Jackson Tenny Sept 14, 2020
Twenty-nine million people have contracted COVID-19 since the beginning of the year, and for some countries, it just keeps getting worse. There is an ongoing international race pushing world leaders to produce a vaccination for COVID-19 as fast as possible. As thousands continue to die every day, this race is of the utmost importance. Unfortunately, producers of possible vaccinations must undergo extensive testing before being available to the public, making the wait for a vaccine much longer. Typically, a vaccine would take years of development and testing before reaching the public; however, with COVID-19, this is not the case. Currently, there are 38 vaccines in clinical trials on humans, and at least 93 preclinical vaccines are under active investigation in animals. While work on a vaccine began back in January, and human testing in March, there is still a lot of work before any vaccine makes its way to the public.
When it comes to vaccines, five types can help counteract COVID-19. Genetic Vaccines are the first of the five, and they are vaccines that use one or more coronavirus genes to help provoke a response in our immune system. Viral Vector Vaccines are vaccines that contain specific viruses that carry coronavirus genes or transform our cells to make viral proteins. Protein-Based Vaccines are vaccines that contain coronavirus proteins, but no genetic material. Attenuated Coronavirus Vaccines are vaccines that were created from weakened or dead coronaviruses. The last type of vaccine is repurposed vaccines, or vaccines that are already in use for other diseases but may protect against COVID-19. Researchers worldwide are exploring all of the vaccination options to produce the most effective vaccination form. Still, before they can get there, they must undergo extensive vaccination testing.
The process for testing a vaccine has four distinctive parts: Preclinical testing, Phase 1 safety trials, Phase 2 expanded trials, and Phase 3 efficacy trials. Preclinical testing involves giving a new vaccine to animals such as mice or monkeys to see if an immune response is produced. If it passes preclinical testing, the vaccine will move onto Phase 1 safety trials, where the vaccine is administered to a small number of people to test safety and dosage and to confirm it stimulates a response in the immune system. Next, it moves to Phase 2 expanded trials, where the vaccine is given to hundreds of people split into groups, such as children and the elderly, to see if the vaccine acts differently per person. Finally, the vaccine moves into Phase 3 efficacy trials, where thousands of people receive the vaccine to see if they become infected. This is compared with a control group that is given a placebo. If a vaccine makes it through all these stages and effectively produces a response in your immune system, the vaccine then undergoes approval from regulators within a country. However, during a pandemic, a vaccine will sometimes receive emergency-authorization and is given to the public without formal approval. This can be dangerous, however China and Russia have both approved vaccines without waiting for the results of Phase 3.
As the United States struggles to slow the spread of COVID-19, many believe the only way out of this situation is by creating a vaccine quickly. Currently, the US government has decided to choose three vaccine candidates to fund Phase 3 trials in a strategy they call: Operation Warp Speed. The three candidates include Moderna’s mRNA-1273, The University of Oxford and AstraZeneca’s AZD1222, and Pfizer and BioNTech’s BNT162.
Moderna develops its vaccines based on messenger RNA to produce viral proteins in the body. They have partnered with the National Institute of Health to create their vaccine research. In March, Moderna was already in human testing and receiving promising results. The US Government has given over $2.5 billion to the company in exchange for 100 million doses if the vaccine created is safe and effective. Unfortunately, Moderna recently lost a patent dispute over some of their vaccination technology, resulting in confusion for the future of this vaccination opportunity.
The University of Oxford has paired with the British-Swedish company AstraZeneca to develop a vaccine as well. This vaccine is centered around a chimpanzee adenovirus called ChAdOx1. During the first two Phases of the trial, the vaccine did not incite any severe side effects in the patients. They found that the immunization raised antibodies against the coronavirus as well as other immune defenses. In August, the EU decided to purchase 400 million doses of the vaccine if its Phase 3 showed promising results. AstraZeneca has indicated they might be able to start delivering emergency vaccines as early as October, depending on the outcome of the studies. Unfortunately, on September 6, one of the volunteers developed an inflammatory side effect, halting global trials until the side effect development is better understood.
BioNTech, a German company, has begun collaboration with Pfizer based in New York and Fosun Pharma of China to develop an mRNA vaccine. They created two different vaccines, both resulting in antibodies against SARS-CoV-2. Recently, the companies have stated they would know if the vaccine works by October and can produce over 1.3 billion vaccines by 2022.
In March, the Trump administration unsuccessfully tried to persuade CureVac to move its research development from Germany to the United States. In September, the chief executive of CureVac described their goal of making 100 million doses by the end of 2020 and gaining approval sometime in 2021. CureVac has also collaborated with Tesla on creating mRNA “micro-factories,” which could potentially be deployed around the world to make billions of doses of the vaccine.
When it comes to mass-producing vaccinations quickly, some shortcuts may have to be made, leading to many ethical questions. Ruth Faden, the founder of the Johns Hopkins Berman Institute of Bioethics, discusses the ethical questions of vaccine distribution and aims to help “Ensure that all people, regardless of where in the world they live, will have the benefit of a COVID-19 vaccine.” She says a few aspects must be discussed: the private sector vs. public sector development, vaccine nationalism, and internal vaccine distribution. As stated before, many private companies are receiving vast amounts of money from national governments to develop a vaccination for COVID-19. This can lead to some potential ethical problems in the future, such as deciding on what price to charge for the vaccination or deciding what countries need the vaccine more than others. This leaves a private company in-charge of determining who will receive life-saving medicine and who will not. The next ethical question is coined by the term “vaccine nationalism.” In this situation, a country must decide how much of a vaccine they will keep and how much they are willing to share with countries with a small supply of the vaccination. Geopolitics and international governmental relations both play large roles in dealing with the ethical questions surrounding vaccine nationalism. The final moral question that Faden introduces is who within a nation gets a vaccination first. The typical answer is “essential workers,” however, we still do not have a clear grasp of what constitutes a worker to be essential for society, and to what extent. How does one decide who gets a vaccination if vaccinations are scarce? Ethically, there are still a lot of conversations to be had surrounding the COVID-19 vaccination. Still, it is reassuring to know that there are many people worldwide dedicated to producing a safe and effective vaccination quickly.
Corum, Jonathan, et al. “Coronavirus Vaccine Tracker.” The New York Times, The New York Times, 10 June 2020, Updated 13 September 2020. www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html.
Pearce, Katie. “Distributing a COVID-19 Vaccine Raises Complex Ethical Issues.” The Hub, Johns Hopkins University, 1 July 2020, www.hub.jhu.edu/2020/07/01/covid-vaccine-ethics-faden/.
“Phase 3 Clinical Trial of Investigational Vaccine for COVID-19 Begins.” National Institutes of Health, U.S. Department of Health and Human Services, 27 July 2020, www.nih.gov/news-events/news-releases/phase-3-clinical-trial-investigational-vaccine-covid-19-begins