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PUTRAJAYA: It will take up to four months for the National Pharmaceutical Regulatory Agency (NPRA) to evaluate data from clinical trials provided by the pharmaceutical giant Pfizer on the Covid-19 vaccine it has developed.
Chief Health Officer Tan Sri Dr. Noor Hisham Abdullah said the NPRA received a formal request from Pfizer on December 15 to register its Covid-19 vaccine in Malaysia.
“We look forward to making an official engagement with the company (Pfizer) later this month.
“NPRA has identified 11 medical experts who are knowledgeable in this particular area, and they will be tasked with examining company-provided documents.
“So this can take 90-120 days to evaluate.
“Our priority is to investigate the safety and efficacy of the vaccine,” Dr. Noor Hisham said at the ministry’s Covid-19 press conference here on Monday (December 21).
Malaysia recently announced that it has purchased 12.8 million doses of the Covid-19 vaccine jointly developed by Pfizer and the German biotech company BioNTech.
The vaccine is expected to cover 6.4 million people, or about 20% of Malaysia’s population.
On the news of a donation of 500,000 doses of the Covid-19 vaccine from the United Arab Emirates (UAE), Dr. Noor Hisham said that the NPRA has not received any formal requests from the country so far.
“We learned from the donation that 500,000 doses of vaccine will be donated to our country.
“But so far it’s just a rumor, nothing has come up,” he said.
He said that, as with the Pfizer-BioNTech vaccine, the NPRA will evaluate data from clinical trials submitted by other sources before the vaccine can be registered in the country.
“Once the documents are submitted, it will take 90-120 days to process.
“Any vaccine or drug that is to be brought into the country must first be registered with the NPRA,” said Dr. Noor Hisham.
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