My Body, My Health, My Choice!
The Issue
On July 15th, 2021, Chamberlain University announced they are implementing a new policy, requiring all students to receive the COVID-19 vaccine by August 28th, 2021.
To make that clear, Chamberlain University is mandating all students receive the COVID-19 vaccine to continue attending Chamberlain. This vaccine is FDA approved for Emergency Use only, has undergone no long-term clinical trials, and has had multiple severe adverse effects, including deaths. “There are no licensed COVID-19 vaccines in the U.S presently. All COVID-19 vaccines are currently approved only as Emergency Use Authorized (EUAs) – and “approval” does not mean “licensed” (Center for Biologics Evaluation and Research). The COVID-19 emergency use vaccines do not meet the criteria for a fully biologically licensed vaccine. All FDA approved vaccines for other diseases, in current use in the US, are fully approved and licensed. The process of clinical trials is arduous and exacting, requiring careful scientific research design and implementation, conducted over adequate time periods, accounting for a myriad of variables, etc.
Consider the development of the polio vaccine. “Polio, a crippling and deadly disease, has been managed/prevented effectively by the polio vaccine. Yet the final Sabin oral vaccine was the result of over 20 years and several hundred thousand children immunized before FDA licensure was granted. There were also devastating consequences as the newly licensed vaccine was administered to the public, and unanticipated adverse events were documented” (Center for Biologics Evaluation and Research). For any drug, including vaccines, to be licensed requires adequate and precise clinical trials, collecting data and establishing safety and efficacy. As you are aware, Preclinical studies include animal or cell study, and if deemed safe, will progress to Phase 1, with a very small number of human subjects with a focus on safety. The next Phase 2 includes a larger group of human subjects targeting a specific disease over a longer time period, seeking both safety and efficacy data. Phase 2 trials are often randomized, blinded, and/or placebo controlled, etc. Optimal dosing is also tested in this phase. If the research drug passes this phase, Phase 3 is designed to determine if the study drug is better than current treatment for the targeted disease/health issue, includes a large number of subjects over a longer period of time, and may be randomized, blinded, and placebo controlled. Close monitoring is again critical to determine safety and efficacy at this point. Last, Phase 4 clinical trials collect data on the drug after it has been FDA approved and licensed for the general public, focusing on long-term risks and benefits.
The current COVID-19 vaccines have been released to the public via an FDA EUA - within one year of the pandemic onset. So why would we be forced to jeopardize our health when no one knows the current or long-term effects of this vaccine? “In 2020, the University of Pennsylvania did a mRNA Review, which can be summed up with this excerpt from the Review. It addresses the lack of sufficient data on mRNA vaccines in 2020, supporting the fact that all of the reliable data for both short-term and long-term trends will be based on the population who is now getting the COVID-19 vaccines”. (Penn Medicine Center for Evidence-based Practice). In summary, this is the largest known experiment on Americans.
The CDC’s Advisory Committee on Immunization Practices acknowledged “there likely is an association with myocarditis and pericarditis among 12-39-year-olds following vaccination. This complication is more likely to occur in boys and young men, and the condition is most likely to appear within the first five days after vaccination.”(Stein 2021). In addition, “. . . the J&J vaccine has been associated with blood clots, and recently the FDA updated the warning label on the vaccine to include increased risk of Guillain-Barré syndrome, a rare neurological disorder” (Stein 2021).
In our program, as nursing students, we learn to educate and inform our patients, as well as encouraging them of their right to make their own informed medical decisions. Why does that not apply to us? Why does Chamberlain University act one way, but within a moment's time, put ALL of their staff and students at risk, force us to be lab rats in a study, assuming NO liability, and expel us if we don’t follow their orders? Insinuating we lack compassion and responsibility toward our fellow man and fail our obligation to keep our communities safe, is a sad commentary from this institution. What happened to “healthcare heroes''?
To say that Chamberlain University's new policy is absolutely devastating is an understatement. My dreams of becoming someone who got to greatly impact and save lives has been stolen. I feel as if my future and everything I have worked so hard for has been robbed.
What I hope people understand is that Chamberlain University pushing this vaccine is not for the health of the Chamberlain students. This requirement is about control and power over their students. If Chamberlain University truly cared about the health of their students, they would assume all liability when requiring their students to enter into a clinical trial. If Chamberlain University truly followed “evidence based practice” like they preach, then they would look at the data of the 99.8% survival rate of COVID-19. They would look at risks of an Emergency Use vaccine and the adverse complications, short-term and long-term, before making their students choose between their dreams and their health. The position that Chamberlain University has put their staff and students in is a disgrace.
Respectfully,
Madeline Mass
Sources:
Center for Biologics Evaluation and Research. (n.d.). Vaccines Licensed for Use in the US. U.S. Food and Drug Administration. https://www.fda.gov/vaccines-blood-biologics/vaccines/vaccines-licensed-use-united-states
ADVERSE EFFECTS OF MESSENGER RNA VACCINES An Evidence Review from the Penn Medicine Center for Evidence-based, Practice December 2020, director Nikhil K. Mull, MD (CEP) Lead analyst: Matthew D. Mitchell, PhD (CEP)Clinical review Patrick J. Brennan, MD. (CMO)http://www.uphs.upenn.edu/cep/COVID/mRNA%20vaccine%20review%20final.pdf at p.11, Primary Studies.
Stein, Christina Hall and Emma. “'My Body, My Choice' Protesters Say of COVID-19 Vaccine Mandate at Henry Ford Health System.” Detroit Free Press, Detroit Free Press, 17 July 2021,
Petition Closed
The Issue
On July 15th, 2021, Chamberlain University announced they are implementing a new policy, requiring all students to receive the COVID-19 vaccine by August 28th, 2021.
