Adverse events report, Antibody Dependent Enhancement, BioNtech, break-through infections, Comirnaty, Covid 19 vaccine, deaths, ICU, informed consent, Pfizer, severe Covid-19 disease in vaccinated, vaccine deaths, Vaccine Enhanced Disease, vaccine roll-out, vaccine trial, Vaccine-Associated Enhanced Disease, Vaccine-Associated Enhanced Respiratory Disease (VAERD), VAED
This is from the batch of Pfizer documents that a US judge recently ordered the FDA to release. Based on the table presented, further below, it appears that in December (2020), January and February (2021) there were 101 post-vaccination Covid-19 infections reported. 75 were severe, and 38 died. This was in the first few months of the Pfizer-BioNTech Covid-19 vaccine program.
Are these Vaccine-Associated Enhanced Disease? Pfizer says that they don’t know. What it suggests, however, is that telling people that the vaccines protect against more serious disease and hospitalizations was known to be inaccurate by early 2021.
Thus, it shouldn’t be a surprise that almost a year later, in September and October 2021, in Ireland, almost half (46%) of Covid-19 positive individuals admitted to ICU (Intensive Care Units) were vaccinated. Over 90% of people in Ireland are vaccinated. So, not only do the Covid vaccines fail to protect against Covid, but vaccinated people are getting serious enough infections to be in Intensive Care: https://www.cso.ie/en/releasesandpublications/br/b-cdc/covid-19deathsandcasesseries36/
In “Informed consent disclosure to vaccine trial subjects of risk of COVID‐19 vaccines worsening clinical disease” by Timothy Cardozo 1 and Ronald Veazey 2 2021 Mar; 75(3): e13795. Published online 2020 Dec 4., the researchers state that: “Vaccines for SARS, MERS and RSV have never been approved, and the data generated in the development and testing of these vaccines suggest a serious mechanistic concern: that vaccines designed empirically using the traditional approach (consisting of the unmodified or minimally modified coronavirus viral spike to elicit neutralising antibodies), be they composed of protein, viral vector, DNA or RNA and irrespective of delivery method, may worsen COVID‐19 disease via antibody‐dependent enhancement (ADE). This risk is sufficiently obscured in clinical trial protocols and consent forms for ongoing COVID‐19 vaccine trials that adequate patient comprehension of this risk is unlikely to occur, obviating truly informed consent by subjects in these trials…. THE RISK OF ADE IN COVID‐19 VACCINES IS NON‐THEORETICAL AND COMPELLING” https://miningawareness.wordpress.com/2021/08/12/informed-consent-disclosure-to-vaccine-trial-subjects-of-risk-of-covid%E2%80%9019-vaccines-worsening-clinical-disease/
The vaccine appears to cause immune suppression, at least for a few months: https://miningawareness.wordpress.com/2021/10/02/is-there-a-covid-vaccine-cancer-connection-apparent-immuno-suppressive-impacts-of-vaccine/
In the Pfizer BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports for 1 Dec. 2020 to 28 Feb 2021 there were at least 1223 deaths, but 9400 unknown outcomes. This was of a total of 42086 reported adverse events in the first few months. The average age (mean) was 51. This wasn’t simply frail elderly people. (See Table 1 on p. 7 https://phmpt.org/wp-content/uploads/2021/11/5.3.6-postmarketing-experience.pdf )
On page 11 the possibility of Vaccine-Associated Enhanced Disease (VAED), including Vaccine-Associated Enhanced Respiratory Disease (VAERD), is discussed. The mean (arithmetic average) was 57.2 years and the median (half above, half below) was 59.5.
Pfizer writes to the US FDA: “VAED may present as severe or unusual clinical manifestations of COVID-19. Overall, there were 37 subjects with suspected COVID-19 and 101 subjects with confirmed COVID-19 following one or both doses of the vaccine; 75 of the 101 cases were severe, resulting in hospitalisation, disability, life-threatening consequences or death. None of the 75 cases could be definitively considered as VAED/VAERD. In this review of subjects with COVID-19 following vaccination, based on the current evidence, VAED/VAERD remains a theoretical risk for the vaccine”.
