COVID-19 Vaccination of Individuals with Down Syndrome—Data from the Trisomy 21 Research Society Survey on Safety, Efficacy, and Factors Associated with the Decision to Be Vaccinated

Hüls, Anke; Feany, Patrick T.; Zisman, Sophia; Costa, Alberto C. S.; Dierssen, Mara; Balogh, Robert; Bargagna, Stefania; Baumer, Nicole; Brandão, Ana Denise; Carfì, Angelo; Chicoine, Brian; Ghosh, Sujay; Lakhanpaul, Monica; Xiong, Chengjie; Lunsky, Yona; Manso, Coral; Okun, Eitan; Asúa, Diego Real de; Rebillat, Anne-Sophie; Rohrer, Tilman; Sgandurra, Giuseppina; Valentini, Diletta; Sherman, Stephanie L.; Strydom, André

doi:10.3390/vaccines10040530

Cited by 10 publications

(8 citation statements)

References 34 publications

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“…Thus, 34 records were excluded, and the remaining 50 records entered our study. Of the 50 studies, 17 articles comparing BP incidence in SARS-CoV-2–vaccinated and control groups that could be pooled were included in the meta-analysis, and the remaining 33 articles were included only in the qualitative synthesis (ie, the characteristics of which were extracted and formatted into eTable 2 in Supplement 1).…”

Section: Resultsmentioning

confidence: 99%

“…The 50 included studies comprised 22 case reports and case series, 2 SCCSs, 2 case-control studies, 3 cross-sectional studies, 16 cohort studies, and 5 RCTs . A summary of the characteristics of the included studies is represented in the Table (case reports and case series are summarized in eTable 3 in Supplement 1) and detailed in eTable 2 in Supplement 1.…”

Section: Resultsmentioning

confidence: 99%

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Association of SARS-CoV-2 Vaccination or Infection With Bell Palsy

Rafati

Pasebani

Jameie

et al. 2023

JAMA Otolaryngol Head Neck Surg

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ImportanceBell palsy (BP) has been reported as an adverse event following the SARS-CoV-2 vaccination, but neither a causative relationship nor a higher prevalence than in the general population has been established.ObjectiveTo compare the incidence of BP in SARS-CoV-2 vaccine recipients vs unvaccinated individuals or placebo recipients.Data SourcesA systematic search of MEDLINE (via PubMed), Web of Science, Scopus, Cochrane Library, and Google Scholar from the inception of the COVID-19 report (December 2019) to August 15, 2022.Study SelectionArticles reporting BP incidence with SARS-CoV-2 vaccination were included.Data Extraction and SynthesisThis study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline and was conducted with the random- and fixed-effect models using the Mantel-Haenszel method. The quality of the studies was evaluated by the Newcastle-Ottawa Scale.Main Outcomes and MeasuresThe outcomes of interest were to compare BP incidence among (1) SARS-CoV-2 vaccine recipients, (2) nonrecipients in the placebo or unvaccinated cohorts, (3) different types of SARS-CoV-2 vaccines, and (4) SARS-CoV-2–infected vs SARS-CoV-2–vaccinated individuals.ResultsFifty studies were included, of which 17 entered the quantitative synthesis. Pooling 4 phase 3 randomized clinical trials showed significantly higher BP in recipients of SARS-CoV-2 vaccines (77 525 vaccine recipients vs 66 682 placebo recipients; odds ratio [OR], 3.00; 95% CI, 1.10-8.18; I2 = 0%). There was, however, no significant increase in BP after administration of the messenger RNA SARS-CoV-2 vaccine in pooling 8 observational studies (13 518 026 doses vs 13 510 701 unvaccinated; OR, 0.70; 95% CI, 0.42-1.16; I2 = 94%). No significant difference was found in BP among 22 978 880 first-dose recipients of the Pfizer/BioNTech vaccine compared with 22 978 880 first-dose recipients of the Oxford/AstraZeneca vaccine (OR, 0.97; 95% CI, 0.82-1.15; I2 = 0%). Bell palsy was significantly more common after SARS-CoV-2 infection (n = 2 822 072) than after SARS-CoV-2 vaccinations (n = 37 912 410) (relative risk, 3.23; 95% CI, 1.57-6.62; I2 = 95%).Conclusions and RelevanceThis systematic review and meta-analysis suggests a higher incidence of BP among SARS-CoV-2–vaccinated vs placebo groups. The occurrence of BP did not differ significantly between recipients of the Pfizer/BioNTech vs Oxford/AstraZeneca vaccines. SARS-CoV-2 infection posed a significantly greater risk for BP than SARS-CoV-2 vaccination.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Association of SARS-CoV-2 Vaccination or Infection With Bell Palsy

Rafati

Pasebani

Jameie

et al. 2023

JAMA Otolaryngol Head Neck Surg

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“…The 50 included studies comprised 22 case reports and case series (30, 53-73), two self-controlled case series (SCCS) (74, 75), two case controls (76, 77), three cross sectionals (78-80), 16 cohorts (48, 81-95), and five RCTs (96-100). A summary of the characteristics of the included studies is represented in Table 1 (case reports and case series are summarized in the supplementary Table S9) and detailed in the supplementary Table S8.…”

