KUALA LUMPUR – Malaysia has yet to receive formal documents from pharmaceutical company Pfizer to allow the Health Ministry to conduct its clinical trials and assessment for registration on its Covid-19 vaccine.
Health director-general Tan Sri Dr Noor Hisham Abdullah said this meant that Malaysia has no information on claims of vaccine supply chain challenges faced by Pfizer.
He was responding to a report by Reuters on Friday that Pfizer was facing difficulties obtaining raw materials required for the production of the vaccine, leading to its decision to slash its 2020 production target by half.
“It is the National Pharmaceutical Regulatory Agency’s (NPRA) responsibility to ensure a product be tested and appraised in terms of safety, quality, and efficacy before it can be registered and marketed in Malaysia.
“However, NPRA has not received any documents from Pfizer for us to assess and conduct trials on the Covid-19 vaccine.
“The ministry will continuously monitor development on the production of the vaccine, and obtain more information on the matter,” he said in a statement today.
Reuters had quoted a Pfizer spokesman as saying that the scale-up of the raw material supply chain took longer than expected, adding that a later-than-expected result from clinical trials has also led to production in smaller numbers.
The Wall Street Journal had also previously reported that early batches of the raw materials for the Pfizer vaccine failed to meet standards.
Pfizer’s vaccine relies on a two-dose regimen, meaning 50 million doses is required to inoculate 25 million people.
On December 2, the UK became the first country in the world to authorise the use of the vaccine in its country. – The Vibes, December 6, 2020
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