July 21st, 2021

 

Open Letter to Trinity Health: Seeking Clarification on Controversial Statements

RE:              Required COVID-19 Vaccination for Trinity Health Colleagues, Clinical Staff and Partners

ATTN:          Mike Slubowski, President and Chief Executive Officer

 Dan Roth, M.D., Executive Vice President and Chief Clinical Officer

CC:              Honorable Kim Reynolds, Governor of Iowa

                    Honorable Tom Miller, Attorney General of Iowa

                    Director Kelly Garcia, Iowa Department of Public Health

 

To Whom It May Concern:

This letter is seeking clarification for statements made in the July 8th memorandum informing Trinity Health employees and business partners (even those working remotely) of new requirements to receive a COVID-19 vaccine as a condition of employment.

In response to the confusion and distress caused by this announcement, we the following undersigned legislators submit the following questions to better understand Trinity Point’s rationale for this policy decision. 

Most importantly, this communication is essential in ensuring Iowa’s public health measures are confidently supported by a witting and engaged public. It is our view that good faith dialogue and clarifying complex issues is necessary to earning public trust in the State of Iowa, and fulfilling the vision of your organization being​​ “the most trusted health partner for life.”

These questions are not ranked by relevance or priority, nor does this constitute an exhaustive list:

 

Questions and requests for clarification re: Required COVID-19 Vaccination for Trinity Health Colleagues, Clinical Staff and Partners, July 8th

1)      Please describe in detail how your vaccination policy serves to “protect people?”

 a)     How does your organization intend to measure health outcomes resulting from your vaccination policy? 

 b)     To what extent does your organization expect mandatory vaccination policy to prevent contraction and transmission of serious illness related to COVID-19?

 i)       Has your organization established any criteria to re-evaluate mandatory vaccination policy in the event of breakthrough infections?

 ii)     To what extent has your organization experienced and assessed breakthrough flu infections post-implementation of mandatory flu vaccination policy?

 

2)     Has your organization been the recipient of any money to expand the number of COVID-19 vaccinated employees or to influence public opinion of the safety and efficacy of the vaccine by the NCIRD 'Vaccinate with Confidence" initiative, the CDC, HHS, or any other government or corporate agency?

 

3)     The July 8th memo states: “the vaccines have proven safe and extremely effective against symptomatic infections, hospitalizations and death. The vaccines are so effective that today more than 99% of people who die from COVID-19 are unvaccinated. The science is clear—vaccines save lives.”

a)     In the June 29, 2021 AP Article “Nearly All COVID Deaths in the US are Unvaccinated” it is reported, “The CDC itself has not estimated what percentage of hospitalizations and deaths are in fully vaccinated people, citing limitations in the data.” Do you have access to data on this subject matter that the CDC does not?

 b)     When stating, “the vaccines have proven safe and extremely effective,” how has your organization evaluated that statement and what are the specific safety and efficacy criteria you are using in your evaluation?

 c)     Are you acknowledging the safety profile of any given vaccine may vary depending on a patient’s unique health needs and/or conditions?

 d)     Please provide the scientific reference(s) and complete data analysis supporting the statement “99% of people who die from COVID-19 are unvaccinated.”

 e)     When making the statement, “... today more than 99% of people who die from COVID-19 are unvaccinated,” does that include data from other countries?

f)       Is it correct to interpret based on the wording, “that today,” the statement is excluding any previous or future data which indicates to the contrary?

g)     When interpreting COVID-19 cases (and deaths) in vaccinated and unvaccinated individuals, is the data you’re relying on using identical PCR testing cycle/threshold protocols?

h)     Does your organization acknowledge the on-going discussion and exploration of potential safety concerns, including the established connection to myocarditis/pericarditis in young males, which was not flagged in the clinical trials?

 

4)     How does your estimate of “75% of Trinity Health colleagues, staff and partners have received at least one dose” compare to herd immunity thresholds put forth by national health policy leaders?

a)     Why is a 75% immunization rate insufficient for your organization?

 

5)     Has your organization made any inquiries as to why your employees have deferred COVID-19 vaccination at this point?

