DCA GRANTS CONDITIONAL APPROVAL TO COVID-19 VACCINES - HEALTH D-G
2 March 2021
PUTRAJAYA: The Drug Control Authority (DCA), in a meeting today, granted conditional approval to three COVID-19 vaccines for use to curb the spread of the COVID-19 infection in the country, said Health director-general Tan Sri Dr Noor Hisham Abdullah.
Dr Noor Hisham said the approval was given to AstraZeneca Solution for Injection; CoronaVac Suspension for Injection – Sinovac; and COMIRNATY Concentrate for Dispersion for Injection.
"This conditional registration requires the holding company to submit an analysis of additional and latest data by rolling submission to be evaluated by the National Pharmaceutical Regulatory Agency (NPRA)," he said at a press conference on the development of COVID-19.
Dr Noor Hisham said it was to ensure that the effectiveness and safety of the vaccines are always updated and the ‘benefits over risk’ of the vaccines remain positive.
Meanwhile, he said NPRA is still assessing two more COVID-19 vaccines namely Gam-COVID-Vac or Sputnik V (manufactured by Gamaleya National Research Centre for Epidemiology and Microbiology, Russia) and CoronaVac Suspension for Injection – Sinovac (fill and finish manufacturing by Pharmaniaga LifeScience Sdn Bhd).
According to Dr Noor Hisham, the Ministry of Health (MOH) would keep improving public health in fighting the COVID-19 pandemic by procuring a supply of vaccines that have been evaluated in terms of their quality, safety and efficacy by NPRA and approved by DCA.
He said the government was highly committed to ensuring that the country’s adult population achieve herd immunity in line with the National COVID-19 Immunisation Programme target. - Bernama