Malaysia grants conditional approval for Moderna Covid-19 vaccine for emergency use

KUALA LUMPUR (Aug 5): Malaysia today has granted conditional approval for the Moderna Covid-19 vaccine, according to Health director-general Tan Sri Dr Noor Hisham Abdullah (pictured).

According to his statement, the conditional approval is for the emergency use of “Spikevax 0.20mg/ml dispersion for injection Covid-19 mRNA Vaccine (nucleoside modified)", also known as Moderna vaccine.

He said the vaccine was manufactured by Rovi Pharma Industrial Services of Spain while the product registration holder is Zuellig Pharma Sdn Bhd.

“MOH [Ministry of Health] would like to inform that this conditional approval 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 benefits over risks for the vaccine products remains positive,” said Dr Noor Hisham in a statement.

Furthermore, he said, the ministry is also committed to improving access to Covid-19 vaccine products in the country, by ensuring the products have been evaluated in terms of quality, safety and effectiveness by the National Pharmaceutical Regulatory Agency and approved by the Drug Control Authority (DCA).

To recap on June 15, DCA approved the Johnson & Johnson (J&J) and CanSino vaccines — both of which require only one dose — for emergency use.

Currently, Malaysia is administering Pfizer-BioNTech, Sinovac and AstraZeneca vaccines, which require two-dose shots.

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