DGDA
ADB to lend $336.5 million to Bangladesh to help develop vaccine production
The Asian Development Bank (ADB) and the government of Bangladesh on Tuesday (November 28, 2023) signed a loan agreement for $336.5 million to establish domestic vaccine, therapeutics, and diagnostics manufacturing capacity and strengthen the national regulator to ensure vaccine supply security in Bangladesh.
Md. Shahriar Kader Siddiky, secretary, Economic Relations Division, and Edimon Ginting, ADB country director for Bangladesh signed the agreement on behalf of Bangladesh and ADB, respectively.
The vaccines, therapeutics, and diagnostics manufacturing and regulatory strengthening project will establish a vaccine, therapeutic, and diagnostics manufacturing facility and warehousing unit in Essential Drugs Company Limited's (EDCL) existing location at Gopalganj, with a capacity to manufacture 58 million vials of vaccines per year, said the regional development bank.
An in-house research and development center will be established to support the production of diagnostic kits and packaging of biosimilar therapeutics.
Read: ADB to provide $200 million to promote energy efficiency, transition in Bangladesh
It will also support the manufacture of at least two full-cycle vaccines by developing a seed bank, master cell bank, and working cell bank, in addition to at least five fill-and-finish vaccines.
“Bangladesh has attained remarkable success in implementing its vaccination programs supported by subsidized vaccines supplied through the Global Alliance for Vaccine and Immunization (GAVI). As Bangladesh graduates from the Least Developed Country status, the supply of vaccine from GAVI will gradually be phased out,” said Country Director Edimon Ginting.
“This project will help create vibrant ecosystem for vaccine production in the country, ensuring sustainable supply in the medium-term, and at the same time, building Bangladesh’s capacity to manage future pandemics better,” he added.
The manufacturing facility will incorporate features to promote gender equality and social inclusion as well as green and resilient production using less energy and materials while reducing waste and carbon missions.
The facility will seek certification from the World Health Organization (WHO) for good manufacturing practices (GMPs).
The ADB loan will support the Directorate General of Drug Administration (DGDA) to upgrade its regulatory capacity to WHO maturity level 3 and beyond. ADB will help strengthen laboratory quality management and regulatory inspection systems while improving testing capacity modalities in compliance with WHO's Global Benchmarking Tool.
Read: JICA to help improve Bangladesh’s justice delivery system
It will create a stable, well-functioning, and integrated regulatory system; help foster international collaboration and trade; and improve private sector participation in Bangladesh's pharmaceutical industry.
The project will help EDCL and DGDA train their staff in essential GMPs, quality assurance, quality control, validation, and calibration programs in compliance with the biosafety levels, according to ADB.
The project is financed through ADB’s $9 billion Asia Pacific Vaccine Access Facility, launched in December 2020 to provide rapid and equitable vaccine-related support to ADB developing member countries.
It builds on ADB’s $940 million support to Bangladesh to purchase safe and effective vaccines against COVID-19 in June 2021.
Read more: ADB provides $90 million for clean water, sanitation services in the Hill Tracts
1 year ago
Napa deaths: DGDA claims syrup was safe
The batch of Napa syrup, which has been at the centre of controversy after the death of two children in Ashuganj, was found safe and standard, said officials of Director General of Drug Administration (DGDA) on Monday.
The DGDA collected samples of the syrup, a product of Beximco Pharmaceuticals, from the shop, from where the medicine was purchased. After testing eight samples of the three batches the unvestigators found the quality of the medicine accurate, said the DGDA source.
DGDA Director General Major General Mohammad Yousuf said this at a press briefing held at its office.
All the reports of eight bottles came out positive and no harmful substance was found in the tested samples, he said.
Replying to a question, whether the medicine was fake, Yousuf, said the used bottle of syrup is with the Criminal Investigation Department (CID) and the actual reason behind the deaths of two children will be known after getting forensic report.
READ: Napa syrup deaths in B’baria: DGDA sends samples for testing
Already two probe bodies have been formed in this connection while samples of the syrups of the same batch have been collected and sent for testing, he added.
