US Disability Data

Part 6 - Relationship with Severe AEs in Pfizer vaccine clinical trial

Data Sources:

1 - Disabilities data from Bureau of Labor Statistics (BLS).
2 - Stephen J. Thomas et al., 9/2021

Update Date: February - 2023

Overview:

In part 5 of our US disabilities analysis, we compared the rise in disability rates post 2/2021 with the analysis of Serious Adverse Events (SAEs) performed in the paper by J. Fraiman et al. in Vaccine journal, where they average the rates of SAEs of both the Pfizer and Moderna clinical trials. We showed that the projected rate of SAEs tends to underestimate the rise in disabilities observed at a population level.

In this part, we expand on the previous analysis by investigating the rates of adverse events (AEs) and Severe Adverse Events (Sev AEs) for the Pfizer trial. These were published in table S3 of the supplementary appendix of the paper by S. J. Thomas et al. that established the vaccine efficacy ("Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months", in New England Journal of Medicine, 9/2021).
A subgroup of participants was monitored for adverse events using an electronic diary for 7 days after each dose, and all participants’ adverse events were recorded from dose 1 to 1 month after dose 2. These latter AEs are described as being ‘unsolicited’ as they were not prompted by the electronic diary. The AEs were measured from August 2020 to December 2020, before the unblinding of the clinical trial. The severity of these adverse events was considered to be mostly mild or moderate.

Comparison with the rate of Severe Adverse Events (Sev AEs) from Pfizer vaccine trial

Summary of the main adverse events
The numbers in the table below were obtained from table S3 of the paper's supplementary appendix. It summarises the Adverse Events during the blinded follow-up period (from dose 1 to 1 month after dose 2) in the Pfizer trial. The yellow shaded cells refer to computed values.

Total Events
Adverse Event	Vaccine (N=21,926) (%)	Placebo (N=21,921) (%)	Risk Difference	Risk Ratio
Any Event	6617 (30.2)	3048 (13.9)	3569
-Related	5241 (23.9)	1311 (6.0)	3930
-Severe	262 (1.2)	150 (0.7)	112
-Life-threatening	21 (0.1)	26 (0.1)	-3
Total Events (per 10,000) - Computed Values
Any Event	3017.9	1390.4	1627.5	2.17
-Related	2390.3	598.1	1792.2	4.0
-Severe	119.5	68.4	51.1	1.75
-Life-threatening	9.6	11.9	-2.3	0.81

Severe adverse events (Sev AEs).

Assumptions for computing the Severe AEs time series:
-> The initial monthly rate of excess Sev AEs corresponds to 51.1 per 10,000 (the rate computed in the table above) divided by the median observation period of 2 months.
-> After 2 months the rate of SAEs falls to 1/2 of the original value and after 4 months it falls to 1/4 of the original rate. After 6 months we assume that the rate of SAEs falls to 1/10 of its original value.
-> The assumptions are based on the thought that different types of severe or serious events could occur over an extended period, but also that most events will be front-loaded. As Sev AEs are not as extreme as SAEs, we assumed a faster drop-off in the rate of events that would lead to a disability over time. The terminal rate of 1/10th of the original value attempts to capture the possibility of longer-term effects. These assumptions constitute our best guesses, and both the starting rate of Sev AEs and the assumption of how they decay (drop off) over time, could be adjusted as more information becomes available.

Severe Adverse events (Sev AEs) have a broader range of definition than Serious Adverse Events, resulting in higher numbers of Severe AEs being reported, as we can observe from the table above.

The chart on the left shows the time series of the change in disability rate from 2/2021 to 11/2022 for the Civilian Labor Force (left scale), and also the time series of the projected rate of Severe AEs from the Pfizer trial. For comparison it also shows the inferred rate of Serious Adverse Events (SAEs) from the combined Pfizer and Moderna trials, which was discussed previously in part 5.
The chart on the right shows the correlation between the rise in the disability rate since 2/2021 and the projected cumulative rate of Severe AEs for the Pfizer trial. The regression R2 is around 88% which is evidence for a strong relationship.

We can observe that the rate of rise in disabilities is very close to the computed rate of excess Severe AEs. We observe that there are 1.34 more projected Severe AEs than the rate of rise in disabilities implying that most Severe AEs could eventually lead to a disability. The rise in the rate of disabilities reported by the individuals surveyed by the BLS lies in between the projected rate of SAEs based on analysis of the combined Pfizer and Moderna trials, and the rate of projected Severe AEs based on those reported in the Pfizer clinical trial.

Observations

• Our results provide a stronger case for establishing a causal relationship between disabilities and the Covid-19 vaccines. The time series of Sev AEs that were computed based on the rate estimated during the Pfizer vaccine clinical trial is shown to be of the same magnitude as the rate of increase in disability rates in the 16-64 Civilian Labor Force during the vaccine rollout. The rate of estimated Severe AEs is about 34% higher than the recorded rise in disabilities (according to the BLS survey).
• It should be noted that our analysis does not attempt to establish that every estimated Sev AE or SAE leads to a disability. We are only trying to establish that the projected rates of SAEs and Sev AEs can explain the rise in measured disabilities at a population level (in the Civilian Labor Force aged 16-64, as measured by the BLS survey).
• We also show that the rise in the rate of disabilities since early 2021 lies in between the rate of SAEs for the combined Pfizer and Moderna trials (analysed in part 5), and the rate of Severe AEs reported in the Pfizer clinical trial.
• Our results provide a possible connection between safety data already observed in the vaccine clinical trials and observations at a population level, providing stronger evidence for a causal relationship between the rise in disabilities and the Covid-19 vaccines.
• We believe that a comprehensive investigation needs to be performed, either in the form of new phase III clinical trials for at least a 3-year period, or a programme of forensic autopsies in a large sample of deceased individuals where the Covid-19 vaccines were not suspected as a co-factor for cause of death.