 

6)     Please describe the process for which an employee can assert a medical and/or religious exemption which prevents them from complying with this policy, and please share the criteria and evaluation process for their application.

 

7)     If an employee states the following when applying for a medical exemption to the COVID-19 vaccine: “Pre-existing cross-reactive and post-infectious T Cell immunity to SARS-CoV-2 is more robust, broad and longer-lasting than vaccine acquired immunity [1],” how would your organization respond?  Please include any scientific references used in the formulation of your response.

a)     What percentage of your colleagues, staff and partners have asserted religious and medical exemptions to your organization’s mandatory influenza vaccination policy?

b)     Is Trinity Health accepting liability for any damages or injuries that may arise as a result of an employee receiving a COVID-19 vaccination to comply with this policy?

c).   Is there anything in the law right now that would indicate your organization is immune or shielded from liability if a colleague, staff, or partner is injured from this employer requiring vaccination?

 

Questions and requests for clarification re: COVID-19 Vaccine Requirement for Colleagues Q&A  Version # 6 July 15, 2021

1)      Your organization asserts: “The COVID-19 vaccine is the single most effective tool in slowing, and even stopping, the spread of COVID-19 and saving lives.” Please provide any and all scientific references supporting this statement

 a)     Are there any clinical examinations and comparisons which measure COVID-19 vaccine outcomes directly against other treatments, or against post-infection immunity? If no, then how do you justify this statement?

 

2)     Your organization asserts: “Young children are increasingly at risk [of COVID-19 infection].” Please provide any and all scientific references or data points supporting that statement.

 

3)     Your organization asserts: “The safety data in those clinical trials has been reinforced with robust surveillance on the 340 million doses administered in the United States since the EUA was granted.” Please describe in detail the robust surveillance you are referring to in this statement.

a)     Does your organization support legal provisions which would make VAERS reporting mandatory?

b)     What training does your organization provide in the filing of a VAERS report?

c)     In what ways is VAERS data readily and easily accessible for colleagues, staff and partners prior to receiving vaccination?

 

4)     Your organization acknowledges, “​​serious complications occurring very rarely”  from COVID-19 vaccination and agrees to paid time off for employees unable to work post-vaccination. Does your organization similarly accept liability for any expenses, bodily injury, loss of consortium, etc. which admittedly may arise as a result of Trinity Health enforcing this policy?

a)     How many colleagues, staff, and partners have forfeited work shifts, requiring paid time off, due to COVID-19 vaccine side effects?

 

5) Your organization states the Delta variant has increased your urgency for this requirement and asserts the vaccination protects against said variant. Please share all supporting scientific references indicating the vaccine provides protection from the Delta variant.

a) Data reported by the UK in Public Health’s England Technical Briefing 17[2] published June 25th, 2021 shows the preponderance of Delta variant fatalities in people over fifty years old had begun or completed a vaccination schedule, (68 vaccinated fatalities versus 38 unvaccinated fatalities). How does your organization interpret that data relevant to vaccine protection from Delta variants in vulnerable populations? 

b) A Reuter’s article first published July 5th, “Israel sees drop in Pfizer vaccine protection against infections,” reports, “The decline [in reported vaccine efficacy] coincided with the spread of the Delta variant”. Was any COVID-19 vaccination data from Israel analyzed by your organization prior to this policy decision?

c) Does your organization have any policy pertaining to the discussion or dissemination of information of scientific controversy, on-going scientific discovery, and/or current events?

d) Does your organization have any policy pertaining to a colleague, staff or partner sharing published news articles which contradict official organization documents?

 

6)     Your organization states unequivocally, “Vaccination produces a higher level of and longer lasting immunity than natural infection.” Please provide any and all scientific references used to support this statement.

a)     Your organization further states, “Studies have shown that vaccination provides a strong boost in protection in people who have recovered from COVID-19. Please cite to which studies your organization is referring and why did you not link to said studies within the FAQ document?

b)     In what ways does your organization make available scientific publications to colleagues, staff, and partners?

c)     Your organization explains the need to vaccinate post COVID-19 infection, “because experts do not yet know how long you are protected from getting sick again after recovering.”  How is that explanation relevant when elsewhere your organization admits, “Regarding vaccination, it’s also not known how long immunity will last and it won’t be known until more data is available?”

d)     If consequential health outcomes won’t be made known until more data is available, why not delay enacting this policy until more data is available?

