Malaysia Vaccine Approval : 90-120 Working Days Minimum!

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The Malaysia Ministry of Health just warned that vaccine approval takes at least 90-120 working days.

This may mean that Malaysians will only start getting vaccinated against COVID-19 from April 2021 onwards…


Malaysia COVID-19 Vaccine Approval : 90-120 Working Days Minimum!

The Malaysia Ministry of Health (KKM) just issued a warning that there is a minimum of 90-120 working days for the approval of any COVID-19 vaccine.

All pharmaceutical products, including COVID-19 vaccines, must first undergo a quality, safety and efficacy evaluation process by the National Pharmaceutical Regulatory Agency (NPRA).

After approval by the NPRA, a COVID-19 vaccine can then be registered with the Drug Control Authority (DCA). This would then allow the vaccine to be marketed in Malaysia.

Malaysia Vaccine Approval : 90-120 Working Days Minimum!


Malaysia COVID-19 Vaccine Approval : Details + Implications

Here are a couple of key points from the announcement and what they could mean…

NPRA Priority Review : 90~120 Working Days

A priority review by the NPRA (National Pharmaceutical Regulatory Agency) takes 90 to 120 working days, or approximately 126 to 168 calendar days (4-6 months).

This process would begin for a COVID-19 vaccine candidate with the submission of a dossier by the manufacturer, which would contain such information :

a. Administrative information (including proper labelling, package insert, patient information leaflet)
b. Quality documents (including manufacturing processes, materials, specification and evidence of consistency)
c. Non-clinical and clinical documents
d. Risk Management Plan and Periodic Benefit-Risk Evaluation Report

It is only after a thorough review, that the NPRA will make its recommendation to the DCA (Drug Control Authority) for approval.

KKM Vaccine Registration Process

Usage Of Vaccine : Only After DCA Approval

There is currently no mention of any emergency use authorisation. Instead, the Malaysia Ministry of Health stated that,

“The final decision on the usage of a vaccine will only be made after receiving approval from DCA and in compliance with prevailing acts and regulations of Malaysia.”

From our understanding, that would mean Malaysia intends to let the process play out completely, possibly to assure the public of the safety and efficacy of the vaccines.

COVID-19 Vaccine Candidate : One Dossier Received On 15 December 2020

NPRA has only received a COVID-19 vaccine candidate dossier from one company – probably the Pfizer-BioNTech vaccine, and it was submitted on 15 December 2020.

A priority review, according to NPRA standards, would take at least 4 calendar months, which would mean the first vaccination using the Pfizer vaccine may only take place by the end of April 2021.

That said, because this is a public emergency, the NPRA is “committed to providing a comprehensive review that is well within the stipulated timeline or earlier“.

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Malaysia COVID-19 Vaccine : Projected Availability

The Malaysian government earlier announced that Pfizer BNT162b2 vaccination would begin in February 2021, with the Prime Minister among the first to receive it, before frontliners.

However, based on what KKM announced, it does not appear that the Pfizer BNT162b2 vaccine would be approved until April 2021.

Even if KKM bowed to political pressure to approve the vaccine in February, Malaysia only purchased 12.8 million doses – only enough to vaccinate 20% of the population.

The next 10% of the population will be covered by the AstraZeneca COVID-19 vaccine, but its dossier does not appear to have been submitted yet.

Assuming the NPRA gets the AstraZeneca dossier by 1 January 2021, it will probably be approved by May 2021.

The other vaccine candidates are much further down the line, so we don’t expect them to come into play until June or July 2021.


COVID-19 : How To Keep Safe!

Here are a few simple steps to stay safe :

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