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KUALA LUMPUR: The Ministry of Health (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 with optimal efficacy in accordance with the requirements set by the world. Health Organization (WHO).
Chief Health Officer Tan Sri Dr. Noor Hisham Abdullah (pix) said that according to the guidelines listed in the document published by the WHO, titled ‘WHO Target Product Profiles for Covid-19 Vaccines’ in April, the vaccine should show a minimum estimated level of vaccine efficacy (EV) of the 50% in clinical trials, although a point estimate of 70% is preferred.
“The vaccine must generate antibodies that can remain in a person’s body for at least six months, but EV is the endpoint in the third phase of clinical trials.
“Currently, there are no published phase three clinical studies for the Covid-19 vaccine that can be evaluated by the ministry’s NPRA. As such, the VE information for each candidate vaccine has not been confirmed, ”he wrote on his Facebook page.
On the safety side, Dr Noor Hisham said that the vaccine should have a sufficient safety profile so that the benefits outweigh the risks (benefit-risk analysis), adding that the vaccine should have only mild adverse effects and transitory.
Meanwhile, on the quality side, Dr. Noor Hisham said there must be evidence of compliance with Good Manufacturing Practice (GMP).
“Manufacturing data must show that all sources of materials used in the manufacturing process are adequately controlled according to international standards, such as the history and qualification of cell banks, virus banks and the identification of all materials of animal origin used for cell culture and virus growth. .
“The manufacturing process data to be provided includes critical process parameters, critical quality attributes (such as purity, identity, vaccine potency), batch records, defined lead times, and the in-process testing scheme, in addition to having to submit the specifications for the drug substance and the drug product.
“Apart from that, other data is also required such as the consistent manufacturing process, including the document protocol, the validation process and the research reports. Even the stability data supporting the expiration of the vaccine and the optimal temperature are also important to ensure the quality of the vaccine if it is used within the recommended temperature range, ”he said. -Called
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