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1. Postmarketing active surveillance of myocarditis and pericarditis following vaccination with COVID-19 mRNA vaccines in persons aged 12 to 39 years in Italy: A multi-database, self-controlled case series study.

Author

Marco Massari, Stefania Spila Alegiani, Cristina Morciano, Matteo Spuri, Pasquale Marchione, Patrizia Felicetti, Valeria Belleudi, Francesca Romana Poggi, Marco Lazzeretti, Michele Ercolanoni, Elena Clagnan, Emanuela Bovo, Gianluca Trifirò, Ugo Moretti, Giuseppe Monaco, Olivia Leoni, Roberto Da Cas, Fiorella Petronzelli, Loriana Tartaglia, Nadia Mores, Giovanna Zanoni, Paola Rossi, Sarah Samez, Cristina Zappetti, Anna Rosa Marra, Francesca Menniti Ippolito, and TheShinISS-Vax|COVID Surveillance Group

Subjects
Medicine
Abstract

BackgroundMyocarditis and pericarditis following the Coronavirus Disease 2019 (COVID-19) mRNA vaccines administration have been reported, but their frequency is still uncertain in the younger population. This study investigated the association between Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) mRNA vaccines, BNT162b2, and mRNA-1273 and myocarditis/pericarditis in the population of vaccinated persons aged 12 to 39 years in Italy.Methods and findingsWe conducted a self-controlled case series study (SCCS) using national data on COVID-19 vaccination linked to emergency care/hospital discharge databases. The outcome was the first diagnosis of myocarditis/pericarditis between 27 December 2020 and 30 September 2021. Exposure risk period (0 to 21 days from the vaccination day, subdivided in 3 equal intervals) for first and second dose was compared with baseline period. The SCCS model, adapted to event-dependent exposures, was fitted using unbiased estimating equations to estimate relative incidences (RIs) and excess of cases (EC) per 100,000 vaccinated by dose, age, sex, and vaccine product. Calendar period was included as time-varying confounder in the model. During the study period 2,861,809 persons aged 12 to 39 years received mRNA vaccines (2,405,759 BNT162b2; 456,050 mRNA-1273); 441 participants developed myocarditis/pericarditis (346 BNT162b2; 95 mRNA-1273). Within the 21-day risk interval, 114 myocarditis/pericarditis events occurred, the RI was 1.99 (1.30 to 3.05) after second dose of BNT162b2 and 2.22 (1.00 to 4.91) and 2.63 (1.21 to 5.71) after first and second dose of mRNA-1273. During the [0 to 7) days risk period, an increased risk of myocarditis/pericarditis was observed after first dose of mRNA-1273, with RI of 6.55 (2.73 to 15.72), and after second dose of BNT162b2 and mRNA-1273, with RIs of 3.39 (2.02 to 5.68) and 7.59 (3.26 to 17.65). The number of EC for second dose of mRNA-1273 was 5.5 per 100,000 vaccinated (3.0 to 7.9). The highest risk was observed in males, at [0 to 7) days after first and second dose of mRNA-1273 with RI of 12.28 (4.09 to 36.83) and RI of 11.91 (3.88 to 36.53); the number of EC after the second dose of mRNA-1273 was 8.8 (4.9 to 12.9). Among those aged 12 to 17 years, the RI was of 5.74 (1.52 to 21.72) after second dose of BNT162b2; for this age group, the number of events was insufficient for estimating RIs after mRNA-1273. Among those aged 18 to 29 years, the RIs were 7.58 (2.62 to 21.94) after first dose of mRNA-1273 and 4.02 (1.81 to 8.91) and 9.58 (3.32 to 27.58) after second dose of BNT162b2 and mRNA-1273; the numbers of EC were 3.4 (1.1 to 6.0) and 8.6 (4.4 to 12.6) after first and second dose of mRNA-1273. The main study limitations were that the outcome was not validated through review of clinical records, and there was an absence of information on the length of hospitalization and, thus, the severity of the outcome.ConclusionsThis population-based study of about 3 millions of residents in Italy suggested that mRNA vaccines were associated with myocarditis/pericarditis in the population younger than 40 years. According to our results, increased risk of myocarditis/pericarditis was associated with the second dose of BNT162b2 and both doses of mRNA-1273. The highest risks were observed in males of 12 to 39 years and in males and females 18 to 29 years vaccinated with mRNA-1273. The public health implication of these findings should be considered in the light of the proven mRNA vaccine effectiveness in preventing serious COVID-19 disease and death.

