KUALA LUMPUR, Nov 28 (NNN-BERNAMA) — The Health Ministry (MOH), 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\u00a0according to requirements set by the World Health Organisation (WHO).<\/p>\n\n\n\n
Health director-general Tan Sri Dr Noor Hisham Abdullah said that based on the guidelines listed in the document published by WHO, titled \u2018WHO Target Product Profiles for COVID-19 Vaccines\u2019 in April, the vaccine should show a minimum level point estimate vaccine efficacy (VE) of 50 per cent in clinical trials, although a point estimate of 70 per cent is preferred.<\/p>\n\n\n\n
\u201cThe vaccine should generate antibodies that can stay in a person\u2019s body for at least six months, but VE is the endpoint in the third phase of clinical trials.<\/p>\n\n\n\n
\u201cCurrently, no phase three clinical studies have been published for the COVID-19 vaccine that can be evaluated by the ministry\u2019s NPRA. As such, the VE information for every vaccine candidate has not been confirmed,\u201d he wrote on his Facebook page tonight.<\/p>\n\n\n\n
On the safety aspect, Dr 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.<\/p>\n\n\n\n
Meanwhile, on the quality aspect, Dr Noor Hisham said they must be evidence of compliance with Good Manufacturing Practices (GMP).<\/p>\n\n\n\n
\u201cThe 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.<\/p>\n\n\n\n
\u201cThe 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.<\/p>\n\n\n\n
\u201cApart 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,\u201d he said.<\/p>\n\n\n\n
— NNN-BERNAMA<\/p>\n","protected":false},"excerpt":{"rendered":"
KUALA LUMPUR, Nov 28 (NNN-BERNAMA) — The Health Ministry (MOH), 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\u00a0according to requirements set by the World Health Organisation (WHO). Health director-general Tan Sri Dr Noor […]<\/p>\n","protected":false},"author":19,"featured_media":99510,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[288,318],"tags":[],"_links":{"self":[{"href":"http:\/\/namnewsnetwork.org\/index.php?rest_route=\/wp\/v2\/posts\/103585"}],"collection":[{"href":"http:\/\/namnewsnetwork.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/namnewsnetwork.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/namnewsnetwork.org\/index.php?rest_route=\/wp\/v2\/users\/19"}],"replies":[{"embeddable":true,"href":"http:\/\/namnewsnetwork.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=103585"}],"version-history":[{"count":0,"href":"http:\/\/namnewsnetwork.org\/index.php?rest_route=\/wp\/v2\/posts\/103585\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"http:\/\/namnewsnetwork.org\/index.php?rest_route=\/wp\/v2\/media\/99510"}],"wp:attachment":[{"href":"http:\/\/namnewsnetwork.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=103585"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/namnewsnetwork.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=103585"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/namnewsnetwork.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=103585"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}