Review
Rotavirus vaccination in Europe: drivers and barriers N Parez, C Giaquinto, C Du Roure, F Martinon-Torres, V Spoulou, P Van Damme, T Vesikari Lancet Infect Dis 2014; 14: 416–25 Service de Pédiatrie, Hôpital Louis Mourier, Colombes, France (N Parez PhD); Department of Paediatrics, University of Padua, Padua, Italy (Prof C Giaquinto MD); PHOCUS Services Ltd, Basel, Switzerland (C Du Roure PhD); Pediatric Infectious Diseases and Vaccines Unit, Area Integrada de Pediatría, Hospital Clínico Universitario de Santiago and Genetics, Vaccines, Infections and Pediatrics Research Group (GENVIP), Healthcare Research Institute of Santiago, University of Santiago, Spain (F Martinon-Torres PhD); Aghia Sophia Children’s Hospital, Athens University School of Medicine, Athens, Greece (V Spoulou PhD); Centre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute, Faculty of Medicine and Health Sciences, University of Antwerp, Belgium (Prof P Van Damme PhD); and University of Tampere Medical School, Tampere, Finland (Prof T Vesikari MD) Correspondence to: Dr N Parez, Service de Pédiatrie, Hôpital Louis Mourier, 92701 Colombes, France [email protected]
Rotavirus gastroenteritis is a vaccine-preventable disease that confers a high medical and economic burden in more developed countries and can be fatal in less developed countries. Two vaccines with high efficacy and good safety profiles were approved and made available in Europe in 2006. We present an overview of the status of rotavirus vaccination in Europe. We discuss the drivers (including high effectiveness and effect of universal rotavirus vaccination) and barriers (including low awareness of disease burden, perception of unfavourable cost-effectiveness, and potential safety concerns) to the implementation of universal rotavirus vaccination in Europe. By February, 2014, national universal rotavirus vaccination had been implemented in Belgium, Luxembourg, Austria, Finland, Greece, Luxembourg, Norway, and the UK. Four other German states have issued recommendations and reimbursement is provided by sickness funds. Other countries were at various stages of recommending or implementing universal rotavirus vaccination.
Introduction Rotavirus gastroenteritis is a disease that can be prevented by vaccination. Two vaccines, RotaTeq (Merck and Co, Whitehouse Station, NJ, USA; Sanofi Pasteur MSD, Lyon, France) and Rotarix (GlaxoSmithKline, Rixensart, Belgium), are available in Europe. Both are live, attenuated rotavirus vaccines given orally that have shown high efficacy and good safety profiles in large clinical trials. These findings have been confirmed in clinical practice, although the vaccines have shown lower efficacy in field trials in less developed countries.1–8 Rotarix is a monovalent human vaccine originating from a G1P[8] strain. RotaTeq is a pentavalent vaccine containing five human-bovine reassortant strains (G1, G2, G3, G4, and P1A[8]).9 Both vaccines aim to prime broad immune responses followed by progressively broader protection, developing through successive natural rotavirus infections.10 Because the vaccines became available in Europe in 2006, universal rotavirus vaccination has been implemented in Austria, Belgium, Luxembourg, Finland, Greece, Luxembourg, Norway, and the UK. Several other countries are at various stages of issuing national recommendations or integrating rotavirus vaccination into their national immunisation programmes. We provide an overview of the status of rotavirus vaccination in Europe in February, 2014, and discuss the drivers and barriers to the implementation of universal rotavirus vaccination.
Status of rotavirus vaccination in 2014 The inclusion of vaccination with either rotavirus vaccine in national immunisation programmes has been recommended worldwide by WHO since 2009.8 Since 2006, the Centers for Disease Control and Prevention Advisory Committee on Immunisation Practices has recommended routine rotavirus vaccination of infants in the USA.11 The same year, vaccination was implemented in this group. Universal rotavirus vaccination was also introduced in Australia in 2007 and in almost 20 American countries, including Brazil (2006) and Mexico (2007).12,13 416
In Europe, evidence-based recommendations for universal rotavirus vaccination were published in 2008 by the European Society for Paediatric Infectious Diseases and the European Society for Paediatric Gastroenterology, Hepatology and Nutrition.14 Despite these recommendations, the present status of universal rotavirus vaccination (table) and vaccination coverage (figure) varies greatly across Europe.
