The Medical Letter on Drugs and Therapeutics
In Brief: Suspension of Johnson & Johnson COVID-19 Vaccine Lifted (online only)
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Med Lett Drugs Ther. 2021 May 17;63(1624):e1
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On April 23, 2021, on advice from the Advisory Committee on Immunization Practices (ACIP), the FDA and CDC recommended that use of the Johnson & Johnson adenovirus-based COVID-19 vaccine resume despite its association with development of thrombosis with thrombocytopenia syndrome (TTS). Administration of the vaccine had been paused on April 13 because of 6 reports of TTS, but after completing a data review that identified a further 9 cases associated with the formulation, the agencies concluded that the benefits of the vaccine outweighed its risks. About 7.98 million doses of the single-dose vaccine had been administered in the US at the time of the review.1-4

All 15 cases of TTS associated with the Johnson & Johnson vaccine occurred in women, 13 of whom were 18-49 years old. Symptom onset occurred 6-15 days after vaccine administration (median 8 days). Cerebral venous sinus thromboses were present in 12 of the women. Platelet factor 4 heparin-induced thrombocytopenia enzyme-linked immunosorbent assay (PF4 HIT ELISA) testing was positive in all 11 women with available results. Three of the women who developed TTS died.4

The fact sheet for the Johnson & Johnson vaccine now includes a warning about the risk of TTS, but use of the formulation has not been restricted based on age or sex.5 No cases of TTS have been associated with the >200 million Pfizer and Moderna mRNA-based COVID-19 vaccine doses administered in the US.4

The American Society of Hematology recommends that patients who present with thrombosis or thrombocytopenia 4-30 days after administration of the Johnson & Johnson vaccine be evaluated promptly for TTS. Patients with confirmed or suspected TTS should not be treated with heparin; intravenous immune globulin and non-heparin anticoagulants should be used instead.6

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