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Contents lists available at ScienceDirect
Vaccine journal homepage: www.elsevier.com/locate/vaccine
Review
Report of the Third European Expert Meeting on Rotavirus Vaccination: Progress in rotavirus universal mass vaccination in Europe HI Huppertz a,∗,1 , M Borte b,1 , V Schuster c,1 , C Giaquinto d , T Vesikari e a
Prof.-Hess-Kinderklinik and Children’s Hospital of the University of Göttingen, Sankt-Jürgen-Str. 1, 28177 Bremen, Germany Children’s Hospital at Municipal Hospital St. Georg Leipzig, affiliated to the University of Leipzig, Delitzscher Strasse 141, 04129 Leipzig, Germany c Hospital for Children and Adolescents, Medical Faculty, University of Leipzig, Liebigstrasse 20a, 04103 Leipzig, Germany d Department of Pediatrics, University of Padova, 35100 Padova, Italy e Vaccine Research Center, University of Tampere Medical School, Tampere, Finland b
a r t i c l e
i n f o
Article history: Received 10 March 2014 Accepted 9 May 2014 Available online xxx Keywords: Europe Rotavirus Vaccine UMV
1. Introduction The Third European Expert Meeting on Rotavirus Vaccination was convened in Leipzig, Germany, in April, 2013. The meeting, chaired by Prof. Michael Borte (University of Leipzig, Germany), Prof. Hans-Iko Huppertz (Bremen and University of Göttingen, Germany) and Prof. Volker Schuster (University of Leipzig, Germany), reflected upon cutting-edge research in rotavirus (RV) vaccination and the recent developments towards wider mass vaccination; by considering the barriers to further implementation, the complex interplay between science, medicine, politics, economics and society was inadvertently highlighted.
diverse settings [1–6]. In recognition of this, the German Academy of Pediatric and Adolescent Medicine was among the first to recommend universal RV vaccination for infants [7]. The World Health Organization (WHO), the European Technical Advisory Group of Experts on Immunisation (ETAGE) and the European Society for Paediatric Infectious Diseases/European Society for Paediatric Gastroenterology, Hepatology, and Nutrition (ESPID/ESPGHAN) have also recommended universal RV immunisation of healthy infants, in parallel with ensuring that adequate measures are taken to attain high vaccination coverage and timely administration of each dose [8–10]. Worldwide, ∼34 countries have implemented universal RV immunisation of infants [9].
2. Rotavirus vaccines
3. Adverse experiences
There are two orally administered RV vaccines—RV1 (RotarixTM , GlaxoSmithKline [GSK] Vaccines, Belgium) and RV5 (RotaTeq® , Merck and Co., Inc., Whitehouse Station, NJ, USA)—that are widely licensed for the prevention of RV gastroenteritis (RVGE). Both vaccines have demonstrated good safety and efficacy profiles in
Prof. Federico Martinón-Torres (Hospital Clinico Universitario de Santiago, Spain) provided evidence of a reversal of the previously noted positive impact of RV vaccination in Spain, which he related to the response to the discovery of porcine circovirus (PCV) in RV vaccines [11,12]. Despite the presence of PCV DNA in both RV vaccines, the Food and Drug Administration (FDA) revised its initial position and lifted the suspension on the use of RV1 and RV5 on the basis that the benefits of RV vaccination by far surpassed the theoretical risks linked with PCV [13]. The European Medicines Agency (EMA) and the WHO retained their original
∗ Corresponding author. Tel.: +49 421 4975411; fax: +49 421 4973311. E-mail address: [email protected] (HI. Huppertz). 1 Contributed equally. http://dx.doi.org/10.1016/j.vaccine.2014.05.029 0264-410X/© 2014 Published by Elsevier Ltd.