Countries with high vaccination coverage High vaccination coverage is defined as more than 90%. The Austrian Advisory Committee on Immunisation recommended universal rotavirus vaccination in Austria in 2006, and it was introduced in 2007, with full reimbursement for the vaccines.15 Local epidemiological data showing a high disease burden in Austrian children were an important driver for the implementation of universal rotavirus vaccination.16 On the basis of the recommendations from the Superior Health Council of Belgium, rotavirus vaccination has been offered to all Belgian children with the other infant vaccines of the national immunisation programme since 2006.15,17 Rotavirus vaccines have to be prescribed by a private doctor; the cost is met by a co-payment system (in 2012–13, €11·30 per dose by the parent, and the rest by health-care insurance). Paediatricians in the National Health Council were important proponents of the integration of rotavirus vaccination in the Belgian national immunisation programme. When rotavirus vaccines became available in Europe in 2006, rotavirus vaccination was recommended by the Superior Hygiene Council (now the Superior Council for Communicable Diseases) of Luxembourg and was included in the national immunisation programme, free of charge.15 This decision was based on the expected reduction in morbidity, use of health-care resources, and cost. The Ministry of Health fully funds and supplies the vaccines. After the 2007 recommendations of the Finnish National Public Health Institute, the National Health Authorities of Finland introduced rotavirus vaccination in the national immunisation programme in 2009, with www.thelancet.com/infection Vol 14 May 2014
Review
full reimbursement for the vaccines.18 The decision to implement universal rotavirus vaccination was based mainly on an analysis18 that estimated that universal rotavirus vaccination would be reasonably cost-effective.
Austria
Recommendations and funding in place
Belgium
Recommendations and funding in place*
Bosnia and Herzegovina
Recommendation and funding process not considered
Countries with moderate vaccination coverage
Bulgaria
Recommendations only in place
Croatia
Recommendations and funding in place†
Cyprus
Recommendations and funding process not considered
Denmark
Recommendations and funding under consideration
Estonia
Recommendations and funding under consideration
Finland
Recommendations and funding in place
France
Recommendations only in place
Germany
Recommendations and funding in place‡
Greece
Recommendations and funding in place§
Hungary
Recommendations and funding process not considered
Ireland
Recommendations only in place
Italy
Recommendations rejected
Latvia
Recommendations only in place
Lithuania
Recommendations and funding process not considered
Luxembourg
Recommendations and funding in place
Malta
Recommendations rejected
Netherlands
Recommendations rejected
Moderate vaccination coverage is defined as between 20% and 40%. Universal rotavirus vaccination is not presently recommended by the national health authorities of Portugal. However, the Portuguese Paediatric Society has been recommending rotavirus vaccination for all children since 2009, endorsing European recommendations.19 In the absence of national recommendations, rotavirus vaccination in Portugal is mainly driven by paediatricians. In 2010, the German Standing Vaccination Committee postponed the introduction of rotavirus vaccination in the national immunisation programme because insufficient cost-effectiveness, safety, and epidemiological data were available.20 Since June, 2012, several sickness funds have decided to reimburse rotavirus vaccination. From sales data, the 2010 estimate for vaccine coverage in Germany was moderate. However, regions with some recommendations had an average vaccine coverage of 58% compared with 20% in states without recommendations.20 In 2013, after review of the scientific literature, the Standing Vaccination Committee recommended the introduction of rotavirus vaccination into the national vaccination schedule in Germany for children younger than 6 months.21 In Greece, after the positive opinion of the Greek National Advisory Committee on Immunisation, rotavirus vaccine was included as optional in the national immunisation programme.22 In April, 2012, the National Organisation of Provided Health Services announced 75% funding of rotavirus vaccines for all infants. For 2012, the coverage was estimated to be up to 35% from 23% in 2010. In 2006, the Interterritorial Council of the Spanish National Health Service decided against the inclusion of rotavirus vaccination in the national immunisation programme after negative recommendations by the vaccine working group.15,23,24 However, rotavirus vaccination of all children in Spain has been supported by the Spanish Association of Paediatrics Vaccines Advisory Committee since 2008.25,26 That support might account for the estimated 40% of rotavirus vaccine coverage in Spain in 2009.24,27 The sudden decrease in the coverage in 2010 (to 22%) is the result of temporary withdrawal of both rotavirus vaccines by the Spanish Medical Agency because of contamination with porcine circovirus.15,27 In Hungary, rotavirus vaccination is not included in the national immunisation programme, mainly because of cost and other health priorities.15 The local burden of disease and the economic benefits of rotavirus vaccination are being assessed.15 In 2010, the estimated vaccine coverage from vaccine sales was 20% (figure). This moderate coverage can be explained by the support www.thelancet.com/infection Vol 14 May 2014
Recommendations and funding status
Norway
Recommendations and funding in place
Poland
Recommendations only from societies
Portugal
Recommendations only from societies
Serbia
Recommendations rejected
Slovakia
Recommendations and funding process not considered
Slovenia
Recommendations and funding process not considered
Spain
Recommendations only from societies
Sweden
Recommendations and funding under consideration
Switzerland
Recommendation and funding process not considered
UK
Recommendations and funding in place
Data not available for Czech Republic, Iceland, Portugal, and Romania. *Rotavirus vaccination is only partly funded by the health-care insurance. †Rotavirus vaccination is recommended for infants classed as at risk. ‡National health authorities approved the introduction of rotavirus vaccination into the national vaccination schedule in 2013, and the health authorities of five of 16 federal states have included it in their childhood immunisation programmes since 2008. §75% of funding.
