The Drug Control Authority (DCA) has approved Bharat Biotech’s Covaxin vaccine, making it the eighth Covid-19 vaccine to be authorised in Malaysia.
Health Ministry director-general Dr Noor Hisham Abdullah said it has been granted conditional approval for use on those above 18 years old.
“The conditional approval still requires information on quality, safety, and efficacy of the product to be continuously evaluated by the National Pharmaceutical Regulatory Agency based on the latest available data.
“This is to ensure the benefit-risk balance of the vaccine remains positive,” he said in a statement today.
There is no mention of whether a booster shot was also approved for the vaccine.
The approval is for vaccines manufactured by Bharat Biotech’s own facilities in India, while the local licence registration holder is Averroes Pharmaceuticals Sdn Bhd.
Similar to Sinovac’s Coronavac and Sinopharm’s Covilo vaccines already approved in Malaysia, Covaxin uses an inactivated form of the SARS-CoV-2 virus as its active ingredient.
The vaccine had also received approval last year from the World Health Organization (WHO) under its emergency-use listing scheme.
In a real-world study of the vaccine’s effectiveness during India’s Delta variant surge last year, two doses of the vaccine was found to be 47 percent effective in preventing symptomatic Covid-19 infection.
The study was published in the peer-reviewed journal Lancet on Nov 23 last year.
Like other inactivated vaccines, however, there appear to be no published studies on its real-world effectiveness against the Omicron variant, which is more transmissible than the Delta variant and more capable of evading immunity elicited by current generation vaccines.
A news article published in the scientific journal Nature last month highlighted the performance of multiple inactivated vaccines against the Omicron variant including Covaxin, saying that inactivated vaccines still retain some potency against Omicron but is considered “sub-optimal”.
HIV/AIDS treatment
In another development, Noor Hisham said the DCA has approved a generic version of the antiretroviral drug Dolutegravir, dubbed Tegrad, for the first-line treatment of HIV/AIDS.
It is to be used in combination with other antiretroviral drugs to treat HIV/AIDS among people aged 12 and above.
“Tegrad is the first generic Dolutegravir to be registered in this country and is the result of a voluntary licensing agreement between the Medicines Patent Pool (MPP) and Dolutegravir’s patent-holder Viiv Healthcare.
“The agreement signed in November 2020 has improved access to generic Dolutegravir in four upper-middle-income countries, namely Malaysia, Azerbaijan, Belarus, and Kazakhstan,” he said.
The MPP is a WHO-backed organisation that facilitates access to cheaper patented HIV/AIDS, tuberculosis, and other drugs for low- and middle-income countries.
Last year, it also struck a deal that would allow poorer countries to manufacture the Covid-19 antiviral drugs Molnupiravir and Paxlovid without paying royalties to Merck and Pfizer.
Noor Hisham said the generic Dolutegravir will be manufactured by Hetero Labs Limited in India, which holds a voluntary licence from the MPP to produce the drug for several countries including Malaysia.
The local license registration holder is Camber Laboratories Sdn Bhd. - Mkini
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