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Thromboembolic events in younger women exposed to Pfizer-BioNTech or Moderna COVID-19 vaccines.
Sessa, Maurizio; Kragholm, Kristian; Hviid, Anders; Andersen, Morten.
  • Sessa M; Pharmacovigilance Research Center, Department of Drug Design and Pharmacology, University of Copenhagen, Copenhagen, Denmark.
  • Kragholm K; Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.
  • Hviid A; Pharmacovigilance Research Center, Department of Drug Design and Pharmacology, University of Copenhagen, Copenhagen, Denmark.
  • Andersen M; Department of Epidemiology Research, Statens Serum Institut, Copenhagen, Denmark.
Expert Opin Drug Saf ; 20(11): 1451-1453, 2021 Nov.
Article in English | MEDLINE | ID: covidwho-1310857
ABSTRACT

Introduction:

Concerns about the increased risk of blood clots associated with the VAXZEVRIA (previously named Oxford-AstraZeneca COVID-19 vaccine) and Johnson & Johnson (Janssen) COVID-19 vaccines raises the question of the thrombotic safety of other COVID-19 vaccines such as Pfizer-BioNTech or Moderna, especially in younger women, who at the early stage of the pandemic was a priority group for vaccination.

Methods:

Using the US-based Vaccine Adverse Event Reporting System (VAERS) and the FDA Event Reporting System (FAERS), we retrieved cases of thrombosis following vaccinations or hormonal contraceptive use in women aged ≤ 50 years. We used the reporting odds ratio (ROR) as a disproportionality measure.

Results:

On 19 March 2021, out of 13.6 million women aged ≤ 50 exposed to at least one dose of Pfizer-BioNTech or Moderna COVID-19 vaccines in the US, only 61 cases were reported with a total of 68 thromboembolic events (1 case per 222,951 vaccinated). None of the thromboembolic events included in our analysis were disproportionally reported for the two COVID-19 vaccines.

Conclusion:

Our results do support that, when compared to hormonal contraceptive use, the mRNA vaccines do not show disproportional reporting of thromboembolic events in younger women.
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Keywords

Full text: Available Collection: International databases Database: MEDLINE Main subject: Thromboembolism / Vaccination / COVID-19 Vaccines Type of study: Diagnostic study / Observational study / Prognostic study Topics: Vaccines Limits: Female / Humans / Middle aged Language: English Journal: Expert Opin Drug Saf Journal subject: Pharmacology / Drug Therapy Year: 2021 Document Type: Article Affiliation country: 14740338.2021.1955101

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Thromboembolism / Vaccination / COVID-19 Vaccines Type of study: Diagnostic study / Observational study / Prognostic study Topics: Vaccines Limits: Female / Humans / Middle aged Language: English Journal: Expert Opin Drug Saf Journal subject: Pharmacology / Drug Therapy Year: 2021 Document Type: Article Affiliation country: 14740338.2021.1955101