a. The CDC and FDA, along with the EUA COVID-19 Vaccine Manufactures, have posted the following information related to the EUA COVID vaccines: On June 23, 2021 the CDC updated guidance recognizing that “Since April 2021, there have been more than a thousand reports to the Vaccine Adverse Event Reporting System (VAERS) of cases of inflammation of the heart—called myocarditis and pericarditis… and on on June 25, 2021, the FDA is announcing revisions to the patient and provider fact sheets for the Moderna and Pfizer-BioNTech COVID-19 vaccines regarding the suggested increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination. For each vaccine, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) has been revised to include a warning about myocarditis and pericarditis and the Fact Sheet for Recipients and Caregivers has been revised to include information about myocarditis and pericarditis. This update follows an extensive review of information and the discussion by CDC’s Advisory Committee on Immunization Practices meeting on Wednesday.
b. The Pfizer Fact Sheet, revised 25 June 21 makes clear that Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the Pfizer-BioNTech COVID-19 Vaccine.
c. The Pfizer Fact Sheet also makes clear, under Benefits, that the “duration of Protection is currently unknown.”
d. As of June 28, 2021, … CDC received reports from 48 U.S. states and territories of 4,686 patients with COVID-19 vaccine breakthrough infection who were hospitalized or died. And A total of 10,262 SARS-CoV-2 vaccine breakthrough infections had been reported from 46 U.S. states and territories as of April 30, 2021.
e. As of May 1, 2021, the FDA and CDC’s Vaccine Adverse Events Reporting System, VAERS showed 384,270 adverse events from the EUA COVID-19 vaccines as reported in the last six months, and 4,812 deaths.
f. FDA reports that there are treatments for COVID-19, “The FDA reached a milestone of approving 1,000 original and supplemental generic drug applications to help in the treatment of patients with COVID-19 since the start of the pandemic.”
g. There are No Licensed COVID-19 Vaccines in the U.S presently .
h. There are No Long-Term Studies supporting Safety and Efficacy of EUA COVID-19 vaccines.
i. No studies yet exist on the long-term impact on someone getting an EUA COVID-19 Vaccine who has had COVID-19.
1. Right to Informed Consent is separate from the Option to Refuse, and is also based on Federal law over EUAs. 21 USCS § 360bbb-3
2. CDC reports, June 23, 2021: “Since April 2021, there have been more than a thousand reports to the Vaccine Adverse Event Reporting System (VAERS) of cases of inflammation of the heart—called myocarditis and pericarditis—happening after mRNA COVID-19 vaccination (i.e., Pfizer-BioNTech, Moderna) in the United States. Selected Adverse Events Reported after COVID-19 Vaccination | CDC
3. FACT SHEET FOR RECIPIENTS AND CAREGIVERS, EMERGENCY USE AUTHORIZED (EUA) OF THE PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19) IN INDIVIDUALS 12 YEARS AND OLDER, Revised 25 June 2021, p. 3: https://www.fda.gov/media/144414/download
4. FACT SHEET FOR RECIPIENTS AND CAREGIVERS, EMERGENCY USE AUTHORIZED (EUA) OF THE PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19) IN INDIVIDUALS 12 YEARS AND OLDER, Revised 25 June 2021, p. 3: https://www.fda.gov/media/144414/download
5. COVID-19 Vaccine Breakthrough Infections Reported to CDC — United States, January 1–April 30, 2021 Weekly / May 28, 2021 / 70(21);792–793, Among these cases, 6,446 (63%) occurred in females, and the median patient age was 58 years (interquartile range = 40–74 years). Based on preliminary data, 2,725 (27%) vaccine breakthrough infections were asymptomatic, 995 (10%) patients were known to be hospitalized, and 160 (2%) patients died.
COVID-19 Vaccine Breakthrough Infections Reported to CDC — United States, January 1–April 30, 2021 | MMWR
6. See Senator Johnson’s Hearing on Adverse Events from the EUA COVID-19 vaccines.
8. “There are currently no licensed mRNA vaccines in the United States.” https://www.covidhealth.com/article/understanding-explaining-mrna-covid19-vaccines
9. According to the Section 564 of the Federal Food, Drug, and Cosmetic Act, a lawful application of the terms of a lawful emergency use authorization (“EUA”) pursuant includes (e)(1)(A)(i)(III):
(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.