Please cite this article in press as: Huppertz HI, et al. Report of the Third European Expert Meeting on Rotavirus Vaccination: Progress in rotavirus universal mass vaccination in Europe. Vaccine (2014), http://dx.doi.org/10.1016/j.vaccine.2014.05.029
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recommendations on RV vaccines. However, Spain suspended RV5 and RV1. During this 5-month suspension of RV vaccines in Spain, vaccine coverage rates fell from 40.0% to 5.0% [11], which coincided with an increase in RVGE hospitalisation rates. After the recommencement of RV vaccination (RV5 only), a gradual decline in RV hospitalisation was observed [12]. Prof. Martinón-Torres concluded his talk by noting that paediatricians remain supportive of RV vaccination but that much work needs to be done to rebuild confidence in vaccine safety among family doctors, and to re-establish public trust in both vaccines and the healthcare system. Dr Manish Patel (Centers for Disease Control and Prevention [CDC], USA) provided an update on intussusception (IS) in Latin America, whilst Dr Doris Oberle (Paul-Ehrlich Institut, Germany) complemented the picture by giving an overview of the risk of IS linked with RV vaccination in Europe. It was confirmed that both RV vaccines were associated with a small risk of IS in infants. In a controlled study in Mexico, an increased risk of IS within 7 days after the first dose of RV1 was noted (incidence ratio: 5.3 [95% confidence interval (CI): 3.0, 9.3]; odds ratio: 5.8 [95% CI: 2.6, 13.0]) [14]. On the other hand, a similar risk of IS after the second (but not first) dose of RV1 was identified in Brazil [15,16]. The risk of IS in Europe was assessed from the safety reports of EudraVigilance (a data processing network and management system for reporting and evaluating suspected adverse drug reactions). In Europe, from launch of the database to April 2013, 202 suspected cases of IS had been spontaneously reported (RV1: 141, RV5: 61). The highest absolute number of IS was reported in Germany (n = 54), followed by France (n = 40), Belgium (n = 30) and Spain (n = 24). In Germany, within the scope of an observed vs expected analysis, no overall elevated risk for IS following RV vaccination was identified [17]. However, it was suggested that infants 3–5 months of age, but not infants
ARTICLE IN PRESS
JVAC-15403; No. of Pages 7
Vaccine xxx (2014) xxx–xxx
Contents lists available at ScienceDirect
Vaccine journal homepage: www.elsevier.com/locate/vaccine
Review
Report of the Third European Expert Meeting on Rotavirus Vaccination: Progress in rotavirus universal mass vaccination in Europe HI Huppertz a,∗,1 , M Borte b,1 , V Schuster c,1 , C Giaquinto d , T Vesikari e a
Prof.-Hess-Kinderklinik and Children’s Hospital of the University of Göttingen, Sankt-Jürgen-Str. 1, 28177 Bremen, Germany Children’s Hospital at Municipal Hospital St. Georg Leipzig, affiliated to the University of Leipzig, Delitzscher Strasse 141, 04129 Leipzig, Germany c Hospital for Children and Adolescents, Medical Faculty, University of Leipzig, Liebigstrasse 20a, 04103 Leipzig, Germany d Department of Pediatrics, University of Padova, 35100 Padova, Italy e Vaccine Research Center, University of Tampere Medical School, Tampere, Finland b
a r t i c l e
i n f o
Article history: Received 10 March 2014 Accepted 9 May 2014 Available online xxx Keywords: Europe Rotavirus Vaccine UMV
1. Introduction The Third European Expert Meeting on Rotavirus Vaccination was convened in Leipzig, Germany, in April, 2013. The meeting, chaired by Prof. Michael Borte (University of Leipzig, Germany), Prof. Hans-Iko Huppertz (Bremen and University of Göttingen, Germany) and Prof. Volker Schuster (University of Leipzig, Germany), reflected upon cutting-edge research in rotavirus (RV) vaccination and the recent developments towards wider mass vaccination; by considering the barriers to further implementation, the complex interplay between science, medicine, politics, economics and society was inadvertently highlighted.
diverse settings [1–6]. In recognition of this, the German Academy of Pediatric and Adolescent Medicine was among the first to recommend universal RV vaccination for infants [7]. The World Health Organization (WHO), the European Technical Advisory Group of Experts on Immunisation (ETAGE) and the European Society for Paediatric Infectious Diseases/European Society for Paediatric Gastroenterology, Hepatology, and Nutrition (ESPID/ESPGHAN) have also recommended universal RV immunisation of healthy infants, in parallel with ensuring that adequate measures are taken to attain high vaccination coverage and timely administration of each dose [8–10]. Worldwide, ∼34 countries have implemented universal RV immunisation of infants [9].
