Covid-19: European countries suspend use of Oxford-AstraZeneca vaccine after reports of blood clots

Wise, Jacqui

doi:10.1136/bmj.n699

Cited by 320 publications

(297 citation statements)

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“…It was authorised by the European Medicines Agency (EMA) for use across the European Union (EU) following endorsement by the European Commission on 29 January 2021 [6]. The safety of the AstraZeneca vaccine was determined following a short-term analysis of data pooled from clinical trials that were conducted in the United Kingdom, Brazil, and South Africa [7]. Approximately 23,745 participants aged 18 years and older had been randomised and received either COVID-19 vaccine AstraZeneca or a control.…”

Section: Introductionmentioning

confidence: 99%

“…Approximately 23,745 participants aged 18 years and older had been randomised and received either COVID-19 vaccine AstraZeneca or a control. The most frequently reported adverse reactions (ARs) from first vaccination were: injection site tenderness (63.7%), injection site pain (54.2%), fatigue (53.1%), headache (52.6%), malaise (44.2%), myalgia (44.0%), pyrexia (includes feverishness (33.6%) and fever >38°C (7.9%)) [6,7]. The majority of ARs were mild to moderate in severity and resolved within a short period following the vaccination [6,7].…”

Section: Introductionmentioning

confidence: 99%

“…The most frequently reported adverse reactions (ARs) from first vaccination were: injection site tenderness (63.7%), injection site pain (54.2%), fatigue (53.1%), headache (52.6%), malaise (44.2%), myalgia (44.0%), pyrexia (includes feverishness (33.6%) and fever >38°C (7.9%)) [6,7]. The majority of ARs were mild to moderate in severity and resolved within a short period following the vaccination [6,7]. Adverse reactions to second vaccinations were of the same nature but 'milder and less frequent' [6].…”

Section: Introductionmentioning

confidence: 99%

“…These trials are able to identify only common adverse events such as local and systemic reactions related to the immunogenicity of the vaccine that occurs shortly after administration. The trials are unlikely to detect rare adverse events that occur with trials in larger populations or delayed reactions that occur a long time after use [7]. Furthermore, currently approved and still being investigated COVID-19 vaccines are using novel and unlicensed technologies [12][13][14].…”

Section: Introductionmentioning

confidence: 99%

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Analysis of Thrombotic Adverse Reactions of COVID-19 AstraZeneca Vaccine reported to EudraVigilance database

Tobaiqy

Elkout

MacLure

2021

Preprint

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The development of safe, effective, affordable vaccines against COVID-19 remains the cornerstone to mitigating this pandemic. Early December 2020, multiple research groups had designed potential vaccines. From 11 March 2021, several European countries temporarily suspended the use of the Oxford-AstraZeneca vaccine amid reports of blood clot events and death of a vaccinated person, despite the European Medicines Agency and the World Health Organization assurance that there was no indication that vaccination was linked. This study aimed to identify and analyse the thrombotic adverse reactions associated with Oxford-AstraZeneca vaccine. This was a retrospective descriptive study using spontaneous reports submitted to the EudraVigilance database in the period from 17 February to 12 March 2021. There were 54,571 adverse reaction reports of which 28 were associated with thrombotic adverse reactions. Three fatalities were related to Pulmonary Embolism; 1 fatality to Thrombosis. With 17 million people having had the AstraZeneca vaccine, these are extremely rare events. The EMA’s Pharmacovigilance Risk Assessment Committee (18 March 2021) concluded that the vaccine was safe, effective and the benefits outweighed the risks. Conducting further analyses based on more detailed thrombotic adverse event reports, including patients’ characteristics and comorbidities, may enable assessment of the causality with higher specificity.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Analysis of Thrombotic Adverse Reactions of COVID-19 AstraZeneca Vaccine reported to EudraVigilance database

Tobaiqy

Elkout

MacLure

2021

Preprint

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“…Till the end of January 2021, 36 cases of ITP have been reported to the Vaccine Adverse Event Reporting System after receiving the Pfizer/BioNTech and Moderna coronavirus disease-19 (COVID-19) vaccines [8]. Also, a recent report in BMJ states that there have been about 150 reported cases of thrombocytopenia post-COVID-19 vaccination recorded in the pharmacovigilance databases [9]. It is still unclear whether this relationship between COVID-19 vaccination and thrombocytopenia is coincidental or causal.…”

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confidence: 99%

Vigilance regarding immune thrombocytopenic purpura after COVID-19 vaccine

et al. 2021

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Introduction: Based on the severity of thrombocytopenia, patients with immune thrombocytopenic purpura (ITP) are at an increased risk of mucocutaneous or major bleeding. Discussion: There has been an increased risk of ITP after administration of various vaccines like influenza, measles-mumpsrubella, hepatitis B, and diphtheria-tetanus-pertussis. The pathogenesis of vaccine-related thrombocytopenia is not completely clear and is probably caused by molecular mimicry. Till date, there have been few reported cases of thrombocytopenia in the pharmacovigilance databases after patients received the Pfizer and Moderna coronavirus disease-19 (COVID-19) vaccines. Conclusion: Emergency physicians should be aware of the occurrence of vaccine-induced ITP in patients who present with bleeding manifestations, especially after the current boost in COVID-19 vaccination drive worldwide.

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COVID-19 Infection Among Women in Iran Exposed vs Unexposed to Children Who Received Attenuated Poliovirus Used in Oral Polio Vaccine

et al. 2021

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Key Points Question Is indirect exposure to live attenuated poliovirus in the oral polio vaccine (OPV) associated with diminished symptomatic infection with SARS-CoV-2? Findings In this cohort study of 4190 women in Iran, none of those indirectly exposed to OPV developed COVID-19 during the 9 months of the study, while 0.74% of age-matched women who had no exposure to OPV did develop COVID-19. Meaning These findings suggest that indirect exposure to live attenuated poliovirus may be associated with decreased symptomatic COVID-19 infection for at least 6 months.

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Covid-19: European countries suspend use of Oxford-AstraZeneca vaccine after reports of blood clots

Cited by 320 publications

References 0 publications

Analysis of Thrombotic Adverse Reactions of COVID-19 AstraZeneca Vaccine reported to EudraVigilance database

Analysis of Thrombotic Adverse Reactions of COVID-19 AstraZeneca Vaccine reported to EudraVigilance database

Vigilance regarding immune thrombocytopenic purpura after COVID-19 vaccine

COVID-19 Infection Among Women in Iran Exposed vs Unexposed to Children Who Received Attenuated Poliovirus Used in Oral Polio Vaccine

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