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1.
Clin Infect Dis ; 76(3): e126-e132, 2023 02 08.
Artigo em Inglês | MEDLINE | ID: mdl-35904210

RESUMO

BACKGROUND: Intramuscular AZD7442 (tixagevimab-cilgavimab [Evusheld; AstraZeneca]) has been found effective among immunocompromised individuals (ICIs) in reducing SARS-CoV-2 infection and severe disease in ICIs. We evaluated the association between AZD7442 administration and SARS-CoV-2 infection and severe disease (COVID-19 hospitalization and all-cause mortality) among selected ICIs, during a fifth Omicron-dominated wave of COVID-19 (December 2021-April 2022) in Israel. METHODS: ICIs aged ≥12 years identified in the Maccabi HealthCare Services database were invited by SMS/e-mail to receive AZD7442. Demographic information, comorbidities, coronavirus vaccination, and prior SARS-CoV-2 infection and COVID-19 outcome data (infection, severe disease) were extracted from the database. Rates of infection and severe disease were compared between those administered AZD7442 and those who did not respond to the invitation over a 3-month period. RESULTS: Of all 825 ICIs administered AZD7442, 29 (3.5%) became infected with SARS-CoV-2 compared with 308 (7.2%) of 4299 ICIs not administered AZD7442 (P < .001). After adjustment, the AZD7442 group was half as likely to become infected with SARS-CoV-2 than the nonadministered group (OR: .51; 95% CI: .30-.84). One person in the AZD7442 group (0.1%) was hospitalized for COVID-19 compared with 27 (0.6%) in the nonadministered group (P = .07). No mortality was recorded among the AZD7442 group compared with 40 deaths (0.9%) in the nonadministered group (P = .005). After adjustment, ICIs administered AZD7442 were 92% less likely to be hospitalized/die than those not administered AZD7442 (OR: .08; 95% CI: .01-.54). CONCLUSIONS: AZD7442 among ICIs may protect against Omicron variant infection and severe disease and should be considered for pre-exposure prophylactic AZD7442.


Assuntos
COVID-19 , SARS-CoV-2 , Humanos , Hospitalização
2.
Oral Dis ; 2023 Mar 17.
Artigo em Inglês | MEDLINE | ID: mdl-36929202

RESUMO

AIMS: The aim of the study was to analyze objective and subjective olfactory/gustatory function in post-COVID-19 infection (PCI). MATERIALS AND METHODS: Patients with past PCR-confirmed COVID-19 infection and persistent olfactory/gustatory complaints were investigated. Olfactory threshold and identification, gustatory detection, identification, and magnitude scaling were tested. RESULTS: A total of 42 PCI subjects were compared to 41 age- and gender-matched controls with no COVID-19 history. All PCI tested had mild COVID-19 disease. Mean interval between COVID-19 confirmations to testing was 7.4 ± 3.1 months. PCI subjects complained of combined dysfunction in 85.7%, isolated olfactory or gustatory dysfunction in 7.1% each. Combined complaints were significantly higher in PCI (p < 0.001). Objective testing showed significantly higher prevalence of dysfunction in PCI versus controls for hyposmia (73.8%, 12.2%), anosmia (11.9%, 0%), odor identification (68.5%, 83.0%), hypogeusia (23% and 2.4%, respectively), and impaired magnitude scaling, (p < 0.05). All PCI subjects with hypogeusia had abnormal gustatory magnitude scaling. CONCLUSIONS: While most PCI subjects complained of combined gustatory and olfactory dysfunction, objective testing showed in the majority an isolated single sense dysfunction, with a low level of agreement between subjective and objective findings. Abnormal objective results for all olfactory and gustatory functions tested may suggest a central rather than peripheral mechanism, although concomitant mechanisms cannot be excluded.

