Bangavax to get conditional approval for clinical trials

Staff Correspondent

17 June, 2021 12:00 AM printer

The National Research Ethics Committee of Bangladesh Medical Research Council (BMRC) has taken decision to give conditional approval of Globe Biotech's Covid-19 vaccine, Bangavax, for human trials.

Globe Biotech will get the permission for conducting clinical trials on humans only after fulfilling some conditions set by the BMRC, its director Prof Dr Ruhul Amin told newsmen on Wednesday.

Globe Biotech submitted the protocol for clinical trials to the BMRC for ethical approval on January 17, but it is yet to receive any response from the regulatory authorities.

“Globe Biotech, a company from China, and a company from India have applied to us regarding the clinical trials of their Covid-19 vaccines in Bangladesh,” he said.

The BMRC director said Globe Biotech would need to complete a number of processes, including a trial of the vaccine on monkeys or chimpanzees, before proceeding to human trials.

Addressing a press conference, Health and Family Welfare Minister Zahid Maleque said the Bangavax vaccine didn’t get approval as they didn’t complete necessary protocol to run the trials.

He said the Globe Biotech has to complete international protocol to get the approval.

Later, talking to reporters at his office, Md Harunur Rashid, chairman of Globe Pharmaceuticals Group of Companies said, “We have not received any official letter from the BMRC yet. Once we receive the letter, we will be able to say more about the (new) conditions.”

He further claimed that Bangavax would be effective against the highly contagious Delta variant of coronavirus that emerged from India.

Asked about the expected pricing of the Bangavax vaccine, he said each dose will cost around $10-$15 for the Bangladesh government. “It will cost more than $20 for the international buyers.”

Claiming that the Globe Biotech has the capacity to produce at least 10 million doses every month, Harunur Rashid said any local vaccine producers will be able to collaborate with us as our vaccine is made of synthetic mRNA.

On December 28 last year, Bangladeshi company Globe Biotech has received approval from the Directorate General of Drug Administration (DGDA) for manufacturing its vaccine for a clinical trial.

On July 2 last year, Globe Biotech announced that they are developing a Covid-19 vaccine as they completed preliminary animal trials successfully.

The World Health Organization (WHO) enlisted the vaccine developed by Globe Biotech Limited.

Globe Biotech Ltd has at first made a contract with the icddr,b to conduct a clinical trial of its coronavirus vaccine but they cancelled their agreement later.

The biotech firm has later assigned the Clinical Research Organization (CRO) to run the trials of their mRNA vaccine.

 


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