2. Rotavirus vaccines
3. Adverse experiences
There are two orally administered RV vaccines—RV1 (RotarixTM , GlaxoSmithKline [GSK] Vaccines, Belgium) and RV5 (RotaTeq® , Merck and Co., Inc., Whitehouse Station, NJ, USA)—that are widely licensed for the prevention of RV gastroenteritis (RVGE). Both vaccines have demonstrated good safety and efficacy profiles in
Prof. Federico Martinón-Torres (Hospital Clinico Universitario de Santiago, Spain) provided evidence of a reversal of the previously noted positive impact of RV vaccination in Spain, which he related to the response to the discovery of porcine circovirus (PCV) in RV vaccines [11,12]. Despite the presence of PCV DNA in both RV vaccines, the Food and Drug Administration (FDA) revised its initial position and lifted the suspension on the use of RV1 and RV5 on the basis that the benefits of RV vaccination by far surpassed the theoretical risks linked with PCV [13]. The European Medicines Agency (EMA) and the WHO retained their original
∗ Corresponding author. Tel.: +49 421 4975411; fax: +49 421 4973311. E-mail address: [email protected] (HI. Huppertz). 1 Contributed equally. http://dx.doi.org/10.1016/j.vaccine.2014.05.029 0264-410X/© 2014 Published by Elsevier Ltd.
Please cite this article in press as: Huppertz HI, et al. Report of the Third European Expert Meeting on Rotavirus Vaccination: Progress in rotavirus universal mass vaccination in Europe. Vaccine (2014), http://dx.doi.org/10.1016/j.vaccine.2014.05.029
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recommendations on RV vaccines. However, Spain suspended RV5 and RV1. During this 5-month suspension of RV vaccines in Spain, vaccine coverage rates fell from 40.0% to 5.0% [11], which coincided with an increase in RVGE hospitalisation rates. After the recommencement of RV vaccination (RV5 only), a gradual decline in RV hospitalisation was observed [12]. Prof. Martinón-Torres concluded his talk by noting that paediatricians remain supportive of RV vaccination but that much work needs to be done to rebuild confidence in vaccine safety among family doctors, and to re-establish public trust in both vaccines and the healthcare system. Dr Manish Patel (Centers for Disease Control and Prevention [CDC], USA) provided an update on intussusception (IS) in Latin America, whilst Dr Doris Oberle (Paul-Ehrlich Institut, Germany) complemented the picture by giving an overview of the risk of IS linked with RV vaccination in Europe. It was confirmed that both RV vaccines were associated with a small risk of IS in infants. In a controlled study in Mexico, an increased risk of IS within 7 days after the first dose of RV1 was noted (incidence ratio: 5.3 [95% confidence interval (CI): 3.0, 9.3]; odds ratio: 5.8 [95% CI: 2.6, 13.0]) [14]. On the other hand, a similar risk of IS after the second (but not first) dose of RV1 was identified in Brazil [15,16]. The risk of IS in Europe was assessed from the safety reports of EudraVigilance (a data processing network and management system for reporting and evaluating suspected adverse drug reactions). In Europe, from launch of the database to April 2013, 202 suspected cases of IS had been spontaneously reported (RV1: 141, RV5: 61). The highest absolute number of IS was reported in Germany (n = 54), followed by France (n = 40), Belgium (n = 30) and Spain (n = 24). In Germany, within the scope of an observed vs expected analysis, no overall elevated risk for IS following RV vaccination was identified [17]. However, it was suggested that infants 3–5 months of age, but not infants
