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141. Health DG: Will take four months to evaluate Pfizer trial data

PUTRAJAYA: It will take up to four months for the National Pharmaceutical Regulatory Agency (NPRA) to evaluate the clinical trial data provided by pharmaceutical giant Pfizer on the Covid-19 vaccine it has developed.


Health director-general Tan Sri Dr Noor Hisham Abdullah said the NPRA received a formal application from Pfizer on Dec 15 to have its Covid-19 vaccine registered in Malaysia.


“We expect to officially engage with the company (Pfizer) around the end of this month.


“The NPRA has identified 11 medical experts who are knowledgeable in this particular area, and they will be tasked to look into the documents that have been provided by the company.



“So, this may take between 90 to 120 days to evaluate.


“Our priority is to look into the safety and efficacy of the vaccine, ” said Dr Noor Hisham at the ministry’s Covid-19 press briefing here Monday (Dec 21).


Recently, Malaysia announced that it has purchased 12.8 million doses of the Covid-19 vaccine jointly developed by Pfizer and German biotechnology firm BioNTech.


The vaccine is expected to cover 6.4 million people, or about 20% of Malaysia’s population.


On news of a donation of 500,000 doses of Covid-19 vaccine from the United Arab Emirates (UAE), Dr Noor Hisham said NPRA has not received any formal application from the country so far.


“We heard about the donation that 500,000 doses of vaccine will be donated to our country.


“But it is just hearsay so far, nothing has been submitted, ” he said.


He said that similarly as with the Pfizer-BioNTech vaccine, the NPRA will evaluate the clinical trial data submitted by other sources before the vaccine can be registered in the country.


“Once the documents are submitted, it will take 90 to 120 days to process.


“Any vaccine or medicine that is to be brought into the country must be registered with the NPRA first, ” said Dr Noor Hisham.

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