Published
2022
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2. Post-marketing active surveillance of myocarditis and pericarditis following vaccination with COVID-19 mRNA vaccines in persons aged 12-39 years in Italy: a multi-database, self-controlled case series study

Author

Marco Massari, Stefania Spila-Alegiani, Cristina Morciano, Matteo Spuri, Pasquale Marchione, Patrizia Felicetti, Valeria Belleudi, Francesca Romana Poggi, Marco Lazzeretti, Michele Ercolanoni, Elena Clagnan, Emanuela Bovo, Gianluca Trifirò, Ugo Moretti, Giuseppe Monaco, Olivia Leone, Roberto Da Cas, Fiorella Petronzelli, Loriana Tartaglia, Nadia Mores, Giovanna Zanoni, Paola Rossi, Sarah Samez, Cristina Zappetti, Anna Rosa Marra, and Francesca Menniti-Ippolito

Abstract

ObjectivesTo investigate the association between SARS-CoV-2 mRNA vaccines, BNT162b2 and mRNA-1273, and myocarditis/pericarditis.DesignSelf-Controlled Case Series study (SCCS) using national data on COVID-19 vaccination and emergency care/hospital admissions.SettingItalian Regions (Lombardia, Friuli Venezia Giulia, Veneto, Lazio).Participants2,861,809 individuals, aged 12-39 years, vaccinated with the first doses of mRNA vaccines (2,405,759 BNT162b2 and 456,050 mRNA-1273) between 27 December 2020 and 30 September 2021.Main outcome measuresFirst diagnosis of myocarditis/pericarditis within the study period. The incidence of events in the exposure risk periods (0-21 days from the vaccination day, subdivided in three equal intervals) for first and second dose was compared with baseline period. The SCCS model was fitted using conditional Poisson regression to estimate Relative Incidences (RI) and Excess of Cases (EC) per 100,000 vaccinated by dose, age, gender and brand.ResultsDuring the study period, 441 participants aged 12-39 years developed myocarditis/pericarditis (346 BNT162b2 and 95 mRNA-1273). During the 21-day risk interval there were 114 cases of myocarditis/pericarditis (74 BNT162b2 and 40 mRNA-1273) corresponding to a RI of 1.27 (0.87-1.85) and 2.16 (1.50-3.10) after first and second dose, respectively.An increased risk of myocarditis/pericarditis at [0-7) days was observed after first [RI=6.55; 95% Confidence Interval (2.73-15.72); EC per 100,000 vaccinated=2.0 (1.5-2.3)] and second dose [RI=7.59 (3.26-17.65); EC=5.5 (4.4-5.9)] of mRNA-1273 and after second dose of BNT162b2 [RI=3.39 (2.02-5.68); EC=0.8 (0.6-1.0)]. In males, an increased risk at [0-7) days was observed after first [RI=12.28, 4.09-36.83; EC=3.8 (3.1-4.0)] and second dose [RI=11.91 (3.88-36.53); EC=8.8 (7.2-9.4)] of mRNA-1273 and after second dose of BNT162b2 [RI=3.45 (1.78-6.68); EC=1.0 (0.6-1.2)]. In females, an increased risk at [0-7) days was observed after second dose of BNT162b2 [RI=3.38 (1.47-7.74); EC=0.7 (0.3-0.9)]. At [0-7) days an increased risk following second dose of BNT162b2 was observed in the 12-17 years old [RI=5.74, (1.52-21.72); EC=1.7 (0.7-1.9)] and in 18-29 years old [RI=4.02 (1.81-8.91); EC=1.1 (0.6-1.3)]. At [0-7) days an increased risk after first [RI=7.58 (2.62-21.94); EC=3.5 (2.4-3.8)] and second [RI=9.58 (3.32-27.58); EC=8.3 (6.7-9.2)] dose of mRNA-1273 was found in 18-29 years old and after first dose in 30-39 years old [RI=6.57 (1.32-32.63); EC=1.0 (0.3-1.1)].ConclusionsThis population-based study indicates that mRNA vaccines were associated with myocarditis/pericarditis in the population younger than 40 years, whereas no association was observed in older subjects. The risk increased after the second dose and in the youngest for both vaccines, remained moderate following vaccination with BNT162b2, while was higher in males following vaccination with mRNA-1273. The public health implication of these findings should be weighed in the light of the overall efficacy and safety profile of both vaccines.

