Acute respiratory infection emergency access in a tertiary care children hospital in Italy, prior and after the SARS-CoV-2 emergence.

Background: The COVID-19 pandemic has changed the epidemiology of acute respiratory infections (ARIs) in children. The aims of the present study were to describe the epidemiological trend of ARI emergency visits and virology results prior and after the SARS-CoV-2 emergence and to estimate the association of ARI emergency department (ED) visits with respiratory viruses. Methods: This study was conducted at the Bambino Gesù Children's Hospital, a tertiary care children's hospital in the Lazio Region, Italy. The demographic and clinical information of children who accessed the ED and were diagnosed with ARI from January 1, 2018 to June 30, 2022 was retrospectively extracted from the electronic health records. The observed temporal trends in viruses diagnosed from respiratory samples were compared with the number of ARI ED visits over the same period through a multivariable linear regression model. Results: During the study period, there were 72,959 ED admissions for ARIs and 33,355 respiratory samples resulted positive for viruses. Prior to the pandemic, respiratory syncytial virus (RSV) and influenza had a clear seasonal pattern, which was interrupted in 2020. In 2021-2022, RSV reached the highest peak observed during the study period, whereas influenza activity was minimal. The peaks of ARI ED visits corresponded to peaks of influenza, RSV, and rhinovirus in the 2018-2019 and 2019-2020 seasons, to SARS-CoV-2 and rhinovirus in 2020, and to RSV and parainfluenza in 2021-2022. Conclusions: ARI resulting in ED visits should be included in the ARI disease burden measurement for a more accurate measure of the impact of preventive measures.

Has Anything Changed in the Frequency of Emergency Department Visits and the Profile of the Adolescent Seeking Emergency Mental Care during the COVID-19 Pandemic?

We described changes caused by the COVID-19 pandemic in the frequency of Emergency Department (ED) visits for mental health disorders (MHDs) in adolescents on a wider temporal range-that is, not just "the waves" of the pandemic-and characterized the profile of the adolescent seeking emergency psychiatric care. We conducted a retrospective longitudinal study by analyzing ED visits for MHDs from 10 March 2019 to 10 March 2021. A total of 1407 ED visits for MHDs were registered: 702 in the pre-COVID-19 and 707 in the COVID-19 period. The cumulative incidence of ED visits for MHDs was 1.22% in the pre-COVID-19 period and 1.77% in the COVID-19 period, with a statistically significant difference (p < 0.001). The principal characteristics of the adolescent with MHDs during the pandemic period: the odds of comorbidities decreased by 26% (p = 0.02), and the odds of transfer from other hospitals decreased by 71% (p < 0.001), while the odds of the ED presentation as first psychiatric episode were twice greater (p < 0.001). The risk of hospitalization increased by 54% (p = 0.001). Regarding psychopathology, the likelihood of attempted suicide increased by 74% during the pandemic (p = 0.02). The rate of mood and eating disorders grew significantly during the COVID-19 pandemic period (p = 0.005 and p = 0.031, respectively). Monitoring ED visits for MHDs and understanding changes in the profile of adolescents presenting to ED helps to reinforce the role of ED in identifying special clinical needs for these vulnerable patients in case of a future public health crisis.

Severe viral respiratory infections in the pre-COVID era: A 5-year experience in two pediatric intensive care units in Italy.

BACKGROUND: Viral respiratory infections are one of the main causes of hospitalization in children. Even if mortality rate is low, 2% to 3% of the hospitalized children need mechanical ventilation. Risk factors for admission to the pediatric intensive care unit (PICU) are well known, while few studies have described risk factors for invasive ventilator support and prolonged hospitalization. METHODS: A retrospective study including all patients aged between 2 and 18 months with a confirmed viral respiratory infection, requiring admission to PICU from September to March between 2015 and 2019, was conducted at Bambino Gesù Children's Hospital in Rome, Italy. RESULTS: One hundred ninety patients were enrolled, with a median age of 2.7 months; 32.1% had at least one comorbidity, mainly prematurity. The most frequent isolated viruses were RSV-B, rhinovirus, and RSV-A; 38.4% needed mechanical ventilation. This subgroup of patients had lower median birth weight compared with patients not requiring mechanical ventilation (2800 g vs. 3180 g, p = 0.02); moreover, comorbidities were present in 43.8% of intubated patients and in 24.8% of patients treated with non-invasive ventilation (p = 0.006). Viral coinfection did not result to be a risk factor for mechanical support, while virus-bacteria coinfection was significantly associated with mechanical ventilation (p < 0.001). Similar risk factors were identified for prolonged hospitalization. CONCLUSIONS: Early identification of patients who could have a sudden respiratory deterioration and need of mechanical ventilation is crucial to reduce complications due to orotracheal intubation and prolonged hospitalization in PICU. Further studies are needed to define high-risk group of patients and to design targeted interventions.

