Vaccine goes through proper evaluation process
KUALA LUMPUR: The PfizerBioNtech vaccine is the first Covid-19 vaccine given conditional registration approval by the Drug Control Authority (DCA) and the National Pharmaceutical Regulatory Agency (NPRA) after going through the proper evaluation process and its use will be closely monitored.
Health director-general Tan Sri Dr Noor Hisham Abdullah said the vaccine produced by PfizerBioNTech, Comirnaty Concentrate for Dispersion For Injection was approved on Jan 8 this year.
“Among the criteria examined by DCA and NPRA are the safety profile of the vaccine, 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 vaccine at the Kuala Lumpur International Airport (KLIA) yesterday.
He said the conditional registration was given to provide immediate access to the Covid19 vaccine during the pandemic period using a ‘risk-based approach’, without compromising on quality, safety and efficacy.
Dr Noor Hisham said other criteria for allowing the conditional approval include the vaccine has been 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 (WHO).
Also present were Health Minister Datuk Seri Dr Adham Baba, Coordinating Minister for the National Covid-19 Immunisation Programme Khairy Jamaluddin and Transport Minister Datuk Seri Dr Wee Ka Siong.
The Airbus 330-300 carrying 312,390 doses of Covid-19 vaccine landed at 10.07 am yesterday and was delivered to 16 vaccine storage centres nationwide, namely six in Selangor, Johor (4), Kuala Lumpur (3), Penang (2) and one in Putrajaya.
Prime Minister Tan Sri Muhyiddin Yassin and Dr Noor Hisham himself will be among the first to receive the Covid-19 vaccine on Wednesday, when the National Covid-19 Immunisation Programme is rolled out on Wednesday, ahead of schedule.