Reactogenicity of BNT162b2 mRNA COVID-19 Vaccine in a Young Working Age Population: A Survey among Medical School Residents, within a Mass Vaccination Campaign, in a Regional Reference Teaching Hospital in Italy

Abstract

Vaccinations are a key prevention measure in fighting the COVID-19 pandemic. The BNT162b2 mRNA vaccine (BioNTech/Pfizer), the first to receive authorization, was widely used in the mass vaccination campaign in Italy. Healthcare workers were identified as a priority group for vaccination, but few studies have assessed its reactogenicity among the young working age population. An online survey was conducted to investigate the adverse reactions occurring in the 7 days following the first and second vaccination doses amongst resident doctors of the University of Genoa, employed at the IRCCS Ospedale Policlinico San Martino of Genoa, between 11 January and 16 March 2021. A total of 512 resident physicians were invited to participate in the study (female = 53.2%; mean age = 28.9 years), of whom 296 (female = 53.4%, mean age = 28.9 years) and 275 (female = 55.3%, mean age = 29.1 years) completed the survey after their first and second vaccination doses, respectively. In the 7 days following the first dose, most common adverse reactions were local pain (96.3%), fatigue (42.6%), headache (33.8%), arthromyalgia (28.0%), and 5.1% reported fever, while following the second dose, participants reported local pain (93.5%), fatigue (74.9%), headache (57.5%), arthromyalgia (58.2%), and fever (30.9%), with a higher prevalence among females. Systemic (but not local) reactions increased following the second vaccination, reaching severe intensity in 9.8% of participants and causing three or more events of moderate intensity in 23.7% of participants. Adverse reactions preventing regular daily activities could cause absenteeism among workers. These results can be useful to inform populations of young individuals, set expectations, and improve adherence to vaccination campaigns.

Safety and immunogenicity of SII-NVX-CoV2373 (COVID-19 vaccine) in adults in a phase 2/3, observer-blind, randomised, controlled study

“…The reactogenicity of the mRNA vaccines is more with the second dose as compared to the first dose. 22 , 23 , 24 With SII-NVX-CoV2373 as well, we find increased reactogenicity after the second dose. It is possible that matrix M adjuvant could be contributing to the increased reactogenicity.…”

Sex-disaggregated outcomes of adverse events after COVID-19 vaccination: A Dutch cohort study and review of the literature

“…Similarly, females had a median 1.96 times higher odds of reporting a local reaction compared to males (range: 1.02-2.90, IQR1.85-2.54) ( 22 , 32 , 42 , 54 , 76 ). With regard to specific common AEFIs, median ORs of 2.42 (range 2.07-4.72), 2.01 (range 1.57-2.61), and 1.77 (range 1.63-1.84) were reported for headache ( 32 , 51 , 67 , 76 ), fatigue ( 22 , 32 , 51 , 67 , 76 ), and fever ( 32 , 68 , 76 ) respectively. TTR was assessed in four articles, all of which reported higher TTR in females compared to males ranging from 1.2-1.9 days in males to 1.4- 2.2 days in females, though the difference was only statistically significant in one article ( 23 , 31 , 54 , 66 ).…”

Short-Term Adverse Events and Antibody Response to the BNT162b2 SARS-CoV-2 Vaccine in 4156 Health Care Professionals

“…Among the strengths, we include a large number of enrolled subjects, the uniform vaccine type and schedule, and the established laboratory technique for IgG determination. The potential pitfalls of the study may derive from the self-reported origin of adverse events, which may lead to a less reliable representation of signs and symptoms and the young age of the participants, likely less representative of the general population [ 28 ]. In the case of self-reported items, however, the literature suggests that this approach may lead to an over-response by subjects who experienced adverse events, and this is likely to stress the safety profile of the vaccine [ 12 , 13 , 29 ].…”