3.
Euro Surveill ; 27(13)2022 03.
Artigo em Inglês | MEDLINE | ID: mdl-35362408

RESUMO

BackgroundCOVID-19 vaccine safety is of major interest worldwide, since there is no prior experience with it. Israel was one of the first countries to widely use the Comirnaty vaccine.AimWe aimed to assess the vaccine's short-term side effects directly from a large population and to predict influencing factors for self-reporting side effects.MethodsIn a retrospective cohort study, we investigated self-reported systemic vaccine side-effects using electronic surveys sent to vaccinated individuals between 20 December 2020 and 11 March 2021, within 3 days following administration of the first and second dose. We determined predictors for reporting systemic side effects by logistic regression.ResultsA total of 1,213,693 patients received at least one vaccine dose and 301,537 (24.8%) answered at least one survey. Among them, 68,162 (30.4%) and 89,854 (59.9%) individuals filled the first and the second dose surveys, respectively, and reported one or more side effects. Most common side effects were fatigue, headache and myalgia. Several respondents reported facial paraesthesia after first and second dose, respectively (n = 1,675; 0.7% and n = 1,601; 1.1%). Individuals younger than 40 years and women reported side effects more frequently than others, but pregnant women reported less. Pregnancy was a weak predictor for reporting any side effect in general and in particular fatigue, myalgia, headache, chills and fever.ConclusionsWe found further support for minor short-term side effects, within 3 days of receiving the Comirnaty vaccine. These findings from vaccine recipients in general and pregnant women in particular can improve vaccine acceptance.


Assuntos
Vacinas contra COVID-19 , COVID-19 , COVID-19/epidemiologia , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Feminino , Humanos , Israel/epidemiologia , Gravidez , Estudos Retrospectivos , Inquéritos e Questionários , Vacinação/efeitos adversos
4.
Clin Immunol ; 232: 108860, 2021 11.
Artigo em Inglês | MEDLINE | ID: mdl-34571262

RESUMO

BACKGROUND: Since July 13, 2021, a third SARS-CoV-2 vaccine BNT162b2 was approved in Israel to immunocompromised and seniors 60 years of age or older. We aimed to evaluate vaccine's reactogenicity. METHODS: A retrospective cohort, using electronic surveys sent to booster vaccine recipients, during July 20-August 10, 2021. RESULTS: 17,820 participated in the survey, with a response rate of 30.2%. 3195 (17.9%) were immunocompromised. Fatigue, myalgia and fever were the most frequent systemic side effects reported (19.6%, 9.2% and 8.1% respectively among immunocompromised; 21.3%, 9.9% and 9.2% respectively among seniors). 67.3% of immunocompromised and 62% of seniors reported experiencing a better or a similar response to the third dose, compared to the second. CONCLUSIONS: Local and systemic reactions after third BNT162b2 vaccine, reported by immunocompromised and seniors, were similar to those observed following previous vaccines and mostly self-resolved. These findings may aid promoting confidence among vaccine providers and recipients.


Assuntos
Vacinas contra COVID-19/imunologia , COVID-19/imunologia , Hospedeiro Imunocomprometido/imunologia , RNA Mensageiro/imunologia , Idoso , Idoso de 80 Anos ou mais , Vacina BNT162 , Estudos Transversais , Feminino , Humanos , Israel , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , SARS-CoV-2/imunologia
5.
J Public Health (Oxf) ; 43(4): 723-730, 2021 Dec 10.
Artigo em Inglês | MEDLINE | ID: mdl-33690854

RESUMO

BACKGROUND: Among the many medical challenges presented by the COVID-19 pandemic, management of the majority of patients in community outpatient settings is crucial. The aim of this study was to describe the characteristics and outcomes among confirmed COVID-19 cases who were managed at three settings: two outpatient settings and one inpatient. METHODS: A retrospective database cohort study was conducted in a large Israeli Health Maintenance Organization. All COVID-19 cases diagnosed between 28 February 2020 and 20 July 2020 were included. Cases in the community settings were managed through a nationwide remote monitoring center, using preliminary telehealth triage and 24/7 virtual care. Outcome parameters included hospital admission, disease severity, need for respiratory support and mortality. RESULTS: About 5448 cases, aged range 0-97 years, were enrolled; 88.7% were initially managed as outpatient either at home or in designated hotels, 3.1 and 2.1% of them, respectively, later required hospitalization. The main reason for hospitalization was dyspnea; 12 were diagnosed with severe disease; 56 patients (1.3%) died, five (0.1%) of whom were initially allocated to the outpatient settings. CONCLUSIONS: Care for appropriately selected COVID-19 patients in the community provides a safe and effective option. This can contribute to reducing the hospitalization burden, with no evidence of increased morbidity or mortality.


