Bangladesh in no hurry to trial Sinovac's virus vaccine

Bangladesh is in no hurry to start a late-stage human trial of a vaccine for the novel coronavirus, developed by China’s Sinovac Biotech Ltd, according to the country's top health officials.

The Bangladesh Medical Research Council or BMRC approved the phase 3 trial of Sinovac's vaccine candidate, known as CoronaVac.

But due to the novelty of the process, health authorities are awaiting approval from the government's top brass before flagging off the trials.

The International Centre for Diarrhoeal Disease Research, Bangladesh or icddr,b is set to conduct the trial of the Chinese vaccine. The vaccine will likely be administered to health workers in the country over the next 18 months. 

As the trial will be held on a national level, the Ministry of Health wants to proceed with caution, Dr ABM Khurshid Alam, director-general of DGHS, told bdnews24.com. The agency is waiting for results of the trials conducted in China, he said.

“The tests will be conducted on a national level. Who will be held accountable if any harm comes from it? Although the BMRC has approved the trial, we can’t start it right away. We should take time.”

The health directorate is waiting for the government’s decision as they need the green light from the National Health Committee, BMRC, the health ministry and even the prime minister.

“We've got the requisition order. But we haven’t received any directive on the issue. DGHS does not have the authority to approve the clinical trial,” said Khurshid.

“The prime minister needs to be involved in the matter. A law needs to be passed in parliament to run a clinical trial. The World Health Organisation may revoke some of its rules as the vaccine is needed urgently. But as long as the rules are in place, we’re legally bound by them.”

Sinovac directly approached the icddr,b about the human trial of its vaccine and even though the BMRC approved it, the government is yet to reach a decision on the matter, according to Khurshid.

“They want to conduct a trial on around 4,500 people in our country. We've asked them if they had done a trial in their country. We need to see the results in the clinical trial done there.”

“We can’t predict the effects it could have on people’s health. We don’t want to put our people at risk. That’s why we’re taking our time. Maybe, we’ll approve the clinical trial after we get the results from other countries.”

Dhaka Medical College Hospital, Mugda General Hospital, Mahanagar General Hospital, Kurmitola General Hospital, Kuwait-Bangladesh Friendship Hospital and Holy Family Hospital had been slated to conduct trials of the vaccine.

But despite getting the nod to test the vaccine a month ago, the process is yet to get underway at these hospitals.

Kuwait-Bangladesh Friendship Hospital is yet to receive any directive on the matter, according to its coordinator Dr Shihabuddin.

“I've contacted the icddr,b and they said the process is still at the primary stage. Talks are ongoing. We can only expect to receive a government order or directive."

Prof Abul Hashem Sheikh, director of Mugda General Hospital, said the hospital is not running any vaccine programme.

“We must receive a letter from the health ministry before we can start a trial. As far as I know, the clinical trial of the vaccine has not been approved by the ministry.”

The icddr,b did not comment on the issue. The organisation will not speak about the matter as it is still in the research phase, according to a representative of icddr,b.

As the coronavirus pandemic grinds on, countries around the globe are scrambling for a vaccine to mitigate the adverse effects of the virus that has already infected over 20 million people and claimed more than 740,000 lives.

Sinovac has completed a mid-stage study (phase 2) in which it said the vaccine candidate appeared to be safe and induced detectable antibody-based immune responses in subjects.

The candidate, known as CoronaVac, is among a few potential vaccines that have entered late-stage trials for a large-scale study to gather proof of efficacy for regulatory approval.

CoronaVac is already undergoing a late-stage trial in Brazil. Sinovac also launched a late-stage human trial in Indonesia on Tuesday that will involve as many as 1,620 patients.

Sinovac announced “positive preliminary” results of phase I and II clinical trials for its COVID-19 vaccine candidate. The trials looked at a total of 743 healthy volunteers between the ages of 18 and 59.

No severe side effects were reported in either phase, with the vaccine inducing a positive immune response, according to Sinovac.