Vaccine was evaluated properly, use will be closely monitored, says DG

Vaccine was evaluated properly, use will be closely monitored, says DG

He says the conditional registration was given without compromising on quality, safety and efficacy.

Dr Noor Hisham Abdullah said the criteria examined were the profile of the vaccine for its quality, safety and efficacy. Picture shows the stocks ready for distribution. (Bernama pic)
KUALA LUMPUR:
The Pfizer-BioNtech vaccine, the first to be given conditional registration approval by the Drug Control Authority (DCA) and the National Pharmaceutical Regulatory Agency (NPRA) went through the proper evaluation process and its use will be closely monitored.

Health director-general Dr Noor Hisham Abdullah said the Covid-19 vaccine produced by Pfizer-BioNTech, Comirnaty Concentrate for Dispersion For Injection, was approved on Jan 8.

“Among the criteria examined by DCA and NPRA are the profile of the vaccine for its quality, safety and efficacy.

“The health ministry is always committed to ensuring the safety and prioritising the health of Malaysians by monitoring and examining all medicines, including vaccines procured,” he said in a statement after the arrival of the first batch of the vaccine at KLIA today.

He said the conditional registration was given to provide immediate access to the vaccine during the pandemic period using a “risk-based approach”, without compromising on quality, safety and efficacy.

Noor Hisham said other criteria for allowing the conditional approval include the vaccine being registered or given emergency use authorisation by the regulatory body of the producing country or the regulatory reference body DCA or the World Health Organisation.

The Airbus 330-300 carrying 312,390 doses of Covid-19 vaccine landed at 10.07am today and was delivered to 16 vaccine storage centres nationwide, namely six in Selangor, four in Johor, three in Kuala Lumpur, two in Penang and one in Putrajaya.

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