Immunocompetent Children Research Articles

Severe Cicatricial Ectropion and Lagophthalmos Secondary to Herpes Zoster Ophthalmicus in an Immunocompetent Child

Severe Cicatricial Ectropion and Lagophthalmos Secondary to Herpes Zoster Ophthalmicus in an Immunocompetent Child

A CASE REPORT ON PULMONARY NOCARDIOSIS IN AN IMMUNOCOMPETENT CHILD

Genus Nocardia usually affects an immunocompromised patient. Predominantly, the infection involves the lungs followed by Central Nervous System. In the paediatric age group, 60% to 70% of cases occur due to an underlying immunocompromised state. Approximately 30% of immunocompetent children can also get infected with Nocardia and present as lymphocutaneous disease, orbital cellulitis, arthritis, or pneumonia A case of pulmonary infection from Nocardia in an immunocompetent patient is reported here. The case patient was a 14-year-old child who presented with chronic off-and-on cough with expectoration from 2 to 3 years. Sputum for AFB smear showed acid-fast bacilli whereas HRCT lung was normal and Mycobacterium tuberculosis was not detected on RT-PCR. Antibiotic coverage was given with Tab. Linezolid 600mg BD and the patient improved gradually. India is endemic for tuberculosis and the clinical presentation of Mycobacterium tuberculosis and Pulmonary nocardiosis overlaps, this case report highlights the importance of suspecting Nocardia spp. infection in such cases as the immunocompetent paediatric age group

Evaluation of the Usefulness of a Serological Test for Diagnosis of Celiac Disease Simultaneously Detecting Specific Antibodies and Total IgA.

The diagnosis of celiac disease (CD) at the first diagnostic step requires the detection of specific class A antibodies to tissue transglutaminase type-2 (TG2 IgA) and the measurement of total immunoglobulin A (tIgA) to exclude IgA deficiency. The aim of the study was to evaluate the new quantitative immunoassay panel allowing for the detection of celiac-specific antibodies with the simultaneous determination of tIgA from the same sample of blood at one time. This retrospective study included 104 pediatric patients divided into groups with recognized CD and IgA deficiency (n = 20; 19%), immunocompetent children with CD (n = 28; 27%), children with IgA deficiency and without CD (n = 28; 27%), and the control group of immunocompetent children without CD (n = 28; 27%). Intestinal biopsy with histopathological evaluation (except five patients with CD who were diagnosed without biopsy) and measurement of reference celiac specific antibodies were performed in all children. Multiparametric quantitative immunoassay Polycheck® Celiac IgA plus total IgA test was used to evaluate its usefulness in CD screening and IgA deficiency diagnosis. The statistical analysis showed the high sensitivity and specificity of both TG2 IgA and tIgA on the multiparametric panel (sensitivity 96% and 100%; specificity 100% and 79%, respectively). The accuracy and area under the ROC curve for tIgA were 0.904 and 0.955, while for TG2 IgA they were 0.982 and 1.000, respectively. Although the sensitivity of IgA antibodies against deaminated gliadin peptides was low (20%), the specificity reached 100%. The study showed that Polycheck® Celiac IgA plus total IgA test is a specific and sensitive tool for simultaneous serological CD screening and recognition of IgA deficiency.

Bacillus Calmette-Guérin Vaccine-Related Osteomyelitis in Immunocompetent Children in Saudi Arabia: A Narrative Review.

