Trial of Chinese Vaccine: Govt indecision puzzles experts

It remains a mystery why Bangladesh government is still in a fix about allowing a clinical trial of the Chinese Covid-19 vaccine here when health experts are saying the trial can help the country access the life-saving vaccine quickly and build national capacity for advanced research.

Globally, more than 100 organisations are working on Covid-19 vaccine development and governments are investing billions of dollars to get the vaccine at the soonest. The UK and US have also signed contracts with vaccine producers to this end.

Against this backdrop, it is an opportunity for Bangladesh to conduct a clinical trial of the vaccine here. The country should invite not only China, but also other countries for vaccine research so it can be part of the global initiatives to fight the pandemic, say medical researchers.

Recently, Bangladesh Medical Research Council (BMRC), the regulator for medical research, has approved the trial of a vaccine developed by Chinese company -- Sinovac Research and Development Co Ltd -- for coronavirus treatment, after more than a month of review.

The company selected icddr,b, a globally reputed medical research organisation, as its local partner in Bangladesh.

Making the decision public on July 19, BMRC Director Mahmood-uz-Jahan said icddr,b would now have to follow some procedures and get permissions from the Directorate General of Health Services (DGHS) and the Directorate General of Drug Administration (DGDA) for conducting the trial.

He also said the trial would be conducted on around 4,200 healthcare staffers.

But two days later, a private TV channel, quoting Health Secretary Abdul Mannan, reported that the approval for the trial was overturned.

Mannan did not clarify anything but said it was a matter of two states and the government would make a decision.

Health Minister Zahid Maleque, however, on July 22 said the government would decide on the trial of the Chinese vaccine upon consultation with the National Technical Advisory Committee (NTAC) on Covid-19.

Contacted, NTAC Chair Prof Mohammad Shahidullah on July 28 told The Daily Star that the government had not yet sought any advice from the committee.  "You please let us know if there is any decision," he said.

The Daily Star talked to four medical scientists having knowledge of vaccine development, but none of them wanted to speak on the record, saying that it has become a "geopolitical issue", which, they said, should not determine anything about the life-saving vaccine.

BENEFITS OF TRIAL

IN BANGLADESH

According to epidemiologists and virologists, three countries – the UK, US and China -- are now at the advanced stage of vaccine trials. Oxford University of the UK and American biotechnology company Moderna have already begun their third phase trials in Brazil.

AstraZeneca, a partner of Oxford, also partnered with Indian private vaccine maker Serum Institute of India to produce doses.

Of two Chinese companies, state-owned Sinopharma began stage-three trials in the UAE on 15,000 people, while Chinese private company Sinovac Research and Development Co Ltd signed a deal with a Brazilian organisation for the phase-three trial. The BMRC of Bangladesh also approved the third phase trial of Sinovac vaccine in Bangladesh.

Medical scientists say a global race is underway to develop an effective vaccine and ensure national demand before supplying doses to other nations. Any country participating in the trial will obviously get quick access to the vaccine, they said.

They also said the countries participating in the research would also get technological support. Besides, local pharmaceutical companies would be able to go for production.

China also said Bangladesh would get priority in getting its vaccine, claimed a source in the vaccine research community, adding that though icddr,b was yet to sign any deal with Sinovac, it was negotiating in this regard.

"If Sinovac's vaccine is found effective through trial in Bangladesh, our companies having expertise can go for manufacturing it locally. We can get access to vaccine at the earliest. This is a huge opportunity for us," said Prof Nazrul Islam, a member of the NTAC on Covid-19.

"Also, trial on the Bangladeshi population means the vaccine's effectiveness will be proved on our population. Thus, the vaccine can be further improved for higher level of effectiveness for the population of this country," the virologist said.

He also said the World Health Organisation has taken global initiatives to distribute coronavirus vaccine through Vaccine Alliance GAVI, once it will be produced. Bangladesh is one of the countries that will get free vaccines, but GAVI also prioritises countries based on their epidemiological situation.

"That means, we have to totally depend on charity for the vaccine," Prof Nazrul said, expressing frustration over the government's indecision over Sinovac's vaccine trial in Bangladesh.

The medical scientists who spoke to this newspaper off the record said only a few countries have the capacity for phase three trials that require standard equipment, human resources as well as the conditions where Covid-19 infection is active. International medical research organisation icddr,b, in that case, is a blessing for Bangladesh. Also, infection is still happening in Bangladesh, they said.

But now, geopolitics seems to have come into the play. Some are saying that Bangladeshi population will be used as guinea pigs for the trial, which is not true at all, said a former scientist at the icddr,b.

China has already conducted trial of Sinovac's vaccine on animals as well as on its army. It is also set to begin the phase three trial in Brazil.

"How can that be possible without rigorous safety measures in place," the scientist said.

Prof Sayedur Rahman, chairman of the Bangladesh Pharmacological Society, in a recent TV talk-show said there were globally-recognised ways of minimising risks in such trials. The BMRC has approved the trial considering all these aspects.

"Also, the volunteers for the trial will be selected from health workers because they can give instant feedbacks. This is meant to minimise risks, if any," he said.

"The research experience, if done, will be an asset for us. The government should take quick decision on this," he said.

Prof Sayedur Rahman also said Bangladesh should not always remain at the "receiving end". With its robust growth of pharmaceutical industry, human and laboratory facilities, the country now needs to participate in global research and help the countrymen and the humanity, he added.