D3.273 - Assessing Anaphylaxis in COVID-19 vaccines: Application of amended Brighton Collaboration Criteria
Background
Anaphylaxis rates post COVID-19 vaccination were reported to be higher than seen with previous vaccinations. Re-evaluation of the data suggested that the Brighton collaboration criteria for anaphylaxis had been incorrectly applied, leading to its revision.
Method
Objective
To assess the utility of the revised Brighton criteria compared to the original criteria, with the aim to improve the accuracy of identification of anaphylaxis post immunisation.
Method
Retrospective case review of acute events following immunisation (AEFI) related to a COVID-19 vaccination. The study period was from 8 December 2020 to 31 January 2021, during which 452 AEFIs were reported. Anaphylaxis was determined according to: the original Brighton criteria; the revised Brighton criteria; WAO 2021 criteria; NIAID criteria. Sensitivity and specificity were calculated for each definition, with clinical determination by three senior allergy specialists on the basis of reported history deemed the gold standard.
Results
The revised Brighton criteria were not quite as sensitive as the original Brighton criteria (see Table) but were associated with an equivalent degree of specificity and lower false postivie rate.
Table I: Sensitivity and specificity of NIAID, WAO, BCC-v1, BCC-v2 to the gold standard.
|
|
NIAID |
WAO |
BCC-1 |
BCC-2 |
|
Sensitivity |
0.86(0.64-0.96) |
0.91(0.69-0.98) |
1.00(0.83-0.90) |
0.85(0.61-0.96) |
|
Specificity |
0.90 (0.86-0.92) |
0.90(0.86-0.92) |
0.87(0.91-0.97) |
0.93(0.89-0.95) |
|
False +ve |
68%(54-79%) |
67%(53-78%) |
67%(56-79%) |
58% (41-73%) |
Conclusion
This study showed approximate equivalence between the original and revised Brighton criteria, also the greater emphasis on objectivity with the latter did reduce the rate of false positive cases. Difficulties with case classification due to inadequate reporting of data remain a key issue.
