DHAKA: Bangladesh’s first homegrown coronavirus disease (COVID-19) vaccine will start human trials next month following ethical approval from the country’s top medical body, its developer said on Wednesday.
Bangavax is a new generation single-dose (messenger) mRNA vaccine that, similar to the Pfizer and Moderna ones, introduces a piece of mRNA that corresponds to a viral protein and triggers an immune response to produce virus antibodies.
Developed by Dhaka-based Globe Biotech Ltd., the vaccine was approved for production by the country’s drug regulator last year.
On Tuesday, the Bangladesh Medical Research Council gave ethical permission to GBL to conduct clinical trials of the vaccine after it had completed tests on monkeys.
Dr. Mohammed Mohiuddin, GBL’s quality and regulatory affairs manager, told Arab News: “If everything goes well, we hope to start the human trial sometime early next month.
“We received permission from the Bangladesh Medical Research Council to conduct the human trial and now we will apply to the Directorate General of Drug Administration early next week for producing the vaccine in our laboratory.”
He noted that the company expected to receive the drug regulator’s approval by the end of next week.
“Our mRNA vaccine performed very well during animal trials and generated 100 percent efficacy, which neutralized the COVID-19 virus within one week of inoculation. This is a single-dose vaccine, and similar technology was used for producing the Pfizer and Moderna vaccines,” he added.
While the Pfizer and Moderna jabs need to be frozen, posing storage and logistical challenges in developing countries, Bangavax can be kept for 30 days in temperatures below 4 degrees Celsius.
Trials conducted by its producer have so far shown its effectiveness against 11 strains of COVID-19, including the highly contagious delta variant which earlier this year wreaked havoc in South Asia.
Bangavax’s first human trial will be conducted with 64 volunteers at Bangabandhu Sheikh Mujib Medical University in Dhaka over a period of 35 days.
Prof. Mamun Al-Mahtab Shwapnil, the university’s hepatology department chairman who will act as principal investigator for the trial, told Arab News: “The volunteers will be under observation at hospital for a couple of days to see if any side effects are there. Sufficient preparations are there to meet any kind of emergency situation.
“We are expecting to complete phase one of human trials by the end of December. Later on, phases two and three will be conducted with a larger sample size of more than 100, and 35,000 people, respectively. If all goes well, we hope to bring the vaccine to market by the middle of next year,” he said.
At every stage of the trial, GBL will be expected to share its results with the World Health Organization.
Prof. Dr. Muzaherul Huq, former WHO regional adviser in Dhaka, told Arab News: “An expert committee of the WHO will analyze the findings and if the committee is satisfied with the research outcomes, only then will it recommend the emergency use authorization.
“When the vaccine gets permission for local use, any other countries in the world may import it for their citizens.”
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Bangladeshi COVID-19 jab to start human trials soon
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Bangladeshi COVID-19 jab to start human trials soon
- Producer expects to introduce single-dose mRNA vaccine to market mid-2022
Paraguay lawmakers approve defense agreement allowing an increased US military presence
ASUNCIÓN: Paraguay’s Chamber of Deputies on Tuesday approved a defense agreement allowing the temporary presence of US military and civilian personnel inside its borders, widely seen as a victory for the Trump administration, which has sought to strengthen its presence in Latin America.
The Status of Forces Agreement, or SOFA, was approved by a large majority of lawmakers and now awaits the signature of President Santiago Peña to take effect. Peña, one of Trump’s closest allies in the region, is expected to sign the deal in the coming days.
The agreement passed with 53 votes in favor and eight against, and four abstentions out of a total 80 lawmakers. Fifteen were not present for the vote.
Signed by both countries in Washington in December, the agreement establishes a legal framework for the presence of US security forces in Paraguay for training, joint exercises, and humanitarian assistance. It also authorizes the United States to have criminal jurisdiction over its personnel while in the country.
The treaty, praised as “historic” by both the US State Department and Paraguayan Foreign Minister Rubén Ramírez Lezcano, was approved by the Paraguayan Senate last week, where debate was more polarized due to concerns over potential violations of sovereignty.
Some legislators argued against the agreement, citing a controversial provision to grant foreign troops immunity from prosecution, equivalent to that handed to diplomatic personnel.
“We believe in international cooperation, but we also believe in strong states, respected institutions and real democratic sovereignty,” said independent congressman Raúl Benítez.
Despite criticisms, Paraguay’s foreign minister backed the agreement, arguing in December that its main purpose is to strengthen cooperation between the United States and Paraguay in fighting transnational organized crime and “terrorism.” He also clarified that “there is no possibility of the installation of US military bases” in Paraguay.
Washington has also praised SOFA, with US Secretary of State Marco Rubio calling it a “historic agreement” that would help facilitate bilateral and multinational training, humanitarian assistance, disaster response, and other shared security interests.
The approval of SOFA comes as Washington seeks to expand its influence in Latin America under the Trump administration’s national security strategy and as a sector of civil society in Paraguay continues to raise its voice against it.
“The security of a country is not built by importing troops or shielding foreign agents with diplomatic immunities,” said Peace and Justice Service, a civil organization which has a presence across Latin America, in a statement released days before the final vote. The treaty, it added, “does not represent progress in security, but rather the formalization of a geopolitics of impunity that undermines the pillars of our national dignity.”
The Status of Forces Agreement, or SOFA, was approved by a large majority of lawmakers and now awaits the signature of President Santiago Peña to take effect. Peña, one of Trump’s closest allies in the region, is expected to sign the deal in the coming days.
The agreement passed with 53 votes in favor and eight against, and four abstentions out of a total 80 lawmakers. Fifteen were not present for the vote.
Signed by both countries in Washington in December, the agreement establishes a legal framework for the presence of US security forces in Paraguay for training, joint exercises, and humanitarian assistance. It also authorizes the United States to have criminal jurisdiction over its personnel while in the country.
The treaty, praised as “historic” by both the US State Department and Paraguayan Foreign Minister Rubén Ramírez Lezcano, was approved by the Paraguayan Senate last week, where debate was more polarized due to concerns over potential violations of sovereignty.
Some legislators argued against the agreement, citing a controversial provision to grant foreign troops immunity from prosecution, equivalent to that handed to diplomatic personnel.
“We believe in international cooperation, but we also believe in strong states, respected institutions and real democratic sovereignty,” said independent congressman Raúl Benítez.
Despite criticisms, Paraguay’s foreign minister backed the agreement, arguing in December that its main purpose is to strengthen cooperation between the United States and Paraguay in fighting transnational organized crime and “terrorism.” He also clarified that “there is no possibility of the installation of US military bases” in Paraguay.
Washington has also praised SOFA, with US Secretary of State Marco Rubio calling it a “historic agreement” that would help facilitate bilateral and multinational training, humanitarian assistance, disaster response, and other shared security interests.
The approval of SOFA comes as Washington seeks to expand its influence in Latin America under the Trump administration’s national security strategy and as a sector of civil society in Paraguay continues to raise its voice against it.
“The security of a country is not built by importing troops or shielding foreign agents with diplomatic immunities,” said Peace and Justice Service, a civil organization which has a presence across Latin America, in a statement released days before the final vote. The treaty, it added, “does not represent progress in security, but rather the formalization of a geopolitics of impunity that undermines the pillars of our national dignity.”
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