Staff Reporter :
The government has given approval to the phase 3, or human, trial of a Covid-19 vaccine in Bangla
desh, developed by the Chinese company Sinovac Biotech Ltd.
The International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) will provide logistic support in conducting the trial.
Icddr,b informed, the vaccine will be applied on around 4,200 healthcare workers of seven Covid-19 dedicated hospitals in Dhaka during the trial period.
The Chinese company will bear the cost of the vaccine and trial process.
The government has given approval to the phase 3, or human, trial of a Covid-19 vaccine in Bangla
desh, developed by the Chinese company Sinovac Biotech Ltd.
The International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) will provide logistic support in conducting the trial.
Icddr,b informed, the vaccine will be applied on around 4,200 healthcare workers of seven Covid-19 dedicated hospitals in Dhaka during the trial period.
The Chinese company will bear the cost of the vaccine and trial process.
As early as possible the trial will begin.
Icddr,b officials said about the vaccine trial procedure, what procedure the other countries apply, that will be done in Bangladesh.
A group of people who will be under trial will be given the original vaccine with coronavirus antidote. Another group will be given without antidote vaccine which call ‘placebo’ in medical term. No group will know about it and both groups will be under six month observation.
For this, a Telemedicine Unit with specialist doctors has been formed which will remain active for 24 hours.
The telemedicine unit will be in regular contact with each of the two teams participating in the trial. They will also be told if there is any problem in their body, major or minor, they should immediately inform the unit and take advice.
Those who will be vaccinated (with antidote and without antidote) will be reviewed every week with information on the effects on each of these two groups. And an expert committee will work on this as well.
The review report of this expert committee will decide on the effectiveness of the vaccine.
Officials say a number of expert committees will work on this whole period, from the start of vaccination to the end of the monitoring period. Whether the participants’ bodies are safe at this time will be monitored with the highest priority.
Dr. K. Zaman, Chief Scientific Officer, icddr,b is in charge of this experimental application or trial.
He said, the healthcare workers from seven covid-19 dedicated hospitals in Dhaka who are willing to take part in the trial will be appreciated.
Health Minister Zahid Maleque said, Chinese Embassy proposed Bangladesh that the Chinese citizens who are working in Bangladesh will also participate (if they want) in the vaccine trial about which Bangladesh has no objection.
The healthcare workers of Mugda General Hospital, Dhaka Medical College Hospital Burn Unit-1, Kurmitola General Hospital, Holy Family Red Crescent Medical College Hospital, Kuwait-Bangladesh Friendship Hospital, Dhaka Medical College Hospital Unit-2, and Dhaka Mahanagar Hospital will participate in the trial.
The health minister further said that he had a detailed meeting with Chinese Ambassador to Bangladesh Li Jiming. The minister told the ambassador to start the process for the trial.
“We will get some 100,000 vaccine equipment for the trial,” Zahid said. “The government believes that this trial will enable Bangladesh to become a priority in terms of vaccine sales.”
When contacted, AKM Tariful Islam Khan, media manager of icddr,b, said on Thursday: “We appreciate the government of Bangladesh for taking time to evaluate our application for the phase 3 trial of Sinovac’s Covid-19 vaccine critically, and finally give approval for the trial.”
The Chinese Foreign Ministry sent a letter to its Bangladesh counterpart on June 7, expressing keen interest in conducting clinical trials in Bangladesh.
Following that, the icddr,b submitted a protocol for the trial to the Bangladesh Medical Research Council (BMRC), an autonomous body that carries out research on medical and health sciences in the country for ethical approval on June 26.
On July 19, BMRC gave ethical approval to icddr,b to conduct Sinovac’s phase 3 trial in Bangladesh.
The trial was scheduled to begin in August, but on July 22, Health Minister Zahid Maleque said the government was considering whether to allow the Chinese company to run the trial in Bangladesh.
“The government is keeping an eye on the effectiveness of Covid-19 vaccines being developed by other countries as well. We will make a final decision based on whichever option is best for the country,” the health minister had said then.
On August 4, Sinovac applied for conducting the phase 3 trial of its Covid-19 vaccine in Bangladesh, to the government through icddr,b.
The company said it would conduct the trial on 4,200 health workers from seven dedicated hospitals across the country, Health Services Division Secretary Abdul Mannan said at that time.
On August 12, the health minister said that the government was going to finalize its decision on the vaccine trial soon.
On August 18, during a two-day sudden visit to Bangladesh, Indian Foreign Secretary Harsh Vardhan Shringla said Bangladesh would be a priority recipient for the Covid-19 vaccine developed in India, in response to the request made by his Bangladesh counterpart Masud Bin Momen.
