The much-talked-about mass trial of a Chinese coronavirus vaccine in Bangladesh has become uncertain after drugmaker Sinovac Biotech Ltd asked the government to co-finance the initiative.
Sinovac Biotech Ltd in a letter on September 24 said the trial would be delayed unless the government provided funds, although the company was supposed to bear the costs as per an agreement.
The Beijing-based vaccine giant sent the letter to the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), which was to conduct the trial.
The icddr,b forwarded it to the health ministry.
“They [Sinovac] informed us that they would be able to start the trial soon if we co-fund the initiative. We will make a decision after talking to the prime minister,” Abdul Mannan, secretary of the health services division at the health ministry, told The Daily Star on Thursday.
“We are not dependent on Sinovac. The government is looking for other avenues to get the vaccine right after it is developed,” he said.
The Sinovac letter did not mention how much fund it would need and why it was seeking funds at the last moment.
The officials concerned refused to comment on the issue.
Experts said Sinovac’s demand was “not fair” and speculated that the company might have run the required number of trials in other countries.
“They probably fulfilled their enrollment criteria for the approval. Now they are placing the financial burden on us,” said Prof Sayedur Rahman, member of the ethical review committee of the Bangladesh Medical and Research Council (BMRC).
There is a requirement for human trials on 10,000 to 30,000 people to get any vaccine approved globally, he said.
Prof Nazrul Islam, a member of the National Technical Advisory Committee (NTAC) on Covid-19, said, “This makes everything unclear.”
Currently, the potential vaccine is being trialled in countries including Brazil, Turkey, and Indonesia.
On July 18, the BMRC gave permission to the icddr,b to conduct human trials of the vaccine at seven hospitals in the capital.
The clinical trial of the Chinese shot was supposed to start by the end of last month as icddr,b was supposed to get the necessary doses for the trial.
As per the contract, Sinovac would provide 110,000 free vaccine doses to Bangladesh if the Phase-III trial of the vaccine is proven safe.
Besides, the company committed to let a “qualified” Bangladeshi drugmaker produce the shots at a discounted price, so that the needs of the people of Bangladesh are met.
Prof Nazrul said, “We recommended the trials considering the technology transfer, because that would have gotten us the vaccines at a cheaper rate.”
Officials at icddr,b said they could not see any reason behind Sinovac’s move.
The icddr,b has already engaged its scientists and appointed necessary human resources for the trial, sources said .
Sinovac has not fixed the price of its vaccine yet. Another Chinese company Sinopharm has announced that two shots of its vaccine, expected to become available in December, might cost around $145.
Meanwhile, Oxford University and AstraZeneca say their vaccine will be about $4 per dose.
Quoting Sinovac Chairman and CEO Yin Weidong, Chinese media on September 25 reported that the company might begin analysing data from final-stage human trials this year to decide whether it is effective enough to seek regulatory approval.
Some western companies are also racing to evaluate efficacy of their vaccines, the report added.
Sinovac can start assessing the vaccine’s ability to protect people as soon as researchers observe at least 61 trial subjects, its CEO told a news conference.