Table: Recommendations and funding status of rotavirus vaccination in Europe
of both the Hungarian Paediatric Association28 and the Association of Hungarian Primary Care Paediatricians.29
Countries with low vaccination coverage Low vaccination coverage is defined as less than 10%. Although national rotavirus vaccination is not recommended in Poland, rotavirus vaccines are on the list of new vaccines considered for public funding by the Advisory Expert Committee for Immunisation Programme and Chief Sanitary Inspectorate. The main barriers to the inclusion of rotavirus vaccination in the national immunisation programme are competition with other vaccines and the cost of the vaccines. Polish experts and societies, including the Polish Society of Vaccinology and the Polish Paediatric Society, strongly support universal rotavirus vaccination. Despite the paucity of funding, physicians are required by law to inform parents 417
Review
FI
SW NW EST LV
DK
IR UK
LI
NL GE
BE
CZ
LX FR
CH IT
PO SP
PL
AU SV CR
SK HU
BS
RO SB
BG
GR >90% 40–89% 20–39%
Rotavirus vaccination in Europe: drivers and barriers N Parez, C Giaquinto, C Du Roure, F Martinon-Torres, V Spoulou, P Van Damme, T Vesikari Lancet Infect Dis 2014; 14: 416–25 Service de Pédiatrie, Hôpital Louis Mourier, Colombes, France (N Parez PhD); Department of Paediatrics, University of Padua, Padua, Italy (Prof C Giaquinto MD); PHOCUS Services Ltd, Basel, Switzerland (C Du Roure PhD); Pediatric Infectious Diseases and Vaccines Unit, Area Integrada de Pediatría, Hospital Clínico Universitario de Santiago and Genetics, Vaccines, Infections and Pediatrics Research Group (GENVIP), Healthcare Research Institute of Santiago, University of Santiago, Spain (F Martinon-Torres PhD); Aghia Sophia Children’s Hospital, Athens University School of Medicine, Athens, Greece (V Spoulou PhD); Centre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute, Faculty of Medicine and Health Sciences, University of Antwerp, Belgium (Prof P Van Damme PhD); and University of Tampere Medical School, Tampere, Finland (Prof T Vesikari MD) Correspondence to: Dr N Parez, Service de Pédiatrie, Hôpital Louis Mourier, 92701 Colombes, France [email protected]
Rotavirus gastroenteritis is a vaccine-preventable disease that confers a high medical and economic burden in more developed countries and can be fatal in less developed countries. Two vaccines with high efficacy and good safety profiles were approved and made available in Europe in 2006. We present an overview of the status of rotavirus vaccination in Europe. We discuss the drivers (including high effectiveness and effect of universal rotavirus vaccination) and barriers (including low awareness of disease burden, perception of unfavourable cost-effectiveness, and potential safety concerns) to the implementation of universal rotavirus vaccination in Europe. By February, 2014, national universal rotavirus vaccination had been implemented in Belgium, Luxembourg, Austria, Finland, Greece, Luxembourg, Norway, and the UK. Four other German states have issued recommendations and reimbursement is provided by sickness funds. Other countries were at various stages of recommending or implementing universal rotavirus vaccination.