Published
2022
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3. Risk of Guillain-Barré syndrome after 2010–2011 influenza vaccination

Author

Galeotti F, Massari M, Beghi E, Chiò A, Logroscino G, Filippini G, Benedetti MD, Pugliatti M, Santuccio C, Raschetti R, The ITANG study Group [Clinical research assistants: Sara Marconi, Giorgia Giussani, Enrica Bersano, Umberto Manera, Stefano Zoccolella, Antonio Leo, Roberta Barki, Marco Turatti, Stefania Leoni, Steering committee of the study: Ettore Beghi, Maria Donata Benedetti, Andrea Calvo, Adriano Chiò, Roberto D’Alessandro, Fernanda Ferrazin, Graziella Filippini, Giancarlo Logroscino, Giampiero Mazzaglia, Maura Pugliatti, Roberto Raschetti, Carmela Santuccio, Loriana Tartaglia, Francesco Trotta, Clinical centers, co investigators: E. Romagna: Roberto MICHELUCCI, Patrizia RIGUZZI, Tommaso SACQUEGNA, Anna Maria BORGHI, Vittoria MUSSUTO, Patrizia DE MASSIS, Rita Rinaldi, Walter NERI, Carlo GUIDI, Maria Rosaria TOLA, Enrico GRANIERI, Valentina SIMIONI, Paolo NICHELLI, Jessica MANDRIOLI, Donata GUIDETTI, Emilio TERLIZZI, Mario Giovanni TERZANO, Giovanni PAVESI, Fabrizio RASI, Claudio CALLEGARINI, Norina MARCELLO, Massimo BONDAVALLI, Alessandro RAVASIO, Marco CURRÒ DOSSI, Annamaria MAURO, Chiara MINARDI, Gabriele GRECO, Stefano AMIDEI, Enrico MONTANARI, Doriana MEDICI, Lombardy: Tommaso RICCARDI, Elisabetta D’ADDA, Luigi BETTONI, Luciano ABRUZZI, Elio AGOSTONI, Francesco BASSO, Andrea MAGNONI, Vittorio CRESPI, Maria REPACI, Antonella CHELDI, Mariagrazia BELLOTTI, Carlo FERRARESE, Natale Augusto CURTÒ, Giovanni MEOLA, Giuseppe ROTONDO, Eduardo NOBILE ORAZIO, Fabrizia TERENGHI, Franco SASANELLI, Alessio GALBUSSERA, Marco MATTIOLI, Marco TIRITICCO, Caterina NASCIMBENE, Alessandra VANOTTI, Stefano JANN, Luisa DE TONI FRANCESCHINI, Vincenzo SILANI, Nicola TICOZZI, Giancarlo COMI, Raffaella FAZIO, Patrizia PERRONE, Andrea GIORGETTI, Alessandro ROMORINI, Pietro BASSI, Domenico SANTORO, Nereo BRESOLIN, Simone TONIETTI, Massimo SUARDELLI, Giacomo BEZZI, Daria BALDINI, Angelo Maurizio CLERICI, Giuseppina CAFASSO, Daniele PORAZZI, Isidoro LA SPINA, Giampiero GRAMPA, Davide ZARCONE, Michele PERINI, Marco POLONI, Emanuela AGAZZI, Massimiliano FILOSTO, Alessandro PADOVANI, Renato BESANA, Edoardo DONATI, Eugenio MAGNI, Marco ARNABOLDI, Vincenzo BELCASTRO, Mario GUIDOTTI, Raffaella CLERICI, Maurizio RIVA, Eugenio VITELLI, Paolo PREVIDI, Giuseppe MICIELI, Elisa CANDELORO, Carlo DALLOCCHIO, Carla ARBASINO, Piedmont: Andrea CALVO: Scdu Neurologia 4—AOU S. Giovanni Battista, Cristina MOGLIA: Scdu Neurologia 4—AOU S. Giovanni Battista, Marco VERCELLINO, Bruno FERRERO, Pietro PIGNATTA, Enrico ODDENINO, Daniele IMPERIALE, Daniela LEOTTA, Maurizio GIONCO, Carlo RAVETTI, Roberto CAVALLO, Nicoletta Di Vito, Claudio GEDA, Simona BORTOLOTTO, Emilio LUDA DI CORTEMIGLIA, Giovanna LIOTTA, Emilio