Changes in incidence rates of outcomes of interest in vaccine safety studies during the COVID-19 pandemic

Yoon

Acta Neuro Scandinavica

et al. 2022

Background and Purpose Miller Fisher syndrome (MFS), a variant of Guillain–Barré Syndrome (GBS), could be underestimated in evaluations of its adverse events (AEs) following COVID‐19 vaccination. We aimed to identify and characterize MFS following COVID‐19 vaccination. Materials and Methods Relevant studies reported on during the COVID‐19 pandemic were identified in the MEDLINE, Embase, and other databases. Results Nine cases of MFS following COVID‐19 vaccination from various regions were included. Unlike MFS following COVID‐19 infection, patients with MFS following COVID‐19 vaccination frequently presented with anti‐GQ1b antibody positivity (44%, 4/9). Unlike GBS following COVID‐19 vaccination, only two of nine (22%) cases of MFS following COVID‐19 vaccination had developed after viral‐vector‐related vaccine administration. Conclusions Miller Fisher syndrome following COVID‐19 vaccination seems to have a different pathophysiology from MFS following COVID‐19 infection and GBS following COVID‐19 vaccination. This neurological syndrome with a rare incidence and difficulty in diagnosis should be considered an AE of COVID‐19 vaccination.

Section: Discussionmentioning

confidence: 99%

“…MFS or other variants of GBS therefore appeared to be underestimated in surveillance systems for COVID‐19 vaccination safety. Moreover, specific environments around the world during the COVID‐19 pandemic may influence the healthcare delivery system and distort valid diagnoses and medical outcome registration 22 …”

Section: Discussionmentioning

confidence: 99%

Miller Fisher syndrome following COVID ‐19 vaccines: A scoping review

Yoon

Acta Neuro Scandinavica

et al. 2022

“…Xu et al conducted a retrospective cohort study and reported that the ITP incidence decreased significantly after the beginning of the pandemic. 20 Another single-center study reported that newly diagnosed thrombocytopenia in children decreased during the lockdown due to the pandemic, probably because of barrier measures that had reduced the incidence of viral triggers thought to be responsible for the vast majority of ITP cases involving children. 21 In the present study, we analyzed the incidence of ITP and severe ITP by age group during a period of decreased viral infections due to NPI to predict the degree to which viral infections contribute to ITP in each age group.…”

Section: Discussionmentioning

confidence: 99%

Changes in the Incidence of Immune Thrombocytopenia in the Coronavirus Disease 2019 Era: A Nationwide Observational Study in Korea

Choi¹,

Jung²,

Kim³

et al. 2023

RMHP

We investigated whether nonpharmaceutical interventions (NPI) to reduce the spread of coronavirus disease 2019 (COVID-19) was associated with a change in the incidence of immune thrombocytopenia (ITP). Patients and Methods: Using the Korean Health Insurance Review and Assessment Services (HIRA) database, individuals newly diagnosed with ITP between January 2015 and December 2020 were identified. The NPI period was defined as February 2020 to December 2020. The ITP incidence in the NPI period was compared with the mean annual incidence during the same months in the pre-NPI period and the incidence predicted by the autoregressive integrated moving average model. Results: In total, 25,723 patients were identified, and the overall annual incidence of ITP was 8.28 per 100,000 persons ([95% confidence interval (CI): 8.18-8.39]. The ITP incidence in the NPI period was 6.60 per 100,000 person-years (95% CI: 6.37-6.85), 0.77 times (95% CI: 0.74-0.80) lower than that during the pre-NPI period [8.62/100,000 (95% CI: 8.50−8.74)]. With the exception for patients aged ≥70 years, the ITP incidence was significantly lower in the NPI period than in the pre-NPI period. The most significant decline in the ITP incidence during the NPI period was observed in the 0-9 years age group [25.76/100,000 vs 14.01/100,000, P <0.001; incidence rate ratio (IRR): 0.54 (95% CI: 0.51-0.58)]. The intravenous immunoglobulin-treated ITP incidence in the NPI period was 1.69/100,000 (95% CI: 1.58-1.81), 0.79 times (95% CI: 0.73-0.85) lower than that in the pre-NPI period 2.15/100,000 (95% CI: 2.09−2.21)]. The incidence of steroid-treated ITP was lower in the NPI period than in the pre-NPI period (2.73/100,000 vs 2.2/100,000, P <0.001), with an IRR of 0.80 (95% CI: 0.76-0.83). Conclusion:This nationwide study revealed a significant decrease in ITP incidence, particularly among children, after the implementation of NPI.

“…Additionally, the hypersomnolence and quality of life of patients with narcolepsy are highly correlated with symptom control through medication use [ 16 ], and the medication use of these patients may have changed during Taiwan’s 2021 lockdown [ 12 , 58 ]. The decline in the incidence of narcolepsy observed during the pandemic suggests that these patients had difficulty reaching out for medical services during this period [ 60 ]; to cope in this scenario, patients may decrease their dosage or comply poorly with their medication regimen. However, drug adherence can also be improved by a less stressful work or study situation and more family supervision during home confinement.…”

Section: Discussionmentioning

confidence: 99%

Impact of Taiwan’s 2021 COVID-19 lockdown on the symptom severity and quality of life of patients with narcolepsy

Chin

Huang

Tang

et al. 2023

Sleep Biol. Rhythms

COVID-19 lockdowns can influence the sleep quality and daytime condition of patients with narcolepsy. Using data from our cohort study, we investigated changes in the quality of life and the symptom severity of patients with narcolepsy during Taiwan’s 2021 lockdown and investigated differences by narcolepsy subtype, sex, and age. Patients with type 1 and type 2 narcolepsy (NT1 and NT2, respectively) aged 6–40 years were retrospectively recruited from our narcolepsy cohort study. These patients were regularly evaluated using the Short Form 36 Health Survey questionnaire (SF-36), the Epworth Sleepiness Scale (ESS), the visual analog scale (VAS) for hypersomnolence, the VAS for cataplexy and sleep diary. We compared the differences between the lockdown and the prelockdown periods by narcolepsy subtype, sex, and age. We used a paired t test analysis to compare differences in the SF-36, ESS, VAS scores and data of sleep diary between the prelockdown and lockdown periods ( p 1), and an independent t test analysis was used to compare the changes in different subgroups between the prelockdown and lockdown periods ( p 2). A total of 120 patients with narcolepsy were recruited (mean age 24.22 ± 6.87 years; 58% male); 80 of the patients had NT1 (mean age 25.25 ± 6.79 years; 60% male) and 40 had NT2 (mean age 22.16 ± 6.64, 53% male). During the lockdown period, the ESS score of total patients was decreased ( p = 0.039) and body mass index was increased ( p = 0.02). The NT1 group decreased significantly ( p 1 = 0.017), especially in men ( p 1 = 0.016) and adults ( p 1 = 0.04); scores for the VT domain of the SF-36 increased significantly in male and adult patients with NT2 ( p 1 = 0.048 and 0.012). Additionally, male patients with NT2 exhibited significantly decreased scores in the physical and emotional role functioning domains ( p 1 = 0.028, 0.024). The children and adolescents with NT1 had significantly decreased scores in the general health domain of the SF-36, but no significant change was noted in that of adults ( p 1 = 0.027, p 2 = 0.012). We observed both negative and positive impacts of Taiwan’s 2021 lockdown on patients with narcolepsy. A more flexible but structured daily routine with adequate sleep time should be considered for this population during lockdown and nonlockdown periods.