NPRA Approves Moderna Covid-19 Vaccine

Malaysia’s local product registration holder for Moderna, an mRNA vaccine, is Zuellig Pharma.

KUALA LUMPUR, August 5 — The National Pharmaceutical Regulatory Agency (NPRA) has given conditional registration for emergency use of Moderna’s mRNA Covid-19 vaccine in Malaysia.

Health director-general Dr Noor Hisham Abdullah said this decision was made during a meeting today by the Drug Control Authority (DCA), which is under the NPRA.  

“This conditional registration requires information on the quality, safety, and effectiveness of the vaccine product to be monitored and evaluated based on the latest data from time to time. It is to ensure that the comparison of benefit over risk for the vaccine product remains positive,” Dr Noor Hisham said in a statement today.

The NPRA-approved vaccine by Moderna, an American pharmaceutical company, is made by Rovi Pharma Industrial Services S A based in Madrid, Spain. The local product registration holder in Malaysia is Zuellig Pharma Sdn Bhd.

Vaccine Minister Khairy Jamaluddin told Parliament last week that Malaysia’s vaccine portfolio has eight types of coronavirus vaccines from six different suppliers, including global vaccine-sharing programme COVAX, that can cover 130.3 per cent of the Malaysian population, or 41,699,650 people.

The vaccines are Pfizer-BioNTech, AstraZeneca-Oxford, Sinovac, CanSino, Sinopharm, and Johnson & Johnson. Also included are the Novavax vaccine from the United States and Sputnik V, which is from the Russian Gamaleya National Research Centre for Epidemiology and Microbiology; both shots are still under evaluation by the NPRA. 

The approval of Moderna makes it the ninth coronavirus vaccine in the national portfolio. So far, the government has rolled out the Pfizer, AstraZeneca, and Sinovac shots. 

Khairy previously said that the Moderna vaccine would be left to the private market as it is too expensive for the government. Sinopharm also is currently available only in the private market.

As of August 4, about 14.9 million people or 45.8 per cent of the country’s total population has received at least a single Covid-19 vaccine dose, while 23.6 per cent have been fully vaccinated.

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