Pfizer’s vaccine could get conditional approval by March


Ragananthini Vethasalam

Director-General of Health Dr Noor Hisham Abdullah says the ministry could conditionally approve the Pfizer-BioNTech Covid-19 vaccine for Emergency Use Authorisation by March next year. – EPA pic, December 23, 2020.

THE Health Ministry is working towards expediting the evaluation process of the Pfizer-BioNTech’s Covid-19 vaccine, said Director-General of Health Dr Noor Hisham Abdullah.

Noor Hisham said the National Pharmaceutical Regulatory Division (NPRA) received the first dossier on December 15.

“We will engage with the company to scrutinise their data and research findings,” he said in a press conference today.

“If everything goes as planned, than we could conditionally approve the vaccine by March,” he added.

Under conditional registration the company will have one year to register its product. However, it must also continuously furnish regulators with the latest data of the vaccine’s effectiveness.

Dr Noor Hisham said on December 21 that it takes about 90 to 120 days to evaluate the clinical data provided by Pfizer.

Last month, Putrajaya struck a deal with Pfizer Inc. to procure 12.8 million doses of the Pfizer-BioNTech Covid-19 vaccine.

This would be sufficient to vaccinate 6.4 million people.

Pfizer recently told The Malaysian Insight that it has submitted the vaccine to the National Pharmaceutical Regulatory Division (NPRA) for approval.

In addition to the submission for Emergency Use Authorisation (EUA) on November 30, the company had also submitted additional documents required by the local regulator on December 14. – December 23, 2020.


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Comments


  • March? If that is 1st March 2021, we have more than 60 days to go..God knows what the situation will be by then in MY. Time is of essence here, i believe.

    Posted 5 years ago by Raghu Thiyagarajan · Reply