The Globe Biotech Limited (GBL) finally received ethical clearance from the Bangladesh Medical Research Council (BMRC) to start human trial of its homegrown Covid-19 vaccine, Bangavax.
The country's lone coronavirus vaccine candidate got the much needed authorisation on Tuesday, the company sources confirmed it.
"We've got ethical clearance from the BMRC. Now we need to submit the authorisation letter to the Directorate General of Drug Administration (DGDA) before starting clinical trial," senior manager (quality and regulatory operations) of Globe Biotech Dr Mohammad Mohiuddin said.
He also said they would submit the letter to the DGDA very shortly to begin the human trials here from December.
When asked about the company's plan to go for commercial production of the Bangladeshi Covid-19 antidote, he said it might take three months to complete first two phases of the trials.
After the trials, the company wants to start third phase of human trials and mass vaccination activities simultaneously like India and China.
"I think we can start commercial production of the vaccine from next March," Mr. Mohiuddin added.
Prof Mamun al-Mahtab Swapnil, principal investigator of the trial, said the BMRC is satisfied with procedures and results of the vaccine's pre-clinical trials on monkeys, which is encouraging.
"We're now preparing to start the human trials. We want to start the process as quick as possible," he added.
GBL, in October last year, announced that its mRNA vaccine showed promise in animal trials on mice. Based on the successful trials, the local drug firm approached the BMRC early this year for ethical clearance before the human trials.
But after seven months of silence, the BMRC approved clinical trials of Bangavax under a condition that "before starting any human trial, the vaccine producer requires to conduct an animal trial on monkeys or chimpanzees."
Then GBL restarted the animal trials on monkeys from August and got satisfactory responses from the trials.
Another report adds: Bangladesh is likely to apply locally manufactured coronavirus vaccines on people next year (2022), as moves have been taken by the government and several private pharmaceutical companies in this regard, an advisor to the Prime Minister (PM) said on Tuesday.
"I believe, the country will start manufacturing vaccines next year," PM's Private Industry and Investment Adviser Salman F Rahman said.
He also said Incepta, Beximco and some other drug makers of the private sector are working to manufacture vaccines locally.
"The government will also produce the vaccine. The Ministry of Health is taking required steps in this regard."
Mr Rahman said these while speaking as the chief guest of a meet the reporters programme, organised by the Dhaka Reporters Unity (DRU) at its office in the city's Segunbagicha area.
Prime Minister Sheikh Hasina is very sincere about local manufacturing of coronavirus vaccines, for which she vowed to extend all supports from the government, he noted.
The issue of providing booster dose to people is being discussed, as still there is risk of infection despite vaccination, the PM's adviser opined, adding that it is also imperative to run vaccine campaign for several years during a pandemic.
Regarding the Oxford-Astrazeneca's Covishield vaccine - manufactured by India's Serum Institute, he said a shipment is expected to arrive in the country next month.
"We are expecting to receive the remaining doses of Serum's vaccine under the agreement within the first quarter of next year."
Mr Rahman also responded to reporters' queries on the country's pharmaceutical sector.
Prices of pharmaceutical products in the country are much lower comparing to other countries, and local healthcare system is also improving, he mentioned.
"Now we are looking to manufacture API (active pharmaceutical ingredients) - raw materials of various drugs - in the country," he added.
DRU President Mursalin Nomani presided over the programme, while General Secretary Moshiur Rahman Khan moderated it.
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