<scp>BNT162b2 mRNA SARS‐CoV</scp>‐2 vaccination does not cause upregulation of endothelial activation markers or hypercoagulability: A prospective, <scp>single‐arm</scp>, longitudinal study

Lim, Xin Rong; Leung, Bernard P.; Sum, Christina Lai Lin; Lim, Gek Hsiang; Chua, Choon Guan; Tu, Tian Ming; Ramanathan, Kollengode; Huang, Mei; Howe, Hwee Siew; Fan, Bingwen Eugene

doi:10.1002/ajh.26462

Cited by 5 publications

(4 citation statements)

References 12 publications

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“…In another study of Campello et al, they also reported that there were no significant features of hypercoagulability or platelet activation after the first dose of BNT162b2 vaccination in healthy volunteers (5). Lim et al also reported similar results after BNT162b2 vaccination showing no upregulated endothelial markers or hypercoagulability (6).…”

Section: Discussionmentioning

confidence: 83%

Unusual arm vein thrombosis after the Moderna (mRNA-1273) COVID-19 vaccination—a case report

Kang¹

2022

Ann Palliat Med

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Background: Since 2019, all over the world is still suffering from managing never-experienced pandemic era of coronavirus-2019 . Prompt development and administration of vaccines contributed lowering severity of the disease, but adverse events related to vaccination were also reported. Exact association between each adverse conditions and vaccination or COVID-19 infection are being investigated.Case Description: A 44-year-old Asian male developed right upper arm diffuse swelling 4 days after receiving the third dose of messenger ribonucleic acid (mRNA)-1273 COVID-19 vaccine in his left deltoid muscle. He was previously healthy, but has history of COVID-19 infection 4 months before the third dose vaccination. Venous duplex ultrasound revealed acute thrombosis in the right cephalic arch, axillary vein, and subclavian vein. There were no abnormal laboratory test results. After 3 months of anticoagulation therapy, arm vein thrombosis was completely resolved upon follow-up duplex ultrasonography.Conclusions: Although, positive COVID-19 polymerase chain reaction (PCR) history might be associated with potential cause of this unusual arm vein thrombosis, we postulate that a possible cause may be secondary to his third dose of mRNA-1273 vaccine given the onset and no prior medical comorbidities. Since the previous studies was mostly done based on mRNA vaccines of other manufacturers rather than Moderna, exact thrombosis mechanism of this case was not established yet. Contralateral arm vein thrombosis is unique to report, and future comprehensive studies are needed.

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Section: Discussionmentioning

confidence: 83%

Unusual arm vein thrombosis after the Moderna (mRNA-1273) COVID-19 vaccination—a case report

Kang¹

2022

Ann Palliat Med

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“…Ostrowsky et al [4] observed a clear-cut post-vaccination increase in blood levels of syndecan-1, along with minimal increments in TM, E-selectin, ICAM-1, ICAM-3 and VCAM-1 with all types of vaccines. In 18 participants with a mean age of 35 years, samples collected pre-vaccination, a median of 17 days after the first dose of Comirnaty vaccine, and a median of 9 days after the second dose, showed no evidence of endothelial activation (ICAM, VCAM-1 and P-selectin) or hypercoagulability (PT, aPTT, FVIII, vWF Ag, Clot waveform analysis) [28] . In that study, the statistically significant, but clinically not relevant, post-vaccination increase in ICAM levels was related by the Authors to a local inflammatory immune response to vaccination.…”

Section: Discussionmentioning

confidence: 96%

Head-to-head comparison of four COVID-19 vaccines on platelet activation, coagulation and inflammation. The TREASURE study

Brambilla¹,

Canzano²,

Valle³

et al. 2023

Thrombosis Research

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“…Smaller studies conducted in Singapore (n=18) and Italy (n=30) compared pre-and postbooster vaccination d-dimers using different assays, in participants vaccinated with two doses of Comirnaty vaccine (42,43). Median baseline d-dimers in the predominantly young (median age 35 years; IQR: 31-44) female (78%) Singaporean cohort was 0.32 µg/ml (IQR 0.22-0.38), with similar results post first (0.21 µg/ml; IQR: 0.14-0.35) and second vaccine doses (0.29 µg/ml: IQR 0.24-0.34) (p=0.…”

Section: )mentioning

confidence: 99%

Clot Twist – D-dimer analysis of healthy adults receiving heterologous or homologous booster COVID-19 vaccine after a single prime dose of Ad26.COV2.S in a phase II randomised open-label trial, BaSiS

Patel,

Le Roux,

Sawry

et al. 2024

Preprint

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BaSiS (BoosterAfterSisonkeStudy) is a prospectively enrolled open-label trial in which healthy adults, with controlled co-morbidities and no prior thrombosis, who received a single Ad26.COV2.S prime vaccination primarily through the Sisonke phase IIIB open label implementation study in South Africa. An exploratory objective evaluated the clotting profiles of participants who were enrolled across 4 sites in South Africa and randomised 1:1:1:1 to receive one of full-dose Ad26.COV2.S, half-dose Ad26.COV2.S, full-dose Comirnaty or half-dose Comirnaty booster. D-dimer testing (INNOVANCE®D-Dimer Assay), as a coagulopathy marker, was conducted pre-booster (baseline) and 2 weeks post-booster. The median age among 285 participants was 42.2 years (IQR:35.5-48.7), 235/285 (82.5%) were female, 269/285 (94.4%) were Black African. Of the 40.4% (115/285) people living with HIV (PLHIV), 79.1% (91/115) were well-controlled on antiretroviral therapy. At baseline, 39.3% (112/285) had elevated d-dimers; all asymptomatic. Females and obese participants were significantly more likely to have elevated baseline d-dimers (OR=4.17; 95% CI:1.88 to 9.26 and OR=2.64; 95% CI:1.57 to 4.43, respectively). Of 169 with normal baseline d-dimers, 29 (17.2%) became elevated 2 weeks post-booster: median increase 0.23µg/ml (IQR:0.15-0.42); those receiving full-dose Comirnaty exhibited lower risk of d-dimer elevation post vaccination, compared to other booster vaccination arms (OR:0.26; 95% CI:0.07 to 0.98). PLHIV experienced significantly higher median increases compared to HIV uninfected participants (0.43 vs 0.17, p=0.004). Elevated d-dimers in asymptomatic, low-risk adults were unexpectedly common but were not associated with thromboembolism, supporting the rationale of using d-dimers only if clinically indicated. Trial Registration: South African Clinical Trails Register number DOH-27-012022-7841.

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BNT162b2 mRNA SARS‐CoV‐2 vaccination does not cause upregulation of endothelial activation markers or hypercoagulability: A prospective, single‐arm, longitudinal study

Cited by 5 publications

References 12 publications

Unusual arm vein thrombosis after the Moderna (mRNA-1273) COVID-19 vaccination—a case report

Unusual arm vein thrombosis after the Moderna (mRNA-1273) COVID-19 vaccination—a case report

Head-to-head comparison of four COVID-19 vaccines on platelet activation, coagulation and inflammation. The TREASURE study

Clot Twist – D-dimer analysis of healthy adults receiving heterologous or homologous booster COVID-19 vaccine after a single prime dose of Ad26.COV2.S in a phase II randomised open-label trial, BaSiS

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