Recurrence of adverse events of special interest after COVID-19 vaccines rechallenge: A Vigibase® study

ABSTRACT

Introduction: Since the beginning of vaccination against COVID-19 in 2020, the occurrence of adverse events of special interest (AESI) after the 1st dose of vaccine raises the question of the potential risk associated with the following injections. Real-life vaccine data collected in pharmacovigilance databases can provide information about the safety of a rechallenge with COVID-19 vaccines. In order to help physicians to decide whether another injection is at risk, we analyzed the cases reported in the WHO pharmacovigilance database, Vigibase®. Material and methods: We identified AESI with major concerns about the safety of a rechallenge with COVID-19 vaccines facial paralysis, immune thrombocytopenia, herpes viral infections, hypertension, hearing loss, Guillain-Barré syndrome (GBS), convulsions, myelitis, encephalitis, myocarditis, pericarditis and acute pancreatitis. We extracted cases with rechallenge of these AESI from VigiBase®, whether the AESI recurred or not, until 24 November 2021. The rate of recurrence of the initial AESI according to the vaccine platform was calculated. Results: 676 cases of AESI with COVID-19 vaccines reported information of recurrence after rechallenge, 320 with positive recurrence and 356 with no recurrence. Facial paralysis, herpes viral infection, GBS and myocarditis mostly did not reccur whatever the vaccine type. Whereas hypertension, hearing loss, convulsion and pericarditis seemed to reoccur only after rechallenge of mRNA vaccines, compared to others vaccines. There were few data for immune thrombocytopenia, encephalitis, myelitis and acute pancreatitis. Discussion/Conclusion: This study provided information about the safety of rechallenge of COVID-19 vaccines after first occurrence of AESI. Such information is of great importance considering that several booster shots are being proposed to populations to improve protection against COVID-19 variants. In case of AESI after COVID-19 vaccine, the decision to maintain the following dose must take into account the patient's individual risk benefit balance as well as his history. Although limited, our results provide clinical elements that may help decision-making.