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Bangavax approved for human trial

  • Staff Correspondent
  • 24 November, 2021 12:00 AM
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Bangavax approved for human trial

Bangavax, a single-dose Covid-19 vaccine developed by local pharmaceutical company Globe Biotech Ltd, has been approved by Bangladesh Medical Research Council (BMRC) for human trials.

“The BMRC has given us ethical permission to conduct Bangavax trials on humans and now we’ll submit the protocol to Directorate General for Drug Administration for clinical trial,” said Dr Md Mohiuddin, Senior Manager (quality and regulation) of Globe Biotech Ltd.

BMRC director Prof Md Ruhul Amin said, “Globe Biotech is now able to conduct Phase-I trial, fulfilling the conditions set by the BMRC. The company will get clearance for widespread use of the vaccine if Phase-2 and Phase-3 trials are found effective and safe enough.”

Earlier, the vaccine developers responded to all the queries and observations of the BMRC to get nod for Bangavax trials on humans.

On July 2 in 2020, Globe Biotech declared that it developed a Covid-19 vaccine.

The results of the trials on animals were published on the Bio-Archive on September 29.

The pharmaceutical company in September of the same year also announced its plan to launch Bangavax trials on humans after completing Phase-II animal trials.

On October 5 last year, Globe Biotech claimed that it found ‘very promising results’ in Bangavax trials on rabbits and mice. Researchers initially named the vaccine ‘Bancovid’ but later renamed it ‘Bangavax’.

The International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) announced that it will conduct human trial of the locally produced vaccine. It signed a memorandum of understanding (MoU) with Globe Biotech on October 14 to conduct phase-I trial.

But Globe Biotech, on December 1, cancelled the agreement with the icddr,b, alleging that icddr,b was showing hardly any interest in conducting trials of the vaccine candidate.

On December 28 last year, the vaccine developer got approval from the DGDA to produce the coronavirus jab to carry out clinical trials.

Globe Biotech on January 6 this year got permission from the Directorate General of Drug Administration to manufacture Bangavax doses necessary for clinical trial.

On January 17, the pharmaceutical company submitted a protocol to the BMRC for ethical approval to conduct Bangavax’s clinical trials.

On June 22, the BMRC sent a letter to Globe Biotech, asking it to conduct trial on monkeys or chimpanzees before going for human trials.

Globe Biotech, on November 1, submitted a report on the results of the Bagavax trial on monkeys to the BMRC as per guidelines.

Bangavax, along with two other vaccines developed by Globe Biotech, were included in the World Health Organization’s draft landscape and tracker of Covid-19 vaccines worldwide, on October 17 last year.