Kuala Lumpur: The Covaxin Covid-19 vaccine has been given conditional approval for use during disasters, health director-general Dr Noor Hisham Abdullah said.
He said the conditional approval was agreed at a Drug Control Authority (DCA) meeting today.
“The approval still requires monitoring of information on product quality, safety and effectiveness, and continuous evaluation by the National Pharmaceutical Regulatory Authority (NPRA) based on the latest data.
“This is to ensure the benefit-risk balance for the vaccine remains positive,” he said in a statement.
He said Covaxin, registered under Averroes Pharmaceuticals Sdn Bhd and manufactured by Bharat Biotech International Ltd in India, will be used for active immunisation to prevent Covid-19 among those aged 18 and above.
Meanwhile, Noor Hisham said in a separate statement that the DCA also agreed to give conditional registration approval for Tegrad (dolutegravir film coated tablets 50mg), the generic version of dolutegravir (DTG).
He said the DCA’s latest evaluation of the product, manufactured by Hetero Labs Ltd in India, revealed that Tegrad was suitable for use in combination with other anti-retroviral products for HIV treatment for those aged 12 and above.
Tegrad is the first generic DTG product registered in the country, under Camber Laboratories Sdn Bhd, he added.
Noor Hisham said approval for the product would provide wider access to the medication at a more affordable cost, regardless of whether it was at a public or private healthcare facility.
