Govt approves human trial of Chinese Covid-19 vaccine in Bangladesh

The government has given approval to the phase 3, or human, trial of a Covid-19 vaccine in Bangladesh, developed by the Chinese company Sinovac Biotech Ltd.

Health Minister Zahid Maleque made the announcement during an online press briefing on Thursday afternoon, following an online meeting with top officials of the Chinese embassy in Dhaka.

“We have given approval for a human trial of the Covid-19 vaccine after examining all necessary research protocols,” the minister said at the briefing.

He did not specify when the trial would begin, but said it would begin soon.

The International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) will provide logistical support in conducting the trial in the country.

“We have decided that doctors, nurses and health workers will get priority in the vaccine trials," the minister said. “The Chinese company will bear the cost of the vaccine and trial process.”

Chinese citizens who are working in Bangladesh will also participate in the vaccine trial, he added.

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 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.

Also Read: Covid-19: The global search for vaccines

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 still 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, seeking to conduct 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 the 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 his sudden two-day 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 Thursday’s briefing.

Till date, only one Covid-19 vaccine has been approved. Russia on August 11 declared itself the first country to approve a coronavirus vaccine, named “Sputnik V.” The announcement met with scepticism and concern as its final trials have yet to be finished.

‘Will allow any company to conduct trial after scrutiny’

Health Minister Zahid Maleque said on Thursday that, after scrutinizing the qualitative standard of the vaccines, the government will consider proposals for trial from any vaccine-producing country.

Replying to a question, he said at present some eight companies were at the advance stage of trials in the world.

If any company or government applied to have trials conducted in Bangladesh, the government might allow them after examining their qualitative standard, he added.

He added that as per his understanding, the Covid-19 vaccine would not be available for mass administration before December this year or January next year.

The minister also said the government was hopeful that the country would get a Covid-19 vaccine from the World Health Organization (WHO) as well by June 2021.

“We have already applied to the WHO to get the vaccine on a priority basis,” he added.

According to the WHO vaccine update published on August 25, over 173 research organizations across the world are working to develop vaccines for Covid-19. Among them, 31 are in clinical evaluation, of whom eight are in the late stage of trial. Of these eight, six vaccines have high chances of acceptance, according to WHO.

Oxford University embodies the biggest hope in developing a vaccine. Its trial is in progress in the UK, and it recently went into a phase 3 trial in South Africa and Brazil. The project may deliver emergency vaccines by October, according to a New York Times report.

Other than Sinovac, CanSino and Sinopharm are the other Chinese companies in the late stage of the trial.

Germany, France, the US and Sweden are also in the race to develop Covid-19 vaccines.

‘Identify most vulnerable group for first vaccine batch’ 

It is not possible to administer the Covid-19 vaccine to the entire population at the same time, so the government should identify the group of people with the highest risk of infection in Bangladesh, and prioritize them for the vaccine, the National Technical Advisory Committee (NTAC) has said.

The committee also recommended formulating guidelines on how the vaccine should be distributed and supplied to the places that require it, with the help of the National Immunization Technical Advisory Group (NITAG), which is in charge of planning vaccine administration in the country.

The NTAC said the government was working diligently to ensure that Bangladesh would get the much-coveted Covid-19 vaccine as soon as possible.

The committee said there were allocations in both World Bank and Asian Development Bank funds for the purchase of the vaccine. Besides, the Expanded Program on Immunization (EPI) of WHO is currently working on how it can distribute and supply the vaccine throughout the country.