Clinical Trials of Covid-19 Vaccine: BMRC to look into pending requests

The pending requests with the Bangladesh Medical Research Council (BMRC) on running trial of vaccines might see some positive outcome as the ethical committee is expected to hold a meeting in a day or two over the issue.

"Hope, there will be some positive outcome," said Prof Dr Shahla Khatun, chairman of the ethical Committee at BMRC.

Uncertainty looms large after India -- the lone supplier of the Covid-19 vaccine -- expressed its inability in delivering vaccines to Bangladesh.

The crisis could have been avoided had the government not relied on a single source and took the advantage of other sources who had offered vaccines to Bangladesh earlier, experts believe.

"Since we've a large population, it is a common sense that we were needed to explore more options [for vaccine]," said Prof Be-Nazir Ahmed, former director of disease control at the Ministry of Health and Family Welfare.

"The way we're heading, vaccine seems our best option. If you're vaccinated, either you'll not be infected or the attack would be mild. Which means, the 44-45 lakh people who received two doses have less risk," he said.

Be-Nazir said, "We're not bound to take vaccine after clinical trial but if a trial turns out successful, we would get priority. We now need to increase our diplomatic endeavour to ensure vaccine from different sources."

Two Chinese and one Indian organisations had applied for clinical trial at the end of last year.

One of the Chinese companies -- Institute of Medical Biology, Chinese Academy of Medical Sciences (IMBCAMS) -- requested the health ministry for carrying out Phase III Clinical Trial of SARS-CoV-2 on December 23, 2020.

The actual trials were still awaiting approval of the ethical committee of BMRC.

IMBCAMS SARS-CoV-2 is an inactivated (vero cell) type vaccine like polio and influenza. These consist of viruses grown in culture and then killed as a means to reduce virulence (ability to infect and cause harm) and thus prevent infection from the vaccine.

One benefit is that they can be given to people with weakened immune systems.

According to www.covid-19vaccinetracker.org, the phase I trial of SARS-CoV-2 began in May 2020 and its results were released in October 2020 and phase II trial began in June 2020.

IMBCAMS started phase III trial late January this year in Malaysia, it shows.

On March 29, IMBCAMS wrote a letter to Bangladesh embassy in China saying that the unexpected delay has seriously impacted the implementation of phase III clinical trial.

"Once the vaccine is successfully marketed, IMBCAMS will give priority to Bangladesh and donate 100,000 doses of vaccine for free," reads the letter.

The Daily Star obtained a copy of the letter which says the trial will be carried out in Malaysia, Brazil, Mexico and Bangladesh in sequence.

According to the letter, IMBCAMS contacted International Center for Diarrhoeal Disease Research, Bangladesh (icddr,b) in August 2020 and signed a clinical trial agreement.

The trial protocol was approved by the Research Review Committee and Ethical Review Committee of icddr,b on December 10, 2020 and December 20, 2020 respectively.

On behalf of IMBCAMS, the Icddr,b submitted the application to BMRC on December 20, 2020.

The first project funds -- US$ 1048846.20 -- was also paid to icddr,b on January 6, 2021 for the trial, the letter reads.

On April 1, the embassy forwarded the letter to the director general of Corona Cell of the Ministry of Foreign Affairs.

Contacted, KSM Mostafizur Rahman, managing director of One Pharma, local agent of the Chinese company, said it is a Tk 50 crore project of which 20 percent money is paid to icddr,b.

"We're yet to get any approval. If the approval is given, IMBCAMS will be able to initiate the trial from July," he said. "One Pharma has infrastructure to preserve vaccines at 2 to 8 degree Celsius and a good network throughout the country."

Contacted, Prof Dr Syed Modasser Ali, chairman of the executive committee at BMRC, said it is always good to have more than one source of vaccine.

"We could not understand that the Covid-19 situation would deteriorate and we don't know when it will stop. So it is better to have more than one source for vaccine," he said.

Asked about the delay, he said the ethical committee is supposed to look after it.

Contacted, Dr Shahla said due to various complexities they could not hold a meeting in this regard.

She did not elaborate any further.