MOH has conditionally approved the antibody-drug Evusheld (100mg/ml) injection product produced by company of AstraZeneca for preventing Covid-19.
Our Health Ministry director-general, Tan Sri Dr. Noor Hisham said that Evusheld injection will be used to prevent Covid-19 infection and intended to use by certain populations such as those over 12 years old who weigh at least 40kg, not able to produce sufficient immune response to Covid-19 vaccination or are contraindicated against Covid-19 vaccination.
Covid-19 vaccination cannot be replaced by Evusheld
Based on Health Ministry director-general Tan Sri Dr Noor Hisham, the decision was made during the 372nd meeting of National Pharmaceutical Regulatory Division (NPRA).
He said the use of Evusheld was based on clinical guidelines issued by MOH, but the product should not be used as a substitute for Covid-19 vaccination and still need to compliance with standard operating procedures (SOPs).
He also mentioned that the National Pharmaceutical Regulatory Division (NPRA) will continuously monitor and assessed as Evusheld's conditional registration approval requires information on the quality, safety and effectiveness of the product to ensure the product's benefit-over-risk remains positive.