Assuntos
COVID-19 , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Estudos de Coortes , Sistemas Pré-Pagos de Saúde , Hospitalização , Humanos , Lactente , Recém-Nascido , Israel/epidemiologia , Pessoa de Meia-Idade , Pandemias , Estudos Retrospectivos , SARS-CoV-2 , Adulto Jovem
6.
Acta Paediatr ; 110(9): 2567-2573, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-34053108

RESUMO

AIM: The effect of reopening schools on children's contribution to SARS-CoV-2 transmission, especially within households, remains controversial. This study describes the clinical presentation of a large ambulatory COVID-19 paediatric cohort and evaluates the role of children in household transmission prior to and following school reopening. METHODS: A retrospective database cohort study was conducted in a large Health Maintenance Organization in Israel. Data of all paediatric, laboratory-confirmed Coronavirus cases between 28/2/2020 and 20/6/2020 were extracted. All cases were analysed for household contacts and primary cases within each family cluster. RESULTS: A total of 1,032 cases under 18 years old (median age 12 years) were included. Of these cases, 432 (41.9%) were asymptomatic; 122 (11.8%) cases acquired the infection at school, and 45 of them were part of two school clusters; 846 children had at least one positive household contact, in 498 family clusters, and among them, 293 primary cases were identified. Only 27 (9.2%) primary cases were under 18 years of age and six (2%) were below 10. The proportion of primary cases did not change after the re-opening of educational facilities. CONCLUSION: Children, particularly under 10 years of age, are less likely to be the vector for SARS-CoV-2 infection within household settings. Opening educational facilities did not change transmission dynamics.


Assuntos
COVID-19 , Adolescente , Criança , Estudos de Coortes , Humanos , Estudos Retrospectivos , SARS-CoV-2 , Instituições Acadêmicas
7.
Healthcare (Basel) ; 12(3)2024 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-38338261

RESUMO

Post-COVID-19 has been recognized as possibly affecting millions of people worldwide. In order to optimize care and ensure equality, we established a multidisciplinary virtual Post-COVID-19 clinic (VPCC) within Maccabi Healthcare Services, the second largest HMO in Israel. This study aims to describe the structure, process and patient satisfaction with this clinic. The multidisciplinary team consisted of physicians, physiotherapists, social workers, occupational therapists and dieticians. Patient entry was to be at least four weeks after COVID-19 infection. A patient satisfaction survey was carried out 7-8 months after the clinic was closed. Demographic data were collected and compared to the general Maccabi COVID-19 population. The clinic treated 1614 patients, aged 16-91, over a period of 18 months. In total, 679 family physicians referred patients. In comparison to the general COVID-19 population, a higher percentage of the VPCC patients lived in the periphery of Israel, South (14.9% compared to 17.8%) and North (17.1% compared to 18.2%). In total, 249 patients answered the survey, and of them, 75% were highly satisfied with the medical care of the physician in the VPCC. A total of 54% of respondents would have preferred a face-to-face consultation, but 50% felt that communication was good in the virtual mode. In conclusion, the VPCC provided a dedicated service for patients, and the virtual format made it equally accessible to all parts of the country.