URSINO, Mario PALERMO, Luca AMBROGIO, Piero MEINERI, Michele DOTTA, Paolo GHIGLIONE, Joseph MAISTRELLI, Susana ONORATO, Maurizio LEONE, Diego Maria PAPURELLO, Angelo VILLANI, Roberto CONTI, Franco COPPO, Fabiana TESSER, Lucia Testa, Silvia Isabella Cattaneo, Maria Teresa Penza, Graziano Gusmaroli, Katia Savio, Franco Perla, Fabrizio Pisano, Fabio Poglio, Luca Pradotto, Valle d’Aosta: Edo Fausto BOTTACCHI, Puglia: Paolo LIVREA, Francesco FEDERICO, Maria TROJANO, Vito COVELLI, Bruno MAGGIO, Vito SANTAMATO, Bruno PASSARELLA, Giovanni ZIMATORE, Giorgio TRIANNI, Gerardo CIARDO, Salvatore INTERNO’, Veneto: Corrado MARCHINI, Sandro ZAMBITO MARSALA, Giorgio MICHIELI, Carlo BORSATO, Giuseppe DIDONÈ, Emma FRASSON, Alberto POLO, Vincenza ARGENTIERO, Vincenzo ROMEO, Novenia PERLOTTO, Roberto L’ERARIO, Gianfranco MICAGLIO, Tiziana ROSSO, Sandro BRUNO, Bruno GIOMETTO, Mirco SERENA, Rocco QUATRALE, Ernesto GASTALDO, Francesco PERINI, Michele DILEONE, Alessandro CASANO, Lauretta SILVESTRI, Alessandro BURLINA, Virginia MUNERATI, Sebastiano D’Anna, Flavio SANSON, Valeria SARTORI, Giuseppe MORETTO, Giovanna SQUINTANI, Salvatore MONACO, Maria Donata BENEDETTI, Simone FUSINA, Claudio BIANCONI, Fabiana PIMAZZONI, Angela BONOMETTI, Giampietro ZANETTE, Marco TURATTI, Sardinia: Stefania LEONI, Giuseppe MURA, Anna TICCA, Piernicola MARCHI, Davide MANCA], D'ALESSANDRO, ROBERTO, CIRIGNOTTA, FABIO, Galeotti F, Massari M, D'Alessandro R, Beghi E, Chiò A, Logroscino G, Filippini G, Benedetti MD, Pugliatti M, Santuccio C, Raschetti R, The ITANG study Group [Clinical research assistants: Sara Marconi, Giorgia Giussani, Enrica Bersano and Umberto Manera, Stefano Zoccolella and Antonio Leo, Roberta Barki, Marco Turatti, Stefania Leoni, Steering committee of the study: Ettore Beghi, Maria Donata Benedetti, Andrea Calvo and Adriano Chiò, Roberto D’Alessandro, Fernanda Ferrazin, Graziella Filippini, Giancarlo Logroscino, Giampiero Mazzaglia, Maura Pugliatti, Roberto Raschetti, Carmela Santuccio, Loriana Tartaglia and Francesco Trotta, Clinical centers and co-investigators: E. Romagna: Roberto MICHELUCCI, Patrizia RIGUZZI, Tommaso SACQUEGNA, Anna Maria BORGHI, Vittoria MUSSUTO, Patrizia DE MASSIS, Fabio CIRIGNOTTA, Rita Rinaldi, Walter NERI, Carlo GUIDI, Maria Rosaria TOLA, Enrico GRANIERI, Valentina SIMIONI, Paolo NICHELLI, Jessica MANDRIOLI, Donata GUIDETTI, Emilio TERLIZZI, Mario Giovanni TERZANO, Giovanni PAVESI, Fabrizio RASI, Claudio CALLEGARINI, Norina MARCELLO, Massimo BONDAVALLI, Alessandro RAVASIO, Marco CURRÒ DOSSI, Annamaria MAURO, Chiara MINARDI, Gabriele GRECO, Stefano AMIDEI, Enrico MONTANARI, Doriana MEDICI, Lombardy: Tommaso RICCARDI, Elisabetta D’ADDA, Luigi BETTONI, Luciano ABRUZZI, Elio AGOSTONI, Francesco BASSO, Andrea MAGNONI, Vittorio CRESPI, Maria REPACI, Antonella CHELDI, Mariagrazia BELLOTTI, Carlo FERRARESE, Natale