BACKGROUND:Laryngeal chondroradionecrosis (LCRN) is a rare but severe complication of radiation therapy. The study aimed to review the management of LCRN and evaluate the clinical benefit of hyperbaric oxygen therapy (HBOT). METHODS:We retrospectively analyzed all radiation-induced LCRN patients between 2006 and 2019 at a tertiary medical center. Diagnosis was based on signs and symptoms of Chandler's classification, imaging, and/or histopathology report. The primary outcome was improvement in Chandler's grade after HBOT. RESULTS:Of 678 irradiated laryngeal cancer patients, 29 (4.3%) were diagnosed with LCRN. The most common primary management was tracheostomy with intravenous steroids and antibiotics (59%). Ten patients received HBOT (34.5%), and six underwent total laryngectomy (21%). In HBOT-treated patients, Chandler's grade significantly improved from a median of 4 (range 2-4) to 2.5 (range 1-4; p = 0.005). CONCLUSIONS:HBOT may benefit in the management of patients with persistence and unresponsive symptoms of LCRN following radiation therapy for laryngeal SCC.
Objective:The study aimed to identify factors affecting the management and prognosis of iatrogenic cervical oesophageal and hypopharyngeal perforations (iCEHPs). Methods:We retrospectively analysed 24 patients treated for iCEHP between 2004 and 2021 at a tertiary university medical centre. Data on demographics, clinical features, imaging, management and outcomes were collected. Factors associated with primary management and patient outcome were assessed. Results:The most common management approach was surgical neck exploration (15 patients, 62.5%). Surgical management was used in 93% of uncontained perforations compared to 11% of contained perforations (p < 0.001). Surgically-treated patients had higher levels of C-reactive protein (CRP) than conservatively-treated patients (median, 18.3 vs 4.8 mg/dL; p = 0.001). Delayed diagnosis (≥ 24 hours) was associated with increased mortality (100 vs 5%; p = 0.011). The mortality rate was significantly higher in patients who had a history of neck irradiation than in patients who did not (67 vs 5%; p = 0.032). Conclusions:Early diagnosis of iCEHP improves outcomes. The appropriate management should be carefully selected on the basis of CRP level and imaging findings. Prior neck radiation is a poor prognostic factor.
Patients with plasma cell disorders (PCD) are at an increased risk for severe morbidity and mortality due to COVID-19. Recent data have suggested that patients with hematological malignancies, including those with PCD, have suboptimal antibody response to COVID-19 vaccination. We compared the antibody titers of 213 patients with PCD to those of 213 immunocompetent healthcare workers after the second vaccine dose of the BNT162b2 mRNA vaccine. Blood samples were taken 2-4 weeks after the second vaccination and analyzed for anti-receptor binding-domain immunoglobulin G (RBD-IgG) antibodies and neutralizing antibodies (NA). At a median of 20 days after the second vaccine dose, 172 patients (80.8%) developed anti-RBD-IgG antibodies with a geometric mean titer (GMT) of 2.7 (95% confidence interval [CI], 2.4-3.1). In the control group 210 (98.9%) developed anti-RBD-IgG antibodies after a median of 21 days, with a GMT of 5.17 (95%CI, 4.8-5.6), p<0.0001. NA were observed in 151 patients with MM (70.9%) and in 210 controls (98.9%). The GMT of NA in patients with MM and controls was 84.4 (95% CI, 59.0-120.6), and 420.2 (95% CI, 341.4-517.1), respectively (p<0.0001). Multivariable logistic regression revealed that the number of prior therapy lines and age were significant predictors of poor humoral response among patients with MM. Injection site reaction, headache and fatigue were the most common adverse events after vaccination. Adverse events were less common in patients with MM than in controls. In conclusion, a significant percentage of patients with MM developed protecting NA to the BNT162b2 mRNA vaccine, which appears to be safe in this patient population.
