The study with the largest sample size I am aware of was published in ELSEVIER on the Science Direct site almost a month ago.
ELSEVIER | Feb 12, 2024
COVID-19 vaccines and adverse events of special interest: A multinational Global Vaccine Data Network (GVDN) cohort study of 99 million vaccinated individuals:
https://www.sciencedirect.com/scienc...64410X24001270
Quote:
Methods
Using a common protocol, this observational cohort study compared observed with expected rates of 13 selected AESI across neurological, haematological, and cardiac outcomes. Expected rates were obtained by participating sites using pre-COVID-19 vaccination healthcare data stratified by age and sex. Observed rates were reported from the same healthcare datasets since COVID-19 vaccination program rollout. AESI occurring up to 42 days following vaccination with mRNA (BNT162b2 and mRNA-1273) and adenovirus-vector (ChAdOx1) vaccines were included in the primary analysis. Risks were assessed using observed versus expected (OE) ratios with 95 % confidence intervals. Prioritised potential safety signals were those with lower bound of the 95 % confidence interval (LBCI) greater than 1.5.
Results
Participants included 99,068,901 vaccinated individuals. In total, 183,559,462 doses of BNT162b2, 36,178,442 doses of mRNA-1273, and 23,093,399 doses of ChAdOx1 were administered across participating sites in the study period. Risk periods following homologous vaccination schedules contributed 23,168,335 person-years of follow-up. OE ratios with LBCI > 1.5 were observed for Guillain-Barré syndrome (2.49, 95 % CI: 2.15, 2.87) and cerebral venous sinus thrombosis (3.23, 95 % CI: 2.51, 4.09) following the first dose of ChAdOx1 vaccine. Acute disseminated encephalomyelitis showed an OE ratio of 3.78 (95 % CI: 1.52, 7.78) following the first dose of mRNA-1273 vaccine. The OE ratios for myocarditis and pericarditis following BNT162b2, mRNA-1273, and ChAdOx1 were significantly increased with LBCIs > 1.5.
Conclusion
This multi-country analysis confirmed pre-established safety signals for myocarditis, pericarditis, Guillain-Barré syndrome, and cerebral venous sinus thrombosis. Other potential safety signals that require further investigation were identified.
|
From page 5 of the PDF version or about 1/5th of the way down from the top in the html version:
Quote:
Table 5
Aggregated OE Ratios by last dose, cardiovascular conditions, period 0–42 days.
|
The authors compiled OE (Observed vs. Expected) Ratios for AESI (Adverse Events of Special Interest) using the health care records of more than 99 Million people vaccinated against Covid-19 in eight countries (Argentina, Australia, Canada, Denmark, Finland, France, New Zealand, and Scotland.)
Looking at the last or most recent dose from each of the three major vaccine makers - Oxford/Astra Zeneca, Pfizer, and Moderna:
For EVERY DOSE:
The OE Ratios for both Myocarditis and Pericarditis were higher than expected and statistically significant.
For both Pfizer and Moderna:
The Myocarditis OE Ratios were MORE THAN TWO TIMES HIGHER than expected.
Sample size: 99 Million vaccinated, 242.8 Million doses, and 23.1 Million person-years of follow-up.
-jp
.
