ABSTRACT
Introduction: Several neurobiological mechanisms have been proposed to support the hypothesis of a higher COVID-19 risk in individuals with Autism Spectrum Disorder (ASD) [1]. Since the end of 2020 EMA and FDA, among others Agencies, issued Emergency Use Authorization for COVID-19 vaccines, approved for prevention of COVID-19 disease [2]. Safety of these vaccines are monitored in all countries. In USA, spontaneous reports are collected in the Vaccine Adverse Event Reporting System (VAERS), that is freely accessible [3]. This continuous and intense safety monitoring is needed to enable a timely evaluation of the benefit/risk profile of COVID-19 vaccines to ensure the benefit of vaccination continues to outweigh risks. Objective(s): To evaluate suspected adverse reactions following vaccination with COVID-19 vaccines in persons with ASD reported to VAERS. Method(s): This study analyzed VAERS reports of suspected adverse reactions following vaccination with Pfizer-BioNTech, Moderna and Janssen COVID-19 vaccines until 04/Mar/2022 in children, adolescents and adults with ASD. Reports were analysed by age, sex, seriousness, type of vaccine (manufacturer), dose, onset interval, length of hospitalisation and outcome. Result(s): Eighty-seven reports have been retrieved from VAERS. The most affected age group is between 18-29 years with a higher percentage distribution in males than in females. Seventy-six (76%) reports were related to non-serious events, thus, he most frequent reactions reported were expected: fever, pain at the injection site and headache. Other adverse reactions are rare and unexpected including febrile seizure and eye rolling. Two cases of amonorrhea were also observed. Among the 11 serious cases, 6 (6.90%) were hospitalized;2 (2.30%) were reported as life-threatening and 2(2.30%) caused permanent disability. Death was reported in one case, occurrin few hours after the vaccination. At the time of the reporting, the patients presented concomitant medical conditions, treated with various product medications, who contributed, therefore, to the onset of events. Conclusion(s): The number of cases reported to VAERS and related to suspected adverse reactions in individuals with ASD does not suggest a safety concern attributable to authorized COVID-19 vaccines at this time in this special population.
ABSTRACT
Introduction: Several neurobiological mechanisms have been proposed to support the hypothesis of a higher COVID-19 risk in individuals with Autism Spectrum Disorder (ASD) [1]. Since the end of 2020 EMA and FDA, among others Agencies, issued Emergency Use Authorization for COVID-19 vaccines, approved for prevention of COVID-19 disease [2]. Safety of these vaccines are monitored in all countries. In USA, spontaneous reports are collected in the Vaccine Adverse Event Reporting System (VAERS), that is freely accessible [3]. This continuous and intense safety monitoring is needed to enable a timely evaluation of the benefit/risk profile of COVID-19 vaccines to ensure the benefit of vaccination continues to outweigh risks. Objective: To evaluate suspected adverse reactions following vaccination with COVID-19 vaccines in persons with ASD reported to VAERS. Methods: This study analyzed VAERS reports of suspected adverse reactions following vaccination with Pfizer-BioNTech, Moderna and Janssen COVID-19 vaccines until 04/Mar/2022 in children, adolescents and adults with ASD. Reports were analysed by age, sex, seriousness, type of vaccine (manufacturer), dose, onset interval, length of hospitalisation and outcome. Results: Eighty-seven reports have been retrieved from VAERS. The most affected age group is between 18-29 years with a higher percentage distribution in males than in females. Seventy-six (76%) reports were related to non-serious events, thus, he most frequent reactions reported were expected: fever, pain at the injection site and headache. Other adverse reactions are rare and unexpected including febrile seizure and eye rolling. Two cases of amonorrhea were also observed. Among the 11 serious cases, 6 (6.90%) were hospitalized;2 (2.30%) were reported as life-threatening and 2(2.30%) caused permanent disability. Death was reported in one case, occurrin few hours after the vaccination. At the time of the reporting, the patients presented concomitant medical conditions, treated with various product medications, who contributed, therefore, to the onset of events. Conclusion: The number of cases reported to VAERS and related to suspected adverse reactions in individuals with ASD does not suggest a safety concern attributable to authorized COVID-19 vaccines at this time in this special population.
ABSTRACT
Introduction: The Istituto Superiore di Sanita and the Agenzia Italiana del Farmaco coordinate the project TheShinISS-Vax, Flu, a post-marketing "active" surveillance of influenza vaccines. We report the results of the investigation using the Self- Controlled Case Series (SCCS) design on influenza vaccine and Guillain-Barre syndrome in vaccinated population aged over than 6 months, during the influenza vaccine campaign 2020-2021 in Italy. Materials and methods: A SCCS multi-regional study was carried out using linked data from Regional Health Care Registries of Valle d'Aosta, Friuli Venezia Giulia, Emilia-Romagna, Toscana, Lazio, Campania, and Puglia. Relative incidence of Guillain-Barre syndrome was estimated, comparing the exposure risk periods (0-41 days from the vaccination day, subdivided in six intervals) with the unexposed period.