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Bangladesh Scientist Claims Success In Trials

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Globe Biotech Limited has claimed to be the first company from Bangladesh to have a Covid-19 vaccine under development.
They  achieved positive results after conducting the preliminary trial on 5 rabbits from June 10 to June 28, said Dr Asif Mahmud, assistant manager and in-charge, Research and Development, Globe Biotech Limited  
‘Importing coronavirus vaccines from abroad will  be very expensive, whenever that happens. We can’t yet say what the exact price of our solution will be. But our target is to produce something affordable,’ said Harunur Rashid, Chairman of Globe Biotech Limited .
Directorate General of Drug Administration (DGDA) spokesperson Auyub Hossain told Easternlink initiatives like this would  always be praised and supported by DGDA.
Meanwhile, Dean of Faculty of Pharmacy of Bangladesh Prof SM Abdur Rahman said developing a vaccine for a virus  with more than 5,000 reformations throughout the world, and 117  in the country, was a major achievement. “ I hope  this local company has  maintained standard procedureS and its work  would be scientifically accepted by the concerned authorities ,” Rahman added.

Exclusive Interview of Scientist Dr Asif Mahmud

EL -Globe Biotech is a research company in Bangladesh. Is it a branch of any other country of the world?
 Dr. Asif – No, in fact, Globe Biotech Limited is a Biological Drug Discovery Company that  has started operations in Bangladesh since 2015.The project was started by our CEO Kankon Nag and CEO Dr. Nazneen Sultana. We have been recruited here since 2016, and prepared 18 bio similar. We are also working on our own Nobel drug. After completing the animal trials of 6 bio similar, we have applied for Ethical Approval through our PRO at Bangladesh Medical Research Council (BMRC), in the Capital. We have  THE ability and experience to invent a vaccine of this Pandemic. Under the supervision of our CEO and COO, after REPORTING  a Covid-19 affected patient in Bangladesh on March 8.We shifted our focus to Sars Cov 2 and started 3 new projects. Number one – we will do kit development, number two – we will do vaccine development for the country and the last one is the biological molecule development.
EL: The research IS DONE  by Globe Biotech independently? Or your research is under supervision of any other country/Authority  in the world?
 Dr. Asif- Globe Biotech is researching independently, under the supervision of our CEO Kakon Nag and COO Naznin Sultana. Both  supervised the team from Canada. They are experienced in this matter. Dr. Kakon was directly involved in the HIV vaccine project.  That experience he is transmitting here. We are conducting research under their direct supervision. A 12-member scientific group started the research on March 18 led by CEO and COO. Both of them supervised the team from Canada.
Regarding genome sequencing, we have referred some 76 genome sequences under their consideration, where we have found that a sequence (numbered 614) has a mutation point that they have used for amino acid bonding.
EL – Which method you followed for the research you are doing from Biotech? And how do you make sure it will work to protect PEOPLE  from the pandemic Covid-19 ?
 Dr Asif – We went for the SPR method for the tests. Surface plasmon resonance (SPR) is a phenomenon where the electrons in the metal surface layer are excited by photons of incident light with a certain angle of incidence, and then propagate parallel to the metal surface. It is an optical technique utilized for detecting molecular interactions. Actually, we have set a vaccine target. We have analyzed the sequences from all the databases we have worldwide, including the sequences in Bangladesh. We set the target by our analysis. We have modified that target according to our needs. We have set multiple targets.
We have placed multiple delivery systems in consideration.
By applying the delivery system we have done an animal trial on Rabbit.
By this we have got a very good antibody titer. And those antibodies have shown strong binding affinity with our antigen. We have a total of additional candidates, some of which we have presented to the press. But The Company is yet to apply for a patent or any publications, and before the patent is ensured it would not disclose the data received from the trial. We have said that we need to convert the data of the preliminary animal trial into a regulated animal trial. That we will do within next 6 to 8 weeks. Then we will apply for Ethical Approval.
 EL – This 6 to 8 weeks period, to get proof of animal trial? Or to launch a  trial on the human body?
Dr. Asif- No, we have already got proof of antibody generation in the preliminary animal trial. Now it needs to be converted to a regulated animal trial. Because, for human trial we have to submit it to the regulatory body for ethical approval. Regulated trials will require some further characterization. Then we will apply for human trials.
EL  – Did you report  your findings to the drug administration of the country?
Dr Asif- Not yet. There is no role of regulatory body now. When we do a regulated animal trial, of course we go to the regulatory body.
EL – What are your expectations? When will the vaccine be released?
Dr. Asif- We have already formulated the regulated animal trial guideline and the tests would be concluded within four to six weeks. After which the company will seek ethical approvals from the Bangladesh Medical Research Council (BMRC) in early September,when the data from the Regulated Animal Trial reaches us within 6 to 7 weeks.
And then we will apply for market authorization to the regulatory authority in December within three months after completing phases 1, 2 and 3. If everything goes smooth and we expect to be able to bring our vaccine to market by December.
EL – If you get government support, do you think your success can come faster ?o
 Dr. Asif- Obviously! This is the first discovery of this vaccine in Bangladesh. Always the  first task comes with more obstacles and hindrances. We will remove the obstacles with the support of the government and will bring the vaccine to the market soonest possible.
Dr Asif said on June 10, the rabbits were isolated and on June 12 they collected serum to analyze if they have already developed the antibody. On June 14 three of them were given the invented dose for the first time.

The second dose was given on June 21 and the third on June 28. Blood serum was collected to see if the antigen and antibody bond was effectively made, raising the resonance to considerable levels. The whole procedure was done following the WHO guideline, he added.

The scientist said at present there WAS  some 7 billion vaccine demand in the world among which only 1.2 billion could be met.  In these circumstances developing a vaccine on our own would make it feasible.

When (and if) they acquire those approvals, the company will be ready to move on to human trials through third parties under the supervision of the Directorate General of Drug Administration (DGDA) in order to assess the effectiveness of the drug, said Asif Mahmud

However, after trials are completed, it would take another six months for the vaccine to be marketed, he claimed.

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