Objective. The aim of this study was to review the long-term complications associated with treatment of patients with sinonasal malignancies (SNMs) and risk factors for these complications. Methods. A retrospective analysis of all patients treated for SNMs at a tertiary care center between 2001 and 2018. A total of 77 patients were included. The primary outcome measure was post-treatment long-term complications.Results. Overall, long-term complications were identified in 41 patients (53%), and the most common were sinonasal (22 patients, 29%) and orbital/ocular-related (18 patients, 23%). In a multivariate regression analysis, irradiation was the only significant predictor of long-term complications (p = 0.001, OR = 18.86, CI = 3.31-107.6). No association was observed between long-term complications and tumour stage, surgical modality, or radiation dose/modality. Mean radiation dose & GE; 50 Gy to the optic nerve was associated with grade & GE; 3 visual acuity impairment (100% vs 3%; p = 0.006). Radiation therapy for disease recurrence was associated with additional long-term complications (56% vs 11%; p = 0.04). Conclusions. Treatment of SNMs has substantial long-term complications, which are significantly associated with radiation therapy.
AIM:Patients with cancer are at an increased risk for severe coronavirus disease of 2019. We previously reported initial findings from a single centre prospective study evaluating antibody response after BNT162b2 vaccine, showing that adequate antibody response was achieved after two doses, but not after one, in patients with cancer vaccinated during anticancer therapy. Herein, we report a follow-up study, evaluating antibody response six months after the second vaccine dose.METHODS:The study included patients with solid tumours undergoing anticancer treatment, and immunocompetent health-care workers serving as controls. Serum titres of the receptor-binding domain (RBD) IgG and neutralising antibodies (Nabs) were measured approximately six months after the second vaccine dose. Complete blood count values were collected and evaluated as predictors for antibody response.RESULTS:The analysis included 93 patients with cancer (66.7% metastatic). Six months after the second vaccine dose (mean 176 ± 20 days), seropositivity rate among patients and controls was 83.9% versus 96.3% (p = 0.0001), respectively. Median RBD-IgG titre was lower among patients compared with controls (2.3 versus 3.2, p = 0.0002). Among seropositive individuals, median Nabs titre was similar between patients with cancer and controls (p = 0.566). Among patients with cancer, lymphocyte and neutrophil counts were not correlated with either RBD-IgG or Nabs titres.CONCLUSIONS:Seropositivity rates and RBD-IgG titre at six months after second BNT162b2 vaccine dose are lower among patients with cancer compared with healthy controls. However, Nabs titre is similar, suggesting a comparable protection among seropositive individuals. Lymphocyte count is not predictive of antibody response.
A retrospective clinicopathological analysis was performed to compare 35 proliferative verrucous leukoplakia (PVL), 40 leukoplakia without dysplasia (LK), 48 oral lichen planus (OLP)/oral lichenoid lesions (OLL), and 11 verrucous carcinoma (VC) (N = 134). The PVL group comprised 24 female and 11 male patients (mean age 66.5 years), with two to six sites involved (mean 3.1 sites) and multiple biopsies over time (mean 7.1/case). All PVL cases developed malignancy: 77.1% squamous cell and 40% verrucous carcinoma; 68.6% had multiple sites of malignancy. None showed local or distant metastatic spread. Five-year disease-specific survival was 88.6%. In LK and OLP/OLL, malignant transformation was significantly lower than in PVL (2.5% and 2.1%, respectively). Invasive squamous cell carcinoma was not reported in any conventional VC. Immunohistochemical histomorphometric analysis for p53, COX-2, and podoplanin showed no significant differences between the groups. PVL may overlap with LK, OLP/OLL, and VC, but has a persistent aggressive behaviour and high malignant transformation rate. The overlapping features may delay recognition as PVL. The results emphasize the need for a detailed clinicopathological definition of PVL, and long-term close monitoring to ensure progression to PVL and malignancy are recognized in time. The management of this persistent aggressive condition is challenging.
