DHAKA, July 19, (BSS) – Bangladesh’s regulatory Medical Research Council (BMRC) today extended “ethical approval” for final or phase-3 human trial of a prospective COVID-19 vaccine by China’s private Sinovac Biotech Ltd, which appeared to be a forerunner in a global race for developing inoculates against coronavirus.
“Our National Research Ethics Committee (of BMRC) has approved phase-3 clinical trial of Sinovac’s (prospective) COVID-19 vaccine,” BMRC director Dr Mahmood-Uz-Jahan told BSS.
He said the BMRC decided to approve the last stage trial of the Chinese vaccine as Dhaka-based International Centre for Diarrheal Disease Research, Bangladesh (ICDR’B) submitted a research protocol seeking to carry out the study.
The BMRC official said the regulator kept in consideration “Bangladesh’s benefit” alongside prospect and safety issues of the vaccine, studying the advancement of the Sinova’s research in China, while reviewing the ICDDR’B proposal.
“We have also reviewed the headway of Sinovac’s COVID-19 vaccine development process . . . we have found they made potential advancements though he trial is still underway in China,” he said.
Jahan, however, said the BMRC approval would require a subsequent endorsement from Directorate General of Health Services (DGHS) and Directorate General of Drug Administration.
But ICDDR’B officials said they still awaited a formal agreement with Sinovac though by now they reached a consensus with the Chinese company to conduct the phase-3 human trial of their vaccine.
“The nitty-gritty details of the proposed agreement have, however, been finalized . . . once the agreement was signed “we will formally announce the detailed trial procedures,” an ICDDR’B official said preferring anonymity.
He said the disease research centre expected the launch the trial “very soon” accomplishing quickly the remaining official procedures.
ICDR’B sought to carry out the trial in eight health units dedicated for COVID-19 patients in Dhaka while it submitted the proposal nearly a month ago for the clinical trial.
These are: Dhaka Medical College Hospital (DMCH) Unit-1, DMCH Unit-2, Kurmitola General Hospital, Kuwait Maitree Hospital, Mohanagar General Hospital, Mugda Medical College hospital and The Holy Family Red Crescent Medical College Hospital.
BMRC officials said the clinical trial would be performed on healthcare professionals in the designated seven hospitals as they are front liners.
They said 2,100 volunteers would be vaccinated while another 2,100 people would remain beyond the vaccination to gauge its efficacy.
Sinovac last month said it expected to complete the last phase of its prospective COVID-19 vaccine before November claiming the inoculate proved “safe and effective” on human so far.
About a dozen vaccines are in different stages of human tests globally, while Chinese researchers appeared as forerunners alongside their western counterparts and drug makers.
None of the vaccine trials, however, have passed large-scale, late-stage phase 3 clinical trials, a mandatory step to avail regulatory approval for sale.
Regulators and experts in the US and Europe, however, said the emergency situation could allow the interim use of an prospective vaccine or vaccines ahead of an official go ahead clearance.
Wealthy countries are placing orders for prospective vaccines before they were even approved as the race for vaccine development intensifies, leaving questions about whether developing nations will get any vaccines in time to save lives.
Beijing earlier promised to make universal its prospective vaccines while prospective vaccine developers in the country also said they were unlikely to keep the shots for China alone.
Sinovac earlier said it alone stood ready to manufacture 100 million doses but it appeared uncertain how quickly other countries would have access to the vaccine if it proves successful while China’s own population currently stands at nearly 1.4 billion.