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PUTRAJAYA: The Ministry of Health will seek to accelerate its evaluation process for the Pfizer Covid-19 vaccine and complete its file in less than 90 days.
Health Director General Tan Sri Dr. Noor Hisham Abdullah said on Wednesday (December 23) that the government could grant the American pharmaceutical company a conditional registration, which would require the company to submit all the latest data on the development of the vaccine when available.
This, he said, included any new data on adverse effects after vaccination.
“In a normal situation, it would take 90-120 days for the National Drug Regulatory Agency (NPRA) to evaluate a vaccine or drug before it can be registered.
“If everything agrees, we can grant the company a conditional registration before March.
“So we will do our best to complete the required process in less than 90 days.
“If we grant a conditional registration to the company, they must continually provide us with the latest data for us to evaluate.
“This could be information on whether the vaccine is effective against certain mutations or if there are complications or side effects after immunization.
“Everything must be done in accordance with NPRA procedures,” Dr Noor Hisham said at his minister’s Covid-19 press conference here.
On Monday, Dr. Noor Hisham had said it would take the NPRA 90 to 120 days to evaluate the clinical trial data provided by Pfizer on its Covid-19 vaccine.
He said the NPRA had received a formal request from Pfizer on December 15 to register its Covid-19 vaccine in Malaysia, with participation sessions scheduled with the company for the end of the month.
Last month, the government announced that it will obtain 12.8 million doses of the Covid-19 vaccine jointly developed by Pfizer and the German company BioNTech.
The amount is said to cover 6.4 million people or 20% of Malaysia’s population.
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