The Management of Workplace Violence against Healthcare Workers: A Multidisciplinary Team for Total Worker Health® Approach in a Hospital.

The risk of aggression against healthcare workers (HCWs) is a globally well-known topic. However, workplace violence (WV) is often considered as part of HCW's job, leading to a general underreporting. This cross-sectional study aims at providing a descriptive analysis of aggressive acts against HCWs registered in a 34-month period in a pediatric hospital. According to a specific protocol, each aggressive act was analyzed by a multidisciplinary team using the "Modified Overt Aggression Scale" (MOAS), the "General Health Questionnaire-12" (GHQ-12), and the "Short Form-36 Health Survey" (SF-36) to build a report addressing improvement measures. A three-domain model of WV was also developed considering: (1) assaulted HCWs, (2) attacker-related issues, and (3) environmental context. Contributing factors to overt aggression were outlined and tested using univariate analyses. Statistically significant factors were then included in a multiple linear regression model. A total of 82 aggressive acts were registered in the period. MOAS scores registered a mean value of 3.71 (SD: 4.09). Verbal abuse was the most common form of WV. HCWs professional category, minor psychiatric disorder, emotional role limitation, type of containment used, and emotion intensity were significantly associated with overt aggression (p < 0.05), as well as the attacker's role in the hospital (p < 0.05). The multiple regression analysis confirmed these findings (p < 0.001). Raising awareness on the aggression risk and contributing factors may lead to a relevant improvement of workplace environment, individual workers' health, and organizational well-being.

Lessons from SARS-CoV-2 Pandemics: How Restrictive Measures Impacted the Trend of Respiratory Infections in Neonates and Infants up to Three Months of Age.

(1) Background: Massive social efforts to prevent the spread of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic have affected the epidemiological features of respiratory infections. (2) Methods: The study aims to describe the trend of hospitalizations for bronchiolitis among newborns and infants up to three months of life in Rome (Italy), in the pre-COVID-19 era and during the pandemic. (3) Results: We observed a marked decrease in the number of neonates and infants with bronchiolitis after national lockdowns in 2020 and the first months of 2021 and a similar trend in the number of bronchiolitis caused by respiratory syncytial virus (RSV). RSV was the leading pathogen responsible for bronchiolitis before the national lockdown in March 2020 (70.0% of cases), while Rhinovirus was the leading pathogen responsible for bronchiolitis (62.5%) during the pandemic while strict restrictions were ongoing. As Italy approached the COVID-19 vaccination target, the national government lifted some COVID-19-related restrictions. A surprising rebound of bronchiolitis (particularly cases caused by RSV) was observed in October 2021. (4) Conclusions: In this study, we describe for the first time the fluctuations over time of RSV bronchiolitis among newborns and young infants in Italy in relation to the restrictive measures containing the spread of the COVID-19 pandemic. Our results are in line with other countries' reports.

Expression analysis of miRNA hsa-let7b-5p in naso-oropharyngeal swabs of COVID-19 patients supports its role in regulating ACE2 and DPP4 receptors.

Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) is the novel coronavirus responsible for worldwide coronavirus disease (COVID-19). We previously observed that Angiotensin-converting enzyme 2 (ACE2) and Dipeptidyl peptidase-4 (DPP4) are significantly overexpressed in naso-oropharyngeal swabs (NPS) of COVID-19 patients, suggesting their putative functional role in the disease progression. ACE2 and DPP4 overexpression in COVID-19 patients may be associated to epigenetic mechanism, such as miRNA differential expression. We investigated if hsa-let7b-5p, reported to target both ACE2 and DPP4 transcripts, could be involved in the regulation of these genes. We verified that the inhibition and overexpression of hsa-let7b-5p matched to a modulation of both ACE2 and DPP4 levels. Then, we observed a statistically significant downregulation (FC = -1.5; p < 0.05) of hsa-let7b-5p in the same COVID-19 and control samples of our previous study. This is the first study that shows hsa-let7b-5p low expression in naso-oropharyngeal swabs of COVID-19 patients and demonstrates a functional role of this miR in regulating ACE2 and DPP4 levels. These data suggest the involvement of hsa-let7b-5p in the regulation of genes necessary for SARS-CoV-2 infections and its putative role as a therapeutic target for COVID-19.

