World, Asia - Pacific

Bangladesh’s locally developed COVID vaccine faces regulatory hurdles

Public health experts call for prompt decision on Bangavax

SM Najmus Sakib   | 15.11.2021
Bangladesh’s locally developed COVID vaccine faces regulatory hurdles FILE PHOTO

DHAKA, Bangladesh

The developers of Bangladesh’s only indigenous COVID-19 vaccine have been facing hurdles in securing permission from the country’s regulatory body to conduct human trials.

Mohammad Mohiuddin, senior manager of quality and regulatory operations at Globe Biotech pharmaceutical company that produced the vaccine, told Anadolu Agency that they have waited months for a response despite providing all the required papers and study results in the approval phases for the single-dose Bangavax vaccine.

They began developing the vaccine in March 2020, shortly after the pandemic hit the country, he informed.

“We started our journey to develop the vaccine at the same time Pfizer and Moderna did. They got all the support for their journey and succeeded. But we failed in the race as the culture of promoting local companies and efforts remain ignored in Bangladesh,” Mohiuddin said.

Bangavax, a locally developed vaccine, will save the public money on vaccine imports, he said, adding it would also provide an opportunity for the vaccine to get a foothold in the global market with a positive financial outlook.

No response for approval

Global Biotech wrote officially to the Bangladesh Medical Research Council (BMRC) in January, seeking permission to conduct human trials as it was close to vaccine production by that time.

“But we didn’t get any response from the BMRC for five months. After repeated attempts, it suddenly asked to conduct trials on animals like monkeys. It wasn’t required for the first time, and we lost five months,” he said.

They then conducted trials on monkeys and submitted the results to the BMRC this month. The BMRC imposed new conditions time and again delayed the approval, he said.

Bangavax has been found effective against 11 coronavirus variants, including the highly contagious Delta variant, according to the compnay official.

“It’s a single-dose vaccine and capable of producing safe and effective COVID-19 antibodies in monkeys in seven days, and it is capable of neutralizing the highly contagious Delta variant as well as other variants of SARS-COV-2,” Mohiuddin stated.

The company developed the mRNA vaccine in July last year, following a full pre-clinical trial at its state-of-the-art animal center.

“Countries around the world say mRNA vaccines do not require trials on monkeys. Moderna got ethical approval for their mRNA vaccine clinical trial in just four days, and we are fighting for approval from the BMRC at a turtle’s pace,” he said.

However, this is the first trial on monkeys in Bangladesh, which is undoubtedly a new milestone in the country’s scientific research, he added.

Prompt action needed to inspire local companies

Rashid-E-Mahbub, a public health expert and rights activist, told Anadolu Agency that the government agency should provide jurisdiction immediately so the vaccine developer can work more on it if needed and know if there are any issues.

“Such an unnecessary delay could demoralize those who want to work and come forward in difficult times. We should promote and inspire science and research work,” added Mahbub, who is also the chairman of the National Committee on Health Rights Movement.

He said there is a global market, and any local company will have to build the capacity to compete in these markets, so support from the government is necessary.

Zafrullah Chowdhury, a public health activist and founder of Gonoshasthaya Kendra, a rural healthcare organization with a modern medical facility, criticized the role of government agencies for causing delays in the review process.

Speaking to Anadolu Agency, he alleged that the government has been extending favors to global businesses.

“Global companies get approval easily while locally developed medicines get stuck in the net of rules and bureaucracy,” he said.

Gonoshasthaya Kendra developed rapid antibody and antigen kits that did not get government approval despite repeated appeals. Instead, the government approved the import of kits on commercial grounds, he alleged.

Chowdhury also criticized the government for vaccine procurement from India and favoring its local distributor.

The government earlier signed a tripartite agreement with India to procure 30 million doses of Oxford/AstraZeneca vaccine from the Serum Institute of India.

After shipping 7 million vaccines in February, India ceased shipments in March.

BMRC claims working accordingly

BMRC Director Ruhul Amin rejected the allegations, claiming that the review process is not slowed down unnecessarily.

“We have received papers from the company, and we completely follow international standards in giving approval to local or global initiatives,” he said.

Amin said global vaccine companies got approvals in a comparatively shorter time as they had already completed some trial phases in their countries. However, there will be a meeting of the BMRC on Nov. 21 and the Bangavax issue will be addressed and a decision on it may come.

Minister of Health and Family Welfare Zahid Maleque also told the media that the government is encouraging local initiatives to manufacture COVID-19 vaccines and is in contact with international countries to do so.

Bangladesh has so far administered 78 million vaccine doses, with 46 million people receiving their first doses and 32 million fully vaccinated.​​​​​​​

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