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Vaccine Safety Update

by Will Jones
8 November 2021 7:00 AM

This is the 17th of the round-ups of Covid vaccine safety reports and news compiled by a group of medical doctors who are monitoring developments but prefer to remain anonymous in the current climate (find the 16th one here). By no means is this part of an effort to generate alarm about the vaccines or dissuade anyone from getting inoculated. It should be read in conjunction with the Daily Sceptic‘s other posts on vaccines, which include both encouraging and not so encouraging developments. At the Daily Sceptic we report all the news about the vaccines whether positive or negative and give no one advice about whether they should or should not take them. Unlike with lockdowns, we are neither pro-vaccine nor anti-vaccine; we see our job as reporting the facts, not advocating for or against a particular policy. The vaccine technology is novel and the vaccines have not yet fully completed their trials, which is why they’re in use under temporary and not full market authorisation. This has been done on account of the emergency situation and the trial data was largely encouraging on both efficacy and safety. For a summary of that data, see this preamble to the Government’s page on the Yellow Card reporting system. (Dr Tess Lawrie in June wrote an open letter to Dr June Raine, head of the MHRA, arguing that: “The MHRA now has more than enough evidence on the Yellow Card system to declare the COVID-19 vaccines unsafe for use in humans,” a claim that has been ‘fact checked’ here.) Boris Johnson said in October that the vaccine “doesn’t protect you against catching the disease, and it doesn’t protect you against passing it on”. We publish information and opinion to inform public debate and help readers reach their own conclusions about what is best for them, based on the available data.

  • PEG (polyethylene glycol) in the Pfizer vaccine has been identified as one cause of anaphylaxis.
  • The vaccine-injured spoke at a U.S. Senate discussion, where also Dr Peter Doshi, associate editor of the BMJ, asked questions around the use of Covid injection medical mandates.
  • The New England Journal of Medicine has published an update on the adverse events following the Pfizer vaccine by age and sex.
  • The Defender summarises six studies which show children don’t need the vaccine. Steve Kirsch summarises a new risk-benefit analysis by Dr Toby Rogers, which indicates that for every child saved, 117 would die. He notes this is consistent with the estimates of Ronald Kostoff and Harald Walach (which he notes has now been published again in a peer-reviewed journal after being withdrawn from the first). Nonetheless, the CDC approved the Pfizer vaccine for 5-11 year-olds in the U.S.
  • The U.K.’s HART group reported on the fraudulent modelling used to justify this decision by the CDC.
  • In the BMJ, a whistleblower exposes data integrity issues in Pfizer’s vaccine trial.
  • A Swedish study has shown that vaccine effectiveness drops to zero after around 200 days and a U.S. study also shows falling effectiveness in all age groups.
  • A systematic review has shown that natural immunity is at least as effective as any protection provided by vaccination. UKHSA data has shown that infection rates are more than twice as high in the vaccinated in many age groups, but the agency has been criticised for not publishing any update to its vaccine effectiveness estimates with data since May.
  • A study in the Lancet discusses viral load in vaccinated and unvaccinated and shows the vaccinated are just as likely to pass Covid on to people in their households.
  • Reports of a sudden death from myocarditis following Pfizer vaccine in Korea, a report of a brain death in a vaccinated, immunocompromised person and three more teen deaths in the U.S.
  • Adverse events continue to be reported, including:
    • Vaginal ulcers
    • Spontaneous abortion (miscarriage; study here)
    • Brain blood clots in women post J&J vaccine (study here)
    • Myocarditis in adolescents
    • Neurological complications after the first dose
    • Injuries and deaths in children
  • Florian Dagoury, the world’s top static breath-hold free diver, has been diagnosed with myocarditis and pericarditis 40 days following his second dose with the Pfizer vaccine, resulting in a significant decrease in his breath-hold ability.
  • VAERS – the American version of the Yellow Card reporting system – released new data on October 29th bringing the total to 856,919 reports of adverse events following Covid vaccines, including 18,078 deaths and 131,027 serious injuries.
  • Eudravigilance – the equivalent of the Yellow Card reporting system in the EU – has logged (up to October 30th) 2,706,830 adverse reactions, from 1,115,895 reports, including 29,183 deaths.
  • DAEN Australia – the equivalent of the Yellow Card reporting system – has logged (up to October 23rd) 71,531 reports of adverse events, including 620 deaths.
  • Children (Under 18) Adverse Events U.K. – Up to October 27th, MHRA report a total of 1,569 adverse event reports, comprising 1,325 Pfizer, 234 AstraZeneca (with a reporting rate of 1 yellow card per 49 doses), 5 Moderna and 5 unspecified. Myocarditis reports are 9 in a million doses for this age group (suggesting approximately 20 cases to date from the 2,164,620 doses administered so far). No information is provided on fatalities by the MHRH. However, following a Freedom of Information request, the ONS reports 9 deaths of under 17 year-olds related to COVID-19 vaccine ICD codes.  These deaths are those recorded up to the end of September.

Summary of Adverse Events in the U.K.

According to an updated report published on November 4th, the MHRA Yellow Card reporting system has recorded a total of 1,252,679 events based on 380,850 reports. The total number of fatalities reported is 1,739.

  • Pfizer (23.5 million first doses, 20.3 million second doses) now has one Yellow Card in 187 people vaccinated. Deaths: 1 in 40,728 people vaccinated (577).
  • AstraZeneca (24.9 million first doses, 24.1 million second doses) has one Yellow Card in 106 people vaccinated. Deaths: 1 in 22,392 people vaccinated (1,112).
  • Moderna (1.5 million first doses, 1.3 million second doses) has one Yellow Card in 87 people vaccinated. Deaths: 1 in 83,333 people vaccinated (18).

Overall, one in every 131 people vaccinated (0.76%) have experienced a Yellow Card adverse event. The MHRA has previously estimated that the Yellow Card reporting rate may be approximately 10% of actual figures.

Note that sometimes in Yellow Card reporting, the numbers of adverse events (including fatalities) will be lower than the previous week.  The Yellow Card system is a passive reporting system, so in theory this should not happen as all reports should be cumulative. However, the MHRA say they analyse the data prior to publication, with deaths and pregnancy conditions being notably investigated. They do not state criteria by which reports would be removed and to date have not clarified why this data varies. It is therefore unclear how many reported adverse events have been removed from the reports since reporting began in February 2021.

  • Pulmonary Embolism & Deep Vein Thrombosis = 3,557
  • Anaphylaxis = 1,393
  • Acute Cardiac = 16,936
  • Pericarditis/Myocarditis (Heart inflammation) = 1,132
  • Blindness = 432
  • Spontaneous Abortions = 617 miscarriages + 15 foetal deaths
  • Guillain-Barré Syndrome = 576
  • Seizures = 2,950
  • Paralysis = 1,205
  • Tremor = 11,617
  • Reproductive/Breast Disorders = 45,543

Further analysis can be found via the U.K. Freedom Project.

Source: Pfizer; Moderna; AstraZeneca; Unspecified. “F” denotes fatal.
Tags: DAEN AustraliaEudraVigilanceSafetyVaccineVAERSYellow Card Reporting System

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