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Review
. 2022 Sep;45(9):1003-1008.
doi: 10.1007/s40264-022-01217-9. Epub 2022 Aug 4.

Assessing Case Fatality on Cases of Thrombosis with Concurrent Thrombocytopenia Following COVID-19 Vaccine AstraZeneca (Vaxzevria) in the United Kingdom: A Review of Spontaneously Reported Data

Samantha Lane  1   2 , Saad Shakir  3   4
Affiliations
Review

Assessing Case Fatality on Cases of Thrombosis with Concurrent Thrombocytopenia Following COVID-19 Vaccine AstraZeneca (Vaxzevria) in the United Kingdom: A Review of Spontaneously Reported Data

Samantha Lane et al. Drug Saf. 2022 Sep.

Erratum in

Abstract

Introduction: Thrombotic thrombocytopenia syndrome (TTS) events were reported very rarely following the coronavirus disease 2019 (COVID-19) vaccine AstraZeneca (Vaxzevria). Clinical and demographic characteristics of the affected people, including the outcomes of TTS events, need to be examined using available information to better understand aspects of this association.

Objective: To analyse clinical and demographic information of TTS events, including calculating the case fatality of reported cases of TTS by age and sex, using spontaneously reported data from the UK's Yellow Card spontaneous reporting system of suspected adverse drug reactions.

Methods: TTS events reported to the Yellow Card scheme were extracted at weekly time points between 12 May 2021 and 25 May 2022. Cumulative numbers of TTS cases and deaths were recorded for each weekly interval, overall and stratified by age, sex, and vaccine dose.

Results: To 25 May 2022, 443 cases (81 fatal, 18.28%) had been reported in the UK. Events more frequently occurred following the first vaccine dose. No trends were observed for case fatality overall, or by age or sex.

Conclusion: In the UK, case fatality of TTS events reported to the Medicines and Health products Regulatory Agency (MHRA) following Vaxzevria has been approximately 17-18% since May 2021. There were no statistical differences in fatality based on age or sex. Most reports followed the first vaccine dose; none have been reported following a third dose to date, although Vaxzervia was not recommended for a third dose of COVID-19 vaccine in the UK. TTS remains very rare, and benefits of vaccination outweigh the risks.

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Conflict of interest statement

The Drug Safety Research Unit (DSRU) receives donations and grants from pharmaceutical companies; however, the companies have no control over the conduct or publication of its studies. The DSRU has received grants to conduct unconditional studies on the Oxford/AstraZeneca COVID-19 vaccine and for conducting Clinical Practice Research Datalink (CPRD) studies for Pfizer, Moderna, and Janssen COVID-19 vaccines. The DSRU has conducted benefit–risk studies on products for COVID-19, including remdesivir, lopinavir/ritonavir, chloroquine and hydroxychloroquine, and convalescent plasma. Professor Shakir is the principal investigator for an active surveillance study for the Oxford/AstraZeneca vaccine, but this assessment is unrelated to this study. Professor Shakir has been a member of Data Safety Monitoring Boards for Ipsen, Biogen, and Diurnal. None of these companies have any involvement with COVID-19 vaccines. Professor Shakir was also invited by AstraZeneca to advise on the events of thrombosis with thrombocytopenia with the COVID-19 vaccine and to be a member of an advisory committee on a safety study of the Oxford/AstraZeneca vaccine in Europe. Samantha Lane has no conflicts of interest with regard to this study.

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