The Bacillus Calmette-Guérin (BCG) vaccine is the most frequently used live-attenuated vaccine worldwide. Since 2002, two BCG vaccination strains, Pasteur 1173 P2 and Tokyo 172-1, have been the mainstay of Saudi Arabian healthcare. In 2005, the Danish 1331 strain was first used as the principal strain in clinical trials. Children can develop osteomyelitis 4-24 months after immunization with the BCG vaccine, an uncommon but serious side effect in immunocompetent children. We conducted this study to review the epidemiology, diagnosis, clinical symptoms, laboratory analyses, imaging features, and management of BCG osteomyelitis in immunocompetent children. Long bone metaphyses and epiphyses are more frequently affected. The diagnosis of BCG osteomyelitis is difficult because the symptoms are vague and subtle, and the duration between presentation and vaccination may range from a few months to a year. Radiography and computed tomography scans for BCG osteomyelitis typically show a devastating lesion with an associated periosteal response. Magnetic resonance imaging frequently reveals a large interosseous abscess indicative of osteomyelitis. There are no current treatment guidelines for BCG osteomyelitis in Saudi Arabia, but antituberculous regimens, particularly isoniazid and rifampicin, have been found to be very effective in previous studies. Although older studies did not favor surgical intervention because of the risk of complications, a few studies performed minor surgical interventions and had good outcomes. As BCG osteomyelitis is an infrequent complication, especially in immunocompetent children, its diagnosis is time-consuming. Therefore, it is critical to inform healthcare workers of this possible complication to make the diagnosis more straightforward and avoid confusion with pyogenic osteomyelitis. As only a few cases have been reported, further studies in Saudi Arabia are required for evidence-based guidelines applicable to actual practice to be established.

1443. Nontuberculous Mycobacterial Cervicofacial Lymphadenitis Therapy: Experience from a Tertiary Care Pediatric Center

Abstract Background Nontuberculous mycobacterial (NTM) infections commonly present as a unilateral, subacute cervical lymphadenitis in immunocompetent children under the age of 5 years. The natural history of NTM lymphadenitis without intervention is slow resolution, and there is a high risk of spontaneous drainage through the skin, often result in a scar. For NTM lymphadenitis, the gold standard is complete surgical excision as it is often curative and limits scar formation. However, surgical intervention, especially complete surgical excision, carries the risk of damage to the facial nerve in the parotid and submandibular region. Antibiotic therapy is thought to interrupt the natural progression of the disease. Methods We conducted a retrospective chart review and reviewed >700 patients, who had a diagnosis of cervical lymphadenopathy and/or atypical mycobacterial based on ICD codes. Patients received a diagnosis of NTM if they had clinical adenitis with NTM detected on culture and/or PCR, acid-fast bacilli identified, or histological findings consistent with mycobacterial infection. Results A total of 17 cases of NTM were identified. The median age was 27 months; 52% were male and 47% were female. The median time of adenopathy prior to presentation to ENT or ID specialist was 2 months. The average size of the involved lymph node was 2.05 cm. Two patients were treated with only medical management, 6 with surgical management, 8 with both, and 1 had observation alone as patient was near resolution. Of the patients on antibiotics, a total of 4 patients had adverse effects (abdominal discomfort, diarrhea, vomiting, and/or rash). Surgical interventions include FNA, incision and drainage, curettage, and complete excision. Four patients required 2nd intervention. One patient had concerns for sinus formation but resolved in < 1 month. No patients had facial nerve palsy or hypertrophic scarring. Conclusion Regardless of management strategy, all children in this study had resolution of NTM. Though there is a consensus that complete surgical resection is the gold standard, we demonstrate that medical management alone (anti-microbial therapy or “wait-and-see” method) can be an alternative first-line treatment. Limitations include retrospective nature of study which is limited by data available in the EMR. Disclosures All Authors: No reported disclosures.

Clinico-Epidemiological Profile and Utility of Diagnostic Techniques in Immunocompetent Children with Cryptosporidium Diarrhoea

