Short-Term Side Effects and SARS-CoV-2 Infection after COVID-19 Pfizer–BioNTech Vaccine in Children Aged 5–11 Years: An Italian Real-World Study

• Published in: Vaccines (Basel) Vol. 10; no. 7; p. 1056
• Main Authors: Capponi, Martina, Pulvirenti, Federica, Cinicola, Bianca Laura, Brindisi, Giulia, Conti, Maria Giulia, Colaiocco, Giovanni, de Castro, Giovanna, Guido, Cristiana Alessia, Duse, Marzia, Midulla, Fabio, Zicari, Anna Maria, Spalice, Alberto
• Format: Journal Article
• Language: English
• Published: Basel MDPI AG 30-06-2022; MDPI
• Subjects: Age groups; Asymptomatic; Children; Chronic illnesses; Clinical trials; Coronaviruses; COVID-19; COVID-19 vaccines; Disease prevention; Disease transmission; Enrollments; FDA approval; Fever; Immunization; Immunogenicity; Infections; Infectious diseases; Nonsteroidal anti-inflammatory drugs; Pandemics; Paracetamol; Pediatrics; Pneumonia; Public health; Questionnaires; safety; SARS-CoV-2; Severe acute respiratory syndrome coronavirus 2; Side effects; Signs and symptoms; Sociodemographics; Statistical analysis; Surveillance; Vaccination; vaccine; Vaccines; Viral diseases; United States > US; Italy
• ISSN: 2076-393X; 2076-393X
• DOI: 10.3390/vaccines10071056

Vaccination against COVID-19 is the most effective tool to protect both the individual and the community from this potentially life-threatening infectious disease. Data from phase-3 trials showed that two doses of the BNT162b2 vaccine were safe, immunogenic, and effective against COVID-19 in children aged 5–11 years. However, no surveys in real-life settings have been carried out in this age range. Here, we conducted a cross-sectional study to evaluate the short-term adverse reactions (ARs) and the rate of protection against infection of the BNT162b2 vaccine in children aged 5–11 years by the compilation of two surveillance questionnaires conceived using Google Forms. Five-hundred and ninety one children were included in the analysis. ARs were reported by 68.9% of the children, being mainly local. The incidence of systemic ARs, especially fever, was higher after the second dose. The incidence of infection after completing the immunization accounted for 13.6% of the children. COVID-19 symptoms reported were mild, with the exception of one case of pneumonia. Only 40% of infected participants needed to take medication to relieve symptoms, mostly paracetamol and NSAIDs, and none reported persistent symptoms. The Pfizer–BioNTech vaccine in children aged 5–11 years is safe and well tolerated. The mild clinical course of COVID-19 in immunized children confirmed the favorable risk–benefit ratio, encouraging parents to immunize their children.