Augusto CURTÒ, Giovanni MEOLA, Giuseppe ROTONDO, Eduardo NOBILE-ORAZIO, Fabrizia TERENGHI, Franco SASANELLI, Alessio GALBUSSERA, Marco MATTIOLI, Marco TIRITICCO, Caterina NASCIMBENE, Alessandra VANOTTI, Stefano JANN, Luisa DE TONI FRANCESCHINI, Vincenzo SILANI, Nicola TICOZZI, Giancarlo COMI, Raffaella FAZIO, Patrizia PERRONE, Andrea GIORGETTI, Alessandro ROMORINI, Pietro BASSI, Domenico SANTORO, Nereo BRESOLIN, Simone TONIETTI, Massimo SUARDELLI, Giacomo BEZZI, Daria BALDINI, Angelo Maurizio CLERICI, Giuseppina CAFASSO, Daniele PORAZZI, Isidoro LA SPINA, Giampiero GRAMPA, Davide ZARCONE, Michele PERINI, Marco POLONI, Emanuela AGAZZI, Massimiliano FILOSTO, Alessandro PADOVANI, Renato BESANA, Edoardo DONATI, Eugenio MAGNI, Marco ARNABOLDI, Vincenzo BELCASTRO, Mario GUIDOTTI, Raffaella CLERICI, Maurizio RIVA, Eugenio VITELLI, Paolo PREVIDI, Giuseppe MICIELI, Elisa CANDELORO, Carlo DALLOCCHIO, Carla ARBASINO, Piedmont: Andrea CALVO: Scdu Neurologia 4—AOU S. Giovanni Battista, Cristina MOGLIA: Scdu Neurologia 4—AOU S. Giovanni Battista, Marco VERCELLINO, Bruno FERRERO, Pietro PIGNATTA, Enrico ODDENINO, Daniele IMPERIALE, Daniela LEOTTA, Maurizio GIONCO, Carlo RAVETTI, Roberto CAVALLO, Nicoletta Di Vito, Claudio GEDA, Simona BORTOLOTTO, Emilio LUDA DI CORTEMIGLIA, Giovanna LIOTTA, Emilio URSINO, Mario PALERMO, Luca AMBROGIO, Piero MEINERI, Michele DOTTA, Paolo GHIGLIONE, Joseph MAISTRELLI, Susana ONORATO, Maurizio LEONE, Diego Maria PAPURELLO, Angelo VILLANI, Roberto CONTI, Franco COPPO, Fabiana TESSER, Lucia Testa, Silvia Isabella Cattaneo, Maria Teresa Penza, Graziano Gusmaroli, Katia Savio, Franco Perla, Fabrizio Pisano, Fabio Poglio, Luca Pradotto, Valle d’Aosta: Edo Fausto BOTTACCHI, Puglia: Paolo LIVREA, Francesco FEDERICO, Maria TROJANO, Vito COVELLI, Bruno MAGGIO, Vito SANTAMATO, Bruno PASSARELLA, Giovanni ZIMATORE, Giorgio TRIANNI, Gerardo CIARDO, Salvatore INTERNO’, Veneto: Corrado MARCHINI, Sandro ZAMBITO MARSALA, Giorgio MICHIELI, Carlo BORSATO, Giuseppe DIDONÈ, Emma FRASSON, Alberto POLO, Vincenza ARGENTIERO, Vincenzo ROMEO, Novenia PERLOTTO, Roberto L’ERARIO, Gianfranco MICAGLIO, Tiziana ROSSO, Sandro BRUNO, Bruno GIOMETTO, Mirco SERENA, Rocco QUATRALE, Ernesto GASTALDO, Francesco PERINI, Michele DILEONE, Alessandro CASANO, Lauretta SILVESTRI, Alessandro BURLINA, Virginia MUNERATI, Sebastiano D’Anna, Flavio SANSON, Valeria SARTORI, Giuseppe MORETTO, Giovanna SQUINTANI, Salvatore MONACO, Maria Donata BENEDETTI, Simone FUSINA, Claudio BIANCONI, Fabiana PIMAZZONI, Angela BONOMETTI, Giampietro ZANETTE, Marco TURATTI, Sardinia: Stefania LEONI, Giuseppe MURA, Anna TICCA, Piernicola MARCHI, Davide MANCA], Galeotti, F, Massari, M, D'Alessandro, R, Beghi, E, Chiò, A, Logroscino, G, Filippini, G, Benedetti, M, Pugliatti, M, Santuccio, C, Raschetti, R, Ferrarese, C, Benedetti, Md, ITANG study, Group, and Giometto, B