Purpose: To assess the Clinical and Epidemiological profile of children 6 months to 5 years having Cryptosporidium diarrhoea and to compare the diagnostic accuracy of rapid diagnostic test (RDT) against modified acid-fast stain technique to detect Cryptosporidium in stool. Materials and Methods: Details of demography, presenting complaints, and detailed examination of children presenting with acute or persistent diarrhoea were recorded in a predesigned proforma. Two Stool samples were collected and examined same day by rapid antigen test and microscopy for presence of antigen or oocyst of cryptosporidium. Results: Out of the total of 280 samples tested, 40 (14.3%) samples were positive for Cryptosporidium. The prevalence of Cryptosporidium in children presenting with diarrhoea in our study came out to be 14.3%. Fever, vomiting and pain abdomen were the most common presenting complaints. Epidemiological factors like providing clean water, proper feeding and hygiene, and avoidance of overcrowding can help in reducing the burden of Cryptosporidium diarrhoea. Persistent diarrhoea was more common among cryptosporidium positive cases. Rapid detection kits enhance the detection rate and are sensitive as well as specific. It could be utilised as an aid in diagnosis of Cryptosporidium diarrhoea. Conclusion: The study shows that cryptosporidial diarrhoea is not uncommon in immunocompetent children. Improvement in personal hygiene, feeding practices and access to safe and potable water can help in reducing burden of this disease. Antigen detection kits aid in early diagnosis. Keywords: Paediatric cryptosporidiosis, Persistent diarrhoea, Sanitation, RDT in diarrhoea, Abdominal pain

Safety of varicella vaccination strategies: An overview of reviews.

The safety of new vaccines under development as well as existing vaccines is a key priority for national and international public health agencies. A number of countries have implemented universal childhood varicella vaccination programmes over the past 30years. However, strategies differ in terms of the number of doses, type of vaccine(s) recommended, age at vaccination and interval between doses for a two-dose schedule. An overview of reviews was undertaken to assess the existing systematic review evidence of the safety of varicella vaccination strategies. The review was restricted to immunocompetent children aged 9months to 6years inclusive. A comprehensive search of databases, registries and grey literature was conducted up to 2 February 2022. Two reviewers independently screened, extracted data and assessed the methodological quality of included reviews. Overlap of included reviews was also assessed. A total of 17 reviews, incorporating both the monovalent varicella only and quadrivalent measles-mumps-rubella-varicella (MMRV) vaccines were included in the overview; six assessed the safety of one-dose strategies, four assessed the safety of two-dose strategies and 14 reviews did not specify the dosing strategy. The evidence suggests that mild local and systemic reactions are relatively common with varicella vaccination. Febrile seizures are also possible adverse effects of both the monovalent and quadrivalent MMRV vaccine, but serious adverse reactions are rare. While most reviews contained methodological flaws, and analysis by vaccine type and dosing strategy was restricted due to lack of detail in reporting of the reviews, there was clear and consistent evidence from a substantial evidence base, comprising 34 randomised controlled trials and 62 other primary studies/reviews, that varicella vaccination is safe.

Burkitt lymphoma after solid-organ transplant: Treatment and outcomes in the paediatric PTLD collaborative.

Burkitt lymphoma arising in paediatric post-solid-organ transplantation-Burkitt lymphoma (PSOT-BL) is a clinically aggressive malignancy and a rare form of post-transplant lymphoproliferative disorder (PTLD). We evaluated 35 patients diagnosed with PSOT-BL at 14 paediatric medical centres in the United States. Median age at organ transplantation was 2.0 years (range: 0.1-14) and age at PSOT-BL diagnosis was 8.0 years (range: 1-17). All but one patient had late onset of PSOT-BL (≥2 years post-transplant), with a median interval from transplant to PSOT-BL diagnosis of 4.0 years (range: 0.4-12). Heart (n= 18 [51.4%]) and liver (n= 13 [37.1%]) were the most frequently transplanted organs. No patients had loss of graft or treatment-related mortality. A variety of treatment regimens were used, led by intensive Burkitt lymphoma-specific French-American-British/Lymphomes Malins B (FAB/LMB), n= 13 (37.1%), and a low-intensity regimen consisting of cyclophosphamide, prednisone and rituximab (CPR) n= 12 (34.3%). Median follow-up was 6.7 years (range: 0.5-17). Three-year event-free and overall survival were 66.2% and 88.0%, respectively. Outcomes of PSOT-BL patients receiving BL-specific intensive regimens are comparable to reported BL outcomes in immunocompetent children. Multi-institutional collaboration is feasible and provides the basis of prospective data collection to determine the optimal treatment regimen for PSOT-BL.

