MALAYSIA Tanah Tumpah Darahku


Friday, August 5, 2022

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


COVID-19 | 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, Health director-general Dr Noor Hisham Abdullah said.

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

"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.

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

"The Ministry of Health 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.

- Bernama

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