Disproportionality analysis of adverse neurological and psychiatric reactions with the ChAdOx1(Oxford-AstraZeneca) and BNT162b2 (Pfizer- BioNTech) COVID-19 vaccines in the United K...

• Autores: Otero Losada, Matilde; Petrovsky, Nikolai; Alami, Abdallah; Crispo, James A. G.; Mattison, Donald; Capani, Francisco; Goetz, Christopher; Krewski, Daniel; Pérez Lloret, Santiago
• Año de publicación: 2022
• Idioma: inglés
• Tipo de recurso: artículo
• Fuente: Expert Opinion on Drug Safety. 2022
• Materia: COVID-19; BNT162b2; VACUNAS; ChAdOx1; FARMACOLOGIA; NEUROLOGIA; PSIQUIATRIA; VIGILANCIA; EFECTOS ADVERSOS
• Institución: Pontificia Universidad Católica Argentina

Fil: Otero Losada, Matilde. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Otero Losada, Matilde. Universidad Abierta Interamericana. Centro de Altos Estudios en Ciencias Humanas y de La Salud; Argentina
Fil: Petrovsky, Nikolai. Universidad de Flinders; Australia
Fil: Petrovsky, Nikolai. Vaxine; Australia
Fil: Alami, Abdallah. Universidad de Ottawa. Facultad de Medicina. Centro McLaughlin para la Evaluación de Riesgos para la Salud de la Población; Canadá
Fil: Alami, Abdallah. Risk Sciences International; Canadá
Fil: Crispo, James A. G. Universidad de Carleton. Escuela de Matemáticas y Estadística; Canadá
Fil: Crispo, James A. G. Escuela de Medicina del Norte de Ontario. División de Ciencias Humanas; Canadá
Fil: Crispo, James A. Universidad de British Columbia. Facultad de Ciencias Farmacéuticas; Canadá
Fil: Mattison, Donald. Vaxine; Australia
Fil: Mattison, Donald. Risk Sciences International; Canadá
Fil: Mattison, Donald. Universidad de Carolina del Sur. Arnold School of Public Health; Estdos Unidos
Fil: Mattison, Donald. Universidad de Ottawa. Escuela de Epidemiología y Salud Pública; Canadá
Fil: Capani, Francisco. Universidad Abierta Interamericana. Centro de Altos Estudios en Ciencias Humanas y de La Salud; Argentina
Fil: Capani, Francisco. Universidad Autónoma de Chile. Facultad de Ciencias de la Salud; Chile
Fil: Capani, Francisco. Universidad John F. Kennedy. Departamento de Biología; Argentina
Fil: Goetz, Christopher. Universidad Rush. Centro Médico. Departamento de Ciencias Neurológicas; Estados Unidos
Fil: Krewski, Daniel. Universidad de Ottawa. Facultad de Medicina. Centro McLaughlin para la Evaluación de Riesgos para la Salud de la Población; Canadá
Fil: Krewski, Daniel. Risk Sciences International; Canadá
Fil: Pérez Lloret, Santiago. Pontificia Universidad Católica Argentina. Laboratorio de Investigación en Ciencia de Datos; Argentina
Fil: Pérez Lloret, Santiago. Universidad de Buenos Aires. Facultad de Medicina. Departamento de Fisiología; Argentina
Abstract: Background: Information on neurological and psychiatric adverse events following immunization (AEFIs) with COVID-19 vaccines is limited. Research design & methods: We examined and compared neurological and psychiatric AEFIS reports related to BNT162b2 (Pfizer-BioNTech) and ChAdOx1 (Oxford-AstraZeneca) COVID-19 vaccines and recorded in the United Kingdom Medicines and Healthcare products Regulatory Agency between 9 December 2020 and 30 June 2021. Results: As of 30 June 2021, 46.1 million doses of ChAdOx1 and 30.3 million doses of BNT162b2 had been administered. The most frequently reported AEFI was headache with 1,686 and 575 cases per million doses of ChAdOx1 and BNT162b2, respectively. AEFIs more frequently reported after CHAdOx1 compared with BNT162b2 vaccination were Guillain-Barré syndrome (OR, 95% CI = 2.53, 1.82–3.51), freezing (6.66, 3.12–14.22), cluster headache (1.53, 1.28–1.84), migraine (1.23,1.17–1.30), postural dizziness (1.24,1.13–1.37), tremor (2.86, 2.68–3.05), headache (1.40, 1.38–1.43), paresthesia (1.11, 1.06–1.16), delirium (1.85, 1.45–2.36), hallucination (2.20, 1.82–2.66), poor quality sleep (1.53, 1.26–1.85), and nervousness (1.54, 1.26–1.89) Reactions less frequently reported with ChAdOx1 than with BNT162b2 were Bell’s palsy (0.47, 0.41–0.55), anosmia (0.58, 0.47–0.71), facial paralysis (0.35, 0.29– 0.41), dysgeusia (0.68, 0.62–0.73), presyncope (0.48, 0.42–0.55), syncope (0.63, 0.58–0.67), and anxiety (0.75 (0.67–0.85). Conclusion: Neurological and psychiatric AEFIs were relatively infrequent, but each vaccine was associated with a distinctive toxic profile. Plain Language Summary We examined reports on adverse neurological and psychiatric effects following immunization with BNT162b2 (Pfizer-BioNTech) and ChAdOx1 (Oxford-AstraZeneca) for COVID-19 to the United Kingdom Medicines and Healthcare products Regulatory Agency between 9 December 2020 and 30 June 2021. Adverse effects following immunization (AEFIs) were relatively infrequent. Compared to BNT162b2, Guillain-Barré syndrome, freezing phenomenon, cluster headache, migraine, postural dizziness, tremor, headache, paresthesia, delirium, hallucination, poor quality sleep, and nervousness were more frequently reported for ChAdOx1. Reactions less frequently reported for ChAdOx1 than for BNT162b2 were Bell’s palsy, anosmia, facial paralysis, dysgeusia, presyncope, syncope, and anxiety.