A Systematic Review of the Diagnosis and Treatment of Non-Typhoid Salmonella Spondylodiscitis in Immunocompetent Children.

The aim of this systematic review is to distinguish the clinical features of immunocompetent children with non-typhoid Salmonella spondylodiscitis and summarize the diagnosis, diagnostic tools, and treatment methods to guide clinicians. The review was conducted according to the preferred PRISMA guidelines. We conducted a literature search in the PubMed, Embase, and Cochrane Library databases. Article screening, data extraction, and study evaluation were performed by two independent reviewers. A total of 20 articles, published between 1977 and 2020, were selected, which included 21 patients with average age of 12.76 years (range, 2-18) without comorbidities; in total, 19% of the patients had positive blood cultures for non-typhoid Salmonella, and 80.9% underwent either CT-guided or open biopsy, which were positive for NTS. All infections were monomicrobial, and 11 different serotypes of non-typhoid Salmonella were identified. Analyzing the reviewed cases, 52.4% of the patients presented with fever, 90.5% had localized pain, and only 19% had gastroenteritis. The most common level of discitis was the lumbar region, especially the L4/L5 level. Primarily, third-generation cephalosporin was administered, and antibiotic treatment was given for an average of 9.6 weeks. Non-typhoid Salmonella spondylodiscitis is a rare clinical entity in healthy and immunocompetent children. The identification of the responsible organism is essential to guide antibiotic therapy and define the treatment duration. A significant limiting factor in this systematic review was the lack of published research articles and case series due to the rarity of the disease.

A link between severe hepatitis in children and adenovirus 41 and adeno-associated virus 2 infections.

Over the past few months there have been reports of severe acute hepatitis in several hundred, otherwise healthy, immunocompetent young children. Several deaths have been recorded and a relatively large proportion of the patients have needed liver transplants. Most of the cases, so far, have been seen in the UK and in North America, but it has also been reported in many other European countries, the Middle East and Asia. Most common viruses have been ruled out as a causative agent; hepatitis A virus (HAV), hepatitis B virus (HBV) and hepatitis C virus (HCV) were not detected, nor were Epstein-Barr virus (EBV), cytomegalovirus (CMV) and human immunodeficiency virus (HIV) in many cases. A small proportion of the children had been infected with SARS-CoV-2 but these seem to be in a minority; similarly, almost none of the children had been vaccinated against COVID-19. Significantly, many of the patients were infected with adenovirus 41 (HAdV-F41). Previously, HAdV-41 had not been linked to hepatitis and is usually considered to cause gastroenteritis in both immunocompetent and immunocompromised patients. In two most recent studies, adeno-associated virus 2 (AAV2) was detected in almost all patients, together with species C and F HAdVs and human herpesvirus 6B (HHV6B). Here, I discuss the possibility that a change in tropism of HAdV-41 and changes in AAV2 may be responsible for their links to acute hepatitis.

An Epidemic of Acute Hepatitis of Unknown Etiology in Children

An Epidemic of Acute Hepatitis of Unknown Etiology in Children

Gastric outlet obstruction due to cytomegalovirus infection in an immunocompetent child.

Gastric outlet obstruction due to cytomegalovirus infection in an immunocompetent child.

