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.

Collecting animals for vaccine trial turned into a 'monkey business' for Globe Biotech Ltd as five of their employees were assaulted by locals following their unannounced arrival in Gazipur on Sunday. " Although Globe was given permission to collect monkeys from Gazipur forests, we did not know they were coming on Sunday," said an official of the local wildlife department Tabibur Rahman. The incident took place in Barmi Bazar area under Sreepur upazila of the district. Read: Biotech's Covid vaccine to get conditional approval for human trials According to local sources, hundreds of people in the area got agitated and surrounded the Globe employees upon receiving information that an unidentified group was putting monkeys inside cages after pushing them with anaesthetic injections. Later police rushed to the spot and rescued the Globe employees. Globe Pharmaceuticals Ltd Media Consultant Anisur Rahman, one of the employees, portrayed the situation as more or less like an extortion. Read: Covid-19: Globe Biotech gets nod to manufacture vaccine for clinical trial “Some of the locals demanded money from us and physically assaulted us when we refused,” he claimed. However, locals claimed that they mistook the Globe employees as poachers and were enraged observing their attitude towards the monkeys. Abul Hashem, president of the Barmi Bazar Merchants' Association, denied allegations and said that the incident could have  easily been  avoided if local administrations were informed earlier. The OC of the Sreepur police station also confirmed the incident to UNB. “We rescued five of them and later let them go after verifying their identities,” he said. Globe Biotech received a licence to produce their potential vaccine for trial on December 28 last year, and subsequently applied for ethical clearance to begin clinical trials (on human subjects) on January 17. That however was held up for a long time. It was only in June that the Bangladesh Medical Research Council, which oversees all such trials, got back to them with certain conditions that had to be met before the clinical trials could go ahead.  The key condition was that Globe would have to run trials on monkeys or chimpanzees first. Although grudgingly at first, Globe was left with no choice but to meet the condition. 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. They would however look to engage one from abroad, they said.  Yesterday's incident raises a few questions- one being why no legal actions have been taken if the Globe employees were assaulted, and secondly how exactly Globe are planning to conduct their trials. The use of their own employees - with positions in the media and administration departments - to catch the monkeys for trial suggests they are not engaging a CRO for the job, even though that is the usual practice. Globe at one stage had entered into an agreement with a firm called Clinical Research Organisation Bangladesh to conduct the human trials component of developing Bangavax, but eventually that got scrapped.  The Animal Welfare Act of 2019 makes certain exceptions to allow for the use of animals for research purposes, and is silent on how they are to be sourced. Even the BMRC has no specific guidelines on animal testing.  Globally, most animals used in research are specifically bred for use in medical research, and there are specific ethical considerations for conducting such trials. But the way they are going about the job of collecting their subjects suggests Globe is paying them scant attention.   Most importantly, the Ministry of Environment, Forests and Climate Change did permit them to source 56 monkeys for clinical trials of their vaccine Bangavax, in the way that they did. They had the necessary No-Objection Certificates to prove it.  They have already collected 30 monkeys from the Bhawal National Park and the Bangabandhu Sheikh Mujib Safari Park.      

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.

Jatiya Party Chairman GM Quader on Sunday urged the government to extend its necessary support to local company Globe Biotech so that it can succeed in developing its vaccine - Bangavax. In a statement, he voiced resentment as Bangladesh Medical Research Council (BMRC) is not giving approval to the company for conducting a clinical trial of the vaccine. “The people of the country want to know in whose interest the trial of Bangavax is not taking place though four months have elapsed (since it has sought permission). The government should extend support for the success of the locally developed vaccine alongside importing foreign ones to prevent the coronavirus,” he said. The Jatiya Party chief said Globe Biotech applied to the BMRCH for ist approval to carry out a clinical trial in January last. “But the permission has not been given yet for reasons unknown.” Even, he said, the World Health Organization has listed Bangavax as a potential vaccine for corona prevention. Also read: Take mega projects to improve healthcare system: GM Quader On December 26 last year, GM Quader said the Directorate General of Drug Administration (DGDA) also allowed Globe Biotech to produce a vaccine for the trial. “But Bangavax cannot make any breakthrough for lack of BMRC’s permission.” Citing researchers of Globe Biotech, the Jatiya Party chairman said a single dose Bangavax found effective in developing antibodies during the animal trial of the vaccine. “The researchers expect to have similar results in clinical trials. As the one-dose vaccine Bangavax is made synthetically, it’s virus-free and 100% halal,” he said. GM Quader said the government should help the company produce its vaccine. “If Bangavax succeeds in the clinical trial, it’ll be possible to export it abroad by meeting the local demand.” Also read: GM Quader for effective steps to prevent waterway accidents He also said Bangladesh's Bangavax can come to the global spotlight by exhibiting its efficiency in preventing the coronavirus.