Globe Biotech applies for approval to run clinical trial of COVID vaccine
Senior Correspondent, bdnews24.com
Published: 17 Jan 2021 02:37 PM BdST Updated: 17 Jan 2021 07:09 PM BdST
Bangladeshi drugmaker Globe Biotech has applied for approval to begin clinical trials of its COVID-19 vaccine candidate 'Bangavax'.
Professor Mamun Al Mahtab, who is leading a team of 57 researchers for the trial, submitted the application and relevant papers – around 10,000 pages - to Bangladesh Medical Research Council or BMRC on Sunday. An assistant director there received the application.
The team seeks to conduct the first and second phases of the trial at a unit of a government hospital. The name of the hospital will be disclosed after the approval.
The researchers aim to experiment the vaccine on more than 100 people in the trial, said Prof Mahtab.
“We have decided the number of participants after checking data from Pfizer and Moderna who had the same number of trial participants,” he said.
Clinical Research Organisation Ltd will run the trial on behalf of Globe, he said.
After checking details of the Globe vaccine, CRO concluded that it is eligible for a clinical trial. “Hence, we prepared the protocol for clinical trial," said Prof Mahtab.
The National Research Ethics Committee of the BMRC will examine the application and forward it to the Directorate General of Drug Administration or DGDA after approval.
The National Clinical Advisory Committee of the DGDA will then evaluate the application.
"The clinical trial can be kicked off once the DGDA approves it. We're prepared to start the work within seven days from getting the approval," said Prof Mahtab.
Bangladeshi nationals, who will have tested negative for COVID-19 with no comorbidities and aged over 18 years, are eligible for the vaccine trial, he said.
Globe Pharmaceutical Chairman Md Harunur Rashid, Globe Biotech CEO Kakan Nag, icddr,b Director Tahmina Shirin and others were also present.
Globe received a licence to produce the potential vaccine for trial on Dec 28 last year.
It is the only Bangladeshi firm in the race to develop an effective and safe coronavirus vaccine, seen as the only way out of the pandemic that has claimed at least 2 million lives and infected more than 94 million globally.
The vaccine was initially called Bancovid, but was later renamed Bangavax in December.
The experimental COVID-19 vaccine features on the World Health Organisation’s list of draft landscape of candidate vaccines.
The drugmaker shared their effort to produce COVID-19 vaccine in a press briefing on Jul 3 last year and later on Oct 10, said the vaccine ‘has proved its efficacy and safety’ when applied on mice.
Initially, Globe Biotech had signed an MoU with the icddr,b for running a clinical trial which was later cancelled due to the lack of interest on icddr,b’s part, said Globe Pharmaceuticals Chairman Rashid.
-
Monkeypox symptoms differ from earlier outbreaks: study
-
EU proposes ban on flavoured heated tobacco products
-
Global monkeypox cases rise to 3,400: WHO
-
Monkeypox is not yet a health emergency
-
Monkeypox case rises to more than 3,200 globally: WHO
-
US probes infant death 'related to baby formula'
-
US halts sales of Juul e-cigarettes
-
Monkeypox 'emergency' decision due from WHO sparks criticism
-
Monkeypox symptoms differ from previous outbreaks: UK study
-
EU proposes ban on flavoured heated tobacco products
-
Monkeypox case count rises to more than 3,400 globally, WHO says
-
At flooded cancer hospital in northeast India, chemotherapy given on the road outside
-
WHO says monkeypox is not yet a health emergency
-
Pfizer/BioNTech say omicron-based COVID shots improve response vs that variant
Most Read
- Bangladesh is gearing up to open its first river tunnel by the end of 2022
- Drastic fall in passenger numbers forces owners to cut Dhaka-Barishal launch fares
- Bangladesh to celebrate Eid-ul-Azha on Jul 10
- Biman Bangladesh jets collide again at Dhaka airport
- Amin Hilaly, ‘missing’ real estate boss named in NSU graft case, is found in Savar
- Bangladesh state minister apologises for power cuts fuelled by gas shortage
- Bangladesh’s exports climb to record $52bn in FY22
- Fire at Meghna Group packaging factory under control after 3.5 hours
- Bangladesh suspends funds for 'less important' projects as austerity drive ramps up
- Bangladesh bans motorcycles from highways for a week during Eid-ul-Azha