KUALA LUMPUR – The Pfizer-BioNtech vaccine, the first Covid-19 vaccine 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 Tan Sri Dr Noor Hisham Abdullah said the vaccine produced by Pfizer-BioNTech, the Comirnaty Concentrate for Dispersion For Injection, was approved on January 8 this year.
“The criteria set by DCA and NPRA for the vaccine’s approval include its safety profile, quality, and efficacy.
“The Health Ministry is always committed to ensuring the safety and prioritising the health of Malaysians by monitoring and examining all procured medicines, including vaccines,” he said in a statement after the arrival of the first batch of vaccines at the Kuala Lumpur International Airport (KLIA) today.
He said the conditional registration was given to provide immediate access to the Covid-19 vaccine during the pandemic period using a “risk-based approach”, without compromising on quality, safety, and efficacy.
Noor Hisham said the other criteria for conditional approval include whether the vaccine has been registered or given emergency use authorisation by the regulatory body of the producing country, the regulatory reference body DCA, or the World Health Organisation.
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 Wee Ka Siong.
Carrying 312,390 doses of Covid-19 vaccine, the Airbus 330-300m landed at 10.07am today and was delivered to 16 vaccine storage centres nationwide, namely six in Selangor, Johor (four), Kuala Lumpur (three), Penang (two), and one in Putrajaya.
Prime Minister Tan Sri Muhyiddin Yassin and 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. – Bernama, February 21, 2021
