Covid-19 Vaccination: Ethics, Efficacy, and Public Approval - Part 2

Part two of a three-part series

Some time has passed since Part One of this three-part series, and the nation has seen an up-tick in positive Covid-19 tests. There have been one million new US cases in just the last 17 days (Johns Hopkins Coronavirus Resource Center, 2020). Over 97,000 children have tested positive in the last two weeks of July (American Academy of Pediatrics). One would think that with the recent increase in virus statistics, there would be more masks and social distancing. The recent motorcycle rally in Sturgis, SD, which brought over 500,000 bikers from across the United States, would suggest otherwise. Schools are scrambling to determine how to safely open. Some parents are deciding to homeschool, some others feel safe sending their children, while others must send their children to maintain their employment.

The process of developing a vaccine is lengthy and surrounded by much red tape. Some are arguing that the red tape surrounding the Covid-19 vaccine is being cut, and at what cost? Does the benefit of potentially allowing the public to return to their normal lives outweigh the risk of a speedy vaccine development process? The general stages in developing a vaccine are as follows as per the Centers for Disease Control (2020):

  • Exploratory Stage

  • Pre-Clinical Stage

  • Clinical Development

    • Phase 1 – Small groups of healthy individuals receive the vaccine

    • Phase 2 – Larger groups receive the vaccine including individuals with the age and physical health that matches those at risk for the disease

    • Phase 3 – Thousands receive the vaccine

  • Regulatory Review and Approval

  • Manufacturing

  • Quality Control

Over 160 research groups have been working on a vaccine, and two groups have advanced their vaccines into the Clinical Development Stage: Pfizer and BioNTech, and Moderna (Galewitz & Aleccia, 2020). Phases One and Two have shown that the vaccines were safe and led to development of antibodies, and Phase Three will be the next step taken in order to prove whether the vaccine reduces the risk of infection (Galewitz & Aleccia, 2020).

Some have argued that there are ethical issues when using volunteers for Clinical Development and testing, especially when it can exploit low income subjects looking for the $1000 to $2000 compensation over two years (Hiltzik, 2020). While scientists note that the vaccine is not a “live” vaccine, meaning that you won’t have a chance of contracting the virus from the vaccine, Clinical Development will involve exposing those vaccinated individuals to the pathogen (virus) to see that the vaccine prevents virus transmission. Researchers are noting that there have never been more volunteers for a drug or vaccine trial, stating that those in the studies believe that there is a greater motivation for developing a solution to the pandemic, and they are looking forward to having an opportunity to protect themselves as soon as possible (Galewitz & Aleccia, 2020).

The final part of this series will focus on the potential development of a usable vaccine, the potential public response, and contact tracing.

Resources

American Academy of Pediatrics. (2020, July 30). Children and COVID-19: State Data Report (Rep.). Retrieved https://downloads.aap.org/AAP/PDF/AAP%20and%20CHA%20- %20Children%20and%20COVID- 19%20State%20Data%20Report%207.30.20%20FINAL.pdf

Centers for Disease Control. (2020). Vaccine Testing and Approval Process. Retrieved from https://www.cdc.gov/vaccines/basics/test-approve.html

Galewitz, P., & Aleccia, J. (2020, August 07). Thousands Volunteer for COVID-19 Vaccine Study. Retrieved from https://www.scientificamerican.com/article/thousands-volunteer- for-covid-19-vaccine-study/

Hiltzik, M. (2020, July 23). Column: Can a COVID-19 vaccine be tested without violating test subjects' human rights? Retrieved from https://www.latimes.com/business/story/2020-07- 23/covid-vaccine-human-rights

Johns Hopkins Coronavirus Resource Center. (2020, August). Home. Retrieved from https://coronavirus.jhu.edu/