Objectives: The BNT162b2 mRNA COVID-19 vaccine has been found to be highly effective in preventing COVID-19 but is associated with increased reactogenicity. We aimed to examine the correlation between immunogenicity and reactogenicity of the BNT162b2 vaccine. Methods: Subjects without prior SARS-CoV-2 infection that participated in active surveillance after being vaccinated with the BNT162b2 vaccine were included. Study participants reported adverse drug reactions (ADRs) through questionnaires administered by text message after receiving each dose of the vaccine. A reactogenicity score was developed based on the type and duration of ADRs. In addition, anti-receptor binding domain (RBD) levels and neutralization assays were performed 7–21 and 7–38 days after the first and second vaccine doses, respectively. Associations between ADRs and antibody levels were assessed by Spearman correlations. Multivariable logistic regression analyses were used to identify factors associated with ADRs. Results: A total of 831 health care workers were included. The mean age was 46.5 years (SD = 11.8) and 75.5% were females. 83.4% and 83.3% had at least one local ADR after the first and second doses, respectively. 33% and 83.2% had at least one systemic ADR after the first and second doses, respectively. Multivariate logistic regression analysis found a significant correlation between ADR score and anti-RBD-IgG titers (r = 0.366; p < 0.0001) after adjustment for age, gender, and days after the second vaccination. High anti-RBD-IgG levels, being younger than 55 and being female, were all correlated with increased rates of ADRs. Conclusion: BNT162b2 mRNA COVID-19 vaccine reactogenicity appears to be correlated with higher post-vaccination antibody levels and is independently associated with younger age and female gender.
Approximately 1-8% of individuals do not develop antibodies following SARS-CoV-2 infection (sero-negatives). One BNT162b2 dose resulted in potent humoral response in 14 sero-negatives and 15 sero-positives, significantly higher than the response of 15 naïve-individuals, to two doses suggesting that COVID-19 provoked a memory response in individuals without detectable antibodies.
Shmueli et al. analysed the immune response to two doses of the Pfizer (BNT162b2) vaccine in 129 patients treated for cancer [1Shmueli E.S. Itay A. Margalit O. Berger R. Halperin S. Jurkowicz M. et al.Efficacy and safety of BNT162b2 vaccination in patients with solid cancer receiving anticancer therapy – a single centre prospective study.Eur J Cancer. 2021; 157: 124-131Abstract Full Text Full Text PDF PubMed Scopus (35) Google Scholar]. They reported that 84% of these patients were seropositive after the second injection, but that the seropositivity rate after each dose was significantly lower than that in the 348 controls. Similar results have been published for a larger prospective study comparing 232 patients and 261 public health workers in good health, which reported anti-SARS-CoV-2 antibody development after the first dose in 84% of the control group but only 29% of cancer patients [2Goshen-Lago T. Waldhorn I. Holland R. Szwarcwort-Cohen M. Reiner-Benaim A. Shachor-Meyouhas Y. et al.Serologic status and toxic effects of the SARS-CoV-2 BNT162b2 vaccine in patients undergoing treatment for cancer.JAMA Oncol. 2021; 7: 1507-1513https://doi.org/10.1001/jamaoncol.2021.2675Crossref PubMed Scopus (127) Google Scholar]. However, after the second dose, 86% of the cancer patients were seropositive. Several studies have confirmed the insufficiency of a single injection in patients with cancer and a weaker, more heterogeneous and less durable immune response following the second injection, attributable to the immunosuppressive effects of cancer itself or of the treatments administered particularly for cytotoxic treatments [3Barrière J. Chamorey E. Adjtoutah Z. Castelnau O. Mahamat A. Marco S. et al.Impaired immunogenicity of BNT162b2 anti-SARS-CoV-2 vaccine in patients treated for solid tumors.Ann Oncol. 2021; 32: 1053-1055Abstract Full Text Full Text PDF PubMed Scopus (100) Google Scholar,4Monin L. Laing A.G. Muñoz-Ruiz M. McKenzie D.R. del Molino del Barrio I. Alaguthurai T. et al.Safety and immunogenicity of one versus two doses of the COVID-19 vaccine BNT162b2 for patients with cancer: interim analysis of a prospective observational study.Lancet Oncol. 