Drug Control Authority approves Pfizer vaccine for 12-year-olds and above

15/06/2021 05:01 PM

KUALA LUMPUR, June 15  -- The 359th Drug Control Authority (DCA) meeting today approved the use of Comirnaty vaccine produced by Pfizer-BioNTech for children aged 12 and above.

Health director-general Tan Sri Dr Noor Hisham Abdullah said Comirnaty was earlier approved for conditional registration on June 8 for active immunisation of individuals aged 18 and above.

"Even though the additional indications were approved, the Ministry of Health is of the view that the priority of vaccination is still for high-risk groups in line with the existing policy set under the National COVID-19 Immunisation Programme, " he said in a statement today.

Apart from that, Dr Noor Hisham said DCA also approved conditional registration for two vaccine products which needed only one dose immunisation for use in the current disaster situation.

He said the two vaccines, 'Convidecia Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)' produced by CanSino Biologics Inc, China, with product registration holder, Solution Biologics Sdn Bhd and 'Janssen COVID-19 Vaccine' manufactured by Johnson & Johnson were given Emergency Use Listing (EUL) by the World Health Organisation (WHO).

Dr Noor Hisham said the 'Janssen COVID-19 Vaccine' obtained by the Malaysian government through the COVAX facility is implemented through a recognition mechanism based on WHO EUL approval.

He said the conditional registration approval required information on the quality, safety and effectiveness of the vaccine product monitored and evaluated based on the latest data from time to time to ensure the benefit over risk comparison remains positive.

“MOH is always enhancing the level of public health in the fight against COVID-19 through the acquisition of vaccine which have been evaluated in terms of quality, safety and effectiveness by the National Pharmaceutical Regulatory Agency (NPRA) and approved by DCA,” he said.

According to him, the government is committed to ensure Malaysians achieve herd immunity in line with the target of the National COVID-19 Immunisation Programme.


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