PUTRAJAYA, Dec 23 — The first batch of Covid-19 vaccines secured from abroad will be granted a conditional registration that could see Malaysians getting doses as early as the first quarter of 2021, Health director-general Tan Sri Dr Noor Hisham Abdullah announced today.
He said regulators will shorten the vetting period for the first vaccine dossier received on December 15, in an attempt to hasten approval.
But he stressed that public health authorities will continuously monitor and compile data from usage, and would review the registration within a period of one year.
“At the moment only one firm has submitted [its dossier] and we would take 90 to over 120 days but since this is top priority... we will try to shorten the period we take to assess the vaccine's efficacy,” he told reporters in a Covid-19 briefing here.
“We have already received the first dossier on December 15 and we have dealt directly with the said firm and if everything goes well, we may see the vaccine get conditional registration before March,” he added.
A conditional registration would require a manufacturer to conduct “rolling submissions”, a process whereby the firm will have to review and provide continuous data of its vaccines within a period of one year, Dr Noor Hisham explained.
“We will try our best to shorten all the processes so that we could give the conditional approval before 90 days,” he said.
“But what is important is this conditional registration means there must be rolling submissions that means any latest data the firm must submit them for scrutinise (for example) if there are complications, side effects, or there are new mutations.”
The standard procedure would take roughly three to four months to register a new vaccine with the National Pharmaceutical Regulatory Agency (NPRA), according to the MoH.
All pharmaceutical products must be registered with the Drug Control Authority for quality, safety and efficacy evaluation process by the NPRA before they can be distributed domestically.
MoH said yesterday it is reviewing four dossiers from US-based drugs manufacturer Pfizer, which has agreed to supply Malaysia 12.8 million doses of vaccine, enough to give free immunisation to 6.4 million Malaysians or 20 per cent of the population.
Dr Noor Hisham had said on Monday that the Covid-19 vaccine will have to go through five phases of tests and trials before it can be approved for use in Malaysia.
The MoH said the NPRA will follow all international guidance and guidelines, such as from WHO and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and the Asean Common Technical Dossier.
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