Amidst the current coronavirus pandemic, governments around the world are piling money into vaccine development, drug discovery and innovation. Vaccines, whilst paramount to our survival, had until recently become an afterthought in our everyday lives, such was the level of comfort and safety we lived in against deadly viral diseases. Vaccines contain attenuated or weakened versions of viruses, or part of their structure (RNA) which allows our immune system to create antibodies which interact with and effectively disarm the virus. The process of vaccine development, antigen detection and manufacture on a mass scale is an extremely expensive and painstaking process which is now under even greater pressure amongst an unprecedented pandemic. Indeed, creating a vaccine in a test-tube is one thing, passing the rigorous safety protocols and scaling up to millions of doses is quite another feat.
When relevant viral structure is identified, the first process of vaccine development has begun. The immune system can develop antibodies which effectively finalise the lock and key metaphor (the viral ‘lock’ structure and the antibody ‘key’) which disarm the virus. Once these antigens have been developed, antibodies from immune individuals can be used to develop further serum or potentially through bio-engineering. Testing the vaccine in test-tubes may prove efficacious, based on the number of failed infections or number of cells which are immune to viral bombardment. But what does this process look like when an experimentally viable vaccine is to be trialled in human or animal volunteers?
Clinical trials occur when the vaccine is first tested in people. Four stages are involved, normally over numerous years, from initial scientific trials in human beings (phase I) right up to creation and beyond (phase IV). Clinical development is subject to strict, rigorous ethical concepts of informed consent from volunteers, with an emphasis on vaccine safety. Safety is paramount, as the principle of injecting millions of people with an ineffective vaccine which could later infect them could be catastrophic.
Development of vaccines may be theorised by looking at the process in a concise way:
Delivery of a vaccine in a vaccination programme is the end result of years of discovery and constant improvement. Only a tiny percentage of the research vaccines progress to full licensing, making the costs of vaccine development unbelievably high. This reality is more prudent now than ever, as multiple vaccines are being developed around the world. Indeed, Bill Gates is developing factories in America to mass produce vaccines before their full clinical licensing in preparedness. This would allow millions of doses to be administered within days of the approval, instead of years later. It is also vital to keep a range of vaccines in development instead of putting ‘all eggs in one basket’, as investment in only one with no further success could backdate the process years. Keeping multiple vaccines in development allows a greater chance at overall success in treating the infectious disease should any other fail at any stage of the testing process. But what are the stages of clinical development?
At the time of writing, there are more than 76 individual vaccines in development and to interest of the World Health Organisation. The feat to create a working vaccine that is in full development in less than a year would be superhuman, and it is most likely that the general population will not be getting vaccinated until before March 2021. At best, this date is optimistic as this assumes no negative effects or outcomes from the series of rigorous clinical trial steps. As aforementioned, we cannot risk injecting people with the virus and causing further infections, which is why these processes take time and proper clinical judgement with rigorous review. There is hope at the end of the tunnel, but with no real vaccines having ever been developed for other coronaviruses such as the common cold, it seems we must look ahead in hope, but become more comfortable with the uncomfortable present.