2021; 22: 765-778Abstract Full Text Full Text PDF PubMed Scopus (427) Google Scholar]. The aim of the study by Shmueli et al. was to investigate the clinical characteristics potentially associated with seronegativity, including age, BMI, type of cancer, stage (localised, metastatic), comorbid conditions and type of treatment [1Shmueli E.S. Itay A. Margalit O. Berger R. Halperin S. Jurkowicz M. et al.Efficacy and safety of BNT162b2 vaccination in patients with solid cancer receiving anticancer therapy – a single centre prospective study.Eur J Cancer. 2021; 157: 124-131Abstract Full Text Full Text PDF PubMed Scopus (35) Google Scholar]. In our view, the degree of lymphopenia is an important factor missing from this list. In June 2021, before the proposal of a third dose of the vaccine for this high-risk population, the French Directorate General for Health recommended a third dose of the vaccine for patients with lymphopenia without specifying a threshold value. In this context, we performed a prospective single-centre study at Foch Hospital in France, with the aim of evaluating antibody titers in patients with a solid tumour (other than lung cancers) who had received two doses of vaccine and were treated as outpatients and to assess the correlation between these titers and lymphopenia. The study was approved by the institutional review board (IRB) of the hospital (00012437). The blood sample for antibody and lymphocyte determinations was taken during the month of July, on the day of chemotherapy or immunotherapy treatment, from a cohort of 237 patients who had received two doses of the Pfizer-BioNTech vaccine (mostly between March and April 2021). The SARS-CoV-2 IgG II Quant assay was used for the detection of anti-spike antibodies. The median antibody level was 1596 AU/ml, and the median lymphocyte count was 1100/mm3. We found a significant correlation between antibody and lymphocyte levels (correlation test; p = 0.01) (Fig. 1). Lymphocyte counts appear to be a simple potential criterion that could be integrated into evaluations, alongside serological tests, to improve the selection of patients requiring an additional booster dose in the future. The type of treatment was not significantly correlated with antibody levels (p = 0.06) in our analysis but may nevertheless be a useful criterion to take into account. The question of the acceptability to patients of a third injection remains in a situation in which the clinical standards have yet to be scientifically established. We are working on the development of appropriate information documents for the patients concerned to help limit the number of refusals [5Stoeklé H.-C. Sekkate S. Angellier E. Hervé C. Beuzeboc P. Refusal of anti-coronavirus disease 2019 vaccination in cancer patients: is there a difference between the sexes?.Eur J Cancer. 2021; 155: 54-55Abstract Full Text Full Text PDF PubMed Scopus (10) Google Scholar]. N/A.
Aim: Patients with cancer are at an increased risk for severe coronavirus disease of 2019, thus data on the safety and efficacy of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccines are essential. We conducted this prospective study of patients with cancer vaccinated with BNT162b2 and monitored for antibody response and safety. The aim was to evaluate the rate of seropositivity and define predictors for non-reactive immune response. Furthermore, we evaluated the frequency and the severity of adverse events. Methods: The study included patients with solid tumours undergoing anticancer treatment and immunocompetent health-care workers serving as controls. Serum titres of the receptor-binding domain (RBD) immunoglobulin G (IgG) and neutralising antibodies were measured 2-4 weeks after each vaccine dose. Results: The analysis included 129 patients, of which 70.5% patients were metastatic. Patients were treated with chemotherapy (55%), immunotherapy (34.1%), biological agents (24.8%), hormonal treatment (8.5%) and radiotherapy (4.6%), that were given either alone or in combinations. The seropositivity rate among patients with cancer and controls was 32.4% versus 59.8% (p < 0.0001) after the first dose and 84.1% versus 98.9% (p < 0.0001) after the second dose, respectively. Median RBD-IgG titre was lower among patients than controls (p < 0.0001). Patients who were seronegative after the second dose had significantly more co -morbidities than that with patients with seropositivity (77.8% vs 41.1%, respectively, p Z 0.0042). Conclusion: Adequate antibody response after BNT162b2 vaccination was achieved after two doses but not after one dose, in patients with cancer vaccinated during anticancer therapy. 2021 Elsevier Ltd. All rights reserved.