8.
Vaccine ; 42(5): 1154-1159, 2024 Feb 15.
Artigo em Inglês | MEDLINE | ID: mdl-38281902

RESUMO

PURPOSE: SARS-CoV-2 vaccine safety is of major interest worldwide, and transparent information about potential side effects is essential to decrease vaccine hesitancy. The aim of this study was to assess SARS-CoV-2 BNT162b2 vaccine short-term side effects among children aged 5-11 years. METHODS: An observational, cross sectional study of vaccine side-effects using electronic surveys sent to parents one week post administration of BNT162b2 vaccine to their child in a large health maintenance organization in Israel. RESULTS: First dose and second dose surveys were filled for 5,842 and 6,126 children, respectively, with a response rate of 32.1% and 24.8%. Local side effects were reported by 68.7% and 69.1% of the first and second survey respondents, and general side effects were reported by 20.8% and 34.5% of them. The symptoms most frequently reported were fatigue, headache and myalgia. Duration of symptoms lasted three days or less among 86.5% and 81.5% of first and second dose survey respondents. Most respondents (92%) reported that their child did not need any medical consultation following vaccination. CONCLUSIONS: We found further support for the BNT162b2 SARS-CoV-2 vaccine short- term safety among children aged 5-11 years. With ongoing pandemic and future booster COVID-19 vaccines, these findings can encourage vaccine confidence for parents and providers.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Criança , Humanos , Vacinas contra COVID-19/efeitos adversos , Vacina BNT162 , Estudos Transversais , COVID-19/prevenção & controle , SARS-CoV-2 , Pais
9.
Biomedicines ; 11(5)2023 May 22.
Artigo em Inglês | MEDLINE | ID: mdl-37239167

RESUMO

Antibiotic overuse and underuse are prevalent in urgent care settings, driven in part by diagnostic uncertainty. A host-based test for distinguishing bacterial and viral infections (MeMed BV) has been clinically validated previously. Here we examined how BV impacts antibiotic prescription in a real-world setting. The intention to treat with antibiotics before the receipt of a BV result was compared with practice after the receipt of a BV result at three urgent care centers. The analysis included 152 patients, 57.9% children and 50.7% female. In total, 131 (86.2%) had a bacterial or viral BV result. Physicians were uncertain about prescription for 38 (29.0%) patients and for 30 (78.9%) of these cases, subsequently acted in accordance with the BV result. Physicians intended to prescribe antibiotics to 39 (29.8%) patients, of whom 17 (43.6%) had bacterial BV results. Among the remaining 22 patients with viral BV results, antibiotic prescriptions were reduced by 40.9%. Overall, the physician prescribed in accordance with BV results in 81.7% of all cases (p < 0.05). In total, the physicians reported that BV supported or altered their decision making in 87.0% of cases (p < 0.05). BV impacts patient management in real-world settings, supporting appropriate antibiotic use.

10.
Vaccines (Basel) ; 11(8)2023 Aug 11.
Artigo em Inglês | MEDLINE | ID: mdl-37631923

RESUMO

Immunocompromised patients (IPs) are at high risk for infections, some of which are vaccine-preventable. The Israeli Ministry of Health recommends pneumococcal conjugate vaccine 13 (PCV13) and pneumococcal polysaccharide vaccine 23 (PPSV23) for IP, but vaccine coverage is suboptimal. We assessed the project's effectiveness in improving the pneumococcal vaccination rate among IP. An automated population-based registry of IP was developed and validated at Maccabi Healthcare Services, an Israeli health maintenance organization serving over 2.6 million members. Included were transplant recipients, patients with asplenia, HIV or advanced kidney disease; or those receiving immunosuppressive therapy. A personalized electronic medical record alert was activated reminding clinicians to consider vaccination during IP encounters. Later, IP were invited to get vaccinated via their electronic patient health record. Pre- and post-intervention vaccination rates were compared. Between October 2019 and October 2021, overall PCV13 vaccination rates among 32,637 IP went up from 11.9% (n = 3882) to 52% (n = 16,955) (p < 0.0001). The PPSV23 vaccination rate went up from 39.4% (12,857) to 57.1% (18,652) (p < 0.0001). In conclusion, implementation of targeted automated patient- and clinician-facing alerts, a remarkable increase in pneumococcal vaccine uptake was observed among IP. The outlined approach may be applied to increase vaccination uptake in large health organizations.