The pandemic within the pandemic: the surge of neuropsychological disorders in Italian children during the COVID-19 era.

BACKGROUND: Quarantine and isolation measures during COVID-19 pandemic may have caused additional stress and challenged the mental health of the youth. Aim of the study is to investigate the COVID-19 pandemic impact on neuropsychological disorders (NPD) of Italian children and adolescents to provide general pediatric recommendations. MATERIAL AND METHODS: A retrospective multicenter observational study was planned by the Italian Pediatric Society (SIP) to explore the impact of COVID-19 on the access of children to pediatric Emergency Departments (pED) for the evaluation of neuropsychological symptoms, collecting the classification codes of diagnoses between March 1, 2019 and March 2, 2021. The period study was split into two sub-periods: a pre COVID-19 period (from March 1 2019 to March 1, 2020) and a COVID-19 period (from March 2, 2020 to March 2, 2021). As additional information, data on NPD hospitalizations in any pediatric department of the involved centers were recorded. RESULTS: During the study period, a total of 533,318 children were admitted to the pED involved in the study. Despite a 48.2% decline of pED admissions, there was a significant increase (83.1%) in patient admissions for NPD. The most frequent NPD conditions which increased during the COVID-19 pandemic were suicidal ideation (+ 147%), depression (+ 115%), eating disorder (+ 78.4%), and psychosis (+ 17.2%). During the pandemic period, a 39.5% increase in NPD hospitalizations was observed as well. The NPD disorders that mostly required hospitalizations were suicidal ideation (+ 134%), depression (+ 41.4%), eating disorder (+ 31.4%), and drug abuse (+ 26.7%). COVID-19 pandemic had a major impact on children's health, mainly on their NPD development. Neuropsychological assessment should be required at the primary level, in the pediatrician's office, to facilitate early capture of the sign of impairment and provide an adequate treatment. CONCLUSION: SIP underlines the psychological consequences of COVID 19 pandemic on the youngest and recommends an early identification of NPD in the pediatric population to avoid other serious consequences for children's physical and mental health.

Children at risk of domestic accidents when are locked up at home: the other side of COVID-19 outbreak lockdown.

BACKGROUND: We proposed to analyze thoroughly the impact of the COVID-19 lockdown (CL) in changes of profiles and in trend of the domestic accidents (DAs) in children. METHODS: This was a single experience, cross-sectional study conducted at the emergency department (ED) of III trauma center. We enrolled children under 18 years admitted to ED with a diagnosis of DAs comparing the CL period from 10th March 2020 to 4th May 2020 with the same period of the previous year,10th March 2019 to 4th May 2019. RESULTS: In CL period, the cumulative incidence of ED visits for DAs increased from 86.88 to 272.13 per 1,000 children and the cumulative incidence of hospitalizations for DAs increased from 409.72 to 534.48 per 1,000 children. We reported in CL a decrease in the severity of ED presentation assessed by proxy measures: the level of priority ED visits reduced by 67% in CL period (OR: 0.33; 95%CI 0.22-0.48; p < 0.001); the likelihood of delayed time of presentation to ED increased by 65% in case of domestic injuries occurring in CL period (OR: 1.65; 95% CI: 1.17-2.34; p = 0.004); the odds of transfer from other hospital decreased by 78% in CL (OR: 0.15-0.33; p < 0.001). Children were more at risk of poisoning (OR:3.35-106.11; p = 0.001), of body foreign ingestion (OR: 1.83-14.39; p = 0.002) and less at risk of animal bite trauma (OR:0.05-0.35; p < 0.001). CONCLUSION: Although the need to stay home has made a decisive breakthrough on the spread of COVID-19, the experience from this study underlines how this preventive measure has also had a downside in term of increased cumulative incidence of ED visits and of hospitalizations for DA.

One Year of Lung Ultrasound in Children with SARS-CoV-2 Admitted to a Tertiary Referral Children's Hospital: A Retrospective Study during 2020-2021.

