KUALA LUMPUR – Conditional approval has been given to the Moderna Covid-19 vaccine for use in Malaysia.
The Health Ministry said the conditional approval is for the emergency use of “Spikevax 0.20mg/ml dispersion for injection Covid-19 mRNA vaccine (nucleoside modified)”.
The product registration holder is Zuellig Pharma Sdn Bhd, and it is manufactured by Rovi Pharma Industrial Services of Spain.
The Spikevax jab is commonly called the Moderna vaccine.
In a statement today, the ministry said the conditional approval requires information on the vaccine’s quality, safety and efficacy based on the latest data from time to time.
“It is to ensure that the comparison of benefits over risks for the vaccine product remains positive.
“MoH is also committed to improving access to Covid-19 vaccine products in Malaysia, by ensuring that they have been evaluated in terms of quality, safety and effectiveness by the National Pharmaceutical Regulatory Agency and approved by the Drug Control Authority (DCA).”
In May, research by United States scientists showed that the Pfizer-BioNTech and Moderna jabs should remain highly effective against two coronavirus variants first identified in India.
The lab-based study was carried out by New York University’s Grossman School of Medicine and Langone Centre. It is considered preliminary as it has yet to be published in a peer-reviewed journal.
For the B.1.617 variant, it was found that there was an almost fourfold reduction in the amount of neutralising antibodies, or Y-shaped proteins that the immune system creates to stop pathogens from invading cells. For B.1.618, the reduction was around threefold.
However, the study does not preclude the possibility that newer variants that are more resistant to vaccines will emerge – highlighting the importance of widespread immunisation at the global level.
In June, DCA approved the Johnson & Johnson and CanSino Covid-19 vaccines for emergency use.
The agency also gave the nod for the Pfizer-BioNTech jab to be used on children aged 12 and above under the National Covid-19 Immunisation Programme.
In a statement, Health Director-General Tan Sri Dr Noor Hisham Abdullah said the Johnson & Johnson vaccine, called Janssen, will be procured via the Covax facility headed by the World Health Organisation (WHO).
Both the Johnson & Johnson and CanSino vaccines are single-dose jabs and have received Emergency Use Listing approval from WHO.
The Pfizer-BioNTech, Sinovac and AstraZeneca jabs currently used in Malaysia are a two-dose regimen. – The Vibes, August 5, 2021
