Dr Kelvin Yii presents his argument in the Dewan Rakyat.
KUCHING: The government should expedite the National Pharmaceutical Regulatory Agency (NPRA) evaluation of Pfeizer-BioNtech’s Covid-19 vaccine as this was a matter of public interest, said Bandar Kuching MP Dr Kelvin Yii.
Dr Yii said this should also include what the schedule is like for preparations for mass-vaccination, including proper education to prevent misinformation, confusion, and hesitancy.
He said based on a recent statement made by the Health Minister Dr Adham Baba, Pfeizer has submitted its dossier and data to NPRA which is under the purview of Ministry of Health (MOH) on Dec 14.
“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.
“Assuming that the application was given Priority Review from Dec 14 onwards, this means that June 14, 2021 is the latest date for Malaysia’s first Covid-19 vaccine approval, after taking into account weekends and public holidays,” he said in a statement here today.
He added that 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 26, 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 have 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 a travel bubble with our neighbouring countries like Singapore,” he said.
Therefore, he said even 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 Science, Technology & Innovation (MOSTI) about a purported March delivery, but this contradicts the Ministry of Health and NPRA’s potential April or June approval,” he said.
Taking into account if Pfizer is forced to postpone the March delivery pending NPRA’s decision, Dr Yii asked if this will affect the amount of the promised 12.8 million doses, as even the US and many other countries are demanding for more doses.
“Will this also affect the schedule for vaccination for our people if the NPRA decision only happens by June latest, does that mean only front liners can be vaccinated followed by the general population will be vaccinated in the third and fourth quarter?” he asked.
His concern, he said, 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 5,000 infections daily from Feb 25, 2021.
“If there is no urgent intervention, we may see our healthcare system being overwhelmed again by April or June next year. 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 their prime minister saying that the first shipment of vaccine is expected in Singapore within the next fortnight before year ends,” he said.
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