During the COVID-19 pandemic, the lung ultrasound (LU) turned out to be a pivotal tool to study the lung involvement in the adult population, but the same was not well evaluated in children. We detected the LU patterns through an integrated approach with clinical-laboratory features in children hospitalized for COVID-19 in relation to the temporal trend of the Italian epidemic. We conducted a retrospective study which took place at a pediatric tertiary hospital from 15 March 2020 to 15 March 2021. We compared the characteristics of the initial phase of the first COVID-19 year-in the spring and summer (15 March-30 September 2020)-and those of the second phase-in the autumn and winter (1 October 2020-15 March 2021). Twenty-eight patients were studied both in the first and in the second phase of the first COVID-19 year. The disease severity score (DSS) was significantly greater in the second phase (p = 0.015). In the second phase of the first COVID-19 year, we detected a more significant occurrence of the following LU features than in the first phase: the irregular pleural line (85.71% vs. 60.71%; p = 0.035), the B-lines (89.29% vs. 60%; p = 0.003) and the several but non-coalescent B-lines (89.29% vs. 60%; p = 0.003). The LU score correlated significantly with the DSS, with a moderate relationship (r = 0.51, p < 0.001). The combined clinical, laboratory and ultrasound approaches might be essential in the evaluation of pulmonary involvement in children affected by COVID-19 during different periods of the pandemic.

Case Report: Precision COVID-19 Immunization Strategy to Overcome Individual Fragility: A Case of Generalized Lipodystrophy Type 4.

A 48-year-old patient affected with congenital generalized lipodystrophy type 4 failed to respond to two doses of the BNT162b2 vaccine, consisting of lipid nanoparticle encapsulated mRNA. As the disease is caused by biallelic variants of CAVIN1, a molecule indispensable for lipid endocytosis and regulation, we complemented the vaccination cycle with a single dose of the Ad26.COV2 vaccine. Adenovirus-based vaccine entry is mediated by the interaction with adenovirus receptors and transport occurs in clathrin-coated pits. Ten days after Ad26.COV2 administration, S- and RBD-specific antibodies and high-affinity memory B cells increased significantly to values close to those observed in Health Care Worker controls.

Reusability of P3 Facial Filter in a Pandemic Emergency: A 3D Analysis of Filter Microstructure with X-ray Microtomography Images after Dry Heat and UV Sterilization Procedures.

OBJECTIVE: Our goal is to evaluate the effects of heat and ultraviolet (UV) irradiation on P3 facial respirator microstructure. INTERVENTION: P3 facial filters were exposed to dry heat and UV sterilization procedures. METHODS: P3 facial filter samples underwent a standardized sterilization process based on dry heat and UV irradiation techniques. We analyzed critical parameters of internal microstructure, such as fiber thickness and porosity, before and after sterilization, using 3D data obtained with synchrotron radiation-based X-ray computed microtomography (micro-CT). The analyzed filter has two inner layers called the "finer" and "coarser" layers. The "finer" layer consists of a dense fiber network, while the "coarser" layer has a less compact fiber network. RESULTS: Analysis of 3D images showed no statistically significant differences between the P3 filter of the controls and the dry heat/UV sterilized samples. In particular, averages fiber thickness in the finer layer of the control and the 60° dry heated and UV-irradiated sample groups was almost identical. Average fiber thickness for the coarser layer of the control and the 60° dry heated and UV-irradiated sample groups was very similar, measuring 19.33 µm (±0.47), 18.33 µm (±0.47), and 18.66 µm (±0.47), respectively. There was no substantial difference in maximum fiber thickness in the finer layers and coarser layers. For the control group samples, maximum thickness was on average 11.43 µm (±1.24) in the finer layer and 59.33 µm (±6.79) in the coarser layer. Similarly, the 60° dry heated group samples were thickened 12.2 µm (±0.21) in the finer layer and 57.33 µm (±1.24) in the coarser layer, while for the UV-irradiated group, the mean max thickness was 12.23 µm (±0.90) in the finer layer and 58.00 µm (±6.68) in the coarser layer. Theoretical porosity analysis resulted in 74% and 88% for the finer and coarser layers. The finer layers' theoretical porosity tended to decrease in dry heat and UV-irradiated samples compared with the respective control samples. CONCLUSIONS: Dry heat and UV sterilization processes do not substantially alter the morphometry of the P3 filter samples' internal microstructure, as studied with micro-CT. The current study suggests that safe P3 filter facepiece reusability is theoretically feasible and should be further investigated.

Early recognition of child abuse through screening indicators at the emergency department: experience of a tertiary urban pediatric hospital.