On Thursday night, two siblings named Yasin Khan,7, and Morsalin Khan,5, son of Ismail Khan, a brick kiln worker, died after given Napa syrup at their home for high fever.
It was bought from a local ‘Ma Pharmacy’ owned by Main Uddin and the syrup had an expiry date mentioned till 2023.
The children were discharged after being given primary medications at District Sadar Hospital. Yasin died on the way home, and Morsalin after reaching home, the family said.
2 years ago
Bangavax finally gets approval for human trial
Bangladesh Medical Research Council (BMRC) has approved in principle Globe Biotech Limited’s Covid-19 vaccine Bangavax for human trial.
“BMRC has given the approval in principle for administering Covid-19 vaccine of Bangavax and we’ll submit an application to the Bangladesh Directorate General of Drug Administration (DGDA), seeking its permission for the clinical trial. The administration of its jabs will start once the final approval is given,” said Dr Mohamamd Mohiuddin, senior manager of BMRC’s Quality and Regulatory Department.
BMRC Director Dr Ruhul Amin signed the letter of approval issued on Tuesday.
Globe Biotech Limited has claimed that Bangavax is 100% effective for fighting 11 variants of Covid-19, including the Delta variant.
Read: Bangavax trial turning into ‘monkey business’ for Globe?
On January 17, Globe Biotech, the only Bangladeshi company trying to develop a Covid-19 vaccine, submitted an application to the BMRC for approval to conduct Bangavax's clinical trials.
On June 16, the BMRC decided to approve Globe Biotech's Covid-19 vaccine, Bangavax, for human trials.
Globe Biotech received a licence to produce their potential vaccine for trial on December 28 last year.
The BMRC, which oversees all such trials, got back to them in June with certain conditions that had to be met before the clinical trials could go ahead.
Read: GM Quader seeks govt support for local vaccine Bangavax
The key condition was that Globe Biotech would have to run trials on monkeys or chimpanzees first.
One of the bottlenecks the company identified at the time was that the country did not have a third-party clinical research organization (CRO) that could conduct such tests on animals.
3 years ago
Two Bangladeshi companies get DGDA nod for marketing oral Covid drug
The Directorate General of Drug Administration (DGDA) has authorised two local pharmaceutical companies for marketing Molnupiravir, the first oral Covid-19 antiviral drug.
Major General Md Mahbubur Rahman, Director General of the DGDA, came up with the information at a press briefing on Tuesday.
“DGDA has approved Molnupiravir for emergency use but it’s not an alternative to vaccine. People must take Covid jabs. This oral medicine has to be taken as per the advice of physicians,” he said.
Also read: Merck agrees to let other drug makers make its COVID pill
“So far, 10 pharmaceutical companies have sought permission for marketing and we have authorised Beximco Pharmaceuticals and Eskayef Pharmaceuticals for marketing. The eight other companies awaiting approval are Square, General, Beacon, Reneta, Insepta, Acme, Health Care and Popular pharmaceuticals,” he added.
3 years ago
Bangladesh approves single-dose Janssen Covid-19 vaccine
The Directorate General of Drug Administration (DGDA) of Bangladesh on Tuesday (June 15, 2021) approved Janssen single-dose Covid-19 vaccine for emergency use in the country.
In a statement, the DGDA said people aged 18 or above can be inoculated with the Janssen vaccine doses.
This is the sixth Covid-19 vaccine to get DGDA nod for emergency use, but the first single-dose jab approved in the country.
The other approved vaccines are: Covishield produced by Serum Institute of India, Sputnik V of Generium Joint Stock Company of Russia, Sinopharm by Beijing Institute of Biological Products Co. Ltd of China, Pfizer vaccine by Pfizer Manufacturing Belgium NV, and Coronavac produced by Sinovac Life Sciences Ltd of China.
Read Can I take COVID vaccines from two different brands?
The Janssen vaccine, developed by Belgian drug manufacturer Janssen-Cilag International NV, received approval from the World Health Organization on March 12 and of European Medicines Agency (EMA) on March 11.
Other regulators like the World Health Organization, the Food and Drug Administration of the United States of America and Health Canada also approved this vaccine for emergency use.
