Adverse reactions and safety profile of the mRNA COVID-19 vaccines among Asian military personnel

Abstract

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

Incidence, risk factors, natural history, and hypothesised mechanisms of myocarditis and pericarditis following covid-19 vaccination: living evidence syntheses and review

“…Findings from 12 studies from the original review 15 were carried forward (Q1=5, 25 26 27 28 29 Q2=2, 29 30 Q3 part 2=10 25 26 27 28 31 32 33 34 35 36 ). From the search update, we identified 34 new reports across all questions (Q1=9, 37 38 39 40 41 42 43 44 45 Q2=5, 37 41 45 46 47 Q3 part 1=1, 48 Q4=3, 39 49 50 Q5=21 9 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 ). We excluded five studies that only reported on combined myocarditis and pericarditis (as we located studies reporting these separately), 71 72 73 74 75 eight studies that did not report on confirmed cases, 76 77 78 79 80 81 82 83 and three studies 84 85 <...…”

“…We included 14 studies (reported in publications, presentations, online reports, accessible data; all are considered here as studies for simplicity), with eight that used active surveillance data sources (eg, medical records or registries) and six that used passive reporting systems. 25 26 27 28 29 37 38 39 40 41 42 43 44 45 Data came from the US, Canada, the UK, Israel, Denmark, Singapore, and internationally (Moderna Global Safety Database). Four studies used the US Vaccine Adverse Events Reporting System for cases, and populations overlapped in analyses for young people aged 5-11 43 44 and 12-17 25 29 years in which two reports were included for each group because they applied different risk intervals (seven days and any duration).…”

“… 27 38 39 41 All studies on myocarditis reported on incident rates by age and sex; the only study reporting on pericarditis by age (5-11 years) reported data for both sexes. 39 Risk of bias was rated as some concerns (n=2 38 39 ) and high (n=6 26 27 28 40 41 45 ), mostly from no adjustment for variables other than age and sex) for studies using data from active surveillance systems and rated as high for all six studies using passive surveillance data.…”

“…We included 14 studies (reported in publications, presentations, online reports, accessible data; all are considered here as studies for simplicity), with eight that used active surveillance data sources (eg, medical records or registries) and six that used passive reporting systems 2526272829373839404142434445. Data came from the US, Canada, the UK, Israel, Denmark, Singapore, and internationally (Moderna Global Safety Database).…”

Myocarditis and Pericarditis following COVID-19 Vaccination: Evidence Syntheses on Incidence, Risk Factors, Natural History, and Hypothesized Mechanisms

“…25–28 31–36 ). From the search update, we identified 34 new reports across all questions (Q1=9 37–45 , Q2=5 37 41 45–47 , Q3=1 48 , Q4=3 39 49 50 , Q5=21 9 51–70 ); we excluded five studies that only reported on combined myo- and/or pericarditis (as we located other studies with these reported separately), 71–75 eight studies that did not report on confirmed cases, 76–83 and three studies 84–86 that did not contribute additional data to other included studies on the same cases. Tables of study characteristics, with all data on results, and risk of bias ratings for questions 1 and 2 are in Appendix 2.…”