Bangladesh joins global COVID-19 vaccine race with Bongavax set for clinical trial

Bangladeshi public health experts welcomed the development as a positive boost to the country’s COVID-19 response. (AFP)
Bangladeshi public health experts welcomed the development as a positive boost to the country’s COVID-19 response. (AFP)
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Updated 08 January 2021

Bangladesh joins global COVID-19 vaccine race with Bongavax set for clinical trial

Bangladesh joins global COVID-19 vaccine race with Bongavax set for clinical trial
  • Previously called Bancovid, the vaccine has been included in the draft landscape of the World Health Organization’s (WHO) COVID-19 vaccine candidates.

DHAKA: Bangladesh has joined the global coronavirus disease (COVID-19) vaccine race with the announcement on Thursday by the producer of its Bongavax that clinical trials were due to start next month.
In late December, the country’s Directorate General of Drug Administration (DGDA) permitted Dhaka-based Globe Biotech Ltd., the developer of Bongavax, to produce the country’s first locally made COVID-19 vaccine.
Previously called Bancovid, the vaccine has been included in the draft landscape of the World Health Organization’s (WHO) COVID-19 vaccine candidates.
Asif Mahmud, who is in charge of Globe Biotech’s research, told Arab News: “We are expecting to go for clinical trial by next month.
“We got the permission from the DGDA last week to produce Bongavax for clinical trial. Now we are allowed to import all the raw materials to manufacture the vaccine,” he said, adding that if all went to plan the vaccine would be ready for mass use by the middle of the year. “Bharat Biotech of India also took six months to develop the vaccine at the final stage and I hope we can do the same. We will apply to the Bangladesh Medical Research Council (BMRC) for ethical permission next week,” Mahmud added.
The company is set to announce the name of the clinical research organization that will conduct the trials.
While the cost of Bongavax doses remains unknown, Mahmud said that being produced locally would make it “definitely cheaper” than the Moderna and Pfizer vaccines.
“We are using raw materials imported from the US, the UK, and some other Western countries. State-of-the-art technologies will be used in this process. There are many taxes and other regulatory issues which are directly involved with costs,” he said.
Bangladeshi public health experts welcomed the development as a positive boost to the country’s COVID-19 response.
Prof. Muzaherul Huq, former WHO adviser and founder of the Public Health Foundation of Bangladesh, told Arab News: “Definitely the homegrown vaccine will help us a lot. Bangladesh has been producing vaccines for many years. But now we need to increase the capacity to make quality vaccines and here the government has to play a vital role.
“Globe Biotech should maintain close contact with WHO authorities to ensure constant monitoring and supervision which will also help them in the market approval process,” he said.
Prof. Benazir Ahmed, former director of disease control at the Bangladeshi Directorate General of Health Services, also called on the producer to make sure its clinical trials were monitored by international vaccinology experts and organizations in order for the vaccine to gain trust at home and abroad.
“The clinical trial should be of a very high standard. It will open the gateway for production of many more vaccines, both for local use and for a huge external market of vaccines,” Ahmed said.
Bangladesh has so far approved for emergency use only the Covishield vaccine developed by the Serum Institute of India (SII) in collaboration with the University of Oxford and AstraZeneca.
Dhaka has ordered 30 million Covishield doses, of which the first batch of 5 million is expected to arrive from India next month.
There has to date been nearly 520,000 reported cases of COVID-19 in Bangladesh, among a population of around 168 million, and more than 7,700 virus-related deaths.
 


UK regulator, vaccine makers discuss virus variants

UK’s medicine regulator has discussed with vaccine manufacturers the need for “potential modifications” to vaccines to ensure they protect against the new coronavirus variants. (AFP/File Photo)
UK’s medicine regulator has discussed with vaccine manufacturers the need for “potential modifications” to vaccines to ensure they protect against the new coronavirus variants. (AFP/File Photo)
Updated 23 January 2021

UK regulator, vaccine makers discuss virus variants

UK’s medicine regulator has discussed with vaccine manufacturers the need for “potential modifications” to vaccines to ensure they protect against the new coronavirus variants. (AFP/File Photo)
  • AstraZeneca says work begun on modified jab as government sounds alarm

LONDON: The UK’s medicine regulator has discussed with vaccine manufacturers the need for “potential modifications” to vaccines to ensure they protect against the new coronavirus variants emerging around the world.

The Medicines and Healthcare products Regulatory Agency (MHRA) said that “there was no evidence that vaccines failed to work against new variants,” but that it had made the issue a priority.

AstraZeneca, which partnered with Oxford University to manufacture a vaccine, said scientists had begun work on a modified vaccine in case it was necessary.

A spokesman said: “It is known that viruses constantly change through mutation, leading to the emergence of new variants.

“These changes are being monitored closely by scientists.

“The University of Oxford and labs across the world are carefully assessing the impact of new variants on vaccine effectiveness, and starting the processes needed for rapid development of adjusted vaccines if these should be necessary.”

Public Health England’s Porton Down laboratory and specialist academic facilities are now researching whether available vaccines are less effective against new coronavirus variants, including those detected in the UK and South Africa.

Studies have suggested that antibodies from former patients and vaccine recipients are still effective against the B117 variant found in the UK, but the 501Y.v2 variant from South Africa could be more resistant. The protective effect of T-cells, which are induced by vaccines and previous coronavirus infections, is also important, but is still being investigated.

“We have no evidence that the vaccines being used do not work against the new coronavirus strains, but we are making this issue a priority,” an MHRA spokesperson said.

“We are in discussion with vaccine manufacturers on potential modifications that may be needed for current vaccines to be effective against new variants, if required.”

Due to the evolutionary nature of viruses, the emergence of new variants has been expected, as has the need for vaccines to be updated.

Influenza vaccines are updated each year to match forms of the flu ahead of time. A decision on the correct flu vaccine to produce takes place around February. Production and testing then takes several months, with a license given only when regulators have reviewed quality, safety and efficacy data.

The MHRA is meeting with its independent expert working group of the Commission on Human Medicines as part of decisions regarding the regulation of vaccines. “Bridging studies” will likely be necessary to give regulators confidence that modifications will not compromise safety.

The spokesperson said: “We can say at this stage that it is unlikely that a full new approval process will be needed.

“No vaccine will be authorized for supply in the UK unless the expected standards of safety, quality and effectiveness are met.”