Will NPRA’s June Approval Affect Early Covid-19 Vaccine Delivery? Yii

By CodeBlue | 17 December 2020

Bandar Kuching MP Dr Kelvin Yii urges the government to expedite the Covid-19 vaccine approval process during the pandemic in the interest of public health.

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KUALA LUMPUR, Dec 17 — Bandar Kuching MP Dr Kelvin Yii questioned the government today if health regulators’ potential approval of Pfizer-BioNTech’s Covid-19 vaccine by June could delay vaccine delivery beyond March.

The DAP lawmaker asked if on the other hand, delivery of one million doses of Pfizer’s vaccine to Malaysia went ahead as scheduled by March, pending the National Pharmaceutical Regulatory Agency’s (NPRA) approval, where would the vaccines be stored and how much storage of the vaccine, which must be kept at minus 70 degrees Celsius, would cost.

“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 United States and many other countries are demanding for more doses due to urgent need,” Dr Yii said in a statement.

“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 frontliners can be vaccinated after that, which means the general population will only be vaccinated in the third and fourth quarter?”

CodeBlue reported that Pfizer sent a dossier containing clinical trial data on its Covid-19 vaccine to the NPRA on December 14, with Health Minister Dr Adham Baba saying that regulators would take a maximum of 120 working days, under a Priority Review, to evaluate the vaccine.

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.

Prime Minister Muhyiddin Yassin, however, previously said Pfizer would deliver one million doses of its Covid-19 vaccine by the first quarter of next year, followed by 1.7 million doses in the second quarter by June, and the remaining doses throughout the rest of 2021. The Malaysian government has made a preliminary purchasing agreement with Pfizer to buy 12.8 million doses to cover 6.4 million people on a two-dose regimen.

Muhyiddin also recently called for expedited delivery of coronavirus vaccines, even as other countries, including the US and the UK, have approved the Pfizer-BioNTech vaccine and begun immunising their citizens.

Deputy Health Minister Dr Noor Azmi Ghazali told CodeBlue yesterday that NPRA’s assessment of the Pfizer-BioNTech could be expedited to 90 working days as a special case, depending on Pfizer’s answers to regulators. This equates to an approval date 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,” Dr Yii said.

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

Singapore’s Prime Minister Lee Hsien Loong said Monday that the first shipment of the Pfizer-BioNTech vaccine would arrive in Singapore by the end of this month, after health regulators approved the vaccine. He estimated sufficient Covid-19 vaccines for all residents in Singapore by the third quarter of 2021.

“Until now, we do not have a clear timeline or details for vaccination even as we’re approaching year end,” Dr Yii said.

He cited the US-based Institute for Health Metrics and Evaluation (IHME) that projected a continuous rise in Covid-19 cases in Malaysia until mid-March next year, hitting over 5,000 infections daily from February 25.

“If there is no urgent intervention, we may see our health care system being overwhelmed again by April or June,” Dr Yii warned.

“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.”

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