Updated Recommendations from the Advisory Committee on Immunization Practices for Use of the Janssen (Johnson &amp; Johnson) COVID-19 Vaccine After Reports of Thrombosis with Thrombocytopenia Syndrome Among Vaccine Recipients — United States, April 2021

MacNeil, Jessica R.; Su, John R.; Broder, Karen R.; Guh, Alice; Gargano, Julia W.; Wallace, Megan; Hadler, Stephen C.; Scobie, Heather M.; Blain, Amy; Moulia, Danielle; Daley, Matthew F.; McNally, Veronica; Romero, José R.; Talbot, H. Keipp; Lee, Grace M.; Bell, Beth P.; Oliver, Sara E.

doi:10.15585/mmwr.mm7017e4

Cited by 177 publications

(155 citation statements)

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“…Findings of thrombosis within this male patient is a rare occurrence following the administration of the J&J vaccine, where the majority of recent cases of thrombosis with thrombocytopenia (TTS) have primarily affected women aged 18-49 years [7]. What is unique and informative about this case is the similarity in thrombotic developments recently found in female recipients of the AstraZeneca vaccine in Europe.…”

Section: Discussionmentioning

confidence: 69%

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A COVID-Positive 52-Year-Old Man Presented With Venous Thromboembolism and Disseminated Intravascular Coagulation Following Johnson & Johnson Vaccination: A Case-Study

Shazley¹,

Alshazley²

2021

Cureus

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The coronavirus disease 2019 (COVID-19) is caused by the severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2). Infection by the SARS-CoV-2 increases the risk for systematic multi-organ complications and venous, arterial thromboembolism. The need for an effective vaccine to combat the pandemic prompted the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) to approve a nationwide distribution of the Ad26.COV2.S vaccine manufactured by Johnson & Johnson (J&J). The use of the vaccine was halted after reported cases of cerebral venous sinus thrombosis (CVST) and thrombocytopenia among recipients. Researchers have postulated these rare occurrences as potentially immune-triggered responses associated with complement-mediated thrombotic microangiopathy (TMA). Thrombotic complications and thrombocytopenia increase the risk for blood clot growth due to the inflammation of immune complexes by pro-thrombotic activation of anti-platelet antibodies.A 52-year-old man presented to the intensive care unit (ICU) with severe dyspnea. He required bilevel positive airway pressure (BiPAP) for supplemental oxygen therapy. Endotracheal intubation was performed due to his worsened respiratory deterioration. Lab results suggested respiratory failure due to decreased partial pressure of oxygen (pO 2 ) and increased partial pressure of carbon dioxide (pCO 2 ). Findings of elevated D-dimer levels with decreased fibrinogen and thrombocytopenia with prolonged prothrombin clotting time were consistent for disseminated intravascular coagulation (DIC). Chest radiography displayed moderate to heavy bilateral airspace consolidations, consistent with multifocal pneumonia suspicious for COVID-19. A computed tomography angiogram (CTA) revealed a mildly enlarged right ventricle and interventricular septum consistent for right heart strain due to a saddle pulmonary embolism (PE) that extended into the main pulmonary lobar segmental arteries bilaterally. The patient was transferred to a higher-level (tertiary) care for radiology intervention to remove the pulmonary embolism found on his lungs.This patient presented with severe dyspnea secondary to massive PE and deep venous thrombosis (DVT) due to SARS-CoV2 infection following the administration of the J&J vaccine. Bilateral thrombus opacities and pulmonary emboli are consistent among COVID-19 patients by intravascular coagulation with increased prothrombin time and D-dimer concentration with a low platelet count. Adverse emboli growths with increased D-dimer and thrombocytopenia strikes a similarity in recipients of the AstraZeneca vaccine due to vaccine-induced immune thrombotic thrombocytopenia (VITT). Administrative use of the J&J vaccine resumed in May 2021. The FDA's reassurance stemmed from their conclusive findings that the vaccine's benefits far outweigh these rare developments, which account for less than 0.01% of the total recipient population. Nevertheless, a further detailed analysis must be conducted on the adverse thrombotic manifestations...

