Bangladesh government has approved the clinical trials of India’s Covaxin, a vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research.
The International Centre for Diarrhoeal Disease Research, Bangladesh had recently sought approval for the clinical trials of the vaccine, Dr Syed Modasser Ali, chairman of Bangladesh Medical Research Council, said on Tuesday. But the approval was delayed due to the coronavirus situation in the country.
“All the documents they presented were scientifically accurate. The National Ethics Committee gave clearance on Jul 18.”
It means they can begin the human trials of Covaxin, according to Ali.
The Icddr,b still has some work left to do, he said. They need to get approval from the Directorate General of Drug Administration to import the vaccine, reports bdnes24.com.
"After importing the vaccine, they must inform us about their plans before beginning the trials. We will monitor the situation regularly.”
Bharat Biotech sought approval from the Bangladesh government in mid-January to hold clinical trials of Covaxin in the country. The vaccine was approved for emergency use in India last January.
Covaxin is an inactivated whole virus vaccine, containing SARS-CoV-2 particles that have been chemically deactivated. That means they can no longer infect cells, but still stimulate a protective immune response.
Covaxin also contains two adjuvants – chemicals designed to strengthen the immune response to the vaccine – aluminium hydroxide, and a toll-like receptor (TLR) 7/8 agonist. The vaccine comes as a two-dose regimen recommended to be taken 28 days apart.
Earlier, on Jun 24, the BMRC approved the Phase III clinical trials of a Chinese vaccine developed by the Institute of Medical Biology and the Chinese Academy of Medical Sciences.
The government, so far, has approved Oxford-AstraZeneca’s COVISHIELD vaccine, Russian Sputnik V vaccine, Chinese Sinopharm and Sinovac vaccines, American Pfizer-BioNTech, Johnson & Johnson and Moderna vaccines for use in Bangladesh.