The vaccine, which was found to be 67% effective in preventing Coronavirus, can be stored at fridge temperatures ranging between 2-8°C, facilitating easy distribution.
Also read: Second consignment of Sinopharm vaccine arrives
Worsening Covid situation in Bangladesh
The Covid-19 situation in Bangladesh continues to worsen as 50 new deaths and 3,319 infections were recorded in 24 hours till 8 am on Tuesday.
The positivity rate fell slightly to 14.27% on Tuesday from Monday’s 14.80%, said a handout issued by the Directorate General of Health Services (DGHS).
With the new figures, the country’s death toll now stands at 13,222 while the caseload at 833,291.
During the period, the fatality rate remained static at 1.59%, shows the DGHS handout.
Also read: Bangladesh continues to report alarming Covid deaths
Vaccination with Pfizer, Sinopharm shots to start June 19
Bangladesh will start administering Sinopharm and Pfizer vaccine doses from June 19, Health Minister Zahid Maleque said on Monday.
A consignment of 600,000 doses of China’s Sinopharm jabs arrived in Bangladesh on Sunday, nine days after the arrival of the first batch of 500,000 doses gifted by Beijing. Bangladesh also received 100,620 doses of the Pfizer Covid-19 vaccine on June 1.
The health minister earlier said Pfizer vaccine shots will be given at four centres in Dhaka to those who have already got registered.
Also read: Why do some people get side effects after COVID-19 vaccines?
Vaccine procurement update
Bangladesh will soon receive 10 lakh and 800 doses of AstraZeneca vaccine soon under COVAX facility, said Foreign Minister Dr AK Abdul Momen on Friday.
Bangladesh Ambassador to the US conveyed the message of this development to the Foreign Minister.
Bangladesh, earlier sought 2 million doses of AstraZeneca vaccine doses from the US for addressing Bangladesh's immediate needs but the US is yet to reply to that particular request.
Read What does it feel like to get COVID-19 after taking the vaccine?
3 years ago
Bangladesh approves emergency use of Pfizer vaccine
The government of Bangladesh has approved the emergency use of Pfizer Covid-19 vaccine in the country.
Directorate General of Drug Administration (DGDA) issued a press release in this regard on Thursday.
This is the fourth Covid-19 vaccine approved for emergency use in Bangladesh.
Recently two other vaccines , Sputnik V produced by Generium Joint Stock Company of Russia, and Sinopharm produced by Beijing Institute of Biological Products Co. Ltd of China got approval of DGDA for emergency use in Bangladesh.
Earlier on January 7, DGDA approved the emergency use of Covishield vaccine, also known as SARS Cov-2 AZD1222, Oxford/ Astra zeneca vaccine, produced by Serum Institute of India.
Earlier on May 18, Health Minister Zahid Maleque said that the country will get at least 106,000 doses of the Pfizer vaccine under the Covax facility.
The Pfizer/BioNTech vaccine was the first coronavirus jab to show promising results in the latter stages of its testing process.
It is a new type called an mRNA vaccine that uses a tiny fragment of genetic code from the pandemic virus to teach the body how to fight Covid-19 and build immunity, according to a BBC report.
The US Food and Drug Administration on Wednesday authorized storage of Pfizer Covid-19 vaccine at standard refrigerator temperatures for up to one month, in an effort to make the vaccine more widely available.
3 years ago
Covid-19: Educational institution closure extended to Jan 30
The government has again extended the closure of educational institutions until Jan 30 as the coronavirus situation shows no sign of improvement.
3 years ago
Bangladesh’s daily Covid-19 infection rate stays below 6%
Bangladesh saw a daily infection rate of 5.57% with 762 new cases reported until early Friday.
3 years ago
Bangladesh’s Covid-19 vaccine storage capacity 140-150m: Health Minister
Health minister Zahid Maleque on Thursday reassured the people that there won’t be any problem in storing and distributing Covid-19 vaccines.
3 years ago
Covid-19: Bangladesh allows emergency use of Oxford-AstraZeneca vaccine
The government on Thursday approved the emergency use of the Oxford-AstraZeneca Covid-19 vaccine.
3 years ago