11.
Biomedicines ; 11(3)2023 Mar 02.
Artigo em Inglês | MEDLINE | ID: mdl-36979745

RESUMO

BACKGROUND: Risk stratification models have been developed to identify patients that are at a higher risk of COVID-19 infection and severe illness. Objectives To develop and implement a scoring tool to identify COVID-19 patients that are at risk for severe illness during the Omicron wave. METHODS: This is a retrospective cohort study that was conducted in Israel's second-largest healthcare maintenance organization. All patients with a new episode of COVID-19 between 26 November 2021 and 18 January 2022 were included. A model was developed to predict severe illness (COVID-19-related hospitalization or death) based on one-third of the study population (the train group). The model was then applied to the remaining two-thirds of the study population (the test group). Risk score sensitivity, specificity, and positive predictive value rates, and receiver operating characteristics (ROC) were calculated to describe the performance of the model. RESULTS: A total of 409,693 patients were diagnosed with COVID-19 over the two-month study period, of which 0.4% had severe illness. Factors that were associated with severe disease were age (age > 75, OR-70.4, 95% confidence interval [CI] 42.8-115.9), immunosuppression (OR-4.8, 95% CI 3.4-6.7), and pregnancy (5 months or more, OR-82.9, 95% CI 53-129.6). Factors that were associated with a reduced risk for severe disease were vaccination status (patients vaccinated in the previous six months OR-0.6, 95% CI 0.4-0.8) and a prior episode of COVID-19 (OR-0.3, 95% CI 0.2-0.5). According to the model, patients who were in the 10th percentile of the risk severity score were considered at an increased risk for severe disease. The model accuracy was 88.7%. CONCLUSIONS: This model has allowed us to prioritize patients requiring closer follow-up by their physicians and outreach services, as well as identify those that are most likely to benefit from anti-viral treatment during the fifth wave of infection in Israel, dominated by the Omicron variant.

12.
J Am Acad Child Adolesc Psychiatry ; 62(8): 920-937, 2023 08.
Artigo em Inglês | MEDLINE | ID: mdl-36764609

RESUMO

OBJECTIVE: Adolescents' mental health was severely compromised during the COVID-19 pandemic. Longitudinal real-world studies on changes in the mental health of adolescents during the later phase of the pandemic are limited. We aimed to quantify the effect of COVID-19 pandemic on adolescents' mental health outcomes based on electronic health records. METHOD: This was a retrospective cohort study using the computerized database of a 2.5 million members, state-mandated health organization in Israel. Rates of mental health diagnoses and psychiatric drug dispensations were measured among adolescents 12 to 17 years of age with and without pre-existing mental history, for the years 2017 to 2021. Relative risks were computed between the years, and interrupted time series (ITS) analyses evaluated changes in monthly incidence rates of psychiatric outcomes. RESULTS: The average population size was 218,146 in 2021. During the COVID-19 period, a 36% increase was observed in the incidence of depression (95% CI = 25-47), 31% in anxiety (95% CI = 23-39), 20% in stress (95% CI = 13-27), 50% in eating disorders (95% CI = 35-67), 25% in antidepressant use (95% CI = 25-33), and 28% in antipsychotic use (95% CI = 18-40). A decreased rate of 26% (95% CI = 0.80-0.88) was observed in ADHD diagnoses. The increase of the examined outcomes was most prominent among youth without psychiatric history, female youth, general secular Jewish population, youth with medium-high socioeconomic status, and those 14 to 15 years of age. ITS analysis confirmed a significantly higher growth in the incidence of psychiatric outcomes during the COVID-19 period, compared to those in previous years. CONCLUSION: This real-world study highlights the deterioration of adolescents' mental health during the COVID-19 pandemic and suggests that youth mental health should be considered during health policy decision making. DIVERSITY & INCLUSION STATEMENT: We worked to ensure sex and gender balance in the recruitment of human participants. We worked to ensure race, ethnic, and/or other types of diversity in the recruitment of human participants. We actively worked to promote sex and gender balance in our author group. The author list of this paper includes contributors from the location and/or community where the research was conducted who participated in the data collection, design, analysis, and/or interpretation of the work.


