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Bangavax gets permission for human trial

  • Staff Correspondent
  • 18 July, 2022 12:00 AM
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Globe Biotech Ltd has received an approval from the Directorate General of Drug Administration (DGDA) to run human trials of its single-dose coronavirus vaccine Bangavax.

Globe Biotech Senior Manager (quality and regulation) Dr Mohammad Mohiuddin told newsmen that the government’s drug authorities gave the approval on Sunday to run human trials of the mRNA vaccine.

During the trial of Bangavax on apes, it has been found that the vaccine is effective against both the Delta and Omicron variants of coronavirus, said the local pharmaceutical company. Globe Biotech authorities hoped that the vaccine will also be effective in human body as well as it has been proved hundred percent safe and effective in ape body.

The World Health Organisation (WHO) has already enlisted the Bangavax vaccine.

Prof Mamun Al Mahtab, chief researcher of the Bangavax clinical trial, will run the human trials of the vaccine at Bangabandhu Sheikh Mujib Medical University (BSMMU) that may start by September.

Globe Biotech sources said human trial of the Bangavax vaccine will be conducted on 60 volunteers divided into two groups at the BSMMU.

During the human trial, volunteers aged 18-55 years will be placed in one group and those aged 55 and above in another group for the trial.

As part of the trial, the volunteers will be given two doses of the vaccine. The second dose will be given 21 days after the first dose. Later, the vaccinated volunteers will be kept under observation for 24 hours after vaccination.

Globe Biotech sources said the human trial is expected to be completed in a total of 35 days.

Earlier in November 2021, Globe Biotech received an approval from Bangladesh Medical Research Council (BMRC) for human trials of the vaccine.

On 2 July 2022, Globe Biotech disclosed that it developed a coronavirus vaccine.