The Drug Control Authority (DCA) in its 362nd meeting today gave conditional registration approval for the Spikevax 0.20 mg/ml Dispersion for Injection Covid-19 mRNA Vaccine (nucleoside modified), also known as Covid-19 Moderna vaccine, for use in the current emergency situation.
Health director-general Dr Noor Hisham Abdullah in a statement said approval for the product was for the product registration holder, Zuellig Pharma Sdn Bhd and the manufacturer, Rovi Pharma Industrial Services of Spain.
“The conditional registration approval required quality information as well as the efficacy of the vaccine to be monitored and evaluated based on the latest data from time to time.
“It is to ensure that the comparison of benefits over risks for the vaccine product remains positive,” he said.
Noor Hisham also said the health ministry is committed to improving access to Covid-19 vaccines in Malaysia by ensuring that the products are evaluated in terms of quality, safety and efficacy by the National Pharmaceutical Regulatory Agency and approved by the DCA.