Immune Response to SARS-CoV-2 Infections in Children with Secondary Immunodeficiencies

Background and PurposeIt is a matter of research, whether children with immunodeficiencies are able to generate an effective immune response to prevent SARS-CoV-2 reinfection. This study aimed to evaluate and compare the seroconversion rates and changes of lymphocyte subsets during COVID-19 in immunocompetent children and those with secondary immunodeficiencies.MethodsIn 55 children — 28 immunocompromised and 27 immunocompetent — hospitalized with confirmed SARS-CoV-2 infection, the level of IgG antibodies against the Spike protein was determined on two to three occasions. In those children from the study group whose immunosuppressive treatment did not alter during the study (n = 13) and in selected children from the control group (n = 11), flow cytometric evaluation of lymphocyte subsets was performed twice — 2 weeks and 3 months post-infection.ResultsSeroconversion reached 96.3% in both studied groups; however, the immunocompromised cohort achieved lower titers of detectable anti-S antibodies. There was no correlation between seroconversion or titers of antibodies and the total number of lymphocytes or their subsets. In the immunocompetent cohort, we reported a significant decrease in NK cells during the infection. In this group and the entire study population, a positive correlation was noticed between the CD4 + /CD8 + T cell ratio and the severity of COVID-19 pneumonia.ConclusionsChildren with secondary immunodeficiencies seroconvert in equal percentages but with a significantly lower titer of anti-S antibodies compared to their immunocompetent peers. The lower number of NK cells in the immunocompetent cohort may result from their participation in antiviral immunity, whereas reduced CD4 + /CD8 + T cell ratios among immunocompromised children may be a protective factor against a severe COVID-19.

COVID-19 in Immunocompromised Children and Adolescents.

COVID-19 in Immunocompromised Children and Adolescents.

P217 Pelvic mycoses— an unusual presentation of Rhizopus arrhizus in an ommunocompetent patient

Poster session 2, September 22, 2022, 12:30 PM - 1:30 PMIntroductionThe rare but increasingly identified infections caused by Mucorales are always detrimental to the patient due to rapid vascular invasion and the need for thorough surgical debridement and definitive antifungal therapy for its cure. Among the Mucorales, maximum cases have been reported among Mucor spp. and Rhizopus spp. Case: Here we present a case of a 9-year-old immunocompetent child presenting with abdominal pain and distension of 1-month duration followed by swelling of bilateral lower limbs, which was gradual in onset. Ultrasonography of the abdomen and pelvis was done which revealed a pelvic mass on the left side. The child developed acute urinary retention during the hospital stay, which was evaluated to reveal a fistulous connection between urethra and rectum for which transverse colostomy was done. The USG-guided biopsy of the left pelvic mass showed broad aseptate hyphae in Hematoxylin and Eosine staining whereas the KOH mount and culture were negative. The follow-up imaging with CT showed circumferential thickening of the recto-sigmoid region and involvement of the posterior bladder wall. Considering the rapidity of the spread of the infection, injection liposomal Amphotericin B at the dose of 5 mg/kg/d, i.v. was started and given for one week with minimal improvement. However, with this clinical picture and patient profile the diagnosis was strongly suspected to be of Basidiobolomycosis of rectosigmoid region. Treatment also was revised to injection of voriconazole at a dose 8 mg/kg/d, i.v. after loading dose which was later shifted to oral dose after 7 days. A repeat USG-guided biopsy was planned for gene sequencing, which identified the organism as Rhizopus arrhizus. On follow-up, patient showed no clinico-radiological improvement and in view of the mycological evidence, the anti-fungal was changed from voriconazole after 2 weeks to oral isavuconazole at the dose of 200 mg/d following the loading after which significant improvement was achieved and patient was discharged.ConclusionMold infection in the form of spreading rectosigmoid mass in an immunocompetent child usually suggests the picture of Basidiobolomycosis. Treating patients only on clinical grounds without mycological confirmation may lead to overlooking of Mucormycosis and may result in adverse outcomes. The diagnosis of Mucormycosis should always be considered as a differential for a fungal infection in the form of mass lesion in abdomen.

