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Pfizer-BioNTech's vaccine approved for children aged 12 and above

KUALA LUMPUR: The Drug Control Authority (DCA) has approved the use of Pfizer-BioNTech's Cominarty vaccine for children aged 12 and above.

Health director-general Tan Sri Dr Noor Hisham Abdullah said though these additional indications have been approved, the Health Ministry was still of the view that vaccination priority was still for the high-risk group, in line with the existing policy set under the Covid-19 National Immunisation Programme (NIP).

In a statement today, he said the authority, after its 359th meeting today, had also agreed to grant conditional registration approval for use during a disaster to two vaccines requiring only one dose, which are the Covidecia Rombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) produced by CanSino Biologics Inc, China, and Johnson & Johnson's Janssen Covid-19 Vaccine which has been granted the World Health Organisation's (WHO) Emergency Use Listing (EUL) approval.

"The Janssen Covid-19 Vaccine obtained by the Malaysian government through the Covax facility is implemented through a recognition mechanism on WHO EUL.

"The Health Ministry wishes to inform that the conditional registration approval requires information on the quality, safety and effectiveness of the vaccine product to be monitored and evaluated based on data from time to time.

"It is to ensure that the comparison of the benefit over risk for the vaccine products remains positive," he added.

Dr Noor hisham said the ministry would continue to enhance public health levels in fighting Covid-19, through the procurement of vaccines which have been evaluated from the aspects of quality, safety and effectiveness by the National Pharmaceutical Regulatory Agency, approved by the DCA.

"The government is also committed to ensure Malaysians achieve herd immunity, in line with NIP targets."

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