KUALA LUMPUR: The health ministry, through the National Pharmaceutical Regulatory Agency (NPRA), will ensure that the Covid-19 vaccine approved to be registered and marketed in Malaysia is safe, of good quality and has optimum efficacy according to requirements set by the World Health Organisation (WHO).
Health director-general Dr Noor Hisham Abdullah said that based on the guidelines listed in the document published by WHO, titled “WHO Target Product Profiles for Covid-19 Vaccines” in April, the vaccine should show a minimum level point estimate vaccine efficacy (VE) of 50% in clinical trials, although a point estimate of 70% is preferred.
“The vaccine should generate antibodies that can stay in a person’s body for at least six months, but VE is the end-point in the third phase of clinical trials.
“Currently, no phase three clinical studies have been published for the Covid-19 vaccine that can be evaluated by the ministry’s NPRA. As such, the VE information for every vaccine candidate has not been confirmed,” he wrote on his Facebook page last night.
On the safety aspect, Noor Hisham said the vaccine must have a sufficient safety profile so that the benefits outweigh the risks (benefit-risk ratio analysis), adding that the vaccine should have only mild and transient adverse effects.
Meanwhile, on the quality aspect, Noor Hisham said there must be evidence of compliance with Good Manufacturing Practices (GMP).
“The manufacturing data should show that all material sources used in the manufacturing process are adequately controlled according to international standards, such as the history and qualification of cell banks, virus banks and identification of all animal-derived materials used for cell culture and virus growth.
“The manufacturing process data that must be provided include the critical process parameters, critical quality attributes (like purity, identity, potency of the vaccine), batch records, defined hold times and the in-process testing scheme, in addition to having to submit the specifications for drug substance and drug product.
“Apart from that, other data such as consistent manufacturing process, including document protocol, validation process and research reports, are also required. Even the stability data supporting the vaccine expiration and optimum temperature is also important in order to ensure vaccine quality if used within the recommended temperature range,” he said.
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