3. Vaccine Safety

Janssen VITT-TTS
Rare, no cause for concern (Joint CDC / FDA statement)
- https://www.cdc.gov/media/releases/2021/s0413-JJ-vaccine.html https://youtu.be/kvLEJbbF3Tk (video of ACIP meeting 4/23/20221) https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-04-23/06-COVID-Oliver-508.pdf (slides from ACIP meeting 4/23/2021) Lift Pause of Janssen COVID-19 vaccine
  - https://www.fda.gov/news-events/press-announcements/fda-and-cdc-lift-recommended-pause-johnson-johnson-janssen-covid-19-vaccine-use-following-thorough https://www.cdc.gov/mmwr/volumes/70/wr/mm7017e4.htm
    - Dec 2021: CDC limits Janssen due to concerns of TTS and GBS (use only under very specific circumstances) https://www.cdc.gov/mmwr/volumes/71/wr/mm7103a4.htm Note: June 2021 CDC found no cause for halting: https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-07/02-covid-alimchandani-508.pdf April 2022: JAMA article demonstrating incidence of GBS 20x in Janssen compared to mRNA COVID-19 vaccines
      - https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2791533
      May 2022: Restricted Access by FDA (despite initially stating not a concern)
      - https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-limits-use-janssen-covid-19-vaccine-certain-individuals https://www.cnn.com/2022/05/05/health/fda-johnson-johnson-vaccine-eua/index.html
      mRNA Vaccines and myocarditis April 2021 reports surfaced from Israel
      - https://www.reuters.com/world/middle-east/israel-examining-heart-inflammation-cases-people-who-received-pfizer-covid-shot-2021-04-25/
      May 2021 (VAST work group was dismissive). https://www.cdc.gov/vaccines/acip/work-groups-vast/report-2021-05-17.html
      - “Within CDC safety monitoring systems, rates of myocarditis reports in the window following COVID-19 vaccination have not differed from expected baseline rates.” (i.e., CDC dismissed initial claims stating it was ‘random statistical coincidence’ and within the ‘background rate occurring in general population’)
      June 23, 2021 Emergency ACIP meeting (concludes safe to proceed despite reports of myocarditis)
      - https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-06/05-COVID-Wallace-508.pdf
      FDA summary briefing document. https://www.fda.gov/media/155931/download
      - Data from Insurance datasets reveal myocarditis rates are 3.7x GREATER than rates noted in VAERS
      Published studies showing increased rates of myocarditis (compared to VAERS)
      - https://www.nejm.org/doi/full/10.1056/NEJMoa2110737 https://www.nejm.org/doi/full/10.1056/NEJMc2207270 https://www.medpagetoday.com/infectiousdisease/covid19vaccine/94892 https://onlinelibrary.wiley.com/doi/epdf/10.1111/eci.13759
      April 2022 CDC MMWR (40 insurance databases)
      - Rate of myocarditis is 267/million (not 80 / million using VAERS alone) https://www.cdc.gov/mmwr/volumes/71/wr/mm7114e1.htm
      Sept 2022 CDC intermediate (90 day minimum) follow-up data on VAERS myocarditis reports (published in Lancet)
      - https://www.thelancet.com/journals/lanchi/article/PIIS2352-4642(22)00244-9/fulltext Highlights 47% lost to follow-up (why is CDC not tracking these cases down more aggressively?) 50% still had residual symptoms 25% were in ICU (contrary to CDC claims of “generally mild”) 48% of those not fully recovered and 28% of those fully or probably fully recovered continued to have activity restrictions at median follow-up of 98 days
      Myocarditis after Booster may be under reported. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8957365/ Latest statement from American College of Cardiology seems to allow for nuanced individualized risk-benefit analysis. https://www.acc.org/Latest-in-Cardiology/Articles/2022/10/14/15/13/ACC-Underscores-Safety-of-COVID-19-Vaccine
      - “Stecker notes that it is reasonable for adolescent and young males to consult with a physician prior to receiving additional mRNA boosters, given the small but elevated risk of myocarditis in this group”
- VAERS vs VSD vs Electronic Medical Record (EMR) / Insurance databases
  - Anaphylaxis
    - The risk of anaphylaxis is also underestimated by 22 times according to this study using active surveillance after COVID vaccination.
      - https://jamanetwork.com/journals/jama/fullarticle/2777417
  - VSD 2:1 with VAERS (i.e., rates of myocarditis)
    - ACIP Presentation slides
      - https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-06-22-23/03-COVID-Shimabukuro-508.pdf
    - Myocarditis rates derived from VAERS vs VSD (VSD demonstrates about 2x VAERS but CDC continues to use VAERS data for its risk-benefit calculations)
  - EMR / insurance 3-4x vs VAERS
    - VAERS rates
      - https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-06-22-23/03-COVID-Shimabukuro-508.pdf
    - Rates of Vaccine myocarditis from Insurance data (CDC and FDA’s own documents)
      - FDA summary briefing for BLA approval
        “Analysis of VAERS data from passive surveillance indicated a reporting rate of 40 cases per 1 million second doses administered to males 18 to 24 years of age, while an FDA meta-analysis of four healthcare claims databases in CBER’s Biologics Effectiveness and Safety System estimated a rate of 148 cases per 1 million males 18 to 25 years of age vaccinated with the 2-dose primary series.”
