The COVAXIN COVID-19 vaccine has been given conditional approval for use during disasters, Health director-general Tan Sri Dr Noor Hisham Abdullah said.
He said that the conditional approval was agreed at the 369th Drug Control Authority (DCA) meeting that took place 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 periodically.
“This is to ensure the benefit-risk balance for the vaccine remains positive,” he said in a statement today.
He said COVAXIN, registered under Averroes Pharmaceuticals Sdn Bhd and manufactured by Bharat Biotech International Limited in India, will be used for active immunisation to prevent COVID-19 caused by the SARS-CoV-2 virus among individuals aged 18 and above.
Meanwhile, Dr Noor Hisham said in a seperate statement that the DCA also agreed to provide conditional registration approval for TEGRAD (Dolutegravir FilmCoated Tablets 50mg), the generic version of dolutegravir (DTG).
He said the decision was made during the DCA’s latest meeting and evaluation of the product, manufactured by Hetero Labs Limited in India, revealed that TEGRAD was suitable for use in combination with other anti-retroviral products for Human Immunodeficiency Virus (HIV) treatment among individuals aged 12 and above.
"TEGRAD is the first generic DTG product registered in the country, under Camber Laboratories Sdn Bhd, and benefits from the Voluntary Licensing (VL) agreement between Medicines Patent Pool (MPP) and the DTG patent holder, ViiV Healthcare signed in November 2020.
"Hetero Labs Limited, India is a manufacturer licensed by MPP under the VL agreement to produce the generic DTG product for certain countries, including Malaysia,” he said.
Dr Noor Hisham said that efforts to procure access for the product under the VL agreement was initiated by the Health Ministry in 2014.
“The ministry began working with MPP so that negotiations with the patent holder involving access to generic DTG medication to treat adult HIV patients could take place the next year,” he said.
This was in line with the World Health Organisation’s (WHO) recommendation that DTG be the first line treatment for HIV patients.
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.
“The Health Ministry, through the NPRA, will continue to monitor and evaluate the latest data periodically regarding the quality, safety and effectiveness of the DTG product to ensure the benefit-risk balance remains positive.
“The ministry is also committed to efforts of increasing access to quality, safe and effective medication for Malaysians,” he added. - Bernama