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DCA approves conditional registration of AstraZeneca vaccine
BERNAMA
2/4/2021
PUTRAJAYA: The Drug Control Authority (DCA) has agreed to approve the conditional registration of the Covid-19 Vaccine AstraZeneca Solution for Injection for use during an emergency.
Health director-general Tan Sri Dr Noor Hisham Abdullah said the decision over the product supplied through the COVAX facility by South Korean manufacturer SK Bioscience Co Limited was made at the 355th DCA meeting today.
“The registration of the Covid-19 vaccine supplied through the COVAX facility is implemented through a recognition mechanism on the Emergency Use Listing (EUL) approval announced by the World Health Organisation (WHO) on Feb 15,“ he said in a statement today.
Dr Noor Hisham said the National Pharmaceutical Regulatory Agency (NPRA) would continue to monitor and evaluate additional and up-to-date data related to the vaccine.
“This is to ensure that the product’s effectiveness and safety information remains up-to-date and the risk-to-benefit ratio of this vaccine remains positive.
“The government is also committed to ensuring that the Malaysian adult population achieves herd immunity, in line with the target of the National Covid-19 Immunisation Programme,“ he said.
BERNAMA
2/4/2021
PUTRAJAYA: The Drug Control Authority (DCA) has agreed to approve the conditional registration of the Covid-19 Vaccine AstraZeneca Solution for Injection for use during an emergency.
Health director-general Tan Sri Dr Noor Hisham Abdullah said the decision over the product supplied through the COVAX facility by South Korean manufacturer SK Bioscience Co Limited was made at the 355th DCA meeting today.
“The registration of the Covid-19 vaccine supplied through the COVAX facility is implemented through a recognition mechanism on the Emergency Use Listing (EUL) approval announced by the World Health Organisation (WHO) on Feb 15,“ he said in a statement today.
Dr Noor Hisham said the National Pharmaceutical Regulatory Agency (NPRA) would continue to monitor and evaluate additional and up-to-date data related to the vaccine.
“This is to ensure that the product’s effectiveness and safety information remains up-to-date and the risk-to-benefit ratio of this vaccine remains positive.
“The government is also committed to ensuring that the Malaysian adult population achieves herd immunity, in line with the target of the National Covid-19 Immunisation Programme,“ he said.
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