Assuntos
Antipsicóticos , COVID-19 , Masculino , Humanos , Adolescente , Feminino , Saúde Mental , COVID-19/epidemiologia , Pandemias , Estudos Retrospectivos
13.
Healthcare (Basel) ; 11(24)2023 Dec 12.
Artigo em Inglês | MEDLINE | ID: mdl-38132041

RESUMO

INTRODUCTION: Correlations between SARS-CoV-2 and bacterial infections have mainly been studied in hospitals, and these studies have shown that such interactions may be lethal for many. In the context of community flora, less is known of the trends and consequences of viral infections relative to subsequent bacterial infections. PURPOSE: This study aims to explore the prevalence and characteristics of bacterial infections in the three months following SARS-CoV-2 infections, in a community, real-world setting. METHODS: In this retrospective cohort study, we compared patients who completed a polymerase chain reaction (PCR) test or an antigen test for SARS-CoV-2 during January 2022, the peak of the Omicron wave, and examined bacterial infections following the test. We searched these cases for diagnoses of the following four bacterial infections for three months following the test: Group A Streptococcus (GAS) pharyngitis, pneumonia, cellulitis, and urinary tract infections (UTI). RESULTS: During January 2022, 267,931 patients tested positive and 261,909 tested negative for SARS-CoV-2. Test-positive compared to test-negative patients were significantly younger (42.5 years old vs. 48.5 years old, p < 0.001), smoked less, and had fewer comorbidities (including ischemic heart disease, diabetes mellitus, hypertension, chronic obstructive pulmonary disease, and chronic renal failure). In the multivariable analysis, test-positive patients had an increased risk for GAS pharyngitis (adjusted odds ratio [aOR] = 1.25, 95% CI 1.14-1.38, p-value < 0.001) and pneumonia (aOR = 1.25, 95% CI 1.15-1.35, p-value < 0.001), a trend towards an increased prevalence of UTI (aOR = 1.05, 95% CI 0.99-1.12, p-value = 0.092), and lower risk for cellulitis (aOR = 0.92, 95% CI 0.86-0.99, p-value < 0.05). CONCLUSIONS: A history of SARS-CoV-2 infection in the past three months increased susceptibility to respiratory tract bacterial infections and the prevalence of UTI.

14.
Vaccines (Basel) ; 10(10)2022 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-36298519

RESUMO

Immune-compromised patients (IPs) are at high risk for infections, some of which are preventable by vaccines. Specific vaccines are recommended for IP; however, the vaccination rate is suboptimal. The aim of this study is to describe the development of an IP registry and to assess vaccination rates in this population. A population-based registry of IPs was developed using an automated extraction of patient electronic health-record data in Maccabi Healthcare Services (MHS), an Israeli health maintenance organization serving over 2.4 million members. Included in the registry were patients receiving immunosuppressive therapy (IT); patients living with HIV (PLWH); solid organ and bone marrow transplant recipients (TR); patients with advanced kidney disease (AKD), and asplenic patients. We evaluated the full schedule for each vaccine's uptake rates for influenza, pneumococcal, meningococcal, and hepatitis B. On 1 October 2019, 32,637 adult immune-compromised patients were identified by the registry. Of them, 1647 were PLWH; 2354 were asplenic; 5317 had AKD; 23,216 were on IT; and 1824 were TR. Their mean age was 57 and 52.4% were females. The crude rate of immune compromise among adult MHS members was 2%. Vaccine coverage rate was overall low for PCV13, with only 11.9% of all IPs in the registry having received one dose. Influenza and PPV23 vaccination rates were higher (45% and 39.4%, respectively). Only 5.3% of all IPs received all three vaccines. Overall, low vaccination coverage was found among IPs. Our registry can serve to identify target-patient populations for interventions and monitor their effectiveness.

