Globe Biotech to apply for ethical permission from BMRC this week
Globe Biotech Limited said that they are preparing to conduct human trials of their Covid-19 vaccine.
Just two months ago, Globe Biotech claimed the vaccine saw success in preliminary animal trials. Company sources said they are planning to publish the results from the full animal trials through a press release in the upcoming week.
When contacted, Globe Biotech Manager (Quality and Regulations) Dr Mohammad Mohiuddin told Dhaka Tribune that the human trials would begin after taking necessary measures as per international protocol.
“We will apply for ethical approval from the Bangladesh Medical Research Council (BMRC) next week,” he said on Thursday night.
“We are currently working on formulating the protocol and guidelines for the trial,” Mohiuddin added.
The Globe Biotech official further said that they have already identified a good number of volunteers who are willing to take part in the trial. A third-party Contract Research Organization (CRO) has also been finalized and Globe Biotech are now working with them to formulate the protocol and guidelines.
“An international standard local CRO has already been finalized to conduct the trial. As the protocol is yet to be finalized, although at the final stage of the process, the number of volunteers and the name of the CRO cannot be disclosed yet,” he explained.
Mohiuddin said he hoped they would get a quick response from BMRC after submitting their application, so that the human trials could start soon.
Company sources said they were ready to begin trial as early as in October.
At a press conference on July 2, Globe Biotech Limited announced that they were developing a Covid-19 vaccine and were at the preclinical stage.
At the time, they said they would need six to eight weeks to complete regulated animal trials, after which they would apply for permission to conduct human trials if the animal trials proved successful.
Depending on the success of the human trials, the vaccine may be ready for the market in early 2021.
According to Dr Asif Mahmud, assistant manager and in-charge of research and development of Globe Biotech, a 12-member scientific group led by Globe Biotech CEO Kakon Nag and COO Naznin Sultana began the vaccine research on March 18.