Even though the authorities concerned in mid-June set conditions for three Covid-19 vaccine-makers, including Globe Biotech Limited, for ethical permission of human trial, the local company is yet to achieve the feat.
This happens as the only Bangladeshi candidate in the global vaccine race has not conducted animal trials of its vaccine, Bangavax, on monkeys or chimpanzees as yet.
However, the IMBCAMS vaccine, developed by the Institute of Medical Biology Chinese Academy of Medical Science (IMBCAMS), which is one of the two other companies—both foreign—have obtained the clearance on June 23, sources said.
Meanwhile, the Bangladesh Medical Research Council (BMRC), which oversees drug-related issues in the country, hopes to clear shortly the vaccine called Covaxin, which is developed by Bharat biotech and the Indian Council for Medical Research (ICMR).
Globe Biotech, however, claims that the animal trials are not necessary before testing Bangavax on humans as it is an mRNA vaccine.
The mRNA vaccines contain a genetic code that trains the immune system to recognize the spike protein on the surface of the virus to generate an immune response.
The company sees the entire process as non-cooperation from the government, and vow to conduct trials on humans and animals spontaneously once cleared.
What are the conditions?
On June 16, BMRC Director Dr Md Ruhul Amin said that 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.
The go-ahead
The BMRC issued a letter on June 23 to the third-party clinical research organization or CRO of the Chinese drugmaker, allowing ethically to conduct human trials of IMBCAMS.
One Pharma, the local agent of the vaccine in Bangladesh, will conduct the trial on 6,400 recipients including physicians and health care professionals from the capital’s eight hospitals.
BMRC Director Prof Dr Ruhul Amin said they gave the approval after contacting the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) which is the CRO of the Chinese vaccine.
“We’ve also contacted the CROs of Bangavax and Covaxin,” he said, adding that they are expecting a result from the CRO of Covaxin in the shortest possible time.
About Bangavax, he said they would get permission once they complete fulfilling the conditions.
The icddr,b is the CRO of Coxavin, while CRO Bangladesh is of Bangavax.
Globe Biotech official, Mohammad Mohiuddin, said their CRO has received a letter from the BMRC.
Company insiders said the language of the letter is not clear to them and they would sit with the regulatory body for clarification, thus, finding a way out to complete the work.
Take of Globe Biotech, experts
Md Harunur Rashid, chairman of the company, on June 16 told the Dhaka Tribune that being a pure mRNA vaccine, the trials on monkeys are unnecessary. Only the modified ones require a trial on monkeys.
He also said that there are no third-party CROs in the country that could conduct monkey trials. So, they have approached Indian and Chinese companies—but they refused to do so for not having any free space for the trial.
Md Harun went on saying that they would still complete the test exploring new companies in the US.
Dhaka University Pharmacy Faculty Dean Dr SM Abdur Rahman sees no harm in the condition given by the BMRC.
“The IMBCAM vaccine and Covaxin have different issues as they have already started the trial elsewhere. But Bangavax is totally a new one and so the BMRC needs to be more cautious,” he added.
