It may all depend on academics, according to a latest op-ed by Dr. Raqibul M. Anwar, a Specialist Surgeon, Global Health Policy and Planning Expert, and Retired Colonel, Royal Army Medical Corps of UK Armed Forces.
Commenting on Dr. Anwar’s opinion piece, professional M. A. Chishty with decades of experience in drug regulatory affairs tells DesPardes, “after successful third trial, FDA is likely to release approval. It will not be within affordable limit of Middle to Poor Class. The US is operating under chronic capitalism where there is no consideration for poor and the capitalist maximizes its profits unjustly on human terrain; and astronomically hits the stocks market to maximize benefit to the Investors without humanistic thinking. We have the other case, where new medication for same treatment is much cheaper taking into account cost of production which is not much variable in the US compared with U.K. It may be noted Oxford is situated in England, which is primarily a welfare state, that’s why Oxford educationists argued with the manufacturers to keep low price to benefit the bottom class as well (this concept is near to Quranic teachings on profiteering). EU regulatory approvals are more straight forward compared with FDA’s where much bureaucracy is involved, though both systems function under WHO and have equivalencies, this poses an obvious question why humanitarian consideration is not accorded by WHO in Regulatory conditions on cost of sale vis-a-vis cost of production? WHO or its autonomous relevant subsidiary can be sued in the US itself, which has independent Judiciary. WHO isn’t responsible for Quality System alone but also for Humanity in its Charter under UN”.
The author writes:
Companies like Merck and Pfizer had benefited beyond their dreams and earned billions by commercially producing the drug penicillin, but the University of Oxford — neither the academics nor the institution — made not a single farthing from their real drudgery, while making the pharmaceutical companies like Pfizer and Merck wealthy beyond their reverie.
A similar scenario is being played out on the world stage now with the development and manufacturing of vaccines for coronavirus. Pfizer and Moderna have both announced the result of their phase III trial with extremely heartening outcomes. Both have utilized a new technique of adopting Messenger Ribo-Neucleic-Acid (mRNA) of the spike protein component of the coronavirus that allows entrance of the virus into human cells, turning human cells into a production factory for the virus, which then destroys infected cells, tissues, and organs with impunity.
Both the vaccine companies produced vaccines based on the viral mRNA to stimulate the human immune mechanism of combating the virus. Both have successfully demonstrated, in their large-scale phase III Trial, that both the vaccines are effective, approximately in 95% of cases, in preventing the virus taking hold and harming the infected individuals.
The principal difference between the two vaccines relates to the method of preservation after manufacturing. The vaccine produced by Pfizer, the second largest pharmaceutical giant in the world, needs to be preserved in an environment ensuring a -92 degree Fahrenheit temperature in an ultra-low freezer in contrast to that of Moderna, a relatively small biotech company, which can be preserved in normal freezer temperature.
The Oxford University vaccine developed by the university and manufactured by AstraZeneca, “ChAdOx1 nCoV-19” is a recombinant vaccine (the viral anatomy is manipulated, restructured, reconstituted), the inner core or template is a modified adenovirus causing common cold in chimpanzees.
As I have mentioned in the past, it is modified in such a way that even if it enters human cells, it is incapable of replicating and thus rendered harmless. The second component of the vaccine is a genetically modified spike glycoprotein of the SARS-CoV-2 virus, that initiates a human immune response and generate antibody and T-cell-mediated longer standing immunity.
The Oxford vaccine received approval for trial towards the end of March, and phase 1 clinical trials started on April 23 in healthy volunteers aged between 18-55. It had completed its phase I and phase II trial involving, among others, the elderly. The result of the large-scale phase III trial is likely to be published next month. The phase II trial data have shown robust responses in the elderly without any mentionable adversity, and this discovery of the robust response in the elderly has not been demonstrated in other vaccines as yet.
This disclosure is extremely important, as the elderly are unlikely, in normal circumstances, to produce significant immune responses due to their declining ability of their immune mechanism.
The Oxford vaccine is already in production. Given the devastation unleashed by the virus, the immediate start of large-scale manufacturing following rigorous safety standards guarantees availability of the high quality, safe vaccine when approved for use, and the Oxford authority believes that their vaccine would not be much behind the Pfizer or the Moderna vaccine in action, and would play a significant role in ending the pandemic.
And here comes the role of the academics in saving the distressed and suffering humanity. Whereas the cost of the vaccine produced by Pfizer and Moderna would vary between $25 to $45, the cost of the Oxford vaccine produced by AstraZeneca will remain at $3-$4 until the pandemic is ended as agreed in the contract between the university and AstraZeneca, making the vaccine affordable for the economically weak and the most vulnerable of society.
The clause in the contract was incorporated in the insistence of the academics involved in the development research, ensuring the access of the poor and vulnerable in their survival endeavor against the most villainous virus in the vicinage.
Dr Raqibul Mohammad Anwar is Specialist Surgeon, Global Health Policy and Planning Expert, and Retired Colonel, Royal Army Medical Corps, UK Armed Forces.
The original op-ed appeared in Dhaka Tribune.