Section: Resultsmentioning

confidence: 99%

Bell’s Palsy Following SARS-CoV-2 Vaccines: A Systematic Review and Meta-Analysis

Rafati

Pasebani

Jameie

et al. 2022

Preprint

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Background and Objective Bell's palsy (BP) has been considered as a serious adverse event following the SARS-CoV-2 vaccination. Many studies have reported BP following vaccination, although neither a causative relationship nor a prevalence of the condition higher than the general population has been established. The outcomes of interest were to compare BP incidence among (a) SARS-CoV-2 vaccine recipients, (b) nonrecipients in the placebo or unvaccinated cohorts, (c) different types of SARS-CoV-2 vaccines, and (d) SARS-CoV-2 infected vs. SARS-CoV-2 vaccinated individuals. Methods We performed a systematic search through MEDLINE (via PubMed), Web of Science, Scopus, Cochrane library, and Google Scholar from the inception to August 15, 2022. We included articles reporting individuals receiving any SARS-CoV-2 vaccine in whom BP had occurred. Studies reporting facial paralysis due to etiologies other than BP were excluded. Random- and fixed-effects meta-analyses using the Mantel-Haenszel method were conducted for the quantitative synthesis. Newcastle-Ottawa scale (NOS) was used to assess the quality. The study was conducted in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline, and the protocol was registered with PROSPERO (CRD42022313299). Analyses were carried out using the R, version 4.2.1 (R package 'meta' version 5.2-0). Results Fifty studies were included, of which 17 entered the quantitative synthesis. First, pooling four phase-3 randomized controlled trials (RCT) indicated BP occurrence was significantly higher in SARS-CoV-2 vaccines (77, 525 doses) compared to placebo (66, 682 doses) (OR = 3.00, 95% CI = 1.10 - 8.18, I2 = 0%). Second, pooling nine observational studies of mRNA SARS-CoV-2 vaccine doses (13, 518,026) and matched unvaccinated individuals (13, 510,701) revealed no significant increase in the odds of BP in the vaccinated group compared to the unvaccinated group (OR: 0.70 (95% CI 0.42-1.16), I2=94%). The third meta-analysis suggested that post-vaccination BP among first dose Pfizer/BioNTech recipients (22,760,698) did not significantly differ from that in first dose Oxford/AstraZeneca recipients (22,978,880) (OR = 0.97, 95% CI = 0.82 - 1.15, I2 = 0%). According to the fourth meta-analysis, BP was significantly more commonly reported after SARS-CoV-2 infection (2,641,398) than after SARS-CoV-2 vaccinations (36,988,718) (RR = 4.03, 95% CI = 1.78 - 9.12, I2 = 96%). Conclusion Our meta-analysis suggests a higher incidence of BP among vaccinated vs. placebo groups. BP occurrence did not significantly differ between Pfizer/BioNTech and Oxford/AstraZeneca vaccines. SARS-CoV-2 infection posed a significantly greater risk for BP than SARS-CoV-2 vaccines.

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“…Promisingly, COVID‐19 vaccination rates have been high in the Down syndrome population (Huls et al . 2022), which may signal more trust in vaccines and eagerness to participate in vaccine research. However, based on our findings and the general hesitancy around vaccines, it is likely that increased clinical participation of individuals with Down syndrome in studies involving vaccinations will remain a challenge.…”

Section: Resultsmentioning

confidence: 99%

Caregivers' perception of adults with Down syndrome willingness to participate in research

Kyprianou

Hendrix²,

Hillerstrom³

et al. 2022

J intellect Disabil Res

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Background Historically, individuals with Down syndrome have been excluded from clinical research. Our objective was to assess the degree of interest adults with Down syndrome have in participating in research from the perspective of the caregivers who care for them. Methods We conducted an online survey of N = 390 caregivers of adults with Down syndrome and asked about interest in research participation and demographics. Results Caregivers were mostly family members, older than 55 years, and White. Caregivers reported that the adult with Down syndrome that they cared for would be more comfortable participating in research that was physiological, such as research involving fit bits (70.2% would participate), exercise (63.3%) or diet apps (53.9%), whereas they would be less likely to participate in clinical trials involving more invasive procedures such as injections (10.9%) and laboratory exams like MRIs (32.0%). We found little difference by age or gender of the adult with Down syndrome or by caregiver education level. Conclusions Our survey identified high interest for less invasive studies, illustrating acceptability of observational and lifestyle studies. More effort may be needed to understand fear and barriers to participation and to create tools and methods to increase interest in more invasive studies.

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COVID-19 Vaccination of Individuals with Down Syndrome—Data from the Trisomy 21 Research Society Survey on Safety, Efficacy, and Factors Associated with the Decision to Be Vaccinated

Cited by 10 publications

References 34 publications

Association of SARS-CoV-2 Vaccination or Infection With Bell Palsy

Association of SARS-CoV-2 Vaccination or Infection With Bell Palsy

Bell’s Palsy Following SARS-CoV-2 Vaccines: A Systematic Review and Meta-Analysis

Caregivers' perception of adults with Down syndrome willingness to participate in research

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