Subjects
Male, Epidemiology, Pharmaco-Epidemiology, medicine.disease_cause, MED/26 Neurologia, Influenza A Virus, H1N1 Subtype, Risk Factors, Influenza A virus, Odds Ratio, influenza vaccination, Guillain-Barré Syndrome, Case–control study, self controlled case series, Prospective Studies, Case-control study, Guillain-Barrè Syndrome, Influenza vaccination, Self controlled case series, Aged, 80 and over, Guillain-Barre syndrome, Respiratory tract infections, Incidence (epidemiology), Incidence, Middle Aged, Vaccination, Guillain-Barrè, epidemic risk , gastrointestinal and respiratory infections, Italy, Influenza Vaccines, Population Surveillance, Regression Analysis, Female, Settore MED/26 - Neurologia, Adult, medicine.medical_specialty, Guillain-Barre Syndrome, Mass Vaccination, NO, Internal medicine, Influenza, Human, medicine, Humans, Pandemics, Aged, business.industry, Odds ratio, medicine.disease, Relative risk, Case-Control Studies, Immunology, Attributable risk, business
Abstract

Influenza vaccination has been implicated in Guillain Barre Syndrome (GBS) although the evidence for this link is controversial. A case–control study was conducted between October 2010 and May 2011 in seven Italian Regions to explore the relation between influenza vaccination and GBS. The study included 176 GBS incident cases aged ≥18 years from 86 neurological centers. Controls were selected among patients admitted for acute conditions to the Emergency Department of the same hospital as cases. Each control was matched to a case by sex, age, Region and admission date. Two different analyses were conducted: a matched case–control analysis and a self-controlled case series analysis (SCCS). Case–control analysis included 140 cases matched to 308 controls. The adjusted matched odds ratio (OR) for GBS occurrence within 6 weeks after influenza vaccination was 3.8 (95 % CI: 1.3, 10.5). A much stronger association with gastrointestinal infections (OR = 23.8; 95 % CI 7.3, 77.6) and influenza-like illness or upper respiratory tract infections (OR = 11.5; 95 % CI 5.6, 23.5) was highlighted. The SCCS analysis included all 176 GBS cases. Influenza vaccination was associated with GBS, with a relative risk of 2.1 (95 % CI 1.1, 3.9). According to these results the attributable risk in adults ranges from two to five GBS cases per 1,000,000 vaccinations.

Published
2013

4. Surveillance of suspected adverse reactions to herbal products used as laxatives

Author

Loriana Tartaglia, Roberto Raschetti, Francesca Menniti-Ippolito, Francesca Renda, Gabriela Mazzanti, and Annabella Vitalone

Subjects
Male, medicine.medical_specialty, Constipation, Pharmacology toxicology, Alternative medicine, MEDLINE, law.invention, herbal laxatives, senna, surveillance, suspected adverse reactions, law, Agency (sociology), medicine, Product Surveillance, Postmarketing, Humans, Pharmacology (medical), Aged, Pharmacology, Traditional medicine, business.industry, General Medicine, Middle Aged, Laxatives, Family medicine, Dietary Supplements, Female, medicine.symptom, Phytotherapy, business
Abstract

To describe and evaluate spontaneous reports of suspected adverse reactions (ARs) associated with herbal laxatives received by the Italian Medicines Agency and the Italian National Institute of Health between April 2002 and January 2011.Spontaneous reports of suspected ARs were individually analyzed by a multidisciplinary group of experts, and a causality assessment was performed.Twenty-six reactions were reported during the study period. Of these, eight were associated with herbal medicinal products and 18 were related to herbal food supplements. Almost 80% of the reports on ARs involved women. The ARs, classified by System Organ Class, were associated with gastrointestinal, skin and subcutaneous tissue, and hepatobiliary disorders. Fifty percent of the reactions were serious, with the patients requiring hospitalization; of these, one was life-threatening. Most of the herbal remedies associated with the reported ARs contained liquorice, dandelion, and/or plants containing anthraquinones. Possible causes of the ARs were long-term use, idiosyncratic reactions or hypersensitivity, and interaction with other treatments. All of these factors and the presence of a large number of components in the same product increased the unpredictability of the final effect.The total number of 26 ARs recorded in 8 years is limited; however, the an under-reporting effect cannot be excluded. Moreover, taking into account the seriousness of the reported ARs, the low number of reports does not represent a guarantee of safety. To reduce the risk of an adverse outcome, herbal laxatives should be used only over the short term.

