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Expedite the evaluation of Pfizer’s Covid-19 vaccine

Press statement by MP for Bandar Kuching, Kelvin Yii Lee Wuen on 17 December 2020:

The government should expedite the NPRA’s evaluation of Pfizer-BioNTech’s vaccine as this is a matter of public interest and should start preparations for mass-vaccination including proper education to prevent misinformation, confusion, and hesitancy.

Based on the recent statement by the Health Minister Dr Adham Baba, Pfizer has submitted its dossier and data to the National Pharmaceutical Regulatory Agency (NPRA) under the Ministry of Health (MOH) 3 days ago on December 14th. In the same statement he has also confirmed that the NPRA’s assessment of the vaccine by Pfizer and German biotechnology company BioNTech would take a maximum of 120 working days.

That will mean that assuming that the application was given Priority Review from December 14, this means that June 14 is the latest date for Malaysia’s first Covid-19 vaccine approval, after taking into account weekends and public holidays.

While based on NPRA’s guidelines, the evaluation could be expedited to 90 working days as a special case depending on the data and answers given by Pfizer, but that will also mean that the vaccine will only be approved in Malaysia by April 26th 2021.

This in my view is still too late due to the nature and urgent need for the vaccine not just for the health sector, but also to boost the economic sector and hopefully restart some of the sectors that has been badly hit by the pandemic. Besides the domestic economic sector, the importance of the vaccine is significant when it comes to opening borders and trade, including creating travel bubble with our neighbouring countries like Singapore.

MP for Bandar Kuching, Kelvin Yii speaking in Parliament

After its approval, distribution and logistics will take even more time and could only start the earliest by May 2021.

If approval will take latest by April or June, does it mean Pfizer will have to postpone delivery until NPRA makes a decision? If not, where will the 1 million doses that was promised during the first quarter be kept during that period and what will be the cost for such storage.

This is based on what was mentioned by the Minister of Sains, Technology & Innovation about a purported March delivery, but this contradicts the Ministry of Health and NPRA’s potential April or June approval.

If Pfizer is forced to postpone the March delivery pending NPRA’s decision, will this affect the amount of the promised 12.8 million doses, as even the US and many other countries are demanding for more doses due to urgent need?

Will this also affect the schedule for vaccination for our people as if the NPRA decision only happens by June latest, does that mean only front liners can be vaccinated after that, which means only the general population will be vaccinated in the third and fourth quarter?


Until now we do not have a clear timeline or details for vaccination even as we’re approaching year end?

For illustrative purposes.

My major concern is that based on the US-based Institute for Health Metrics and Evaluation (IHME)’s projection, Malaysia is projected to experience a continuous rise in Covid-19 cases until mid-March 2021, hitting over 5000 infections daily from February 25th. If there is no urgent intervention, we may see our healthcare system being overwhelmed again by April or June. This shows an urgent need for the vaccine to be rolled out as soon as possible once it is certified safe and efficient.

In the US, the UK and Canada have already begun inoculating their citizens with the Pfeizer-BioNTech vaccine. Singapore’s regulators have also approved Pfizer’s Covid-19 vaccine, with the PM Lee Hsien Loong saying that the first shipment of vaccine is expected in Singapore within the next fortnight before year end.

An article screenshot of Singapore’s approval of the vaccine

While I am all for the Ministry’s efforts to verify and do the necessary evaluations to make sure that the vaccine is safe, and efficient for our people, but due to the nature of the pandemic and for interest of public health, the government needs to take an extra and special step to expedite the approval process so that the people can get the necessary inoculation as soon as possible.

So I believe there should be an extraordinary step taken during this extraordinary time to make sure we are not left behind without compromising on the safety and security of our people.

Kelvin Yii Lee Wuen.
MP Bandar Kuching

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