BACKGROUND: Emergency Departments play a pivotal role in detecting cases of child abuse. Despite the efforts made in the past decades on the need for a screening method for the early detection of abuse victims, a unique instrument shared by the international scientific community has not been made. These instruments should be able to help recognizing whether it is necessary to further investigate the child's condition. The aim of the study is to illustrate the screening indicators in use since 2010 in the Emergency Department of the Bambino Gesù Children's Hospital to early recognise the victims of abuse and the modifying process of the screening tool undertaken over the years. METHODS: We retrospectively analyzed the process that led to the editing of the indicators of child abuse in use nowadays at the Bambino Gesù Children's Hospital. We codified three clinical pathways to apply in case of suspected abuse. Furthermore, we investigated the medical records of screening-positive accesses in the Paediatric Emergency Department of the Bambino Gesù Children's Hospital from January 2008 to October 2020. RESULTS: An estimation of positive screening, regarding the type of abuse suspected, and the number of accessed in ED was made, resulting in a cohort of 956 patients. In 2010 we created a list of 14 items grouped in three clusters: anamnestic declarations or incongruences, carelessness/neglect and evident lesions at physical examination. Positivity to one of the items allows the actuation of the investigating protocol named as clinical pathway.In 2013, after three years of experience, the criteria were edited to increase specificity. The application of screening led to a median number of 82 suspected cases/year from 2013 to 2020. CONCLUSION: A screening tool is essential and productive for the early recognition of victims of abuse. An in-deep analysis of suspected cases through a standardized method, such as the clinical pathway, allowed reaching the diagnosis in a more accurate and precise manner.

Persistent B cell memory after SARS-CoV-2 vaccination is functional during breakthrough infections.

Breakthrough SARS-CoV-2 infections in fully vaccinated individuals are considered a consequence of waning immunity. Serum antibodies represent the most measurable outcome of vaccine-induced B cell memory. When antibodies decline, memory B cells are expected to persist and perform their function, preventing clinical disease. We investigated whether BNT162b2 mRNA vaccine induces durable and functional B cell memory in vivo against SARS-CoV-2 3, 6, and 9 months after the second dose in a cohort of health care workers (HCWs). While we observed physiological decline of SARS-CoV-2-specific antibodies, memory B cells persist and increase until 9 months after immunization. HCWs with breakthrough infections had no signs of waning immunity. In 3-4 days, memory B cells responded to SARS-CoV-2 infection by producing high levels of specific antibodies in the serum and anti-Spike IgA in the saliva. Antibodies to the viral nucleoprotein were produced with the slow kinetics typical of the response to a novel antigen.

Intention of Parents to Immunize Children against SARS-CoV-2 in Italy.

Several countries have targeted adolescents for immunization against SARS-CoV-2 to mitigate COVID-19 spread. In Italy, immunization for children ≥ 12 years has been available starting from June 2021. We conducted a cross-sectional study to investigate the knowledge, attitude and intention to vaccinate children < 18 years in Italian families. We used a multinomial logistic regression model to investigate factors associated with intention to vaccinate. We collected a total of 1696 responses. Among the 491 families of children ≥ 12 years, 41.2% would not vaccinate their children and 21.2% were uncertain, while among the 1205 families of children < 12 years, 36.1% would not vaccinate and 33.8% were uncertain. Determinants of intention to vaccinate both age groups were perceived safety and efficacy of vaccines and perceived risk of transmitting infection to adults. For children < 12 years, additional determinants were perceived risk of being infected and being hospitalized because of COVID-19. In view of the expanding strategy to vaccinate adolescents and the availability of immunization for children < 12 years, our results call for a communication strategy targeted at families of children focused on the safety and efficacy of COVID-19 vaccine in children and on the dynamics of infection spread across different age groups. As perceptions in families are volatile and may change rapidly over time, repeated surveys for measuring attitudes to vaccinate would be advisable.

No evidence of SARS-CoV-2 in hospitalized patients with severe acute respiratory syndrome in five Italian hospitals from 1st November 2019 to 29th February 2020.