S6.1d First case report of pediatric blood stream infection by Candida magnoliae in a known case of B cell ALL post -induction chemotherapy in Central India

S6.1 Antifungal Prophylaxis in Children with Cancer and HSCT, September 22, 2022, 4:45 PM - 6:15 PM ObjectivesDocumentation and dissemination of findings of a rare fungal isolate in an immunosuppressed child.MethodsA case study with rare fungal isolate in correlation to age, clinical condition, sample, and comorbidity was done. A 6-year-old male child was admitted for routine management of B cell acute lymphoid leukemia. The patient completed induction chemotherapy in July 2021. The patient was planned for consolidation in the last week of July and to rule out any infection blood and urine samples were sent. Paired blood samples were received in pediatric automated BacT/Alert blood culture bottles. After 8 days both the blood culture bottles flashed positive. On gram stain, budding yeast cells oval to globose were seen. No pseudohyphae were seen. Nigrosin staining result was negative. It was processed further on HiCrome™ agar showing cream-colored colonies at 370 C, cornmeal agar with 1% tween 80 for Dalmau technique showed only oval to globose yeast cells with blastoconidia, enlarged cells appearing as chlamydoconidia without pseudohyphae or true hyphae were seen. Glucose and sucrose were fermented and trehalose was weakly fermented. Urease was negative. Isolate was identified as Candida glabrata/Candida auris. Antifungal susceptibility showed elevated MIC for fluconazole but susceptible to amphotericin B, voriconazole, and caspofungin. As part of routine collaboration with reference center PGIMER, bloodstream Candida isolates were sent for confirmation, and quality control.ResultsThe isolate phenotypically suspected as C. glabrata causing fungemia was confirmed by the reference center as C. magnoliae. Currently, patient is on routine follow-up and doing well. On reviewing of available literature on C. magnoliae; bloodstream infections in two low birth weight neonates from Brazil, one immunocompetent child with tenosynovitis from the USA, and a terminal oncology patient from Italy were noted.In a Chinese study of 2007, phylogenetic analysis showed a close relationship of C. magnoliae to Candida krusei.ConclusionImmunosuppression with longstanding or repeated hospital admissions is a risk for nosocomial fungal infections, especially, bloodstream infections. Already confusing phenotypic identification among C. glabrata, C. auris, C. haemoulonii, and now the current isolate C. magnoliae further complicates and challenges diagnostic workflow impacting timely management of cases. Further studies and more documentation of such findings in literature are necessary for newer insights.

Management and outcome of febrile neutropenia in admitted presumed immunocompetent patients with suspected viral illness.

Febrile neutropenia (FN) creates concern in paediatrics due to the risk of serious bacterial infections (SBI). Protocols with empiric antibiotics designed for hematology and oncology are often applied in healthy children with FN despite lower rates of SBI in this population. This study quantifies rates of infections in presumed immunocompetent children hospitalized with suspected viral illnesses and FN. This was a retrospective chart review of healthy children admitted to the Stollery Children's Hospital between 2007 and 2017 with fever, absolute neutrophil counts < 0.5 × 109/L, and viral symptoms. Primary outcomes were the incidence of SBI and bacterial pneumonia. Of 383 encounters reviewed, 96 admissions for 82 patients met inclusion criteria. Eighty-eight encounters (91.7%) were managed with empiric antibiotics. Viruses were identified in 42% of encounters. Three blood cultures were positive for coagulase-negative Staphylococcus and one for Coryneforms, all considered contaminants. There were three urinary tract infections and two pneumonias. Eighty-three per cent of patients had normalization of neutrophil counts, with a median neutropenia duration of 3.2 months. Follow-up diagnoses included chronic benign neutropenia of childhood (N = 17) and three rheumatologic/autoimmune conditions (N = 3). Our results support previous findings of low rates of invasive bacterial infections in healthy children with FN. With an SBI rate of 3.1% and few patients found to have any pathologic etiology for their neutropenia, prospective studies would be valuable to evaluate the need for a practice change regarding antibiotic use in low-risk patients with suspected viral-induced neutropenia.

Hepatic Lesions in an Immunocompetent Child Previously Treated for Cat Scratch Disease With Azithromycin.

