Three C-19 vaccines of Globe Biotech get WHO enlistment
Bangladeshi company Globe Biotech's three homegrown vaccines have got entry into World Health Organization candidate list as WHO has enlisted all three Covid-19 vaccines in its trial list.
WHO release said Globe's vaccine was listed in the WHO's draft landscape of Covid-19 candidate vaccines on October 15.
"We are the only company in the world to be listed with three vaccine candidates - DNA plasmid vaccine, Adenovirus Type 5 Vector and D614G variant LNP-encapsulated mRNA," a Globe Biotech press release said on Saturday.
Through this approval it has been proved that Bangladeshi company's homegrown vaccine, the first D614G variant mRNA-based vaccine candidate in the world that elicits neutralising antibody and balances cellular immune response.
Dr Kakon Nag, Globe Biotech's chief executive told journalists, "It's a matter of immense pride for all Bangladeshis to have the Globe vaccine listed on the WHO website. Because the name that came is Globe Biotech Ltd, Bangladesh. This is the first time we have seen the name of Bangladesh in the WHO list for the discovery of the vaccine."
Earlier, Manager (quality and regulatory operations) of Globe Biotech Dr Mohammad Mohiuddin said they did the coronavirus spike sequencing through which it enters into human body.
In the sequencing they found that the virus went through a genetic mutation
in the position of its 614 number protein, which converted into G614 from D614, he also said.
Because of the transition, the virus became more infectious and deadly, and many global studies blamed the G614 variant for recent spread of the pandemic.
"Those who started developing vaccines in the early pandemic period did not consider the variant, but we did. So, we are very confident that our vaccine will work, as it is scientifically proved." Mohiuddin added that they have brought the mutated deadly spike protein of the virus into their vaccine target sequencing to prevent spread of the infection.
On July 2, Globe Biotech announced that it was developing a Covid-19 vaccine after completing preliminary animal trials successfully.
On October 5, the company said it had received 'very promising' results from pre-clinical trials on rabbits and mice.
Bangladeshi lone coronavirus vaccine candidate Globe Biotech earlier achieved another much-needed milestone, as a globally recognised journal has certified its 'Bancovid' scientifically okay for human trial.
The New York-based Cold Spring Harbor Laboratory (CSHL)-operated bio archive or BioRxiv published the results of its pre-clinical trials on September 30.
It termed the Bangladeshi company's homegrown vaccine the first D614G variant mRNA-based vaccine candidate in the world that elicits neutralising antibody and balances cellular immune response.
Citing results of its animal modelling trials, CSHL stated that Bancovid did not produce any noticeable effect for local or systemic toxicity as primarily evident by the absence of four cardinal signs of inflammation - redness (latin rubor), heat (calor), swelling (tumor) and pain (dolor).
The CBC (complete blood count) and blood chemistry did not show significant changes in relevant profiles, suggesting that the vaccine behaved safely in animals.
Claiming that they have got very promising results from pre-clinical trials on rabbits and mice of the coronavirus vaccine styled 'Bancovid' developed by it, Bangladesh's Globe Biotech Ltd said they want to bring it to the market by January next if they are allowed to launch the first phase of human trials soon.
Meanwhile, Globe Biotech on Wednesday reached an agreement with the ICDDR,B for conducting human trial of its Covid-19 vaccine. ICDDR,B, however, would require permission from the Bangladesh Medical Research Council before conducting the trial, officials said.
'We've reached an agreement with our contract research organisation - ICDDR,B for conducting the phase-1 human trial,' Globe Biotech in-charge of research and development Asif Mahmud told media on Wednesday.
With the achievement, Globe Biotech overcame the last requirement in seeking ethical approval from Bangladesh Medical Research Council (BMRC) for conducting the vaccine's human modelling experiment.
"We hope the government will stand beside us and assist us in every necessary area. If we all can make collective efforts, we hope, we'll be able to start giving our vaccine to people across Bangladesh by January next," Harunur Rashid, chairman of Globe Biotech, told a press conference at a city hotel last week.
Giving thanks to his team, he said developing a vaccine is a daunting task. But our team worked hard and made an impossible job possible. We've built a cent percent foundation for the vaccine as we're now at the stage of conducting phase-1 and phase-2 clinical trials," he said.
He urged the government and the regulatory body, including DGDA, to allow them to conduct the clinical trials of the vaccine as soon as possible. "We believe our vaccine will turn out to be one of the effective vaccines in the world and we'll be able to save many lives. But we need government patronage to make it possible."