Informed Consent

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*originally published Feb., 2021

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The accuracy of information regarding COVID-19 vaccines can vary in the marketing of the vaccines and at vaccine administration sites. Please review the most updated vaccine fact sheets carefully before choosing to be inoculated.

The purpose of this post is to provide information because all information is necessary for informed consent. More information, more education, more dialogue, more transparency, and less censorship is the solution to misinformation.

Please see Additional Information and Sources on page 3 for important links.

This post may be updated periodically with possible changes, omissions or additions.

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The decision to receive a COVID-19 vaccine or any medical intervention is a private decision between an individual and their healthcare provider based on individual risks and benefits.

The decision not to receive a COVID-19 vaccine does not make an individual “anti-vax.” The public should be encouraged to make informed medical decisions with their healthcare providers. Open and honest public discussion is not being conducted to address evidence for very legitimate concerns and fears. No one should hand off matters pertaining to their own health and/or personal autonomy to people who do not know them or their health history.

No one should be bribed, shamed, coerced, segregated, stigmatized, discriminated against, or mandated to take an investigational COVID-19 vaccine released under an emergency use authorization.

Naturally-acquired immunity from previous infection counts toward herd or population immunity.

• Under the PREP Act, companies like Pfizer and Moderna have total immunity from liability if something unintentionally goes wrong with their vaccines.

• There is no long-term safety data from the use of mRNA vaccines which interact with the immune system in a novel way. Reported safety and efficacy data is extremely short-term.

• There is insufficient evidence to support the need for mass vaccination campaigns of populations considered low risk, including children and the naturally immune.

• Individuals are not and have never been at equal risk for severe disease or death from COVID-19 if infected, both young and old.

• The risks for adverse outcomes for young individuals may be higher with the vaccine in the short term than the negligible risk with the virus itself.

Children do not readily acquire SARS-CoV-2 (very low risk), spread it to other children or teachers, or endanger parents or others at home.

Age-specific survival rates based on CDC’s IFR estimates, Sept. 2020:

0-19 years old, 99.997 percent

20-49 years old, 99.98 percent

50-69 years, 99.5 percent

70 years old or older, 94.6 percent

• Do COVID-19 vaccines qualify in fact as a public health measure capable of providing collective benefit that supersedes individual risk? Potential exposure impacts others as do many other behaviors and forms of illness that must be weighed in order to balance individual autonomy and collective benefit. Ethical discussions have not taken place with respect to things demanded others do with their bodies; conclusions are not self-evident since the science is still unfolding.

• Positive PCR test results do not equate to symptom presentation or infection with SARS-CoV-2. The relation of PCR with infectiousness is not clear. Positive PCR test results do not rule out bacterial infection or co-infection with other viral pathogens. The agent detected may not be the definite cause of disease. Inflated case numbers and death misclassifications drive hysteria and fear. It is essential to understand if individuals are dying with or from the disease.

• COVID-19 is one of thousands of health threats. Other critical health matters are not receiving much needed attention during the pandemic, and the media’s coverage of the pandemic dissuades patients from seeking essential care. The marketing campaign for these vaccines is unprecedented. Why?

• The behavior of epidemics, both infections and death statistics, follow a bell-shaped curve which rises, crests and descends per Farr’s Law.

• There is no FDA-approved vaccine to prevent COVID-19 as stated on the vaccine fact sheets.

• The duration of protection against COVID-19 is currently unknown as stated on the vaccine fact sheets.

• COVID-19 vaccines may not protect everyone as stated on the vaccine fact sheets.

• Immune function is a strong determinant of an individual’s risk of and complications from pathogens. There is a high degree of individual variability in antibody responses to a pathogen in the amount, type, and quality of antibodies made, including the components of immune memory.

• COVID-19 vaccines are not yet licensed. They have been released under an Emergency Use Authorization by the FDA.

“In general, FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities.”

• Under an EUA, COVID-19 vaccines cannot be made mandatory for any individual.

Federal law: Title 21 U.S.C. § 360bbb-3(e)(1)(A)(ii)(I-III) of the Federal Food, Drug, and Cosmetic Act states: Individuals to whom the product is administered are informed—

(I) that the Secretary has authorized the emergency use of the product;
(II) of the significant known and potential benefits and risks of such use, and
of the extent to which such benefits and risks are unknown; and
(III) of the option to accept or refuse administration of the product, of the
consequences, if any, of refusing administration of the product, and of the
alternatives to the product that are available and of their benefits and risks.

Per the COVID-19 Vaccine Tracker, there are presently 135 vaccine candidates and 20 “approved” vaccines. This post includes links to vaccine fact sheets/information for four (4) COVID-19 vaccines.

COVID-19 vaccine fact sheets and websites

Pfizer-BioNTech Covid-19 Fact Sheet

Pfizer-BioNTech Covid-19 vaccine website

Pfizer-BioNTech Covid-19 vaccine fact sheet language translations

Pfizer-BioNTech Covid-19 vaccine short term efficacy and safety data

Moderna Covid-19 Fact Sheet

Moderna Covid-19 vaccine website

Moderna Covid-19 vaccine fact sheet language translations

Moderna Covid-19 vaccine short term efficacy and safety data

COVID-19 Vaccine Information Sheet for AstraZeneca/COVISHIELD

AstraZeneca Covid-19 Information Hub

Janssen COVID-19 vaccine fact sheet (manufacturer Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson)

*The FDA’s EUA now includes a warning that rare clotting events might occur after vaccination, primarily among women ages 18–49 years.

 Johnson and Johnson Covid-19 Media Hub

Janssen Covid-19 vaccine short term efficacy and safety data