Covid-19: Conditional approval for Spikevax vaccine for aged 12 and above

KUALA LUMPUR: The Spikevax Covid-19 vaccine produced by Rovi Pharma Industrial Services in Spain has been given conditional approval in Malaysia for those who are 12-years-old and above, says Tan Sri Dr Noor Hisham Abdullah.

The Health director-general said the decision was made at the 375th Drug Control Authority (DCA) meeting on Thursday (Aug 4).

“Spikevax has previously been approved for conditional registration for individuals aged 18 and above,” he said in a statement.

He said so far, the DCA had given approval to the Comirnaty vaccine and CoronoVac for 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).

“The Health Ministry 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