Objectives: The immunogenicity and safety of the Pfizer-BioNTech BNT162b2 mRNA vaccine in people living with human immunodeficiency virus type 1 (PLWH) are unknown. We aimed to assess the immunogenicity and safety of this vaccine in PLWH. Methods: In this prospective open study, we enrolled 143 PLWH, aged >= 18 years, who attended our clinic and 261 immunocompetent health-care workers (HCWs). Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) receptor binding domain (RBD) IgG and neutralizing antibodies were measured. Adverse events, viral load and CD4 cell counts were monitored. Results: At a median of 18 days (interquartile range 14-21 days) after the second dose, anti-RBD-IgG was positive in 139/141 (98%) PLWH. Among HCWs, 258/261 (98.9%) developed anti-RBD-IgG at a median of 26 days (interquartile range 24-27 days) after the second dose. Following the second dose, immune sera neutralized SARS-CoV-2 pseudo-virus in 97% and 98% of PLWH and HCWs, respectively. Adverse events were reported in 60% of PLWH, mainly pain at the injection site, fatigue and headache. AIDS-related adverse events were not reported. Human immunodeficiency virus load increased in 3/143 (2%) patients from <40 copies/mL to <= 100 copies/mL. CD4(+) T-cell count decreased from a geometric mean of 700 cells/mu L (95% CI 648-757 cells/mu L) to 633.8 cells/mu L (95% CI 588-683 cells/mu L) (p < 0.01). Conclusions: BNT162b2 mRNA vaccine appears immunogenic and safe in PLWH who are on antiretroviral therapy with unsuppressed CD4 count and suppressed viral load. (C) 2021 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.
The BNT162b2 messenger RNA (mRNA) vaccine against severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) has been shown to be safe and effective in immunocompetent patients. The safety and efficacy of this vaccine in liver transplantation (LT) recipients is still under evaluation. The objective of this study was to assess the safety and efficacy of the BNT162b2 vaccine among transplant recipients. The immune responses of 76 LT recipients receiving 2 doses of the vaccine were compared with those of 174 age‐matched immunocompetent controls. Postvaccination immunoglobulin G (IgG) antibodies against the receptor‐binding domain (RBD) of SARS‐CoV‐2 and neutralizing antibodies (NA) to the BNT162b2 mRNA vaccine were determined at least 14 days after the second dose of the vaccine. IgG antibody titers ≥1.1 were defined as positive antibodies. Adverse effects were monitored during the study period. Following administration of the second dose, transplant recipients showed reduced immune responses compared with controls (72% versus 94.2%; P < 0.001). At a median time of 38 days after the second vaccination, the geometric mean of RBD IgG and NA titers were 2.1 (95% confidence interval [CI], 1.6‐2.6) and 150 (95% CI, 96‐234) among transplant recipients and 4.6 (95% CI, 4.1‐5.1) and 429 (95% CI, 350‐528) in the control group, respectively (P < 0.001). Antibody responses were lower in transplant recipients who were receiving combined immunosuppression therapy and in those with impaired renal function. Among the LT recipients with negative antibody responses, 1 became infected with SARS‐CoV‐2, but no recipients with positive antibody responses became infected. Overall, most (n = 39 [51%]) adverse effects self‐reported by transplant recipients were mild and occurred more often in women than in men. Compared with patients who were immunocompetent, LT recipients had lower immune responses. The durability of immune responses to the BNT162b2 vaccine among LT recipients requires further investigation.
