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Dr Noor Hisham: Conditional approval for first batch of Covid-19 vaccines before March; shots available soon after

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Dr Noor Hisham: Conditional approval for first batch of Covid-19 vaccines before March; shots available soon after

Securing the first batch of Covid-19 vaccines from abroad will grant conditional registration. That would 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.

Monitoring and supervising

But he stressed that public health authorities will continuously monitor. They will also compile data from usage, and would review the registration within a period of 1 year.

“At the moment just one firm has submitted [its dossier] and we would take 90 to over 120 days but since this is top priority… we are going to attempt to shorten the period we take to assess the vaccine’s efficacy,” he told reporters during a Covid-19 briefing here.

“We have already received the primary dossier on December 15. We also have dealt directly with the said firm and if everything goes well. May we even see the vaccine get conditional registration before March,” he added.

A conditional registration would require a manufacturer to conduct “rolling submissions”. It is a process whereby the firm will need to review and supply continuous data of its vaccines within a period of 1 year, Dr Noor Hisham explained.

“We will try our greatest to shorten all the processes so we could give the conditional approval before 90 days,” he said.

Rolling submissions

“But what’s important is that this conditional registration means there must be rolling submissions. This means any latest data the firm must submit them for scrutinizing (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.

It is a must for all pharmaceutical products with the Drug Control Authority for quality, safety and efficacy evaluation process. The NPRA will do it before they will be distributed domestically.

MoH said yesterday it’s reviewing four dossiers from US-based drugs manufacturer Pfizer. Which has agreed to provide Malaysia 12.8 million doses of vaccine. This is enough to give free immunization 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 need to go through five phases of tests and trials. This is before it can be approved to be used in Malaysia.

The MoH said the NPRA will follow all international guidance and guidelines. For example, from the WHO and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. Also the ASEAN Common Technical Dossier.

 

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