Other documents detail adverse ‘events for which a contributory effect of the vaccine could not be excluded’

Posted BY: Judicial Watch

(Washington, DC) – Judicial Watch announced today that it received 1,081 pages of records from the U.S. Department of Health and Human Services (HHS) detailing internal discussions about myocarditis and the COVID vaccine. Other documents detail adverse “events for which a contributory effect of the vaccine could not be excluded.”

Judicial Watch obtained the records through a Freedom of Information Act (FOIA) lawsuit against HHS (Judicial Watch v. U.S. Department of Health and Human Services (No. 1:22-cv-00660)) after the Food and Drug Administration (FDA), which is an agency of HHS, failed to respond to an August 30, 2021, FOIA request for:

All emails sent to and from members of the Vaccines and Related Biological Products Advisory Committee regarding adverse events, deaths and/or injuries caused by investigatory vaccines for the prevention or treatment of SARS-CoV-2 and/or COVID-19 currently produced by Pfizer/BioNTech, Moderna and/or Johnson & Johnson.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) is the U.S. Government’s central advisory body, along with Advisory Committee on Immunization Practices (ACIP), advising whether to approve COVID vaccines.

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On May 13, 2021, senior CDC Director, Division of Birth Defects and Infant Disorders Dr. Amanda Cohnwrote to FDA Director of the Center for Biologics Evaluation and Research (CBER) Dr. Peter Marks and other officials about COVID-19 vaccines: “I have another issue to discuss as well, reports of myocarditis in adolescents. I am putting together an email, but this may come to the surface this weekend.”

In a section of an FDA briefing document submitted by Johnson & Johnson/Janssen to the FDA regarding trials of its COVID vaccine, J&J notes that five people experienced serious adverse events: “selected events among vaccine recipients for which a contributory effect of the vaccine could not be excluded based on FDA assessment of the clinical information provided.”

These adverse events included deep vein thromboses, pulmonary embolism, transverse sinus thrombosis, seizure and hemiparesis (inability to move one side of the body) occurring anywhere from three to 28 days following vaccination.

In a section of the same briefing document as above, titled “Pregnancies,” the briefing document notes that of four women who became pregnant following the Janssen shot, two of the babies were lost – one due to an ectopic pregnancy and the other due to “spontaneous abortion.”

In a section of the document titled “Safety Summary,” the study states: “Numerical imbalances were reported between vaccine and placebo recipients for thromboembolic events (15 versus 10) and tinnitus (6 versus 0).”

“It beggars belief that the Biden administration tried to hide these key documents that would serve to inform the public about the safety of the COVID vaccines,” said Judicial Watch President Tom Fitton.

Through FOIA, Judicial Watch has uncovered a substantial amount of information about COVID-19 issues:

Recently, HHS records detail the extensive plans for a propaganda campaign to push the COVID-19 vaccine.

NIH records reveal an FBI “inquiry” into the NIH’s controversial bat coronavirus grant tied to the Wuhan Institute of Virology. The records also show National Institute of Allergy and Infectious Diseases (NIAID) officials were concerned about “gain-of-function” research in China’s Wuhan Institute of Virology in 2016. The Fauci agency was also concerned about EcoHealth Alliance’s lack of compliance with reporting rules and use of gain-of-function research in the NIH-funded research involving bat coronaviruses in Wuhan, China.

Department of Veterans Affairs records detailed the adverse reactions of veterans to the COVID-19 vaccines. As of April 2021, Veteran’s Health Services reported 895 serious reactions which included: 20 cardiac arrests, 36 strokes, 15 cases of deep vein thrombosis, 10 heart attacks, and 19 pulmonary embolisms. They also reported over 26,000 less serious reactions. The agency withheld individual report details asserting privacy exemptions under FOIA.

Centers for Disease Control and Prevention records that show Director Rochelle Walensky’s communications, include a request for details about the death of a teenager who died days after receiving a coronavirus vaccination.

The records also include a study paid for and conducted by Pfizer and BioNTech that found:

Adverse event analyses during the blinded period are provided for 43,847 ≥16-year-olds (Table S3). Reactogenicity events among participants not in the reactogenicity subset are reported as adverse events, resulting in imbalances in adverse events (30% vs 14%), related adverse events (24% vs 6%), and severe adverse events (1.2% vs 0.7%) between BNT162b2 and placebo groups. Decreased appetite, lethargy, asthenia, malaise, night sweats, and hyperhidrosis were new adverse events attributable to BNT162b2 not previously identified in earlier reports.

HHS records reveal that from 2014 to 2019, $826,277 was given to the Wuhan Institute of Virology for bat coronavirus research by the NIAID. NIAID records show that it gave nine China-related grants to EcoHealth Alliance to research coronavirus emergence in bats and was the NIH’s top issuer of grants to the Wuhan lab itself. The records also include an email from the vice director of the Wuhan Lab asking an NIH official for help finding disinfectants for decontamination of airtight suits and indoor surfaces.

HHS records include an “urgent for Dr. Fauci ” email chain, citing ties between the Wuhan lab and the taxpayer-funded EcoHealth Alliance. The government emails also reported that U.S. billionaire Bill Gates’s foundation worked closely with the Chinese government to pave the way for Chinese-produced medications to be sold outside China and help “raise China’s voice of governance by placing representatives from China on important international counsels as high level commitment from China.”

HHS records include a grant application for research involving the coronavirus that appears to describe “gain-of-function” research involving RNA extractions from bats, experiments on viruses, attempts to develop a chimeric virus and efforts to genetically manipulate the full-length bat SARSr-CoV WIV1 strain molecular clone.

HHS records show the State Department and NIAID knew immediately in January 2020 that China was withholding COVID data, which was hindering risk assessment and response by public health officials.

University of Texas Medical Branch (UTMB) records show the former director of the Galveston National Laboratory at the University of Texas Medical Branch (UTMB), Dr. James W. Le Ducwarned Chinese researchers at the Wuhan Institute of Virology of potential investigations into the COVID issue by Congress.

HHS records regarding biodistribution studies and related data for the COVID-19 vaccines show a key component of the vaccines developed by Pfizer/BioNTech, lipid nanoparticles (LNPs), were found outside the injection site, mainly the liver, adrenal glands, spleen and ovaries of test animals, eight to 48 hours after injection.

Records from the Federal Select Agent Program (FSAP) reveal safety lapses and violations at U.S. biosafety laboratories that conduct research on dangerous agents and toxins.

HHS records include emails between National Institutes of Health (NIH) then-Director Francis Collins and Anthony Fauci, the director of National Institute of Allergy and Infectious Diseases (NIAID), about hydroxychloroquine and COVID-19.

HHS records show that NIH officials tailored confidentiality forms to China’s terms and that the World Health Organization (WHO) conducted an unreleased, “strictly confidential” COVID-19 epidemiological analysis in January 2020.

Fauci emails include his approval of a press release supportive of China’s response to the 2019 novel coronavirus.