Pregnant and lactating women were excluded from the initial clinical trials in which the safety and efficacy of the BNT162b2 messenger RNA vaccine were evaluated. Consequently, recommendations regarding vaccination of pregnant and lactating women were equivocal.1The American College of Obstetricians and Gynecologists Practice AdvisoryCOVID-19 vaccination considerations for obstetric gynecologic care.https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2020/12/vaccinating-pregnant-and-lactating-patients-against-covid-19Date: 2020Google Scholar Therefore, our aim was to assess whether SARS-CoV-2 immunoglobulins (Igs) can be detected in breastmilk samples of lactating women following SARS-CoV-2 vaccination and whether it can be detected in the serum and oral mucosal secretions of their breastfed infants. This was a longitudinal cohort study, conducted between December 2020 and April 2021. Samples were collected from lactating women who were vaccinated against COVID-19 after delivery and their breastfed infants. Blood samples and breastmilk were obtained from all study participants, and dried blood spot (DBS) samples from breastfed infants were collected on Guthrie cards. In addition, the saliva of infants was collected from oral mucosa immediately after breastfeeding and at 30, 90, and 150 minutes after breastfeeding. All serum samples were tested for the presence of SARS-CoV-2 IgG. DBS and milk samples were tested for SARS-CoV-2 IgG and IgA by a receptor-binding domain enzyme-linked immunosorbent assay, and a sample cutoff (S/Co) of ≥1.1 was considered a positive result. In addition, a neutralization assay was performed on milk samples using a green fluorescent protein reporter-based pseudotyped virus with a vesicular stomatitis virus backbone coated with SARS-CoV-2 spike protein. Sera, not capable of reducing viral replication by 50% at a dilution of 1 to 8, were considered nonneutralizing. Women who were diagnosed with COVID-19 infection and those who were vaccinated before birth were excluded. Maternal sera and breastmilk samples were obtained from 61 participating women. All maternal serum and breastmilk samples were positive for SARS-CoV-2 IgG with median concentrations of 31.7 S/Co (interquartile range [IQR], 25.1–38.1) and 6.3 S/Co (IQR, 5.1–7.4), respectively. There was a significant positive correlation between the SARS-CoV-2 IgG levels in the maternal serum samples and those in breastmilk samples (r=0.514; P=.0001). Moreover, 18 of 47 milk samples (38.3%) were found to neutralize SARS-CoV-2 infectivity (Figure). SARS-CoV-2 IgG was detected in the oral mucosa of 3 of 5 (60%) breastfed infants. However, all of the DBS samples obtained from 21 infants were negative for these antibodies. SARS-CoV-2 IgA in secretory form was detected in 15% of the breastmilk samples with a median of 0.4 S/Co (IQR, 0.3–0.7). In this longitudinal cohort study, lactating women vaccinated against COVID-19 were found to have SARS-CoV-2 IgG in their breastmilk samples, and nearly half of the samples enabled neutralization of SARS-CoV-2 infectivity. IgG antibodies were found in the oral mucosa of 3 (60%) of the infants' samples, but IgG antibodies were not found in their circulation. To date, there are 3 studies of vaccinated lactating women, which enrolled 5, 31, and 84 women, respectively. All of these studies found vaccine-generated IgG and IgA antibodies in breastmilk samples,2Gray K.J. Bordt E.A. Atyeo C. et al.Coronavirus disease 2019 vaccine response in pregnant and lactating women: a cohort study.Am J Obstet Gynecol. 2021; 225: 303.e1-303.e17Abstract Full Text Full Text PDF PubMed Scopus (431) Google Scholar, 3Perl S.H. Uzan-Yulzari A. Klainer H. et al.SARS-CoV-2-specific antibodies in breast milk after COVID-19 vaccination of breastfeeding women.JAMA. 2021; 325: 2013-2014Crossref PubMed Scopus (211) Google Scholar, 4Kelly J.C. Carter E.B. Raghuraman N. et al.Anti-severe acute respiratory syndrome coronavirus 2 antibodies induced in breast milk after Pfizer-BioNTech/BNT162b2 vaccination.Am J Obstet Gynecol. 2021; 225: 101-103Abstract Full Text Full Text PDF PubMed Scopus (48) Google Scholar however, none evaluated the neutralizing capacity of breastmilk antibodies or the presence of antibodies in the infants' serum or oral mucosa. Our findings may suggest that breastfed infants acquire passive immunity against COVID-19. However, in view of our observation that SARS-CoV-2 IgG was not detected in the infants' serum, it seems that vaccination during pregnancy may provide better protection to the infants through transplacental passage of antibodies.5Prabhu M. Murphy E.A. Sukhu A.C. et al.Antibody response to coronavirus disease 2019 (COVID-19) messenger RNA vaccination in pregnant women and transplacental passage into cord blood.Obstet Gynecol. 2021; 138: 278-280Crossref PubMed Scopus (100) Google Scholar
