The need for further research as announced by AstraZeneca has raised questions about the availability of its Covid-19 vaccine in the market as early as expected.
Bangladesh is only looking to Oxford/AstraZeneca because of its prospects of early availability and easy storage and transportation compared to other vaccine candidates.
AstraZeneca and its partner, the University of Oxford, announced on Monday that it was seeking regulatory approval for the vaccine after it showed an average 70% effectiveness. On Thursday, the British drugmaker announced that it needed further research on its Covid-19 vaccine after questions emerged over the protection it offers.
But the additional testing is unlikely to affect regulatory approval in Europe.
Beximco Pharmaceuticals, which will import the vaccine for Bangladesh from India's Serum Institute, also hopes that it won't be too late to get the approval since Oxford/AstraZeneca has conducted its trial on many samples.
Rabbur Reza, chief operating officer, Beximco Pharmaceuticals, told The Business Standard if everything goes well, Bangladesh will get the vaccine from the Serum Institute, India, at the end of January or the beginning of February.
However, Beximco authorities have not been able to say exactly when the vaccine will be available after questions were raised about the Oxford-AstraZeneca vaccine.
"Maybe in a week, we will get a result. We have spoken with the Serum Institute. They are also in communication with AstraZeneca. We might get updated information about this vaccine on Monday," added Reza.
The Beximco high-up hopes that it will not be too late to get the approval since Oxford/AstraZeneca has conducted its trial on many samples.
"Since this is science, nothing can be said right now till we get to an exact result," he said.
AstraZeneca and its partner, the University of Oxford, announced on Monday that it was seeking regulatory approval for the vaccine after it showed 70% effectiveness on average.
The medical team also said their vaccine was 62% and 90% effective, depending on the level of doses applied.
Their trials followed two different dosing regimens – the first used two regular doses with 62% efficacy and the second had a lower dose, followed by a regular dose, with an efficacy of 90%.
These varying results raised questions of effectiveness.
Prof David Salisbury, immunisation expert and associate fellow of the global health programme at the Chatham House think tank, told the BBC, "You've taken two studies for which different doses were used and come up with a composite that does not represent either of the doses. I think many people are having trouble with that."
The head of British drug manufacturer AstraZeneca said on Thursday further research was needed on its Covid-19 vaccine after questions emerged over the protection it offers.
"Now that we've found what looks like a better efficacy, we have to validate this, so we need to do an additional study," AstraZeneca Chief Executive Pascal Soriot told Bloomberg.
He said he expected that to be another "international study but this one could be faster because we know the efficacy is high, so we need a smaller number of patients."
Prof Sayedur Rahman, chairman, Department of Pharmacology at Bangabandhu Sheikh Mujib Medical University, told The Business Standard the Oxford scientists carried out their vaccine trial and came across a problem.
"It is difficult to say how quickly they will overcome that," he added.
Oxford has now begun its vaccine trial on 30,000 people in the United States. The approval depends on the results of this trial.
At the moment, it will be difficult to get global approval of the vaccine in terms of the research being done in Brazil, UK and India because the vaccines have individual designs, said sources.
On 5 November, the health ministry of Bangladesh signed a tripartite memorandum of understanding (MoU) with the Serum Institute of India and local pharmaceutical company Beximco Pharmaceuticals Limited to import the vaccine being developed by Oxford/AstraZeneca.
Some 30 million doses have been secured. The vaccine will reach 1.5 crore people or 9% of the population.
In the initial six months of the first phase, Serum will supply three crore doses of the vaccine – 50 lakh per month.
In addition, Beximco will bring in another million more vaccines for the private sector.
Due to the lack of a cold chain system, Bangladesh has not signed an agreement with the US companies Pfizer and Moderna that are currently in the process of getting approval for their vaccines.
Dr Shamsul Haque, director, Expanded Programme for Immunisation (EPI), said they do not have the capacity to store and supply Pfizer and Moderna vaccines under the EPI programme. The country has a system to store vaccines at a temperature of two to six degree Celsius.
The Oxford/AstraZeneca vaccine can be kept at refrigerator temperatures of 2 to 8 degree Celsius for at least six months.
However, the Moderna vaccine has to be stored at -20C (-4F) — or at refrigerator temperature for up to 30 days — while the Pfizer/BioNTech vaccine must be stored at -75C (-103F), and used within five days once refrigerated at higher temperatures.
However, the 19th meeting of the National Technical Advisory Committee on 18 September expressed concern that it would be too late to get the vaccine from Gavi, the vaccine alliance.
At the time, the committee recommended communicating with more than one source for vaccines instead of depending on a sole provider, and arranging for the specified temperature system required for storing vaccines.
Additional Secretary (public health) to the health ministry Md Mostafa Kamal told The Business Standard Oxford/AstraZeneca studied on a single dose, one-and-a-half doses and two doses while others have carried out their research on just a single dose.
"This is the difference. It appears that the Oxford vaccine might be delayed in getting approval, as well as our chances to get it," he added.