Hepatic Lesions in an Immunocompetent Child Previously Treated for Cat Scratch Disease With Azithromycin.

Usefulness of Procalcitonin in the Diagnosis of Bacterial Infection in Immunocompetent Children.

Bacterial infections (BIs) need to be differentiated from non-BIs (NBIs) to enable prompt administration of antibiotics. Therefore, inflammatory biomarkers are needed as they can accurately identify BIs. This study evaluated the usefulness of procalcitonin (PCT) in the diagnosis of BI in immunocompetent children. We retrospectively reviewed the medical records of patients <18 years who underwent PCT measurements between July 2012 and June 2019. In total, 474 patients were enrolled and divided into the BI (n = 205) and NBI groups (n = 269). The BI group was subcategorized into the invasive BI (IBI; n = 94), mucosal BI (MBI; n = 31), toxigenic BI (TBI; n = 23), and localized BI (LBI; n = 57) subgroups. The NBI group was further subcategorized into the viral infection (VI; n = 118) and inflammatory disease groups (ID; n = 151). PCT was compared with the levels of C-reactive protein (CRP), white blood cell (WBC), and erythrocyte sedimentation rate (ESR). Between the BI and NBI groups, PCT (4.2 ± 16.9 vs. 1.1 ± 2.5 ng/mL; p = 0.008) and ESR (39.1 ± 32.4 vs. 54.8 ± 28.2 mm/h; p < 0.001) were significantly different. Between the IBI and other groups, WBC (14,797 ± 7148 vs. 12,622 ± 5770 × 106/L; p = 0.007), ESR (35.3 ± 30.3 vs. 51.5 ± 30.3 mm/h; p < 0.001), and PCT (8.1 ± 23.8 vs. 1.0 ± 3.4 ng/mL; p = 0.005) were significantly different. However, none of the biomarkers were useful in differentiating BI from NBI. While WBC (area under curve (AUC) = 0.615, p = 0.003) and PCT (AUC = 0.640, p < 0.001) were useful, they fared poorly in differentiating IBI from other groups. Thus, additional studies are needed to identify more accurate biomarkers capable of differentiating BIs, especially IBIs.

Safety Monitoring of Pfizer-BioNTech COVID-19 Vaccine Booster Doses Among Children Aged 5-11 Years - United States, May 17-July 31, 2022.

On May 17, 2022, the Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) for BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine to authorize a homologous* booster dose for children aged 5-11 years ≥5 months after receipt of the second primary series dose† (1) based on findings from a clinical trial conducted among 401 children aged 5-11 years (2). To further characterize the safety of booster vaccination in this age group, CDC reviewed adverse events and health impact assessments after receipt of a Pfizer-BioNTech third dose reported to v-safe, a voluntary smartphone-based safety surveillance system for adverse events occurring after COVID-19 vaccination, and adverse events reported to the Vaccine Adverse Event Reporting System (VAERS), a passive vaccine safety surveillance system comanaged by CDC and FDA. During May 17-July 31, 2022, approximately 657,302 U.S. children aged 5-11 years received a third Pfizer-BioNTech dose (either a third primary series dose administered to immunocompromised children or a booster dose administered to immunocompetent children)§; 3,249 Pfizer-BioNTech third doses were reported to v-safe for children in this age group. Local and systemic reactions were reported to v-safe after a second dose and a third dose with similar frequency; some reactions (e.g., pain) were reported to be moderate or severe more frequently after a third dose. VAERS received 581 reports of adverse events after receipt of a Pfizer-BioNTech third dose by children aged 5-11 years; 578 (99.5%) reports were considered nonserious, and the most common events reported were vaccine administration errors. Three (0.5%) reports were considered serious; no reports of myocarditis or death were received. Local and systemic reactions were common among children after Pfizer-BioNTech third dose vaccination, but reports of serious adverse events were rare. Initial safety findings are consistent with those of the clinical trial (2).