KUALA LUMPUR – Although it typically takes 90 to 120 days to register a medication – vaccine or not – Health director-general Tan Sri Dr Noor Hisham Abdullah said the government may expedite the process for Covid-19 inoculations.
He said this will be done in the national interest, considering the danger and health risks the coronavirus pose.
Dr Noor Hisham was responding to Prime Minister Tan Sri Muhyiddin Yassin’s statement earlier today that the Pfizer Covid-19 vaccine, which was only submitted for registration on December 15, would be available for mass roll-out as early as February.
“As this is a matter of national interest, we will facilitate (the registration) in our review as soon as possible. The clock began ticking the day Pfizer submitted its application.
“We hope to expedite the process. The National Pharmaceutical Regulatory Agency (NPRA) will give priority (to these vaccines) in 90 days or less, depending on data obtained,” he told The Vibes today.
The NPRA is a government agency under the Health Ministry in charge of ensuring therapeutic substances for the local market are safe, effective and of quality.
Yesterday, in a press conference, Dr Noor Hisham had said that it takes 90 to 120 days to register Covid-19 vaccines before they can be allowed to be administered here, as they must go through a stringent five-step process before receiving approval.
He had also said the ministry would consider conditional registration for the vaccines while monitoring the side effects of the immunisations.
Earlier today in a video message, Muhyiddin had said the first batch of Pfizer vaccines could be rolled out to the masses from as early as February. If true, this would mean that the registration process for the vaccine will only take about two months.
Dr Noor Hisham said Malaysia will have an advantage as far as the Pfizer vaccination is concerned as it will be able to monitor closely the outcome in the UK, which started its immunisation programme earlier this month.
In this regard, he pointed to some of the guidelines on the side effects and data pertaining to Pfizer issued by the UK government since its roll-out.
Among other things, he said the vaccine may not be safe for pregnant women, those with weak immunity due to drug consumption or have immune-suppressing diseases, and may not be suitable for those aged 16 and below.
He added that the UK guidelines state that it is not known if the vaccine will cause infertility, while noting that it is only 95% effective against the virus. – The Vibes, December 22, 2020
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