Case Study about the COVID-19 Vaccine Process (Case Study Sample)

The COVID-19 Vaccine Process as a Case Study
Yining Wang
Western Sydney University
The COVID-19 Vaccine Process as a Case Study
Scientists worldwide have been working tirelessly to secure a vaccine for the novel COVID19 virus, with numerous promising candidates emerging. The urgency in finding a lasting solution through a vaccine has been prompted by the severity of the virus, with the global death toll stands at approximately 1.69 million. Over 50 COVID19 candidates in trials work in concert with the World Health Organization (WHO) to hasten the pandemic response. However, the most notable candidates include the Oxford Vaccine produced by Oxford University in the UK, the CoronaVac by a Chinese company Sinovac Biotech, the Moderna Vaccine by US-based company Moderna collaboration with the National Institute of Allergy and Infectious Diseases (NIAID). Besides, Russia has produced a COVID19 virus vaccine candidate dubbed Sputnik V while the Pfizer Vaccine being produced by Pfizer, an American-based pharmaceutical company, and BioNTech, a German biotechnology company. This essay will explore, based on theoretical perspectives, intellectual property rights, and innovation concerns in the race to secure the COVID19 vaccine.
The efficiency of knowledge transfer, hence the manufacturing and pricing under intellectual property rights in developing the COVID19 vaccine, has come under scrutiny. Throughout the years, the policies advocated and adopted have been a cause for concern, hence curtailed efforts in dealing with the COVID19 situation. The restrictions in the sharing of crucial research have on the availability and consequently affordability of candidate vaccine. According to El Said (2020), the gradual strengthening of intellectual property protection has been predominantly made by developed countries, which has prompted the rise in medicines' prices and medical technologies access. This move has ensured that the developed countries maintain their status as net importers of intellectual property (IP) related goods and services, which brought about creating agreements related to intellectual property. Typically, the intellectual property rights of developing a new drug are left under the sole control of a private firm responsible for manufacturing and retailing. There has been little to no buy out of intellectual property rights, which would ensure the generic manufacturing of the COVID19 vaccine hence its affordability. The manufacturing and pricing stages of the COVID19 development influenced by intellectual property rights have curtailed the vaccine's availability to mostly low and middle-income countries.
Moreover, ethical concerns have been raised for the longest time regarding intellectual property rights in the pharmaceutical industry and, more recently, in the COVID19 vaccine quest. The most salient concern has been whether to safeguard personal autonomy and choice or protect the lives of those at risk from the pandemic. Intellectual property rights enable the patent holders to exercise exclusive rights to produce and distribute the vaccine manufactured using patented technology. The patent is covered by the law and restricts third parties from using the technology to create the vaccine in large quantities farfetched. According to Schumpeter (2013), patents lead to a phenomenon he described as 'Creative Destruction' whereby patent holders are guaranteed profits while the rest suffer as a result. The scarcity dilemma has stemmed from restrictions in production on account of intellectual property rights that have since been witnessed in resource supply and vaccine development and distribution (Gostin, Friedman & Wetter, 2020). Developed countries such as the US and the UK have ordered large quantities of the Pfizer vaccine creating a shortage. Albeit the UK and the US were advancing their national interests, low and middle-income countries will have a hard time containing the virus through vaccination. Hence, intellectual property rights continue to place the pharmaceutical industry in a moral and legal dilemma.
Undoubtedly, the development of the COVID19 vaccine has been met with challenges synonymous with innovation, one of which being the associated risk. Despite the growing need by the world's population in reaching a permanent solution via administering a vaccine, it does not dispel the concern for the safety of the vaccines sourced from a myriad of vaccine candidates. Notably, vaccines' security is not absolute as side effects accompany them; hence the risk is determined by balancing unwanted side effects and expected benefits (Gallanger, 2020). For instance, to assess the Pfizer-BioNTech vaccine's viability, the US had to conduct extensive clinical trials to ascertain whether the potential benefits outweighed the potential harm of being infected with the virus. Notably, the search for the vaccine was prompted by the need for finding a solution to a problem as a form of a demand pull in innovation (Vernardakis, 2016). The data generated from clinical trials will be utilized to evaluate the effectiveness and safety of the vaccine. In the US, for instance, the Food and Drug Administration (FDA) has been tasked with the responsibility of conducting clinical trials based on standards that they set forth. If the vaccine meets the criteria, it could be approved for use (CDC, 2020). Thus, it is explicit that innovation comes with its associated risks that need to be monitored and assessed on whether it is for the greater good.
Notably, forms of innovation, like the production of the COVID19 vaccine, go through intricate processes to promptly respond to the masses ' needs. According to Vernardakis (2016), the success of an innovation depends on stellar timing. The availability of innovation-enabling technologies is in abundance, while the socio-economic conditions are enabled by time. The two COVID19 vaccine candidates Moderna and Pfizer have been at the forefront in the research and clinical trials hence recording a relatively shorter lead time than the rest. By mid-November 2020, the two candidates had already carried out phase III trials, with both of them recording over 94% effective rate. Both Moderna and Pfizer used genetic engineering technology to synthesize the vaccine using messenger RNA molecules (Fischetti, 2020). Hence, it was evident that the availability of state-of-the-art technology enabled them to shorten the vaccine trials. There has been a growing need for a long-term solution in the form of a vaccine globally, fostering a social environment for vaccine production. Pfizer forecasts producing approximately 50 million doses by the end of 2020 and 1.3 billion doses in 2021. On the other hand, Moderna plans to manufacture a colossal amount of COVID19 doses of about 20 million by the end of 2020 and 1 billion by 2021. Hence for innovation to thrive, the forces of demand and supply need to be ideal.
The research and development of innovation like the development of the COVID19 vaccine have its associated failure or effectiveness rate. Notably, the efficacy rate of the various vaccine candidates denotes their effectiveness. The AstraZeneca and Oxford vaccine candidates reported an average efficacy rate of 70% from an analysis conducted in the United Kingdom and Brazil. Unlike tests in the UK, In Brazil, the tests were conducted on volunteers who received full doses administered at the prime and boost stages. The Russian vaccine candidate dubbed Sputnik V, which utilized various adenovirus strains at the boost and prime stages and subsequently recorded an efficacy rate of 91.4% (Zimmer, 2020). The efficacy rate might, at times, be used interchangeably with effectiveness, but they are slightly different. Whereas the efficacy rate meant the actual measurement made during a clinical trial, the rate of effectiveness enumerated how well the vaccine might work in the real world.
On the other hand, the Moderna and BioNTech vaccine that incorporated technology that worked on messenger RNA had a high efficacy level of approximately 95% (Cohen, 2020). The cost of the vaccine varies significantly based on the vaccine candidate producing it. For instance, the Moderna vaccine cost would range from $32 to $37 whilst the company making the Pfizer vaccine is reportedly charging $20. The AstraZeneca-Oxford vaccine will go for $3 to $4, but unlike the other vaccines mentioned earlier, it requires two doses (Meredith, 2020). Thus, effectiveness and cost are part of any innovation measure, even in developing the COVID19 vaccine.
There has been an explicit need for coordination and collaborative efforts in research and development and knowledge access. International cooperation between governments through the dif