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Conditional approval for Spikevax vaccine for 12-year-olds and above

05/08/2022 12:43 AM

KUALA LUMPUR, Aug 4 (Bernama) -- The Spikevax brand COVID-19 vaccine produced by Rovi Pharma Industrial Services in Spain has been given conditional approval for use in Malaysia by 12-year-olds and above, said Health director-general, Tan Sri Dr Noor Hisham Abdullah.

He said the decision was made at the 375th Drug Control Authority (PBKD) meeting today.

"Spikevax has previously been approved for conditional registration for use by individuals aged 18 and above," he said in a statement today.

He said so far, the DCA had 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 by individuals aged 12 years and above.

Dr Noor Hisham said the National Pharmacy Regulatory Agency (NPRA) would be monitoring the quality, safety and effectiveness of the vaccine (Spikevax) to ensure that the benefit over risk of the product remained positive.

"The Ministry of Health (MOH) is committed to improving the people's access to medicines for the treatment or prevention of the spread of COVID-19 in Malaysia by ensuring that they are evaluated appropriately based on the aspects of quality, safety and effectiveness," he added.






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