KUALA LUMPUR: The Drug Control Authority has given a conditional approval for the use of India's Covaxin for those aged 18 and above.
Averroes Pharmaceuticals Sdn Bhd, which holds the licence for the vaccine, and its manufacturer Bharat Biotech International Ltd, India, were given the regulator's nod under emergency use protocols in a meeting here, today.
Health director-general Tan Sri Dr Noor Hisham Abdullah said the conditional approval means the regulators still required information on the quality, safety and effectiveness of the product.
"These aspects would be continuously monitored by the National Pharmaceutical Regulatory Agency based on current data updates. This is to ensure the benefit risk analysis remains positive."
Dr Noor Hisham said the ministry was committed to increasing people's access to vaccines for the purpose of preventing the spread of Covid-19 in the country by ensuring that immunisations are evaluated thoroughly based on quality, safety and efficacy.
The BBC previously reported that the vaccine ran into controversy after India's regulators gave it emergency approval in January at a time when the third phase of the trial was still underway, drawing questions from experts.
Bharat Biotech reportedly published data on the vaccine's 78 per cent efficacy.