Safety and antibody response of the BNT162b2 SARS-CoV-2 vaccine in children aged 5-11 years with underlying diseases: A prospective observational study.

BACKGROUND: Data on the safety and antibody response of the BNT162b2 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mRNA vaccine in children aged 5-11 years with underlying diseases are limited. Thus, our study aimed to address this gap. METHODS: This prospective observational study investigated the antibody titers for SARS-CoV-2 spike protein receptor-binding domain (S-IgG) and nucleocapsid protein (N-IgG) in patients aged 5-11 years with chronic underlying diseases following two doses of BNT162b2. Additionally, a questionnaire was used to assess adverse events (AEs) arising within 7 days after each dose. Data on severe AEs arising within 28 days after each dose were extracted from the patients' electronic medical records. RESULTS: Among 122 patients, 24.6% (30/122) were immunocompromised. Furthermore, 79 patients experienced at least one AE following vaccination, but all recovered without sequelae, including one severe case after the first dose. The seropositivity rate after the second dose was 99.1% (116/117). Excluding 19 N-IgG-positive patients, the geometric mean antibody titer (GMT) was significantly higher in immunocompetent patients than in immunocompromised patients (1496 U/mL [95% confidence interval 1199-1862] vs. 472 U/mL [200-1119], p = 0.035). Additionally, the GMT of S-IgG was higher in N-IgG-positive patients than in N-IgG-negative patients (8203 [5847-11482] U/mL vs. 1127 [855-1486] U/mL, p < 0.001). CONCLUSIONS: BNT162b2 is acceptably safe and immunogenic for children aged 5-11 years with underlying diseases. Although seroconversion was satisfactory in immunocompromised patients, the titers were lower than in immunocompetent patients.

Association between use of antipyretics and antibody titers after two doses of the BNT162b2 SARS-CoV-2 vaccine in adolescents and young adults with underlying diseases.

There are few reports on the association between antipyretic use and antibody titers in adolescents and young adults following SARS-CoV-2 vaccination. Multivariable linear regression analyses were performed to examine the association between antipyretic use and antibody titers. The use of antipyretics was not associated with antibody titers (ß coefficient [95% CI] = -0.107 [-0.438 to 0.224]).

Safety of and antibody response to the BNT162b2 COVID-19 vaccine in adolescents and young adults with underlying disease.

BACKGROUND: Data are limited regarding the safety of and antibody response to the BNT162b2 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) messenger ribonucleic acid vaccine in adolescents and young adults with underlying disease. METHODS: This prospective observational study enrolled patients age 12-25 years with chronic underlying disease who received 2 doses of BNT162b2. A 18-item questionnaire was used to assess adverse events within 7 days post-vaccination, and data regarding severe adverse events were collected from electronic medical records. An antibody titer for the receptor-binding domain of the spike protein in SARS-CoV-2 was used to assess antibody response after the second vaccine dose. RESULTS: Study participants were 429 patients (241 [56.2%] age 12-15 years; 188 [43.8%] age 16-25 years). The most common underlying diseases were genetic or chromosomal abnormalities and/or congenital anomalies, followed by endocrine or metabolic diseases; 32% of participants were immunocompromised. Severe adverse events were observed after the second dose in 1 (0.4%) patient age 12-15 years and in 2 (1.1%) patients age 16-25 years; all patients recovered. Seropositivity after the second vaccine dose was 99.0%. The geometric mean antibody titer was higher in patients age 12-15 years versus 16-25 years (1603.3 [1321.8-1944.7] U/mL vs. 949.4 [744.2-1211.0] U/mL). Compared with immunocompetent patients, immunocompromised patients had a lower antibody titer (2106.8 [1917.5-2314.7] U/mL vs. 467.9 [324.4-674.8] U/mL). CONCLUSIONS: Vaccination with BNT162b2 was acceptably safe and immunogenic for adolescents and young adults with underlying disease.

Three-dimensional Navigation for Thoracoscopic Sublobar Resection Using a Novel Wireless Marking System.

We developed a novel localization technique for small intrapulmonary lesions using radiofrequency identification (RFID) technology. Micro-RFID markers with nickel-titanium coils were designed to be placed from subsegmental bronchi to the peripheral parenchyma. In this preclinical study, thoracoscopic subsegmentectomy of a canine pseudotumor model was performed to demonstrate the feasibility and three-dimensional positional accuracy of the system. To recover subcentimeter pseudotumors, markers were bronchoscopically placed to determine the resection line: (1) next to the pseudotumor; (2) in the responsible subsegmental bronchi as the central margin; and (3) on the intersubsegmental plane as the lateral margin. Specific marker positions were located by wireless communication using a wand-shaped probe with a 30-mm communication range, with the distance to the marker indicated by gradual changes in sound pitch. Thirty-four markers were placed for 10 pseudotumors (14.6 mm from the pleura) in 10 canines. Three markers were placed at a mean distance of 5.5 mm from the pseudotumors, and 11 central and 20 lateral markers were placed at mean distances of 17.2 and 20.7 mm from the pseudotumors, respectively. Central markers (20.5 mm from the pleura) were detected within 16.0 seconds in 2.9-mm-diameter bronchi. All resection stumps were within 5.4 mm (range 2-8 mm) from each marker, and pseudotumors were removed with adequate surgical margins toward the central (11.5 mm; range 7-16 mm) and lateral (12.4 mm; range 9-17 mm) directions. RFID wireless markers provided precise three-dimensional positional information and are a potential viable alternative to conventional markers.

Localizing small lung lesions in video-assisted thoracoscopic surgery via radiofrequency identification marking.

BACKGROUND: To facilitate accurate localization of small lung lesions in thoracoscopic surgery, we employed a micro-radiofrequency identification tag designed to be delivered through the 2-mm working channel of a flexible bronchoscope. This report presents the results of preclinical studies of our novel localizing technique in a canine model. METHODS: To evaluate functional placement, three types of tags [Group A, tag alone (n = 18); Group B, tag + resin anchor (n = 15); and Group C, tag + NiTi coil anchor (n = 15)] were bronchoscopically placed in subpleural areas and subsegmental bronchi via our new delivery device; tags were examined radiographically on days 0-7 and day 14. In addition, eight tags, which were placed at a mean depth of 13.3 mm (range 9-15.7 mm) from visceral pleura in bronchi with a mean diameter of 1.46 mm (range 0.9-2.3 mm), were recovered by partial lung resection under video-assisted thoracoscopic surgery using a 13.56-MHz wand-shaped probe with a 30-mm communication range. RESULTS: Peripheral airway placement: Group C had a significantly higher retention rate than the other two groups (retention rate at day 14: Group A, 11.1 %; Group B, 26.7 %; Group C, 100.0 %; P < 0.0001). Central airway placement: Overall retention rate was 73.3 % in Group C, and placement was possible in bronchi of up to 3.3 mm in diameter. Outcomes of partial resection: Tag recovery rate was 100 %, mean time required for tag detection was 10.8 s (range 8-15 s), and mean surgical margin from the delivered tag was 9.13 mm (range 6-13 mm). CONCLUSION: Radiofrequency identification marking enabled accurate localization with depth, which could ensure effective deep resection margins.