ASTRAZENECA VACCINE GETS CONDITIONAL REGISTRATION
WHO gave approval for the vaccine for emergency use in Feb, says Health D-G
THE Drug Control Authority (DCA) has granted conditional registration for the AstraZeneca Covid-19 vaccine for use in the country during 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.
“The EUL approval for the AstraZeneca-SK Bioscience vaccine was announced by the World Health Organisation on Feb 15, 2021,” he said yesterday.
Dr Noor Hisham said the conditional registration required the National Pharmaceutical Regulatory Division (NPRA) to monitor and evaluate additional and upto-date data on the vaccine product from time to time.
This, he said, was to ensure its effectiveness and safety were always updated and the benefit over risk comparison of the vaccine remained 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 adult population achieves herd immunity in line with the targets of the National Covid-19 Immunisation Programme.”