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In this letter to The New England Journal of Medicine, researchers from Janssen Vaccines and Prevention in the Netherlands address a case report describing cerebral venous sinus thrombosis (CVST) associated with severe thrombocytopenia and disseminated intravascular coagulation in an individual who received the Ad26.COV2.S (Johnson & Johnson/Janssen) vaccine.
The authors state that evidence is currently insufficient to determine a causal relationship between these adverse events and the vaccine, pointing out that CVST is very rare and that the FDA and the CDC consider the occurrence of CVST associated with low platelets to be extremely low.
A case report by Muir et al. describes thrombosis, including cerebral venous sinus thrombosis (CVST), associated with severe thrombocytopenia and disseminated intravascular coagulation in a recipient of the Ad26.COV2.S vaccine (Johnson & Johnson/Janssen) against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Among the more than 75,000 participants in the clinical trial program for our Janssen Ad26.COV2.S vaccine (of which approximately 50,000 received active vaccine), a single case of CVST with thrombocytopenia occurred in a vaccine recipient. We paused our program to review this case from our first phase 3 study; after consultation with external clinical experts, no clear causality was established, and the data and safety monitoring board agreed that we could restart the study. The vaccine recipient was subsequently found to have had antibodies against platelet factor 4 (PF4) at the time of the event, a finding similar to that in the case described by Muir and colleagues. As part of our postauthorization pharmacovigilance program, Janssen ongoing safety surveillance received reports of six cases of CVST with thrombocytopenia occurring 7 to 14 days after vaccination, including the case described by Muir et al. On April 13, 2021, in an abundance of caution, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) recommended a pause in vaccination with Ad26.COV2.S in the United States to allow further study of the situation and to provide physicians guidance on the diagnosis, treatment, and reporting of CVST in combination with low platelets. These cases were reported among more than 7.2 million persons who had been vaccinated with Ad26.COV2.S globally as of April 14, 2021. Thus, the reporting rate is less than 1 in 1,000,000 vaccinations, though it is possible that the cases are underreported.