To make that clear, Chamberlain University is mandating all students receive the COVID-19 vaccine to continue attending Chamberlain. This vaccine is FDA approved for Emergency Use only, has undergone no long-term clinical trials, and has had multiple severe adverse effects, including deaths. “There are no licensed COVID-19 vaccines in the U.S presently. All COVID-19 vaccines are currently approved only as Emergency Use Authorized (EUAs) – and “approval” does not mean “licensed” (Center for Biologics Evaluation and Research). The COVID-19 emergency use vaccines do not meet the criteria for a fully biologically licensed vaccine. All FDA approved vaccines for other diseases, in current use in the US, are fully approved and licensed. The process of clinical trials is arduous and exacting, requiring careful scientific research design and implementation, conducted over adequate time periods, accounting for a myriad of variables, etc.
Consider the development of the polio vaccine. “Polio, a crippling and deadly disease, has been managed/prevented effectively by the polio vaccine. Yet the final Sabin oral vaccine was the result of over 20 years and several hundred thousand children immunized before FDA licensure was granted. There were also devastating consequences as the newly licensed vaccine was administered to the public, and unanticipated adverse events were documented” (Center for Biologics Evaluation and Research). For any drug, including vaccines, to be licensed requires adequate and precise clinical trials, collecting data and establishing safety and efficacy. As you are aware, Preclinical studies include animal or cell study, and if deemed safe, will progress to Phase 1, with a very small number of human subjects with a focus on safety. The next Phase 2 includes a larger group of human subjects targeting a specific disease over a longer time period, seeking both safety and efficacy data. Phase 2 trials are often randomized, blinded, and/or placebo controlled, etc. Optimal dosing is also tested in this phase. If the research drug passes this phase, Phase 3 is designed to determine if the study drug is better than current treatment for the targeted disease/health issue, includes a large number of subjects over a longer period of time, and may be randomized, blinded, and placebo controlled. Close monitoring is again critical to determine safety and efficacy at this point. Last, Phase 4 clinical trials collect data on the drug after it has been FDA approved and licensed for the general public, focusing on long-term risks and benefits.
The current COVID-19 vaccines have been released to the public via an FDA EUA - within one year of the pandemic onset. So why would we be forced to jeopardize our health when no one knows the current or long-term effects of this vaccine? “In 2020, the University of Pennsylvania did a mRNA Review, which can be summed up with this excerpt from the Review. It addresses the lack of sufficient data on mRNA vaccines in 2020, supporting the fact that all of the reliable data for both short-term and long-term trends will be based on the population who is now getting the COVID-19 vaccines”. (Penn Medicine Center for Evidence-based Practice). In summary, this is the largest known experiment on Americans.
The CDC’s Advisory Committee on Immunization Practices acknowledged “there likely is an association with myocarditis and pericarditis among 12-39-year-olds following vaccination. This complication is more likely to occur in boys and young men, and the condition is most likely to appear within the first five days after vaccination.”(Stein 2021). In addition, “. . . the J&J vaccine has been associated with blood clots, and recently the FDA updated the warning label on the vaccine to include increased risk of Guillain-Barré syndrome, a rare neurological disorder” (Stein 2021).
In our program, as nursing students, we learn to educate and inform our patients, as well as encouraging them of their right to make their own informed medical decisions. Why does that not apply to us? Why does Chamberlain University act one way, but within a moment's time, put ALL of their staff and students at risk, force us to be lab rats in a study, assuming NO liability, and expel us if we don’t follow their orders? Insinuating we lack compassion and responsibility toward our fellow man and fail our obligation to keep our communities safe, is a sad commentary from this institution. What happened to “healthcare heroes''?
To say that Chamberlain University's new policy is absolutely devastating is an understatement. My dreams of becoming someone who got to greatly impact and save lives has been stolen. I feel as if my future and everything I have worked so hard for has been robbed.
What I hope people understand is that Chamberlain University pushing this vaccine is not for the health of the Chamberlain students. This requirement is about control and power over their students. If Chamberlain University truly cared about the health of their students, they would assume all liability when requiring their students to enter into a clinical trial. If Chamberlain University truly followed “evidence based practice” like they preach, then they would look at the data of the 99.8% survival rate of COVID-19. They would look at risks of an Emergency Use vaccine and the adverse complications, short-term and long-term, before making their students choose between their dreams and their health. The position that Chamberlain University has put their staff and students in is a disgrace.
Respectfully,
Madeline Mass
Sources:
Center for Biologics Evaluation and Research. (n.d.). Vaccines Licensed for Use in the US. U.S. Food and Drug Administration. https://www.fda.gov/vaccines-blood-biologics/vaccines/vaccines-licensed-use-united-states
ADVERSE EFFECTS OF MESSENGER RNA VACCINES An Evidence Review from the Penn Medicine Center for Evidence-based, Practice December 2020, director Nikhil K. Mull, MD (CEP) Lead analyst: Matthew D. Mitchell, PhD (CEP)Clinical review Patrick J. Brennan, MD. (CMO)http://www.uphs.upenn.edu/cep/COVID/mRNA%20vaccine%20review%20final.pdf at p.11, Primary Studies.
Stein, Christina Hall and Emma. “'My Body, My Choice' Protesters Say of COVID-19 Vaccine Mandate at Henry Ford Health System.” Detroit Free Press, Detroit Free Press, 17 July 2021,
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Petition created on July 19, 2021