 

7)     Your organization lists “proven effective treatments such as remdesivir, polyclonal antibodies, dexamethasone, deaths are still occurring.” Does this mean to imply that deaths are not occurring in individuals who’ve been vaccinated?

 

8)    When considering medical exemptions, how does your organization determine the existence of an allergy to a vaccine component?

a)     Due to the established risks of a potential allergic reaction, is there anyway to determine if a person is allergic to the vaccine without administering the vaccine?

 

9)     Your organization states more than 35,000  pregnant women have been vaccinated with “no harmful effects”. How does your organization support that statement considering 1,073 VAERS reports for miscarriages through July 9th?

 

10) Your organization states, “there is no concern about vaccination effects on fertility for men or women.” Does that mean there is no concern among your organization's colleagues, staff, and partners or is that indicating those who are setting your organization’s policy have no concern? 

a)     “Concern” is sometimes defined as “a matter of interest or importance to someone.” Is this statement indicating the exploration of fertility effects post-vaccination are of no interest or importance?

b)     Beginning June 2021, Dr. Bryan Bridle, in his analysis of the “Japanese Biodistribution Study” publicly posited the COVID spike protein accumulates in organs and tissues including the spleen, bone marrow, the liver, adrenal glands, and in “quite high concentrations” in the ovaries. How does your organization evaluate such statements?

 

Questions and requests for clarification re: COVID-19 Vaccine FAQs

1)      In the answer to FAQ #10, your organization states, “Since this virus is new, it’s not yet known how long natural immunity might last.” Additionally, your organization states, “Regarding vaccination, it’s also not known how long immunity will last and it won’t be known until more data is available.”  In the answer to FAQ #15, your organization claims, “[immunity from natural infection] is not as strong as protection that follows vaccination.” 

a)     How can your organization assert vaccine induced immunity is stronger than natural immunity after previously responding the length of immunity in both cases is unknown?

 

2)     In FAQ #19, your organization agrees that full FDA approval will relieve vaccine hesitancy. Since full FDA approval for at least one COVID-19 vaccine product is expected early 2022, why did you decide to implement the policy now?

a)     Are you aware of legal arguments which indicate your mandatory vaccine policy is not permissible under FDA emergency use authorization provisions?

 

3)     In FAQ #22 your organization states, “There is not enough information to know if it [COVID-19 vaccination] will help with “long haul” symptoms. Elsewhere your organization states, “preventing infection with vaccination also prevents long-term complications (Long-haul COVID).

a)     What is your organization's medical understanding of the biological mechanisms involved in long-haul COVID?

b)     Please provide all scientific references informing your organization’s understanding of long-haul COVID.

 

4)     FAQ #28 recommends the annual flu vaccine. Does your organization possess any data on the safety of coadministration of influenza and COVID-19 vaccinations?

 

5)     FAQ #29 asks again on the topic of vaccination post natural COVID-19 infection. Does this indicate that this topic is of particular interest to your organization's colleagues, staff, and partners?

a)     How can your organization enact a mandatory COVID-19 vaccination policy while simultaneously admitting gaps in understanding to the lasting impact of both natural and vaccine induced immunity?

b)     Your organization states again, “Experts won’t know how long immunity produced by vaccination lasts until more data is available on how well it works.” What are examples of other health policies or personal health procedures your organization mandates with incomplete data?

c)     By admitting incomplete data on vaccine induced immunity, which is the primary purpose of the vaccination, would it be reasonable for a colleague, staff or partner to deduce there is incomplete data on other aspects of the vaccination, such as safety and necessity?

 

6)     In FAQ #46, your organization appears to affirm recommending a vaccination to a person who has experienced multiple bad reactions to past vaccines. Does your organization have an estimate of how many colleagues, staff, and partners fit that description within your organization, and if your organization would offer additional safety screening protocols and observation for such individuals?

