Malaysia : COVID-19 Vaccine Maybe Available Only In April!

The Malaysia Ministry of Health just warned that COVID-19 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 the fastest they can approve a COVID-19 vaccine is a minimum of 90-120 working days.

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) for use and sale in Malaysia.

 

Malaysia COVID-19 Vaccine Approval : What It May Mean…

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) would begin with the submission of a dossier by the manufacturer, which would contain these information :

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

After a thorough review that takes 90 to 120 working days, approximately 126 to 168 calendar days (4-6 months), the NPRA will make its recommendation to the DCA (Drug Control Authority) for approval.

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“.

Recommended : Pfizer + Moderna mRNA Vaccines : How Do They Work?

 

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 from COVID-19 :

• Avoid suspected cases or disease hotspots, like hospitals, if possible!
• Avoid public events and crowds
• Keep our hands clean with soap or hand sanitiser
• If you need to wear a surgical mask, make sure you put it on and remove it properly!

Recommended : COVID-19 : Hand Sanitiser or Soap? Which Is Better?
Recommended : Surgical Mask : How To CORRECTLY Wear + Remove!
Recommended : Grocery Shopping Safety During COVID-19
Recommended : COVID-19 Food Safety : Fruits, Vegetables, Takeouts

 

Recommended Reading

• 444 COVID-19 Deaths In Malaysia As Of 23 December 2020
• Malaysia : 3.2 Million To Get AstraZeneca COVID-19 Vaccine!
• Karex Pontian : Closed After 28 COVID-19 Cases!
• Singapore First Asian Country To Receive Pfizer Vaccine!
• Two Panasonic Factories Closed After 116 Gets COVID-19!
• Did Pfizer Use Toxic Placebo In COVID-19 Vaccine Trial?
• Scam Alert : Fake Public Bank SMS Messages!
• Did The Pfizer COVID-19 Vaccine Kill 6 Trial Volunteers?
• Can The Pfizer COVID-19 Vaccine Cause Bell’s Palsy?
• St Francis Xavier Church Melaka Priest Positive For COVID-19!
• MITI : Work From Home Still Apply In CMCO / TEMCO Areas!
• Was A Lazada Delivery Guy Caught Licking A Parcel?
• EkoCheras Mall : One Tower Resident Positive For COVID-19!
• New CMCO SOP (December 2020) For Peninsular Malaysia
• New RMCO / PKPP SOP (December 2020) For Malaysia
• End Of An Era : Sony To Shut Down Penang Facility!
• Did The Second Penang Bridge Get Hit By Giant Waves?
• Did China Create These Amazing Dancing Robots?
• Malaysia : 6 Million To Get Pfizer COVID-19 Vaccine In 2021!
• A Father’s Last Words Before Dying Of COVID-19…
• Is HKL Preparing For 3,000 New COVID-19 Cases A Day?
• RM399 Laguna Redang Holiday : A Umance Scam?
• Register With MySejahtera / Logbook, Or Get Fined RM1K!
• Can A Ringing Phone Cause A Gas Stove To Explode?
• Can You Cure A Heart Attack By Slapping The Elbow?
• Soap vs Sanitiser : Which Works Better Against COVID-19?

 

Support Us!

If you like our work, you can help support us by visiting our sponsors, or even donating to our fund. Any help you can render is greatly appreciated!