The conditions include a requirement for monkey trials before human trials are conducted
The Bangladesh Medical Research Council (BMRC) has decided in principle to grant ethical permission to Globe Biotech Ltd for human trials of Bangavax, the country’s only homegrown Covid-19 vaccine candidate, subject to a fulfilment of certain conditions.
Two foreign vaccine candidates that have also applied to the BMRC for ethical permission to conduct human trials will have to meet the same conditions, BMRC officials said after a meeting on the matter yesterday.
Globe Biotech sought permission for human trials five months ago.
The officials declined to disclose the conditions and said the companies concerned would be sent letters in this regard soon.
Officials of Globe Biotech said they would meet the demands of the health authorities, but it would likely delay production and increase costs.
Wishing to remain anonymous, an official said the demand for trials on monkeys or chimpanzees before those on humans would affect production, as the country did not have a third-party clinical research organization (CRO) that could conduct such tests.
‘Permission only if all conditions are met’
Following yesterday’s meeting, BMRC Director Dr Md Ruhul Amin said it had been decided in principle to permit clinical trials of three vaccine candidate companies, including Globe Biotech. One of the foreign companies is from India, while the other is from China.
“All the companies have to comply with some conditions, including trials on monkeys or chimpanzees first to test efficacy. If needed, we will review the documents of the monkey trials submitted by the CRO companies as well,” he added.
“This is the BMRC protocol. We will approve (human trials) only if all conditions are met properly," the BMRC director said, without mentioning further details of the conditions.
Meanwhile, Health Minister Zahid Maleque told the media at the secretariat that vaccines were a very complex issue.
“We want to help local manufacturers, we are empathetic to them. But before that, they have to submit the necessary documents after completing all the procedures. They have to maintain the protocol recognized internationally. We cannot put human lives at risk,” he said.
“If they follow proper protocols, they will get permission for the trial from the health authorities,” the minister added.
Earlier, he said that the government was in the process of producing vaccines in the country, but it might take time to develop the necessary facilities.
Conditions will delay human trials by 2 months
Globe Biotech officials said they were yet to issue a formal response to the BMRC decision, but they were happy to see progress after five months of deadlock.
However, they also said the conditions might increase production costs and delay the vaccine significantly.
Globe Biotech Chairman Md Harunur Rashid said: “There are two types of mRNA vaccines: pure and modified. The modified one requires trials on monkeys.
“As Globe is making the pure mRNA one, trials on monkeys are unnecessary. Furthermore, there are no third-party CROs in the country that could conduct monkey trials,” he added.
“Regardless of the drawbacks, Globe will fulfil all the conditions that the government requires it to,” the company chairman further said.
He also said Globe had contacted some CROs in India and China, but the CROs had said they could not conduct monkey trials right now as they had a loaded capacity.
“We may have to explore the option of the US now,” Harunur Rashid added.
In response to a question, he said monkey trials and other conditions might increase Globe’s expenditure by $1.5-2 million.
When asked for an idea on when the vaccine could become available, he said it was difficult to say.
“The price will depend on the availability of raw materials and production cost. It may be sold for $10-15 per dose locally, and for more internationally,” the chairman added.
He claimed Bangavax would be effective against the highly contagious Delta variant of coronavirus that had emerged in India.
“We have the capacity to produce at least 10 million doses every month. Any local vaccine producers will be able to collaborate with us, as our vaccine is made of synthetic mRNA,” the Globe Biotech chief added.
Journey of Bangavax production till now
Globe Biotech announced its attempt at producing a Covid 19 vaccine, later named Bangavax, on July 2 last year. It is the first company in Bangladesh to have a Covid-19 vaccine in the process of development.
The company claims to have had success in preliminary trials on five rabbits between June 10 and June 28 last year.
On December 1, Globe Biotech announced that it would part ways with the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) in the conducting of human trials for Bangavax.
On December 28, the Directorate General of Drug Administration (DGDA) gave Globe Biotech permission to manufacture Bangavax for clinical trials.
On January 17 this year, the company sought approval from the BMRC for clinical trials.
In early February, the BMRC asked Globe for responses to over a hundred queries. Progress on the vaccine had remained stalled since then till yesterday.