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Section: Discussionmentioning

confidence: 69%

“…The Vaccine Adverse Event Reporting System (VAERS) received 15 additional reports of thrombosis with thrombocytopenia syndrome (TTS). The decrease in platelet count found in TTS strikes a similarity to heparin-induced thrombocytopenia (HIT), in which platelet-activated antibodies develop in the absence of exposure to heparin [7].…”

Section: Introductionmentioning

confidence: 99%

A COVID-Positive 52-Year-Old Man Presented With Venous Thromboembolism and Disseminated Intravascular Coagulation Following Johnson & Johnson Vaccination: A Case-Study

Shazley¹,

Alshazley²

2021

Cureus

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“…Common side effects after vaccination include injection site reactions, fever, chills, and malaise, but there are rare reports of venous thrombosis after vaccination [ 26 ].…”

Section: Resultsmentioning

confidence: 99%

Vaccine-induced immune thrombotic thrombocytopenia and cerebral venous sinus thrombosis post COVID-19 vaccination; a systematic review

Dorche

Bahmanyar

Sharifian-Dorche

et al. 2021

Journal of the Neurological Sciences

202

178

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Introduction The common reported adverse effects of COVID-19 vaccination consist of the injection site's local reaction followed by several non-specific flu-like symptoms. However, rare cases of vaccine-induced immune thrombotic thrombocytopenia (VITT) and cerebral venous sinus thrombosis (CVST) after viral vector vaccines (ChAdOx1 nCoV-19 vaccine, Ad26.COV2 vaccine) have been reported. Herein we systemically reviewed the reported cases of CVST and VITT following the COVID-19 vaccination. Methods This systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. We searched PubMed until May 19, 2021, and the following Keywords were used: COVID Vaccine & Neurology, AstraZeneca COVID vaccine, ChAdOx1 nCoV-19 COVID vaccine, AZD1222 COVID vaccine, Janssen COVID vaccine, Johnson & Johnson COVID vaccine, Ad26.COV2 COVID vaccine. The authors evaluated the abstracts and titles of each article for screening and inclusion. English reports about post-vaccine CVST and VITT in humans were collected. Results Until May 19, we found 877 articles with the searched terms. We found 12 articles, which overall present clinical features of 36 patients with CVST and VITT after the ChAdOx1 nCoV-19 vaccine. Moreover, two articles were noted, which present 13 patients with CVST and VITT after Ad26.COV2 vaccine. The majority of the patients were females. Symptom onset occurred within one week after the first dose of vaccination (Range 4–19 days). Headache was the most common presenting symptom. Intracerebral hemorrhage (ICH) and/or Subarachnoid hemorrhage (SAH) were reported in 49% of the patients. The platelet count of the patients was between 5 and 127 cells×109/l, PF4 IgG Assay and d-Dimer were positive in the majority of the reported cases. Among 49 patients with CVST, at least 19 patients died (39%) due to complications of CVST and VITT. Conclusion Health care providers should be familiar with the clinical presentations, pathophysiology, diagnostic criteria, and management consideration of this rare but severe and potentially fatal complication of the COVID-19 vaccination. Early diagnosis and quick initiation of the treatment may help to provide patients with a more favorable neurological outcome.

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“…ACIP met to review reports of TTS after Janssen COVID-19 vaccination in April 2021; the committee met again in June 2021 to review reports of myocarditis after mRNA COVID-19 vaccination, particularly after the second dose. At both meetings, ACIP reviewed the individual- and population-level benefits and risks for vaccination and concluded that the benefits of vaccination for individual persons and at the population-level outweigh the risks; details of the findings have been described previously ( 7 , 8 ). FDA added information about these serious adverse events to the EUA fact sheets * ; CDC updated patient and clinician education and communication materials, † and federal agencies continue to closely monitor reports of these serious adverse events.…”

mentioning

confidence: 99%

Use of COVID-19 Vaccines After Reports of Adverse Events Among Adult Recipients of Janssen (Johnson & Johnson) and mRNA COVID-19 Vaccines (Pfizer-BioNTech and Moderna): Update from the Advisory Committee on Immunization Practices — United States, July 2021

Rosenblum¹,

Hadler²,

Moulia³

et al. 2021

MMWR Morb. Mortal. Wkly. Rep.

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Updated Recommendations from the Advisory Committee on Immunization Practices for Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine After Reports of Thrombosis with Thrombocytopenia Syndrome Among Vaccine Recipients — United States, April 2021

Cited by 177 publications

References 5 publications

A COVID-Positive 52-Year-Old Man Presented With Venous Thromboembolism and Disseminated Intravascular Coagulation Following Johnson & Johnson Vaccination: A Case-Study

A COVID-Positive 52-Year-Old Man Presented With Venous Thromboembolism and Disseminated Intravascular Coagulation Following Johnson & Johnson Vaccination: A Case-Study

Vaccine-induced immune thrombotic thrombocytopenia and cerebral venous sinus thrombosis post COVID-19 vaccination; a systematic review

Use of COVID-19 Vaccines After Reports of Adverse Events Among Adult Recipients of Janssen (Johnson & Johnson) and mRNA COVID-19 Vaccines (Pfizer-BioNTech and Moderna): Update from the Advisory Committee on Immunization Practices — United States, July 2021

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