Thrombotic events following Covid-19 vaccines compared to Influenza vaccines.

IMPORTANCE

The actual risk of thrombotic events after Covid-19 vaccination is unknown.

OBJECTIVE

To evaluate the risk of thrombotic events after Covid-19 vaccination.

DESIGN

Retrospective cohort study which included consecutive adult patients vaccinated with the first dose of Covid-19 vaccine between January 1 and May 30, 2021, and a historic control group, defined as consecutive patients vaccinated with influenza vaccine between March 1 and July 30, 2019.

SETTING

Hospital Italiano de Buenos Aires, a tertiary hospital in Argentina.

PARTICIPANTS

Non-Hospitalized Adults vaccinated with the first dose of a Covid-19 vaccine.

EXPOSURE: Vaccination with Covid-19 vaccines available during the study period: Gam-COVID-Vac (Sputnik), ChAdOx1 nCoV-19 (AstraZeneca/Oxford or Covishield), BBIBP-CorV (Beijing Institute of Biological Products) (Sinopharm). Active comparator group exposure was Influenza vaccine.

MAIN OUTCOME: Primary endpoint was cumulative incidence of any symptomatic thrombotic event at 30 days, defined as the occurrence of at least one of the following: symptomatic acute deep venous thrombosis (DVT); symptomatic acute pulmonary embolism (PE); acute ischemic stroke (AIS); acute coronary syndrome (ACS) or arterial thrombosis.

RESULTS

From a total of 29,985 adult patients who received at least a first dose of Covid-19 vaccine during study period and 24,777 who received Influenza vaccine in 2019, we excluded those who were vaccinated during hospitalization. We finally included 29,918 and 24,753 patients respectively. Median age was 73 years old (IQR 75-81) and 67% were females in both groups. Thirty six subjects in the Covid-19 vaccination group (36/29,918) and 15 patients in the Influenza vaccination group (15/24,753) presented at least one thrombotic event. The cumulative incidence of any thrombotic event at 30 days was 12 per 10,000 (95%CI 9-17) for Covid-19 group and 6 per 10,000 (95%CI 4-10) for Influenza group (p-value=0.022).

CONCLUSIONS AND RELEVANCE: This study shows a significant increase in thrombotic events in subjects vaccinated with Covid-19 vaccines in comparison to a control group. The clinical implication of these findings should be interpreted with caution, in light of the high effectiveness of vaccination and the inherent risk of thrombosis from Covid-19 infection itself.