Government / Public Policy

DCA approves conditional registration of AstraZeneca vaccine

KUALA LUMPUR: The Drug Control Authority (DCA) has granted conditional registration for the Covid-19 Vaccine AstraZeneca Solution for Injection for use in the country during a disaster.

Health director-general Tan Sri Dr Noor Hisham Abdullah said the DCA meeting, which convened for the 355th time on April 2 had agreed to the conditional registration for the vaccine, supplied through the COVAX facility by manufacturer SK Bioscience Co Limited, South Korea.

"The registration of Covid-19 vaccine supplied through the COVAX facility is implemented through a recognition mechanism on the Emergency Use Listing (EUL) approval granted by the World Health Organisation.

"EUL approval for the AstraZeneca-SK Bioscience vaccine was announced by WHO on Feb 15, 2021," he said in a statement today.

Dr Noor Hisham said the conditional registration requires the National Pharmaceutical Regulatory Division (NPRA) to monitor and evaluate additional and up-to-date data on the vaccine product from time to time.

This, he said was to ensure its effectiveness and safety are always updated and the benefit over risk comparison of the vaccine remains positive.

"The health ministry will constantly improve the level of public health in combating the Covid-19 epidemic through the procurement of vaccine supplies that have been evaluated in terms of quality, safety and effectiveness by the NPRA and approved by the DCA.

"The government is also committed to ensuring that the Malaysian adult population achieves herd immunity in line with the targets of the National Covid-19 Immunisation Programme," he added.

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