Annals of the Academy of Medicine Singapore · 2021 · 24 citations · 17 references
Veterinary MedicineImmunologyInfectious DiseasesImmunizationPharmacovigilanceVaccinologyAdverse Events Following ImmunizationClinical Vaccine TrialsVaccinationVaccine ReactogenicityVaccine SafetyVaccine Safety SurveillanceAdverse Events Following Booster VaccinationAdverse Reactions ReportingAdverse Vaccine ReactionsInjection Site IrritationMrna Vaccine ReactogenicitySerious Adverse EventsVaccine Safety AssessmentVaccine-associated Adverse Event
Introduction: The use of novel mRNA platforms for COVID-19 vaccines raised concern about vaccine safety, especially in Asian populations that made up less than 10% of study populations in the pivotal vaccine trials used for emergency use authorisation. Vaccine safety issues also remain a concern in assessing the clinical risks and benefits of vaccine boosters, particularly in specific age groups or segments of the population. This study describes a vaccination exercise involving Asian military personnel, and the adverse reactions and safety events observed. Methods: Minor adverse reactions, hospitalisations and adverse events of special interest were monitored as part of the organisation’s protocol for safety monitoring of COVID-19 vaccinations. All vaccine recipients were invited to complete an online adverse reaction questionnaire. Medical consults at the military’s primary healthcare facilities were monitored for vaccine-related presentations. All hospitalisations involving vaccine recipients were analysed. Adverse reaction rates between doses, vaccines and age groups were compared. Results: A total of 127,081 mRNA vaccine doses were administered to 64,661 individuals up to 24 July 2021. Common minor adverse reactions included fever/chills, body aches and injection site pain. These were more common after dose 2. Younger individuals experienced minor adverse reactions more frequently. Rare cases of anaphylaxis, Bell’s palsy and myocarditis/pericarditis were observed. No deaths occurred. Conclusion: Minor adverse reactions were less common than reported in other studies, and rates of anaphylaxis, Bell’s palsy and myocarditis/pericarditis were comparable. Our study supports the favourable safety profile of mRNA COVID-19 vaccines, which may help guide decisions about booster doses if required. Keywords: COVID-19, mRNA vaccine, public health, vaccine, vaccine safety
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Bao‐Liang Zhong, Wei Luo, Hai-Mei Li et al. · International Journal of Biological Sciences · 2020 · 3.3K citations · Full text
Medicine, Infectious Disease Control, Infectious Diseases +11
Safety of the BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting
Noam Barda, Noa Dagan, Yatir Ben‐Shlomo et al. · New England Journal of Medicine · 2021 · 1.1K citations · Full text