PUTRAJAYA: The Spikevax vaccine produced by Rovi Pharma Industrial Services, Spain has been given conditional approval for people aged 12 and above to prevent the spread of Covid-19.
According to Utusan Malaysia, Director General of Health, Tan Sri Dr. Noor Hisham Abdullah said that the decision was agreed through the 375th Drug Control Authority Meeting (PBKD) that convened today.
According to him, Spikevax was previously approved for conditional registration for use among individuals aged 18 and above.
“Until now, PBKD has given approval to the Comirnaty vaccine (produced by Pfizer-BioNTech) and CoronoVac (produced by Sinovac Life Sciences Co. Ltd, China and Pharmaniaga Lifescience Sdn. Bhd., Malaysia) for use among individuals aged 12 years and above.
“The approval of this conditional registration requires information on the quality, safety and effectiveness of the vaccine product to be continuously monitored and evaluated by the National Pharmaceutical Regulatory Division (NPRA),” he said in a statement today.
Noor Hisham said, monitoring is also done based on the latest data from time to time to ensure that the benefit-risk comparison for the product remains positive.
The Ministry of Health is always committed to improving people’s access to medicines for the treatment or prevention of C-19 transmission in Malaysia.
This is by ensuring that it is properly assessed based on aspects of quality, safety and effectiveness.