BMRC approved the trials of Covaxin in Bangladesh on July 18
Bangladesh has recently approved the clinical trial of the Indian indigenous coronavirus vaccine, Covaxin, which has been jointly developed by Bharat Biotech and the Indian Council of Medical Research (ICMR).
However, the beginning of clinical trials in Bangladesh may be delayed as the Indian authorities say that they need more time to reevaluate the logistics and facilities to run the trial.
The delay between the time India applied for and received approvals to run the trial as well as the current Covid situation in Bangladesh due to the ongoing vaccination program is a reason behind the current need for readjustment of human trials of Covaxin, a top official at the Indian High Commission in Dhaka has said.
According to sources, the Bangladesh Medical Research Council (BMRC) approved the Covaxin trials in Bangladesh on July 18.
BMRC Chairman Syed Modasser Ali, former health adviser to Prime Minister Sheikh Hasina, said on Monday: “We approved the human trial of Covaxin in Bangladesh at our last meeting.”
“As far as I know there are no complications in running Covaxin’s clinical trials in Bangladesh. I think they will start it soon here,” Modasser Ali added.
However, the source at Indian High Commission in Dhaka said: “We submitted the proposal for Phase III trials in October 2020. It has taken eight months to get the approval, so we need to revisit the entire proposal now.”
The original proposal was to run the Phase III trials, followed by data collection, efficacy proof, emergency use authorization by the regulator in Bangladesh, and then deployment followed by co-production.
He said all the arrangements were finalized in early December last year, before the vaccine was deployed in India and elsewhere.
“Now that several million doses have been administered in India and elsewhere, and since healthcare workers and others in Bangladesh who would have been part of the trials have by now been vaccinated already, the company and the regulators in India and Bangladesh will need to see what is needed next and what we can do now,” the official said.
According to India’s external affairs ministry, no Covaxin doses have been supplied to Bangladesh.
India has so far provided 3.3 million Covishield doses as gift and seven million doses under a vaccine purchase agreement to Bangladesh.
The Hindustan Times, quoting an official document of Delhi, said: “The Indian government, through its missions abroad, facilitated the regulatory approval of Covaxin by drug regulators in various countries.”
Previously, Reuters reported in January, citing an official at Bangladesh’s medical research body that Bharat Biotech had applied to conduct trials for Covaxin in the country.
The Hindustan Times newspaper also noted in its report that the approval had apparently followed a push from the Indian side.
However, Indian High Commission sources said that there was a lack of interest in Covaxin among some quarters in Bangladesh as the country had also signed agreements with China for 30 million doses of the Sinopharm vaccine and was set to ink a separate deal for Russia’s Sputnik V vaccine.
The Bangladesh side is also upset over the inability of Serum Institute of India (SII) to deliver 30 million doses of the Covishield vaccine in line with the contract signed last November.
Vaccine exports from India were halted in April amid a devastating second wave of infections.
Under the agreement with SII, Bangladesh would have received five million doses each month from January to June 2021.