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

PUTRAJAYA, Dec 23 – The first batch of Covid-19 vaccines obtained abroad will receive a conditional registration that could allow Malaysians to receive doses starting in the first quarter of 2021, Health Director General Tan Sri, Dr. Noor Hisham Abdullah.

He said regulators will shorten the investigation period for the first vaccine dossier received on December 15, in a bid to speed up approval.

But he stressed that public health authorities will continuously monitor and compile the usage data and review the registry within a one-year period.

“At the moment, only one company has submitted [its dossier] and we would take 90 to more than 120 days, but since this is the top priority … we will try to shorten the period we take to evaluate the efficacy of the vaccine, “he told reporters at a Covid-19 briefing here.

“We already received the first dossier on December 15 and we have dealt directly with that firm and if all goes well, we may see that the vaccine gets conditional registration before March,” he added.

A conditional registration would require a manufacturer to make “rolling submissions,” a process whereby the company will have to review and provide continuous data on its vaccines over a one-year period, explained Dr. Noor Hisham.

“We will do everything possible to shorten all processes so that we can give conditional approval before 90 days,” he said.

“But the important thing is that this conditional registration means that there must be continuous submissions, which means that any more recent data that the company must submit for scrutiny (for example) if there are complications, side effects or new mutations.”

The standard procedure would take approximately three to four months to register a new vaccine with the National Pharmaceutical Regulatory Agency (NPRA), according to the Health Ministry.

All pharmaceuticals must be registered with the Drug Control Authority for the NPRA’s quality, safety and efficacy evaluation process before they can be distributed nationally.

The Health Ministry said yesterday it is reviewing four files from US-based drug maker Pfizer, which has agreed to supply Malaysia with 12.8 million doses of vaccine, enough to give 6.4 million Malaysians free immunization. or 20 percent of the population.

Dr Noor Hisham had said on Monday that the Covid-19 vaccine will have to go through five phases of testing and trials before it can be approved for use in Malaysia.

The Ministry of Health said that NPRA will follow all international guidelines and guidelines, such as that of the WHO and the International Council for the Harmonization of Technical Requirements for Pharmaceutical Products for Human Use and the Asean Common Technical Dossier.