Published
2012

5. Effectiveness and safety of the A-H1N1 vaccine in children: a hospital-based case-control study

Author

Maurizio de Martino, Maura Baraldi, Fernanda Ferrazin, Carmelina Calitri, Irene Raffaldi, Sara Sollai, Stefania Gamba, Alessia De Nisco, Giorgio Perilongo, Costantino Romagnoli, Liviana Da Dalt, Elena Chiappini, Loriana Tartaglia, Francesco Mannelli, Bianca Domenichini, Elisabetta Venturini, Federica Bertuola, Giuseppe Traversa, Michele Dinardo, Annalisa Capuano, Manuela Bianciotto, Rossella Rossi, Clara Gabiano, Luciano Sagliocca, Nadia Mores, Antonio Chiaretti, Giulia Bersani, Eleonora Di Rosa, Elisabetta Parretta, Umberto Raucci, Francesca Parata, Fortunata Fucà, Anna Maria Calvani, Claudia Fancelli, Salvatore Renna, Pier-Angelo Tovo, Antonino Reale, Nicola Pirozzi, Carmela Santuccio, Antonio Francesco Urbino, Silvia Vendramin, Francesca Menniti-Ippolito, Eleonora Lorenzon, Teresa Pisapia, Francesco Trotta, Pasquale Di Pietro, Riccardo Riccardi, Monica Frassineti, Concita Rafaniello, Vincenzo Tipo, Roberto Da Cas, Rachele Mazzantini, Francesco Trovato, Laura Giordano, and Valentina Favero

Subjects
business.industry, Epidemiology, Research, H1N1, Case-control study, virus diseases, General Medicine, Hospital based, medicine.disease, respiratory tract diseases, medicine, Medical emergency, business
Abstract

Objective To verify whether vaccination against the A-H1N1 virus in the paediatric population was effective in preventing the occurrence of influenza-like illness (ILI) or was associated with adverse events of special interest. Design, setting and patients A case–control analysis was performed as part of surveillance of children hospitalised through the emergency departments of eight paediatric hospitals/wards for ILI, neurological disorders, non-infectious muco-cutaneous diseases and vasculitis, thrombocytopaenia and gastroduodenal lesions. Results Among 736 children enrolled from November 2009 to August 2010, only 25 had been vaccinated with the pandemic vaccine. Out of 268 children admitted for a diagnosis compatible with the adverse events of special interest, six had received the A-H1N1 vaccine, although none of the adverse events occurred within the predefined risk windows. Only 35 children out of 244 admitted with a diagnosis of ILI underwent laboratory testing: 11 were positive and 24 negative for the A-H1N1 virus. None of the A-H1N1 positive children had received the pandemic vaccine. The OR of ILI associated with any influenza vaccination was 0.9 (95% CI 0.1 to 5.5). Conclusions The study provides additional information on the benefit–risk profile of the pandemic vaccine. No sign of risk associated with the influenza A-H1N1 vaccine used in Italy was found, although several limitations were observed: in Italy, pandemic vaccination coverage was low, the epidemic was almost over by mid December 2009 and the A-H1N1 laboratory test was performed only during the epidemic phase (in, Article summary Article focus To assess the effectiveness of the influenza A-H1N1 vaccine and the occurrence of adverse events of special interest in the paediatric population. Key messages During the 2009–2010 influenza season, very limited information was available on the safety and effectiveness of the influenza A-H1N1 vaccine. Together with other post-marketing studies, our findings provide additional information on the benefit–risk profile of the pandemic vaccine. Strengths and limitations of this study The study focused on influenza-like illness and adverse events of special interest that were sufficiently severe to cause hospitalisation in children and provided additional information on the benefit–risk profile of the pandemic vaccine. A-H1N1 vaccination coverage in Italy during the 2009–2010 influenza season was very low, with around 4% of the general population and only 3.7% of the children included in this study having been vaccinated. The influenza outbreak was almost over by the first half of December 2009, and both the incidence and severity of the disease were lower than expected.

Published
2011

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