Bangladesh Approves Clinical Trials of Bharat Biotech's Covaxin

Bangladesh has given its approval to the clinical trials of Covaxin, an Indian vaccine produced by Bharat Biotech in partnership with the Indian Council of Medical Research.

Dr Syed Modasser Ali, head of Bangladesh Medical Research Council, told the media on Tuesday that the International Centre for Diarrhoeal Disease Research had recently attained authorisation for the vaccine's clinical trials. However, because of the coronavirus situation in the country, the approval was delayed.

“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 Dr Ali.

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.