regulator, Indonesia’s BPOM and the Singapore Health Sciences Authority have all approved the use of the vaccine. Even the CDSCO of India is evaluating it in 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 a rate of 2,000 infections per day, Malaysia will have another 258,000 infected if the current increase doesn’t go away, not to mention the havoc the standard operating procedures (SOP) that are provoking the economic, health and educational sectors.
The NPRA should have worked with its foreign counterparts, including Singapore, on the safety aspects of the vaccine to speed up the approval process. Why can’t our public officials think outside of the box during emergencies? They seem to think that everything remains the same even in an emergency and that bureaucracy must be strictly adhered to.
This is undoubtedly the result of mediocrity in our civil service. A product that the government only cares about employing as many people as it can without worrying about efficiency or quality.
Descend: The US FDA approved the Pfizer vaccine for emergency use based on the recommendation of an advisory panel consisting of more than 20 independent scientific experts, infectious disease physicians, and statisticians. The big question is whether Malaysia has such a panel of experts to review the approval process.
The Ministry of Health must bear in mind that (1) it is critical that our health heroes get vaccinated as soon as possible so that they can protect themselves from Covid-19, and (2) a faster approval process will inspire hope and confidence for our economy.
Illustrated Globalist: This is an unsatisfactory explanation from the Director General of Health. NPRA shouldn’t reinvent the wheel. This is not Viagra, where you can take your time to approve it. For the love of God, this is a medical, financial and mental health emergency.
More lives and livelihoods would be lost from this procrastination. Think of all the leaders who risk their lives every day. I would assume that NPRA members are safely protected in their air-conditioned offices with little to no risk of contracting Covid-19.
How come Singapore passed it so quickly? They did not wait months.
I would like to ask Noor Hisham if our NPRA has ever rejected a drug that has been approved by the UK, US or Europe.
Eliminate the red tape from NPRA and “copy and paste” approvals from the most established pharmaceutical authorities in Singapore, UK, Switzerland, Europe, US and Canada.
Don’t let the Little Napoleons show their power. Every day lost means more lives lost.
Fair and impartial: Look, Noor Hisham, are you saying we citizens have to watch the numbers rise every day from tens to hundreds and now thousands, just so the NPRA Department can approve the use of vaccines?
To sum up a few figures: 2,000 for Malaysia equals roughly 20,000 for the US I think this is quite an alarming figure given the size of our country. Are you questioning the legitimacy of approvals from the FDA, UK Pharmaceutical Body and Singapore?
Time is of the essence. Cheer up, for the love of God! We would like to know the real reason for the delay, please. Stop playing with the health and lives of citizens by giving these sick and lame excuses for the need to test the vaccine more.
VioletPanda7423: Dear CEO, you cannot use the same schedule for evaluating the vaccine as for other medications.
Having been an external advisor to the Ministry of Health for some of the new drugs, I know how late the process can be. Of course, each step of the process could be sped up without compromising the safety of the screening process and the vaccine.
You just need to sit down and work out a schedule for it and shorten the time frame for everyone involved. However, if this delay is due to external factors that you cannot disclose, that’s another story.
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