Bangavax and two other vaccines to meet human trial conditions
Globe Biotech and two Indian and Chinese drugmakers must submit documents on the effectiveness and side effects of the vaccines on monkeys
The Bangladesh Medical Research Council (BMRC) has set conditions for the human trial of three more coronavirus vaccines, including local drugmaker Globe Biotech's Bangavax, and two others from China and India respectively.
Before "human trials", the institutes will have to fulfil all conditions as per BMRC rules.
The decision was made at a meeting of the National Research Ethics Committee of the BMRC on Wednesday morning.
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"We have decided in principle to approve the three vaccines. But they must meet certain conditions," BMRC Director, Professor Dr Ruhul Amin, told journalists after the meeting.
"All documents on the effectiveness and side effects of these vaccines on monkeys or chimpanzees must be submitted to the BMRC prior to Phase-1 trials. The issue of safety in human use will be seriously considered. If these rules are followed, we will definitely approve."
In addition to Bangavax, it has been decided in principle to approve the applications of Bharat Biotech and the Vero cell vaccine by the Institute of Medical Biology, Chinese Academy of Medical Sciences.
Two icddr,b scientists sought approval for the Chinese and Indian vaccines, and Globe Biotech for Bangavax.
Dr Ruhul Amin said, "It is not that the Globe vaccine has received approval for a clinical trial. But we are positive, even though several issues have been raised, including safety issues."
He said the three companies that have applied for first and second phase clinical trials will be informed of the Bangladesh Medical Research Council's (BMRC) decision.
"If necessary, the Contract Research Organisations (CROs) of the three companies can be called at any time to know the current status of the institutes," he added.
On 28 December, Globe Biotech, a Bangladeshi biotech firm, got approval from the Directorate General of Drug Administration (DGDA) to produce Covid-19 vaccine candidate Bangavax to carry out clinical trials.
On 16 January it submitted its trial protocol to the BMRC for the clinical trials of its Covid-19 vaccine, Bangavax.
Earlier, the company on 5 October 2020, noted that vaccine trials on rabbits and mice had shown "very promising results."
Bangladesh has so far approved the emergency use of six vaccines – Oxford-AstraZeneca, Sinopharm of China, Sputnik-V of Russia, Pfizer-BioNTech, CronaVac of China, and Johnson & Johnson.
