With this, Globe Biotech Ltd has entered the global race for a Covid-19 vaccine as a first-ever Bangladeshi company.
This, however, doesn’t guarantee the vaccine’s effectiveness or success, experts said.
“This is a good progress, but this does not mean these vaccines are successful. There is a long way to go”, Prof Sayedur Rahman, chairman of pharmacology at Bangabandhu Sheikh Mujib Medical University (BSMMU), told The Daily Star recently.
Earlier on October 5, Kakan Nag, CEO of the Globe Biotech Ltd, alleged that the WHO is “delaying the enlistment unnecessarily”.
Bardan Jung Rana, country representative of WHO, told The Daily Star, “Coming into the landscape doesn’t mean anything; it doesn’t mean okay… There are lot of things [after that].”
He also said there was no delay but the headquarters had been reviewing the documents.
On October 5, Globe Biotech announced that its first vaccine candidate, which is developed based on D614G variant mRNA vaccine, had passed in the pre-clinical trial on mice and was ready for a clinical trial.
It has not disclosed anything about the two other vaccine candidates – the DNA plasmid vaccine and the Adenovirus Type-5 vector vaccines.
In a press release yesterday, Globe Biotech Ltd claimed its company is the only organisation which has three Covid-19 vaccine candidates in the WHO draft landscape.
All the three have been listed as pre-clinical stage vaccine candidates.
Meanwhile, Globe Biotech Ltd has signed an MoU with icddr,b, which will conduct all three phases of the clinical trials, Dr Mohammad Mohiuddin, manager of the Globe Biotech Ltd told The Daily Star yesterday.
“The icddr,b is now preparing the trial protocol. Once completed, it will apply to the BMRC [Bangladesh Medical and Research Council] for the trial approval,” he added.
According to the US Centre for Disease Control (US-CDC), the general stages of the development cycle of a vaccine are: exploratory stage, pre-clinical stage, clinical development, regulatory review and approval, and manufacturing and quality control.
The final stage trial or Phase-III clinical trial means the vaccine is at its final stage of major trials, in which the vaccine is given to thousands of people and tested for efficacy and safety.
“Globally, many vaccines have been failing even at the final stage of trials. And BANCOVID [the vaccines from Bangladesh] has just passed the first stage. It does not authenticate the vaccine is effective. We could be sure about the efficacy after the mass scale human trial,” Muniruddin Ahmed, a professor of pharmacy at the Dhaka University, told The Daily Star recently.
Meanwhile, Bangladesh yesterday recorded 23 Covid-19 deaths and 1,209 new cases overnight.
The recovery count rose to 3,02,298 after another 1,560 patients were discharged from hospitals in 24 hours until 8:00am yesterday, a press release of the Directorate General of Health Services (DGHS) said.
“Twenty-three more Covid-19 patients died during the same period, increasing the death toll to 5,646,” the release said.
It said the tally of infections has surged to 3,87,295 as 1,209 new cases were confirmed after 11,573 samples were tested at 110 authorised laboratories across the country during the time.
Of the total samples tested, 10.45 percent tested positive, the release added.
Among the total infections, 78.05 percent patients have recovered, while 1.46 percent died so far since the first Covid-19 positive cases were reported in the country on March 8.