15.
JAMA Pediatr ; 176(5): 470-477, 2022 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-35142809

RESUMO

Importance: Pregnant women were excluded from the BNT162b2 messenger RNA (mRNA) COVID-19 vaccine (Pfizer-BioNTech) preauthorization trial. Therefore, observational data on vaccine safety for prenatally exposed newborns are critical to inform recommendations on maternal immunization. Objective: To examine whether BNT162b2 mRNA vaccination during pregnancy is associated with adverse neonatal and early infant outcomes among the newborns. Design, Setting, and Participants: Population-based cohort study comprising all singleton live births in March through September 2021, within a large state-mandated health care organization in Israel, followed up until October 31, 2021. Exposure: Maternal BNT162b2 mRNA vaccination during pregnancy. Main Outcomes and Measures: Risk ratios (RR) of preterm birth, small birth weight for gestational age (SGA), congenital malformations, all-cause hospitalizations, and infant death. Stabilized inverse probability weighting was used to adjust for maternal age, timing of conception, parity, socioeconomic status, population subgroup, and maternal influenza immunization status. Results: The cohort included 24 288 eligible newborns (49% female, 96% born at ≥37 weeks' gestation), of whom 16 697 were exposed (n = 2134 and n = 9364 in the first and second trimesters, respectively) to maternal vaccination in utero. Median (IQR) follow-up after birth was 126 days (76-179) among exposed and 152 days (88-209) among unexposed newborns. No substantial differences were observed in preterm birth rates between exposed and unexposed newborns (RR = 0.95; 95% CI, 0.83-1.10) or SGA (RR = 0.97; 95% CI, 0.87-1.08). No significant differences were observed in the incidence of all-cause neonatal hospitalizations (RR = 0.99; 95% CI, 0.88-1.12), postneonatal hospitalizations after birth (RR = 0.95; 95% CI, 0.84-1.07), congenital anomalies (RR = 0.69; 95% CI, 0.44-1.04), or infant mortality over the study period (RR = 0.84; 95% CI, 0.43-1.72). Conclusions and Relevance: This large population-based study found no evident differences between newborns of women who received BNT162b2 mRNA vaccination during pregnancy, vs those of women who were not vaccinated, and contributes to current evidence in establishing the safety of prenatal vaccine exposure to the newborns. Interpretation of study findings is limited by the observational design.


Assuntos
Vacina BNT162 , COVID-19 , Resultado da Gravidez , Vacina BNT162/efeitos adversos , COVID-19/epidemiologia , COVID-19/prevenção & controle , Estudos de Coortes , Feminino , Humanos , Lactente , Recém-Nascido , Nascido Vivo , Masculino , Gravidez , Resultado da Gravidez/epidemiologia , Nascimento Prematuro/epidemiologia
16.
Vaccine ; 40(30): 4038-4045, 2022 06 26.
Artigo em Inglês | MEDLINE | ID: mdl-35641358

RESUMO

PURPOSE: As protection from COVID-19 following two doses of the BNT162b2 vaccine showed a time dependent waning, a third (booster) dose was administrated. This study aims to compare the antibody response following the third dose versus the second and to evaluate post-booster seroconversion. METHODS: A prospective observational study conducted in Maccabi Healthcare Services. Serial SARS-CoV-2 Spike IgG tests, 1,2,3 and 6 months following the second vaccine dose and one month following the third were obtained. Neutralizing antibody levels were measured in a subset of participants. Per individual SARS-CoV-2 Spike IgG titer ratios were calculated one month after the booster administration compared to titers one month following the second dose and prior to booster. RESULTS: Among 110 participants,56 (51%) were women. Mean age was 61.7 ± 1.9 years and 66 (60%) were immunocompromised. One month after third dose, IgG titers were induced 7.83 (95 %CI 5.25-11.67) folds and 2.40 (95 %CI 1.90-3.03) folds compared to one month after the second, in the immunocompromised and immunocompetent groups, respectively. Of the 17 immunocompromised participants who were seronegative after the second dose, 4 (24%) became seropositive following the third. Comparing the titers prior to the third dose, an increase of 50.7 (95 %CI 32.5-79.1) fold in the immunocompromised group and 25.7 (95 %CI 19.1-34.7) fold in and immunocompetent group, was observed. CONCLUSION: A third BNT162b2 vaccine elicited robust humoral response, superior to the response observed following the second, among immunocompetent and immunocompromised individuals.


Assuntos
COVID-19 , Vacinas , Anticorpos Antivirais , Formação de Anticorpos , Vacina BNT162 , COVID-19/prevenção & controle , Feminino , Humanos , Imunoglobulina G , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , SARS-CoV-2
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