On August 20, the National Technical Advisory Committee (NTAC) for the government’s Covid-19 management recommended allowing phase 3 trials of Covid-19 vaccine in Bangladesh, urging the government to make all-out preparations to bring the newly-developed vaccine into the country.
Sinovac has already started the phase 3 trial in Indonesia and is preparing to start similar trials in several other countries, including Turkey, the health minister said at its Thursday’s briefing.
A group of people who will be under trial will be given the original vaccine with coronavirus antidote. Another group will be given without antidote vaccine which call ‘placebo’ in medical term. No group will know about it and both groups will be under six month observation.
For this, a Telemedicine Unit with specialist doctors has been formed which will remain active for 24 hours.
The telemedicine unit will be in regular contact with each of the two teams participating in the trial. They will also be told if there is any problem in their body, major or minor, they should immediately inform the unit and take advice.
Those who will be vaccinated (with antidote and without antidote) will be reviewed every week with information on the effects on each of these two groups. And an expert committee will work on this as well.
The review report of this expert committee will decide on the effectiveness of the vaccine.
Officials say a number of expert committees will work on this whole period, from the start of vaccination to the end of the monitoring period. Whether the participants’ bodies are safe at this time will be monitored with the highest priority.
Dr. K. Zaman, Chief Scientific Officer, icddr,b is in charge of this experimental application or trial.
He said, the healthcare workers from seven covid-19 dedicated hospitals in Dhaka who are willing to take part in the trial will be appreciated.
Health Minister Zahid Maleque said, Chinese Embassy proposed Bangladesh that the Chinese citizens who are working in Bangladesh will also participate (if they want) in the vaccine trial about which Bangladesh has no objection.
The healthcare workers of Mugda General Hospital, Dhaka Medical College Hospital Burn Unit-1, Kurmitola General Hospital, Holy Family Red Crescent Medical College Hospital, Kuwait-Bangladesh Friendship Hospital, Dhaka Medical College Hospital Unit-2, and Dhaka Mahanagar Hospital will participate in the trial.
The health minister further said that he had a detailed meeting with Chinese Ambassador to Bangladesh Li Jiming. The minister told the ambassador to start the process for the trial.
“We will get some 100,000 vaccine equipment for the trial,” Zahid said. “The government believes that this trial will enable Bangladesh to become a priority in terms of vaccine sales.”
When contacted, AKM Tariful Islam Khan, media manager of icddr,b, said on Thursday: “We appreciate the government of Bangladesh for taking time to evaluate our application for the phase 3 trial of Sinovac’s Covid-19 vaccine critically, and finally give approval for the trial.”
The Chinese Foreign Ministry sent a letter to its Bangladesh counterpart on June 7, expressing keen interest in conducting clinical trials in Bangladesh.
Following that, the icddr,b submitted a protocol for the trial to the Bangladesh Medical Research Council (BMRC), an autonomous body that carries out research on medical and health sciences in the country for ethical approval on June 26.
On July 19, BMRC gave ethical approval to icddr,b to conduct Sinovac’s phase 3 trial in Bangladesh.
The trial was scheduled to begin in August, but on July 22, Health Minister Zahid Maleque said the government was considering whether to allow the Chinese company to run the trial in Bangladesh.
“The government is keeping an eye on the effectiveness of Covid-19 vaccines being developed by other countries as well. We will make a final decision based on whichever option is best for the country,” the health minister had said then.
On August 4, Sinovac applied for conducting the phase 3 trial of its Covid-19 vaccine in Bangladesh, to the government through icddr,b.
The company said it would conduct the trial on 4,200 health workers from seven dedicated hospitals across the country, Health Services Division Secretary Abdul Mannan said at that time.
On August 12, the health minister said that the government was going to finalize its decision on the vaccine trial soon.
On August 18, during a two-day sudden visit to Bangladesh, Indian Foreign Secretary Harsh Vardhan Shringla said Bangladesh would be a priority recipient for the Covid-19 vaccine developed in India, in response to the request made by his Bangladesh counterpart Masud Bin Momen.
On August 20, the National Technical Advisory Committee (NTAC) for the government’s Covid-19 management recommended allowing phase 3 trials of Covid-19 vaccine in Bangladesh, urging the government to make all-out preparations to bring the newly-developed vaccine into the country.
Sinovac has already started the phase 3 trial in Indonesia and is preparing to start similar trials in several other countries, including Turkey, the health minister said at its Thursday’s briefing.