Introduction Rotavirus gastroenteritis is a disease that can be prevented by vaccination. Two vaccines, RotaTeq (Merck and Co, Whitehouse Station, NJ, USA; Sanofi Pasteur MSD, Lyon, France) and Rotarix (GlaxoSmithKline, Rixensart, Belgium), are available in Europe. Both are live, attenuated rotavirus vaccines given orally that have shown high efficacy and good safety profiles in large clinical trials. These findings have been confirmed in clinical practice, although the vaccines have shown lower efficacy in field trials in less developed countries.1–8 Rotarix is a monovalent human vaccine originating from a G1P[8] strain. RotaTeq is a pentavalent vaccine containing five human-bovine reassortant strains (G1, G2, G3, G4, and P1A[8]).9 Both vaccines aim to prime broad immune responses followed by progressively broader protection, developing through successive natural rotavirus infections.10 Because the vaccines became available in Europe in 2006, universal rotavirus vaccination has been implemented in Austria, Belgium, Luxembourg, Finland, Greece, Luxembourg, Norway, and the UK. Several other countries are at various stages of issuing national recommendations or integrating rotavirus vaccination into their national immunisation programmes. We provide an overview of the status of rotavirus vaccination in Europe in February, 2014, and discuss the drivers and barriers to the implementation of universal rotavirus vaccination.
Status of rotavirus vaccination in 2014 The inclusion of vaccination with either rotavirus vaccine in national immunisation programmes has been recommended worldwide by WHO since 2009.8 Since 2006, the Centers for Disease Control and Prevention Advisory Committee on Immunisation Practices has recommended routine rotavirus vaccination of infants in the USA.11 The same year, vaccination was implemented in this group. Universal rotavirus vaccination was also introduced in Australia in 2007 and in almost 20 American countries, including Brazil (2006) and Mexico (2007).12,13 416
In Europe, evidence-based recommendations for universal rotavirus vaccination were published in 2008 by the European Society for Paediatric Infectious Diseases and the European Society for Paediatric Gastroenterology, Hepatology and Nutrition.14 Despite these recommendations, the present status of universal rotavirus vaccination (table) and vaccination coverage (figure) varies greatly across Europe.
Countries with high vaccination coverage High vaccination coverage is defined as more than 90%. The Austrian Advisory Committee on Immunisation recommended universal rotavirus vaccination in Austria in 2006, and it was introduced in 2007, with full reimbursement for the vaccines.15 Local epidemiological data showing a high disease burden in Austrian children were an important driver for the implementation of universal rotavirus vaccination.16 On the basis of the recommendations from the Superior Health Council of Belgium, rotavirus vaccination has been offered to all Belgian children with the other infant vaccines of the national immunisation programme since 2006.15,17 Rotavirus vaccines have to be prescribed by a private doctor; the cost is met by a co-payment system (in 2012–13, €11·30 per dose by the parent, and the rest by health-care insurance). Paediatricians in the National Health Council were important proponents of the integration of rotavirus vaccination in the Belgian national immunisation programme. When rotavirus vaccines became available in Europe in 2006, rotavirus vaccination was recommended by the Superior Hygiene Council (now the Superior Council for Communicable Diseases) of Luxembourg and was included in the national immunisation programme, free of charge.15 This decision was based on the expected reduction in morbidity, use of health-care resources, and cost. The Ministry of Health fully funds and supplies the vaccines. After the 2007 recommendations of the Finnish National Public Health Institute, the National Health Authorities of Finland introduced rotavirus vaccination in the national immunisation programme in 2009, with www.thelancet.com/infection Vol 14 May 2014
Review
full reimbursement for the vaccines.18 The decision to implement universal rotavirus vaccination was based mainly on an analysis18 that estimated that universal rotavirus vaccination would be reasonably cost-effective.
