KUALA LUMPUR, March 28 — All COVID-19 vaccine candidates that are being developed in the country have yet to be commercialised, the Dewan Negara was told today.
Deputy Minister of Science, Technology and Innovation Datuk Ahmad Amzad Hashim said the vaccine candidates must undergo research and development (R&D) process, clinical and pre-clinical studies before they can be commercialised.
“Every step of the vaccine production must comply with the regulations and standards set by the National Pharmaceutical Regulatory Agency (NPRA) as well as international organisations,” Ahmad Amzad said during question and answer session here today.
He said this in response to a question from Senator Datuk Paul Igai who wanted to know the current status on the manufacture of local COVID-19 vaccines as well as the list of vaccines that have been developed and commercialised by Malaysia.
Ahmad Amzad said the country was currently developing two types of COVID-19 vaccines, namely inactivated and messenger ribonucleic acid, or mRNA vaccines.
On the production of the inactivated vaccine, he said it was now at the preclinical study phase and the the proof of concept study which started in Feb 2022 was expected to complete by July 2022, following which data analysis would be conducted and completed by end December this year.
“For the mRNA-based vaccine, it is at the laboratory stage, namely in-vitro transcription on the first cell cell line) culture which began in June 2021 and is expected to be completed by Dec this year.
“If the proof of concept on these two vaccines is successful, the production of these vaccines will be continued through laboratories which adhere to Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP),” he said.
