"1 Introduction
In March 2021, a signal of unusual clotting with concurrent low platelets following exposure to the coronavirus disease 2019 (COVID-19) Vaccine AstraZeneca (Vaxzevria) emerged in Europe, resulting in suspension of the vaccine in several countries while investigations commenced...
The aim of this study was to analyse the publicly available spontaneous reporting data from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card Scheme, and to calculate the case fatality of reported cases of thrombosis with concurrent thrombocytopenia (TTS), stratified by age, sex, and vaccine dose...
3 Results and Discussion
To 25 May 2022, 443 cases of thrombosis with concurrent thrombocytopenia had been reported to the Yellow Card scheme, of which 81 were fatal cases. Therefore, the overall cumulative case fatality was estimated at 18.28% (95% confidence interval [CI] 14.79–22.20%)... The reporting rate of TTS is therefore estimated at 15.74 cases reported per million first doses of Vaxzevria and 2.12 cases of TTS reported per million second doses of Vaxzevria administered in the UK population, indicating that this is a very rare event...
Among the TTS cases reported... people aged ≥ 80 years seemed to have the highest case fatality of all other age groups, with 50.00% (95% CI 15.70–84.30%) of the eight cases reported to have a fatal outcome. The 18–29 years age group had the next highest cumulative case fatality of all reported TTS events, with 22.58% (95% CI 9.59–41.10%) of reports having a fatal outcome (n = 7 of 31 reports for this age group). The highest number of reports received were for the 40–49 years age group (n = 111, of which 15 were fatal [13.51%, 95% CI 7.77–21.31%]) ...
Reports were approximately balanced between males and females, with 221 reported events from females and 217 reports from males to 25 May 2022 ...
4 Conclusion In the UK, case fatality of TTS following Vaxzevria... has remained stable at approximately 17–18% since May 2021. Of the events reported to the MHRA, no statistical differences in fatality were observed based on age or sex. Reports of TTS following Vaxzevria to the Yellow Card scheme are highest following a first vaccine dose."
A correction to this article was published on 03 September 2022 (https://link.springer.com/article/10.1007/s40264-022-01233-9)
This article has been updated (https://link.springer.com/article/10.1007/s40264-022-01217-9#change-history )
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