OBJECTIVE:To assess reasons for noncompliance with COVID-19 vaccination among healthcare workers (HCWs). DESIGN:Cohort observational and surveillance study. SETTING:Sheba Medical Center, a 1,600-bed tertiary-care medical center in Israel. PARTICIPANTS:The study included 10,888 HCWs including all employees, students, and volunteers. INTERVENTION:The BNT162b2 mRNA COVID-19 vaccine was offered to all HCWs of the hospital. Noncompliance was assessed, and pre-rollout and post-rollout surveys were conducted. Data regarding uptake of the vaccine as well as demographic data and compliance with prior influenza vaccination were collected, and 2 surveys were distributed. The survey before the rollout pertained to the intention to receive the vaccine, and the survey after the rollout pertained to all unvaccinated HCWs regarding causes of hesitancy. RESULTS:In the pre-rollout survey, 1,673 (47%) of 3,563 HCWs declared their intent to receive the vaccine. Overall, 8,108 (79%) HCWs received the COVID-19 vaccine within 40 days of rollout. In a multivariate logistic regression model, the factors that were significant predictors of vaccine uptake were male sex, age 40-59 years, occupation (paramedical professionals and doctors), high socioeconomic level, and compliance with flu vaccine. Among 425 unvaccinated HCWs who answered the second survey, the most common cause for hesitancy was the risk during pregnancy (31%). CONCLUSIONS:Although vaccine uptake among HCWs was higher than expected, relatively low uptake was observed among young women and those from lower socioeconomic levels and educational backgrounds. Concerns regarding vaccine safety during pregnancy were common and more data about vaccine safety, especially during pregnancy, might improve compliance.
BACKGROUND:Despite high vaccine coverage and effectiveness, the incidence of symptomatic infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been increasing in Israel. Whether the increasing incidence of infection is due to waning immunity after the receipt of two doses of the BNT162b2 vaccine is unclear. METHODS:We conducted a 6-month longitudinal prospective study involving vaccinated health care workers who were tested monthly for the presence of anti-spike IgG and neutralizing antibodies. Linear mixed models were used to assess the dynamics of antibody levels and to determine predictors of antibody levels at 6 months. RESULTS:The study included 4868 participants, with 3808 being included in the linear mixed-model analyses. The level of IgG antibodies decreased at a consistent rate, whereas the neutralizing antibody level decreased rapidly for the first 3 months with a relatively slow decrease thereafter. Although IgG antibody levels were highly correlated with neutralizing antibody titers (Spearman's rank correlation between 0.68 and 0.75), the regression relationship between the IgG and neutralizing antibody levels depended on the time since receipt of the second vaccine dose. Six months after receipt of the second dose, neutralizing antibody titers were substantially lower among men than among women (ratio of means, 0.64; 95% confidence interval [CI], 0.55 to 0.75), lower among persons 65 years of age or older than among those 18 to less than 45 years of age (ratio of means, 0.58; 95% CI, 0.48 to 0.70), and lower among participants with immunosuppression than among those without immunosuppression (ratio of means, 0.30; 95% CI, 0.20 to 0.46). CONCLUSIONS:Six months after receipt of the second dose of the BNT162b2 vaccine, humoral response was substantially decreased, especially among men, among persons 65 years of age or older, and among persons with immunosuppression.