 

7)     Your organization’s response to FAQ #47 flatly asserts there is “no evidence” fertility or reproductive organs are affected by the COVID-19 vaccination. Please describe the nature and scope of the investigation your organization conducted to reach this conclusion.

 

8)    In FAQ #55 your organization flatly states there is “no noteworthy number of COVID-19 vaccine injuries compared to other vaccines.” Can your organization please provide the figures and illustrate the comparison?

 

9)     In FAQ #60 your organization states “the COVID-19 vaccines have undergone the most scrutiny for safety of any vaccines in US history.” Can you qualify that statement further and compare how the emergency-use authorized COVID-19 vaccine has undergone more scrutiny than vaccines that have been approved for decades?

 

10) In FAQ #65, your organization unequivocally answers ‘No’ in response to a question on the consequences of vaccination on yet-to-be mothers and their potential future babies, “since no babies have been born yet since the vaccine has been available.” Then immediately following, your organization reveals studies are underway and planned on “pregnant people” and further that vaccine manufacturers are still reviewing data.

a)     How can you offer an immediate and resolute “No” while simultaneously admitting data is still being reviewed and studies are still being planned and conducted?

b)     How and why did your organization arrive at the term “pregnant people” rather than pregnant women, since pregnancy by definition is categorically restricted to biological women?

c)     Has your organization evaluated how the adoption of language such as “pregnant persons” could impact vaccine hesitancy?

 

11)  FAQ #66 asks “how can you determine long term effects if [COVID-19 vaccination] hasn’t even been out one year?” Your organization responds by invoking, “historically speaking.” Since two of the vaccines utilize previously unused technology, what basis is there to use historic vaccination records?

 

12) In FAQ #68, your organization says a fully vaccinated person does not need to quarantine or test following a known exposure. How does the transmission of SARS-CoV-2 / COVID-19 differ between a vaccinated and unvaccinated person?

 

13) In FAQ #71, your organization repeats the principle of respecting human dignity. How would you respond to the charge that threatening someone’s employment to coerce them into an invasive medical procedure with unknown risks is a violation of human dignity?

a)     Your organization further states the ethic of “efforts to develop and distribute an effective vaccine should emphasize solidarity.” In what ways has your organization demonstrated this principle?

 

14) Does FAQ #72 indicate your organization will not be accepting religious exemptions to those who object to being injected with certain cell lines used in the development of the vaccine?

 

Thank you for your consideration of these urgent matters. As you are surely aware, there is increasing skepticism and distrust involving public health recommendations. The public expects rigorous application of scientific methods with full and total transparency. The people of Iowa ask for specific and clear explanations on what indeed has been determined and informed by scientific methods and illustrated by overwhelmingly clear and convincing data.

 

Your organization’s assistance in meeting the expectations of the people of Iowa to this effect would be greatly appreciated. In recognition of the urgency of the public health crisis, we would appreciate a prompt reply.

 

Signed:

Brooke Boden

State Representative District Twenty-Six

 

 Jon Jacobsen

State Representative District Twenty-Two

 

 Sandy Salmon

State Representative District Sixty-Three

 

 Skyler Wheeler

State Representative District Four

 

 Henry Stone

State Representative District Seven

 

 Thomas Gerhold

State Representative District Seventy-Five

 

 Cherielynn Westrich

State Representative District Eighty-One

 

 Jeff Shipley

State Representative District Eighty-Two

 

Steven Bradley

State Representative District Fifty-Eight

  

Terry Baxter

State Representative District Eight

 

Anne Osmundson

State Representative District Fifty-Six

 

Mark Cisneros

State Representative District Ninety-One

 

Dennis Guth

State Senator District Four

 

Jason Schultz

State Senator District Nine

 

Jim Carlin

State Senator District Three

 

Brad Zaun

State Senator District Twenty

 

Jesse Green

State Senator District Twenty-Four

 

 

[1]  Le Bert, N., Tan, A.T., Kunasegaran, K. et al. SARS-CoV-2-specific T cell immunity in cases of COVID-19 and SARS, and uninfected controls. Nature 584, 457–462 (2020). https://doi.org/10.1038/s41586-020-2550-z 

[2]  SARS-CoV-2 variants of concern and variants under investigation in England Technical briefing 17, page 14