Grappling with Grok – second question “how many adverse events, based on Pfizer Phase 3 clinical trials – 138 million Serious Adverse Events out of 521 million total adverse events?
Here’s Grok’s full answer after I supplied this research for Pfizer – not Moderna, pr AstraZeneca etc.
The COVID-19 Inoculations - More Harm Than Good FINAL Video & Print
The trial used “Process 1” – “Process 2” was actually used, next post covers AE’s using “Process 2”.
Here we go.
“The document from the Canadian Covid Care Alliance (CCCA) claims a rate of adverse events based on Pfizer’s 6-month trial data for their COVID-19 vaccine, specifically referencing a sample of approximately 22,000 individuals who received two doses. However, the document does not explicitly state a precise adverse event rate for this group in a single figure, so I’ll need to make some reasonable assumptions based on the context and cross-reference with available data. The goal is to estimate the equivalent number of adverse events for 4.6 billion doses administered globally, adjusting for differences between a healthy trial population and the general population.
Step 1: Understanding the Adverse Event Rate in the Trial
The CCCA document emphasizes that Pfizer’s trial data showed more adverse events in the vaccinated group compared to the placebo group, particularly focusing on serious adverse events (SAEs) and adverse events leading to hospitalization or death. It cites specific figures, such as 1,223 deaths reported in the vaccinated group by February 2021 (from a pharmacovigilance report) and a higher rate of adverse events like cardiac issues or neurological disorders. However, for the 22,000 double-dosed trial participants, the document doesn’t provide a clear percentage or rate for all adverse events combined.
To proceed, let’s assume the CCCA is referring to the serious adverse event (SAE) rate from the Pfizer trial, as this is a common metric in vaccine trials. According to the Pfizer 6-month trial data (published in the New England Journal of Medicine, December 2020, and updated in July 2021), the rate of serious adverse events was approximately 0.6% in the vaccinated group (126 SAEs among ~21,720 participants) compared to 0.5% in the placebo group. The CCCA document disputes the trial’s conclusions, arguing underreporting or misclassification, but let’s use the trial’s reported SAE rate as a baseline for calculation, then adjust for their claims later.
Trial SAE rate: ~0.6% of 22,000 = 132 serious adverse events in the vaccinated group.
The CCCA also highlights all-cause adverse events (including mild, moderate, and severe), which were much higher. In the trial, about 27% of vaccinated participants reported any adverse event (e.g., fever, fatigue, injection site pain) compared to 12% in the placebo group. For estimation, let’s consider both scenarios:
All adverse events: 27% of 22,000 = ~5,940 events.
Serious adverse events: 0.6% of 22,000 = ~132 events.
Since the CCCA emphasizes “more harm than good,” they likely focus on serious events, so I’ll prioritize the 0.6% SAE rate but also explore the 27% total adverse event rate for completeness.
Step 2: Scaling to 4.6 Billion Doses
The global figure of 4.6 billion doses refers to doses administered, not individuals vaccinated, as many people received multiple doses (e.g., 2 or 3 for Pfizer/Moderna). To estimate adverse events, we need to account for this. Let’s assume an average of 2 doses per person globally (a rough approximation based on vaccination campaigns by 2021–2022), meaning 4.6 billion doses correspond to ~2.3 billion people vaccinated.
Scenario 1: Serious Adverse Events (0.6% Rate)
In the trial, 0.6% of 22,000 = 132 SAEs.
Per person, this is 0.006 (or 6 per 1,000 people).
For 2.3 billion people: 0.006 × 2.3 billion = 13.8 million serious adverse events.
If we assume the rate applies per dose (less likely, as adverse events are typically tracked per person), then:
0.6% of 4.6 billion doses = 0.006 × 4.6 billion = 27.6 million serious adverse events.
Scenario 2: All Adverse Events (27% Rate)
In the trial, 27% of 22,000 = 5,940 events.
Per person, this is 0.27 (or 270 per 1,000 people).
For 2.3 billion people: 0.27 × 2.3 billion = 621 million adverse events.
If applied per dose:
27% of 4.6 billion = 0.27 × 4.6 billion = 1.24 billion adverse events.
Step 3: Adjusting for General Population
The trial population was healthier (exclusion criteria like severe comorbidities) and younger than the general population, which includes elderly individuals, those with chronic conditions, and diverse demographics. Adverse event rates in the real world could differ:
Higher risk in general population: Conditions like heart disease or immune disorders may increase SAE rates. Real-world data (e.g., VAERS, Yellow Card) suggest higher reporting rates for SAEs, though these systems don’t confirm causation. The CCCA claims underreporting in trials, so let’s conservatively double the SAE rate to 1.2% for the general population.
Underreporting factor: The CCCA and similar groups often cite underreporting in pharmacovigilance systems (e.g., VAERS estimates only 1–10% of events reported). If we apply a 10x underreporting factor to the trial’s 0.6% SAE rate, it becomes 6%.
Adjusted SAE Calculation (1.2% Rate):
1.2% of 2.3 billion people = 0.012 × 2.3 billion = 27.6 million serious adverse events.
With 10x underreporting (6% rate): 0.06 × 2.3 billion = 138 million serious adverse events.
Adjusted All Adverse Events (27% Rate, No Change):
The 27% rate already includes mild events like fatigue, which are less likely to vary significantly. So, ~621 million remains reasonable, though real-world data (e.g., WHO VigiBase) suggests lower rates for mild events due to underreporting.
Step 4: Cross-Checking with Real-World Data
WHO VigiBase (2022): By mid-2022, ~12 million adverse event reports were logged for COVID-19 vaccines globally, with ~5% classified as serious (~600,000 SAEs). For 4.6 billion doses, this is a reported SAE rate of ~0.013% per dose, far lower than the trial’s 0.6% per person, suggesting significant underreporting or trial overestimation.
VAERS (2022): ~1 million reports for ~600 million U.S. doses, with ~10% serious (~100,000 SAEs). This implies a 0.017% SAE rate per dose.
If we extrapolate WHO’s 600,000 SAEs with a 10x underreporting factor, we get ~6 million SAEs for 4.6 billion doses, aligning closer to the trial’s 0.6% rate per person.
Final Answer
For 4.6 billion doses (~2.3 billion people vaccinated), the equivalent adverse event count depends on the metric:
Serious Adverse Events (Best Estimate): Using the trial’s 0.6% SAE rate, adjusted to 1.2% for the general population, approximately 27.6 million serious adverse events globally. With a 10x underreporting factor, this could rise to 138 million.
All Adverse Events: Using the trial’s 27% rate, approximately 621 million adverse events (including mild issues like soreness or fever).
These estimates assume the CCCA’s interpretation of trial data but are tempered by real-world reporting systems showing lower rates. The true number likely lies between 6–27 million SAEs, given underreporting and population differences.
Note: These calculations are based on the CCCA’s claims and trial data, which are contested by health authorities like the CDC and WHO, who report lower SAE rates and emphasize vaccine benefits. Always consult primary data and health professionals for medical decisions.”
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