Evaluation of Stroke Risk Following COVID-19 mRNA Bivalent Vaccines Among U.S. Adults Aged ≥65 Years

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ABSTRACT In January 2023, the United States Food and Drug Administration and the Centers for Disease Control and Prevention noted a safety concern for ischemic stroke in adults ≥65 years receiving the BNT162b2; WT/OMI BA.4/BA.5 COVID-19 bivalent vaccine. This self-controlled case series analysis evaluated stroke risk among Medicare fee-for-service beneficiaries aged ≥65 years receiving: 1) a Pfizer-BioNTech (BNT162b2; WT/OMI BA.4/BA.5) or Moderna (mRNA-1273.222) COVID-19 bivalent vaccine, 2) high-dose/adjuvanted influenza vaccines, and 3) concomitant COVID-19 bivalent vaccines and influenza vaccines, from August 31 to November 6, 2022. The primary analysis did not find elevated stroke risk following COVID-19 bivalent vaccines. In the age subgroup analyses, only the ≥85 year age group had a risk of NHS (Incident Rate Ratio (IRR)=1.36, 95% CI 1.09 – 1.69 [1-21 days]) and NHS/TIA (IRR=1.28, 95% CI 1.08 – 1.52 [1-21 days]) with BNT162b2 Bivalent WT/OMI BA.4/BA.5. Among beneficiaries receiving a concomitant COVID-19 bivalent vaccine and a high-dose/adjuvanted influenza vaccine, an increased risk was observed for NHS (IRR=1.20, 95% CI 1.01 – 1.42 [22-42 days]) with BNT162b2 Bivalent WT/OMI BA.4/BA.5 and for TIA (IRR=1.35, 95% CI 1.06 – 1.74 [1-21 days]) with mRNA-1273.222. Results of the secondary analyses showed a small increased risk of NHS following high-dose or adjuvanted influenza vaccines (IRR=1.09, 95% CI 1.02 – 1.17 [22-42 days]).

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