BACKGROUND: On 9th January 2020, China CDC reported a novel coronavirus (later named SARS-CoV-2) as the causative agent of the coronavirus disease 2019 (COVID-19). Identifying the first appearance of virus is of epidemiological importance to tracking and mapping the spread of SARS-CoV-2 in a country. We therefore conducted a retrospective observational study to detect SARS-CoV-2 in oropharyngeal samples collected from hospitalized patients with a Severe Acute Respiratory Infection (SARI) enrolled in the DRIVE (Development of Robust and Innovative Vaccine Effectiveness) study in five Italian hospitals (CIRI-IT BIVE hospitals network) (1st November 2019 - 29th February 2020). OBJECTIVES: To acquire new information on the real trend in SARS-CoV-2 infection during pandemic phase I and to determine the possible early appearance of the virus in Italy. MATERIALS AND METHODS: Samples were tested for influenza [RT-PCR assay (A/H1N1, A/H3N2, B/Yam, B/Vic)] in accordance with the DRIVE study protocol. Subsequently, swabs underwent molecular testing for SARS-COV-2. [one-step real-time multiplex retro-transcription (RT) PCR]. RESULTS: In the 1683 samples collected, no evidence of SARS-CoV-2 was found. Moreover, 28.3% (477/1683) of swabs were positive for influenza viruses, the majority being type A (358 vs 119 type B). A/H3N2 was predominant among influenza A viruses (55%); among influenza B viruses, B/Victoria was prevalent. The highest influenza incidence rate was reported in patients aged 0-17 years (40.3%) followed by those aged 18-64 years (24.4%) and ≥65 years (14.8%). CONCLUSIONS: In Italy, some studies have shown the early circulation of SARS-CoV-2 in northern regions, those most severely affected during phase I of the pandemic. In central and southern regions, by contrast no early circulation of the virus was registered. These results are in line with ours. These findings highlight the need to continue to carry out retrospective studies, in order to understand the epidemiology of the novel coronavirus, to better identify the clinical characteristics of COVID-19 in comparison with other acute respiratory illnesses (ARI), and to evaluate the real burden of COVID-19 on the healthcare system.

Pediatric Hospitalization for Varicella in an Italian Pediatric Hospital: How Much Does It Cost?

BACKGROUND: Varicella is a common pediatric infection. Even if it generally has a benign course, it may complicate and require hospitalization. The aim of our study was to estimate the acute hospitalization cost (AHC) for varicella in the acute phase in a pediatric population. METHODS: We calculated the AHC of pediatric patients admitted for varicella at Bambino Gesù Children Hospital, Rome, Italy, from 1 November 2005 to 1 November 2020. RESULTS: In the study period, 825 pediatric patients affected by varicella were hospitalized. The mean hospitalization cost was EUR 4015.35 (range from EUR 558.44 to EUR 42,608.00). Among patients, 55% were unvaccinable due to either their age or their immunosuppression status. They would benefit from herd immunity, reducing the overall AHC by EUR 182,196,506. Since the introduction of the compulsory vaccination against varicella in Italy, we observed a significant reduction in AHC cost of 60.6% in 2019 and of 93.5% in 2020. Finally, from the beginning of the COVID-19 pandemic, we documented a decline of 81.2% and 76.9% in varicella hospitalization, compared to 2018 and 2019, respectively. CONCLUSIONS: Varicella AHC is an important economic and health assessment point and can be useful for improving preventive strategies.

Humoral and Cellular Response Following Vaccination With the BNT162b2 mRNA COVID-19 Vaccine in Patients Affected by Primary Immunodeficiencies.

Mass SARS-Cov-2 vaccination campaign represents the only strategy to defeat the global pandemic we are facing. Immunocompromised patients represent a vulnerable population at high risk of developing severe COVID-19 and thus should be prioritized in the vaccination programs and in the study of the vaccine efficacy. Nevertheless, most data on efficacy and safety of the available vaccines derive from trials conducted on healthy individuals; hence, studies on immunogenicity of SARS-CoV2 vaccines in such populations are deeply needed. Here, we perform an observational longitudinal study analyzing the humoral and cellular response following the BNT162b2 mRNA COVID-19 vaccine in a cohort of patients affected by inborn errors of immunity (IEI) compared to healthy controls (HC). We show that both IEI and HC groups experienced a significant increase in anti-SARS-CoV-2 Abs 1 week after the second scheduled dose as well as an overall statistically significant expansion of the Ag-specific CD4+CD40L+ T cells in both HC and IEI. Five IEI patients did not develop any specific CD4+CD40L+ T cellular response, with one of these patients unable to also mount any humoral response. These data raise immunologic concerns about using Ab response as a sole metric of protective immunity following vaccination for SARS-CoV-2. Taken together, these findings suggest that evaluation of vaccine-induced immunity in this subpopulation should also include quantification of Ag-specific T cells.