Austria
Recommendations and funding in place
Belgium
Recommendations and funding in place*
Bosnia and Herzegovina
Recommendation and funding process not considered
Countries with moderate vaccination coverage
Bulgaria
Recommendations only in place
Croatia
Recommendations and funding in place†
Cyprus
Recommendations and funding process not considered
Denmark
Recommendations and funding under consideration
Estonia
Recommendations and funding under consideration
Finland
Recommendations and funding in place
France
Recommendations only in place
Germany
Recommendations and funding in place‡
Greece
Recommendations and funding in place§
Hungary
Recommendations and funding process not considered
Ireland
Recommendations only in place
Italy
Recommendations rejected
Latvia
Recommendations only in place
Lithuania
Recommendations and funding process not considered
Luxembourg
Recommendations and funding in place
Malta
Recommendations rejected
Netherlands
Recommendations rejected
Moderate vaccination coverage is defined as between 20% and 40%. Universal rotavirus vaccination is not presently recommended by the national health authorities of Portugal. However, the Portuguese Paediatric Society has been recommending rotavirus vaccination for all children since 2009, endorsing European recommendations.19 In the absence of national recommendations, rotavirus vaccination in Portugal is mainly driven by paediatricians. In 2010, the German Standing Vaccination Committee postponed the introduction of rotavirus vaccination in the national immunisation programme because insufficient cost-effectiveness, safety, and epidemiological data were available.20 Since June, 2012, several sickness funds have decided to reimburse rotavirus vaccination. From sales data, the 2010 estimate for vaccine coverage in Germany was moderate. However, regions with some recommendations had an average vaccine coverage of 58% compared with 20% in states without recommendations.20 In 2013, after review of the scientific literature, the Standing Vaccination Committee recommended the introduction of rotavirus vaccination into the national vaccination schedule in Germany for children younger than 6 months.21 In Greece, after the positive opinion of the Greek National Advisory Committee on Immunisation, rotavirus vaccine was included as optional in the national immunisation programme.22 In April, 2012, the National Organisation of Provided Health Services announced 75% funding of rotavirus vaccines for all infants. For 2012, the coverage was estimated to be up to 35% from 23% in 2010. In 2006, the Interterritorial Council of the Spanish National Health Service decided against the inclusion of rotavirus vaccination in the national immunisation programme after negative recommendations by the vaccine working group.15,23,24 However, rotavirus vaccination of all children in Spain has been supported by the Spanish Association of Paediatrics Vaccines Advisory Committee since 2008.25,26 That support might account for the estimated 40% of rotavirus vaccine coverage in Spain in 2009.24,27 The sudden decrease in the coverage in 2010 (to 22%) is the result of temporary withdrawal of both rotavirus vaccines by the Spanish Medical Agency because of contamination with porcine circovirus.15,27 In Hungary, rotavirus vaccination is not included in the national immunisation programme, mainly because of cost and other health priorities.15 The local burden of disease and the economic benefits of rotavirus vaccination are being assessed.15 In 2010, the estimated vaccine coverage from vaccine sales was 20% (figure). This moderate coverage can be explained by the support www.thelancet.com/infection Vol 14 May 2014
Recommendations and funding status
Norway
Recommendations and funding in place
Poland
Recommendations only from societies
Portugal
Recommendations only from societies
Serbia
Recommendations rejected
Slovakia
Recommendations and funding process not considered
Slovenia
Recommendations and funding process not considered
Spain
Recommendations only from societies
Sweden
Recommendations and funding under consideration
Switzerland
Recommendation and funding process not considered
UK
Recommendations and funding in place
Data not available for Czech Republic, Iceland, Portugal, and Romania. *Rotavirus vaccination is only partly funded by the health-care insurance. †Rotavirus vaccination is recommended for infants classed as at risk. ‡National health authorities approved the introduction of rotavirus vaccination into the national vaccination schedule in 2013, and the health authorities of five of 16 federal states have included it in their childhood immunisation programmes since 2008. §75% of funding.
Table: Recommendations and funding status of rotavirus vaccination in Europe
of both the Hungarian Paediatric Association28 and the Association of Hungarian Primary Care Paediatricians.29
Countries with low vaccination coverage Low vaccination coverage is defined as less than 10%. Although national rotavirus vaccination is not recommended in Poland, rotavirus vaccines are on the list of new vaccines considered for public funding by the Advisory Expert Committee for Immunisation Programme and Chief Sanitary Inspectorate. The main barriers to the inclusion of rotavirus vaccination in the national immunisation programme are competition with other vaccines and the cost of the vaccines. Polish experts and societies, including the Polish Society of Vaccinology and the Polish Paediatric Society, strongly support universal rotavirus vaccination. Despite the paucity of funding, physicians are required by law to inform parents 417
Review
FI
SW NW EST LV
DK
IR UK
LI
NL GE
BE
CZ
LX FR
CH IT
PO SP
PL
AU SV CR
SK HU
BS
RO SB
BG
GR >90% 40–89% 20–39%