“Table 5. Important Potential Risk
Important Potential Risk
PostAuthorizationCasesEvaluation(cumulative to 28 Feb 2021) Total Number of Cases in the Reporting Period (N=42086)
Vaccine-Associated Enhanced Disease (VAED), including Vaccine-Associated Enhanced Respiratory Disease (VAERD)
No post-authorized AE reports have been identified as cases of VAED/VAERD, therefore, there is no observed data at this time. An expected rate of VAED is difficult to establish so a meaningful observed/expected analysis cannot be conducted at this point based on available data. The feasibility of conducting such an analysis will be re-evaluated on an ongoing basis as data on the virus grows and the vaccine safety data continues to accrue.
The search criteria utilised to identify potential cases of VAED for this report includes PTs indicating a lack of effect of the vaccine and PTs potentially indicative of severe or atypical COVID-19a.
Since the first temporary authorization for emergency supply under Regulation 174 in the UK (01 December 2020) and through 28 February 2021, 138 cases [0.33% of the total PM dataset], reporting 317 potentially relevant events were retrieved:
Country of incidence: UK (71), US (25), Germany (14), France, Italy, Mexico, Spain, (4 each), Denmark (3); the remaining 9 cases originated from 9 different countries;
Cases Seriousness: 138;
Seriousness criteria for the total 138 cases: Medically significant (71, of which 8 also serious for disability), Hospitalization required (non-fatal/non-life threatening) (16, of which 1 also serious for disability), Life threatening (13, of which 7 were also serious for hospitalization), Death (38). Gender: Females (73), Males (57), Unknown (8); Age (n=132) ranged from 21 to 100 years (mean = 57.2 years, median = 59.5);
Case outcome: fatal (38), resolved/resolving (26), not resolved (65), resolved with sequelae (1), unknown (8); Of the 317 relevant events, the most frequently reported PTs (≥2%) were: Drug ineffective (135), Dyspnoea (53), Diarrhoea (30), COVID-19 pneumonia (23), Vomiting (20), Respiratory failure (8), and Seizure (7).
Conclusion: VAED may present as severe or unusual clinical manifestations of COVID-19. Overall, there were 37 subjects with suspected COVID-19 and 101 subjects with confirmed COVID-19 following one or both doses of the vaccine; 75 of the 101 cases were severe, resulting in hospitalisation, disability, life-threatening consequences or death. None of the 75 cases could be definitively considered as VAED/VAERD. In this review of subjects with COVID-19 following vaccination, based on the current evidence, VAED/VAERD remains a theoretical risk for the vaccine. Surveillance will continue.
a. Search criteria: Standard Decreased Therapeutic Response Search AND PTs Dyspnoea; Tachypnoea; Hypoxia; COVID19pneumonia; RespiratoryFailure; AcuteRespiratory DistressSyndrome; CardiacFailure; Cardiogenicshock; Acute myocardialinfarction; Arrhythmia; Myocarditis; Vomiting; Diarrhoea; Abdominalpain; Jaundice; Acutehepaticfailure; Deepveinthrombosis; Pulmonaryembolism; PeripheralIschaemia; Vasculitis; Shock; Acutekidneyinjury; Renalfailure; Alteredstate ofconsciousness; Seizure; Encephalopathy; Meningitis; Cerebrovascularaccident; Thrombocytopenia; Disseminatedintravascularcoagulation; Chillblains; Erythemamultiforme; Multipleorgan dysfunctionsyndrome; Multisysteminflammatory syndrome in children.”
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There’s a lot more important information here, such as strokes, etc: “5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATIONADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021
Report Prepared by:
Link – https://phmpt.org/wp-content/uploads/2021/11/5.3.6-postmarketing-experience.pdf
Link to more documents – https://phmpt.org
Is this data kept in China, along with clinical trial data?
Excerpts exposed here: