Safety surveillance after BNT162b2 mRNA COVID-19 vaccination: results from a cross-sectional survey among staff of a large Italian teaching hospital
Keywords:
vaccination, COVID-19, vaccine, cross-sectional study, pharmacovigilance, adverse drug reaction reporting systemsAbstract
Background and aim: Comirnaty® was the first COVID-19 vaccine available for the vaccination campaign of healthcare workers in Italy. With the aim of assessing vaccine safety, we conducted a cross-sectional survey administrating a voluntary-based questionnaire on adverse events following immunisation (AEFIs) in San Raffaele Hospital, Milano, Italy.
Methods: From 4th January 2021 to 27th April 2021, we collected 2,659 questionnaires (response rate: 24,5%). We analyzed data, reporting AEFIs by gender, age, self-reported severity, type, time of insurgence and duration, and estimating relative-risk ratios (RRR) and corresponding 95% confidence intervals (CI).
Results: The most reported symptoms were injection site pain, fatigue, headache, myalgia, chills, fever, and arthralgia. Severe systemic reactions were more frequent after receiving the second dose (RRR 6.25, 95% CI 4.57-8.55), in women (RRR 3.33, 95% CI 2.30-4.82), and less frequent in individuals aged 60 or more (RRR 0.26, 95% CI 0.14-0.49). In addition, we noted a wide range of adverse events of special interest (AESIs).
Conclusions: Consistently with clinical trials and pharmacovigilance surveillance, AEFIs were frequent, but severe ones were uncommon, supporting the massive implementation of the COVID-19 vaccination campaign and providing valuable data for a risk profiling of vaccinees. (www.actabiomedica.it)
References
Signorelli C, Scognamiglio T, Odone A. COVID-19 in Italy: impact of containment measures and prevalence estimates of infection in the general population. Acta Biomed. 2020;91(3-s):175-9.
Amerio A, Aguglia A, Odone A, et al. Covid-19 pandemic impact on mental health of vulnerable populations. Acta Biomed. 2020;91(9-s):95-6.
Odone A, Delmonte D, Scognamiglio T, Signorelli C. COVID-19 deaths in Lombardy, Italy: data in context. Lancet Public Health. 2020;5(6):e310.
Signorelli C, Odone A, Gianfredi V, et al. COVID-19 mortality rate in nine high-income metropolitan regions. Acta Biomed. 2020;91(9-s):7-18.
COVID-19 vaccines 2021 [Available from: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19-vaccines.
Burgess RA, Osborne RH, Yongabi KA, et al. The COVID-19 vaccines rush: participatory community engagement matters more than ever. Lancet. 2021;397(10268):8-10.
Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals 2021 [Available from: https://clinicaltrials.gov/ct2/show/NCT04368728.
EMA recommends first COVID-19 vaccine for authorisation in the EU 2021 [Available from: https://www.ema.europa.eu/en/news/ema-recommends-first-covid-19-vaccine-authorisation-eu.
COVID-19 vaccines: authorised 2021 [Available from: https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/vaccines-covid-19/covid-19-vaccines-authorised#authorised-covid-19-vaccines-section.
National Pharmacovigilance Network 2021 [Available from: https://www.aifa.gov.it/en/rete-nazionale-di-farmacovigilanza.
Polack FP, Thomas SJ, Kitchin N, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020;383(27):2603-15.
Gee J, Marquez P, Su J, et al. First Month of COVID-19 Vaccine Safety Monitoring - United States, December 14, 2020-January 13, 2021. MMWR Morb Mortal Wkly Rep. 2021;70(8):283-8.
Fischinger S, Boudreau CM, Butler AL, Streeck H, Alter G. Sex differences in vaccine-induced humoral immunity. Semin Immunopathol. 2019;41(2):239-49.
Klein SL, Marriott I, Fish EN. Sex-based differences in immune function and responses to vaccination. Trans R Soc Trop Med Hyg. 2015;109(1):9-15.
Ruggieri A, Anticoli S, D'Ambrosio A, Giordani L, Viora M. The influence of sex and gender on immunity, infection and vaccination. Ann Ist Super Sanita. 2016;52(2):198-204.
Flanagan KL, Fink AL, Plebanski M, Klein SL. Sex and Gender Differences in the Outcomes of Vaccination over the Life Course. Annu Rev Cell Dev Biol. 2017;33:577-99.
Pinti M, Appay V, Campisi J, et al. Aging of the immune system: Focus on inflammation and vaccination. Eur J Immunol. 2016;46(10):2286-301.
Castelo-Branco C, Soveral I. The immune system and aging: a review. Gynecol Endocrinol. 2014;30(1):16-22.
Gustafson CE, Kim C, Weyand CM, Goronzy JJ. Influence of immune aging on vaccine responses. J Allergy Clin Immunol. 2020;145(5):1309-21.
Ciabattini A, Nardini C, Santoro F, Garagnani P, Franceschi C, Medaglini D. Vaccination in the elderly: The challenge of immune changes with aging. Semin Immunol. 2018;40:83-94.
Crooke SN, Ovsyannikova IG, Poland GA, Kennedy RB. Immunosenescence: A systems-level overview of immune cell biology and strategies for improving vaccine responses. Exp Gerontol. 2019;124:110632.
Soiza RL, Scicluna C, Thomson EC. Efficacy and safety of COVID-19 vaccines in older people. Age Ageing. 2021;50(2):279-83.
Fifth AIFA report on surveillance of COVID-19 vaccines 2021 [Available from: https://www.aifa.gov.it/en/-/quinto-rapporto-aifa-sulla-sorveglianza-dei-vaccini-covid-19.
Bardenheier BH, Gravenstein S, Blackman C, et al. Adverse events following mRNA SARS-CoV-2 vaccination among U.S. nursing home residents. Vaccine. 2021.
Jęśkowiak I, Wiatrak B, Grosman-Dziewiszek P, Szeląg A. The Incidence and Severity of Post-Vaccination Reactions after Vaccination against COVID-19. Vaccines (Basel). 2021;9(5).
Shimabukuro TT, Cole M, Su JR. Reports of Anaphylaxis After Receipt of mRNA COVID-19 Vaccines in the US-December 14, 2020-January 18, 2021. Jama. 2021;325(11):1101-2.
Shimabukuro TT, Nguyen M, Martin D, DeStefano F. Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS). Vaccine. 2015;33(36):4398-405.
Menni C, Klaser K, May A, et al. Vaccine side-effects and SARS-CoV-2 infection after vaccination in users of the COVID Symptom Study app in the UK: a prospective observational study. Lancet Infect Dis. 2021.
Djanas D, Yusirwan, Martini RD, et al. Survey data of COVID-19 vaccine side effects among hospital staff in a national referral hospital in Indonesia. Data Brief. 2021;36:107098.
Gianfredi V, Pennisi F, Lume A, et al. Challenges and Opportunities of Mass Vaccination Centers in COVID-19 Times: A Rapid Review of Literature. Vaccines. 2021;9(6):574.
Rief W. Fear of Adverse Effects and COVID-19 Vaccine Hesitancy: Recommendations of the Treatment Expectation Expert Group. JAMA Health Forum. 2021;2(4):e210804-e.
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