Bharat Biotech of India and the Institute of Medical Biology under the Chinese Academy of Medical Sciences have sought approval from the Bangladesh Medical Research Council to conduct the phase-3 trial of their potential COVID-19 vaccines in Bangladesh, officials told New Age on Friday.
An application from Anhui Zhifei Longcom Biopharmaceutical seeking the approval for the trial of another Chinese vaccine candidate is also under way as the company has already reached an agreement with Bangabandhu Sheikh Mujib Medical University in this regard, BSMMU confirmed.
BMRC director Mahmood-uz-Zahan said that India’s Bharat Biotech and China’s Institute of Medical Biology had sought the approval for the phase-3 clinical trials in Bangladesh.
Reputable international research organisation ICDDR,B will conduct the trials if approved, he said.
‘We are yet to analyse their applications. The approval would be given once the BMRC ethical committee gives its nods,’ Mahmood said.
The ICDDR, B declined to comment on the grounds of the non-disclosure agreements with the companies.
About the interest of the Chinese firm Anhui Zhifei Longcom Biopharmaceutical, BSMMU vice-chancellor Kanak Kanti Barua said that they had reached an agreement with the company to conduct the trial of their vaccine at their facility.
He said that the proposal for the BMRC approval was under process without giving further details.
Earlier, Chinese firm Sinovac’s late-stage trial of a potential vaccine in Bangladesh was halted after Dhaka refused to meet the Chinese company’s demand for co-funding for the trial.
Bharat Biotech started a late-stage trial for their COVAXIN vaccine in India in November.
The company has not disclosed the peer-reviewed results of the vaccine’s phase-1 and phase-2 trials, but the pre-print results say that the vaccine is safe and effective.
The Indian government has approved the Bharat Biotech vaccine for emergency use, drawing widespread criticism in that country of the vaccine securing an authorisation without having efficacy data.
The peer-reviewed results of the phase-1 and phase-2 trials of the potential vaccine developed by the Institute of Medical Biology under the Chinese Academy of Medical Sciences have not also been published, but the pre-print results of this vaccine too claim it to be safe and effective.
According to BSMMU pharmacology professor Sayedur Rahman, Bangladesh should participate in vaccine trials as they enable the country to have access to vaccines if succeeded while it is also an opportunity to build national capacity.
But, he said, the results of phase-1 and phase -2 trials of any potential vaccine candidates are crucial before approving their phase-3 trial in Bangladesh.
‘We need to think about the safety of the people,’ he said.
Bangladesh with a population of over 160 million people has so far had a couple of sources, including the World Health Organisation’s COVAX initiative, of vaccines to conduct the mass immunisation against COVID-19 that has so far killed roughly 8,000 people and infected half a million others.
As of now, Bangladesh has signed a deal with the Serum Institute of India and its local vendor Beximco Pharma to purchase three crore doses of the Oxford-AstraZeneca vaccine.
The Serum has not yet published any data from its India trials of the vaccine named Covishield, although there is phase 1-3 data from AstraZeneca, which has produced the original version of the vaccine.
Under the purchase deal, the first cache of 50 lakh doses out of the total three crore doses bought is expected to arrive in the country by January 25, health minister Zahid Maleque said on Thursday.
Bangladesh as a low-come country will also get 68 million doses of vaccines from the global vaccine alliance GAVI under the COVAX initiative to ensure access of poor countries to COVID-19 vaccines.
Beximco Pharma has meanwhile received approval for private import and sale of COVID-19 vaccines on the local market alongside the government’s mass vaccination drive, drawing criticism by health rights campaigners, as they said that it would give Beximco a monopoly to make money out of the COVID-19 crisis.
Beximco will sell each dose of the Oxford-AstraZeneca vaccine at US$14 to the private buyers.
The Indian government handed over to Bangladesh 20 lakh doses of the Covishield vaccine on Thursday as gift.
Bangladesh plans to begin its mass COVID-19 vaccination early February.
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