PUTRAJAYA (Dec 24): The Ministry of Health (MoH) is seeking to reduce the time needed to evaluate the safety and efficacy of the Covid-19 vaccine produced by US pharmaceutical giant Pfizer to less than 90 days, so a conditional approval for the drug may be granted before next March.
In normal circumstances, just the first phase of the five-phase evaluation process — which involves going through the documentation of the vaccine development process — may take between 90 and 120 days, said Health director-general Tan Sri Dr Noor Hisham Abdullah.
Evaluation of the vaccine has already started as the first scientific documents, also known as dossier, for its registration were received by the National Pharmaceutical Regulatory Agency (NPRA) on Dec 15, he said.
"So we will try our best to carry out the processes that have been identified so that we can reduce the time for us to conditionally register the vaccine within a period of less than 90 days.
"If everything is in order, maybe we will be able to conditionally approve the vaccine before March," he told reporters during the daily MoH Covid-19 press conference yesterday.
It was previously reported that the vaccine produced would have to go through the five-phase evaluation process before it can be approved for use by the public here.
In the second phase, the ministry will check to ensure Malaysia can procure the vaccine and that it has the logistics to handle it, while the third step will be for identifying priority groups such as front liners and the vulnerable. The fourth stage involves checking the after-effects of the vaccine, while the final step is to assess its effectiveness in curbing the spread of Covid-19.
Conditional approval with rolling submissions
A conditional approval means the vaccine will be allowed to be administered in Malaysia but with monitoring by the ministry for a period of one year, said Dr Noor Hisham.
Pfizer will also be bound by the practice of "rolling submissions", meaning the company is required to continue submitting the latest data from its clinical trials for the NPRA to continuously review them.
"The company will have to submit their latest data for us to examine whether they are effective in cases with mutations [in the coronavirus], and whether there are complications or side effects and so on. So we will monitor adverse events following immunisation," Dr Noor Hisham said.
By granting the conditional approval, Dr Noor Hisham said the ministry may still override its decision, based on the latest data it reviews from the administration of the vaccine.
On Nov 24, the government, through the MoH, signed a preliminary purchasing agreement with Pfizer to obtain 12.8 million doses of its Covid-19 vaccine to meet the immunisation needs of 20% or 6.4 million Malaysians.
Under this agreement, Pfizer has pledged to deliver one million doses of its vaccine in the first quarter of 2021, 1.7 million doses in the second quarter, 5.8 million doses in the third quarter, and 4.3 million doses in the final quarter.
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