BMRC
Bangavax finally gets approval for human trial
Bangladesh Medical Research Council (BMRC) has approved in principle Globe Biotech Limited’s Covid-19 vaccine Bangavax for human trial.
“BMRC has given the approval in principle for administering Covid-19 vaccine of Bangavax and we’ll submit an application to the Bangladesh Directorate General of Drug Administration (DGDA), seeking its permission for the clinical trial. The administration of its jabs will start once the final approval is given,” said Dr Mohamamd Mohiuddin, senior manager of BMRC’s Quality and Regulatory Department.
BMRC Director Dr Ruhul Amin signed the letter of approval issued on Tuesday.
Globe Biotech Limited has claimed that Bangavax is 100% effective for fighting 11 variants of Covid-19, including the Delta variant.
Read: Bangavax trial turning into ‘monkey business’ for Globe?
On January 17, Globe Biotech, the only Bangladeshi company trying to develop a Covid-19 vaccine, submitted an application to the BMRC for approval to conduct Bangavax's clinical trials.
On June 16, the BMRC decided to approve Globe Biotech's Covid-19 vaccine, Bangavax, for human trials.
Globe Biotech received a licence to produce their potential vaccine for trial on December 28 last year.
The BMRC, which oversees all such trials, got back to them in June with certain conditions that had to be met before the clinical trials could go ahead.
Read: GM Quader seeks govt support for local vaccine Bangavax
The key condition was that Globe Biotech would have to run trials on monkeys or chimpanzees first.
One of the bottlenecks the company identified at the time was that the country did not have a third-party clinical research organization (CRO) that could conduct such tests on animals.
2 years ago
BMRC clears Indian Covaxin’s clinical trials in Bangladesh
Bangladesh Medical and Research Council (BMRC) has approved in principle the clinical trials of Indian Covid-19 vaccine Covaxin in Bangladesh.
BMRC Chairman Prof Dr Syed Modasser Ali shared the information with UNB on Tuesday.
On July 18, Covaxin, a Coronavirus vaccine jointly developed by Bharat Biotech and the Indian Council of Medical Research (ICMR), got the clearance for its clinical trials in Bangladesh, he said.
Read: Vaccine coproduction deal with Sinopharm ready for signing: FM
Contract Research Organization (CRO) icddr,b had applied seeking permission for the clinical trials of the Indian vaccine in Bangladesh a few months ago.
After the review of necessary documents, the vaccine got clearance from the BMRC, said Dr Modasser.
He, however, said the approval of the Directorate General of Drug Administration (DGDA) will be needed to start the clinical trials of Covaxin in the country.
Read: No Covid vaccine crisis in the country, says Quader
India has planned to facilitate its clinical trials in Bangladesh in a bid to enhance the recognition of indigenous coronavirus vaccine, Covaxin, according to Indian media reports.
India has not supplied any Covaxin doses to Bangladesh so far.
3 years ago
Biotech's Covid vaccine to get conditional approval for human trials: BMRC
The National Research Ethics Committee of Bangladesh Medical Research Council (BMRC) on Wednesday decided to approve Globe Biotech's Covid-19 vaccine, Bangavax, for human trials.
Globe Biotech will get the final nod on conducting clinical trials on humans only after meeting some conditions set by the BMRC, its director Prof Dr Ruhul Amin said this after a virtual meeting.
On January 17, Globe Biotech, the only Bangladeshi company trying to develop a Covid-19 vaccine, submitted a protocol to the BMRC for ethical approval to conduct Bangavax’s clinical trials.
Vaccination drive in Bangladesh
Bangladesh, the prime recipient of Oxford-AstraZeneca vaccines, suspended the registration for Covid-19 vaccination due to jab shortage amid a delay in the arrival of shipments from India.
However, Health Minister Zahid Maleque on Tuesday announced that administering of Sinopharm and Pfizer vaccine doses will begin on June 19.
Also read: International vaccine institute to be set up in Bangladesh: Hasina
Some 4,257,499 people got the second dose of AstraZeneca vaccine while the number is 58,20,015 for the first one.
Besides, the total number of people receiving their first jab of Chinese Sinopharm vaccine is 2,162.
The health minister earlier said Pfizer vaccine shots will be given at four centres in Dhaka to those who have already registered.
The Directorate General of Drug Administration (DGDA) on Tuesday approved Janssen Covid-19 vaccine for emergency use in the country.
This is the sixth Covid-19 vaccine to get DGDA nod for emergency use, but the first single-dose jab approved in the country.
The other approved vaccines are: Covishield produced by Serum Institute of India, Sputnik V of Generium Joint Stock Company of Russia, Sinopharm from Beijing Institute of Biological Products Co. Ltd of China, Pfizer vaccine manufactured by Pfizer Manufacturing Belgium NV, and Coronavac produced by Sinovac Life Sciences Ltd of China.
Also read: Alarming Covid surge in Bangladesh, 60 more die
Vaccine procurement update
Bangladesh will soon receive 10 lakh and 800 doses of AstraZeneca vaccine soon under COVAX facility, said Foreign Minister Dr AK Abdul Momen on Friday.
Bangladesh Ambassador to the US conveyed the message of this development to the Foreign Minister.
Bangladesh, earlier sought 2 million doses of AstraZeneca vaccine doses from the US for addressing Bangladesh's immediate needs but the US is yet to reply on that particular request.
Meanwhile, the second consignment of the Sinopharm vaccine, amounting to some 600,000 doses, arrived here on Sunday as a gift from the Chinese government.
Bangladesh has also received 100,620 doses of the Pfizer Covid-19 vaccine on June 1.
3 years ago
Chinese Ambassador willing to take first dose in Sinovac’s Phase III trial in Bangladesh
Chinese Ambassador to Bangladesh Li Jiming will volunteer to be the first participant in the phase III trial of a Covid-19 vaccine candidate in Bangladesh, once it is approved by the government.
4 years ago
Covid-19 Vaccine: BMRC approves icddr,b to conduct phase-3 trial in Bangladesh
Bangladesh Medical Research Council (BMRC) on Sunday approved the icddr,b to conduct the phase-3 human trial of Covid-19 vaccine developed a Chinese company.
4 years ago