        https://www.fda.gov/media/155931/download
    - CDC MMWR on myocarditis
      - “This study used EHR data from 40 health care systems* participating in PCORnet, the National Patient-Centered Clinical Research Network (7), during January 1, 2021–January 31, 2022. “
      - https://www.cdc.gov/mmwr/volumes/71/wr/mm7114e1.htm
    - Approximate numbers for comparing myocarditis rates
      - VAERS 80 / million
      - VSD 150 / million
      - Insurance / hospital database 250-300 / million
      - So, why does CDC continue to use VAERS data alone in its risk-benefit calculations?
    - FL Recommends AGAINST mRNA Vx for 18-38-year-olds (84% increased risk of death). https://floridahealthcovid19.gov/wp-content/uploads/2022/10/20221007-guidance-mrna-covid19-vaccines-analysis.pdf
    - Dr. Paul Offit recommends young healthy kids NOT get Booster
  - https://news.yahoo.com/young-healthy-people-may-not-need-bivalent-boosters-offit-155018744.html
    - Israel study: increased cardiac arrest associated with Vx. https://www.nature.com/articles/s41598-022-10928-z
    - Preprint from Japan (increased CV mortality with mRNA Vx). https://www.medrxiv.org/content/10.1101/2022.10.13.22281036v1.full.pdf
    - Safety in toddlers (1 in 200 had severe adverse reactions)
      - https://twitter.com/FLSurgeonGen/status/1586327074578497536
      - https://www.nejm.org/doi/full/10.1056/NEJMoa2209367
    - Australian government offering compensation for COVID Vx deaths. https://www.servicesaustralia.gov.au/deceased-covid-19-vaccine-recipient-payments-and-funeral-costs-you-can-claim-through-covid-19?context=55953
    - Need for active longitudinal surveillance with control group. https://www.nature.com/articles/d41586-021-00880-9
      - “This kind of surveillance can detect signs of rare adverse events, but most systems are not designed to determine their exact cause, says Black. That is because they only contain data for events that have been reported, and lack a comparison group to track adverse events that occur in unvaccinated populations.”
      - “A more complete understanding of vaccine safety could be garnered from active surveillance systems that collect adverse event data — both background rates and after a vaccine — from electronic health records without relying on people reporting them directly. For example, the US Centers for Disease Control and Prevention collects data from nine health-care organizations across the country in the Vaccine Safety Datalink. In the consensus report from the 2018 IABS meeting, researchers called for an international network of active surveillance systems, which would allow public-health agencies to share data more easily, and hopefully determine the causes of adverse reactions quickly and definitively.”
CDC caught in lies, withholding information, spreading misinformation?
- https://www.theepochtimes.com/exclusive-cdc-officials-told-they-spread-misinformation-but-still-didnt-issue-correction-emails_4826960.html
- CDC / FDA withholding autopsy reports despite FOIA request by Epoch Times
  - https://www.theepochtimes.com/exclusive-fda-withholding-autopsy-results-from-people-who-died-after-getting-covid-19-vaccines_4763765.html
- CDC Director Rochelle Walensky admits pandemic response mistakes
  - “pretty dramatic, pretty public mistakes”
  - https://www.ft.com/content/d482491f-ed0b-41fd-ab63-195cd195b082
- “The C.D.C. Isn’t Publishing Large Portions of the Covid Data It Collects”
  - https://www.nytimes.com/2022/02/20/health/covid-cdc-data.html
- CDC site on V-Safe
  - https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafe.html
- CDC V-safe data released pursuant to court order
  - https://www.prnewswire.com/news-releases/cdcs-covid-19-vaccine-v-safe-data-released-pursuant-to-court-order-301639584.html
  - https://www.foxnews.com/video/6313218294112
- ICAN’s V-Safe data analysis (7.7% of 10M users required medical attention)
  - https://icandecide.org/v-safe-data/
Duration of mRNA and Spike protein after injection
- CDC originally (Oct 2021) stated “Our cells break down mRNA and get rid of it within a few days after vaccination” and that “Scientists estimate that the spike protein, like other proteins our bodies create, may stay in the body up to a few weeks.”
  - https://web.archive.org/web/20211031174254/https:/www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html
- July 2022 it was modified
  - https://web.archive.org/web/20220716011916/https:/www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html
- But in Sept 2022 that section (both sentences above) was deleted without explanation
  - https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/how-they-work.html
- Several studies demonstrate persistence of mRNA and / or spike protein longer than CDC’s original (unsubstantiated) claims:
  - https://www.cell.com/cell/fulltext/S0092-8674(22)00076-9
  - https://pubmed.ncbi.nlm.nih.gov/35884842/
  - https://academic.oup.com/cid/article/74/4/715/6279075
  - https://pubmed.ncbi.nlm.nih.gov/34654691/