Health Ministry looking to evaluate Pfizer vax within 90 days

PUTRAJAYA: The Health Ministry will be looking to speed up its process of evaluating Pfizer’s Covid-19 vaccine and completing its dossier in less than 90 days.

Health director-general Tan Sri Dr Noor Hisham Abdullah said on Wednesday (Dec 23) that the government could grant the American pharmaceutical company a conditional registration, which would require the firm to submit all latest data of the vaccine’s development when available.

This, he said, included any new data on adverse effects following immunisation.

“In a normal situation, the National Pharmaceutical Regulatory Agency (NPRA) would take about 90 to 120 days to evaluate a vaccine or medicine before it can be registered.

“If everything is in accordance, 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 continuously furnish us with the latest data for us to evaluate.

“This could be information on whether the vaccine is effective towards certain mutations, or whether there are complications or side effects after immunisation.

“It must all be done according to NPRA’s procedures, ” said Dr Noor Hisham at his minstry’s Covid-19 press conference here.

On Monday, Dr Noor Hisham had said it would take 90 to 120 days for NPRA to evaluate the clinical trial data provided by Pfizer on its Covid-19 vaccine.

He said the NPRA had received a formal application from Pfizer on Dec 15 to have its Covid-19 vaccine registered in Malaysia, with engagement sessions with the company scheduled at the end of the month.

Last month, the government announced that it will be obtaining 12.8 million doses of Covid-19 vaccine jointly developed by Pfizer and German firm BioNTech.

The amount is said to cover 6.4 million people or 20% of the Malaysian population.