РОТАВИРУСНЫЕ ВАКЦИНЫ ДОКУМЕНТ ПО ПОЗИЦИИ ВОЗ (ЯНВАРЬ 2013 Г.)

1. See http://www.who.int/immunization/sage/en

2. Sanderson C. et al. Global review of rotavirus morbidity and mortality data by age and WHO region. Report to WHO/IVB, 2011 (www.who.int/entity/immunization/sage/meetings/2012/april/presentations_background_docs/en/ — 45k).

3. Detailed review paper on rotavirus vaccines (presented to the WHO Strategic Advisory Group of Experts (SAGE) on Immunization in April 2009). Geneva, World Health Organization. 2009. Available from (http://www.who.int/immunization/sage/3_Detailed_ Review_Paper_on_Rota_Vaccines_17_3_2009.pdf).

4. WHO estimate for January 2012: http://www.who.int/immunization_monitoring/burden/rotavirus_estimates/en/index.html

5. Parashar D.U. et al. Global illness and deaths caused by rotavirus disease in children. Emerging Infectious Diseases, 2003, 9: 565–572.

6. Weekly Epidemiological Record. 2008; 47: 421–425. URL: http://www.who.int/wer

7. Hu L. et al. Rotavirus non-structural proteins: structure and function. Current Opinion in Virology. 2012, 2: 380–388.

8. Manual of rotavirus detection and characterization methods (WHO/IVB/08.17). Geneva, World Health Organization. 2009. Available from http://www.who.int/nuvi/rotavirus/WHO_IVB_08.17_eng.pdf, accessed January 2013.

9. Gladstone B.P. et al. Protective effect of natural rotavirus infection in an Indian birth cohort. New England Journal of Medicine, 2011, 365: 337–346.

10. Velazquez F.R., Matson D.O., Calva J.J. et al. Rotavirus infection in infants as protection against subsequent infections. New England Journal of Medicine, 1996, 335: 1022–1028.

11. Oral rehydration salts. Production of the new ORS (WHO/FCH/CAH/06.1). Geneva, WHO/UNICEF. 2006. Available from http://whqlibdoc.who.int/hq/2006/WHO_FCH_CAH_06.1.pdf, accessed January 2013.

12. Angel J. et al. Rotavirus immune responses and correlates of protection. Current Opinion in Virology. 2012. P. 419–425.

13. Clark H.F. et al. Rotavirus vaccines. In: Plotkin S., Orenstein W., Offit P., eds. Vaccines, 6 th ed. Elsevier Saunders. 2013. P. 669–687.

14. Groome M.J. et al. Five-year cohort study on the burden of hospitalisation for acute diarrhoeal disease in African HIV-infected and HIV-uninfected children: potential benefits of rotavirus vaccine. Vaccine. 2012; 30 (Suppl. 1): A173–178.

15. Cunliffe N.A. et al. Effect of concomitant HIV infection on presentation and outcome of rotavirus gastroenteritis in Malawian children. Lancet. 2001; 358 (9281): 550–555.

16. Guidelines to assure the quality, safety and efficacy of live attenuated rotavirus vaccine Annex 3). Geneva, World Health Organization. 2007. WHO Technical report series 941.

17. Available from http://www.who.int/entity/biologicals/publications/trs/areas/vaccines/rotavirus/Annex %203 %20rotavirus %20vaccines.pdf, accessed January 2013.

18. See http://www.who.int/entity/immunization_standards/vaccine_quality/Rotarix_ liquid_tube_product_insert_text_2009.pdf

19. See http://www.who.int/entity/immunization_standards/vaccine_quality/Rotarix liquid_oral_applicator_product_insert_text_2009.pdf

20. See http://www.who.int/entity/immunization_standards/vaccine_quality/RotaTeq_ Product_Insert.pdf and http://www.merck.com/product/usa/pi_circulars/r/rotateq/rotateq_pi.pdf

21. Soares-Weiser K. et al. Vaccines for preventing rotavirus diarrhoea: vaccines in use. Cochrane Database Systematic Review. 2012; 11: CD008521.

22. To aid in cause of death and burden of disease analyses, subregions are stratified (A through E) based on levels of child and adult mortality: Stratum A., very low child and very low adult mortality; Stratum B., low child and low adult mortality; Stratum C., low child and high adult mortality; Stratum D., high child and high adult mortality; Stratum E., high child and very high adult mortality. The 9 low- and middle-income subregions included in the model are:

23. African Region: D and E; Region of the Americas: B and D; South-East Asia Region: B and D, Eastern Mediterranean Region: B and D, and Western Pacific Region: B. Please consult the List of Member States by WHO region and mortality stratum available at www.who.int/entity/whr/2003/en/member_states_182–184_en.pdf,accessed January 2013.

24. Grading of scientific evidence — Tables 1–4: Does RV1 and RV5 induce protection against rotavirus morbidity and mortality in young children both in low and high mortality settings? Available from http://www.who.int/immunization/position_papers/rotavirus_grad_rv1_rv5_protection

25. Patel M.M. et al. Removing the Age Restrictions for Rotavirus Vaccination: A Benefit-Risk Modeling Analysis. PLoS Medicine. 2012; 9: e1001330.

26. Giaquinto C. et al. Summary of effectiveness and impact of rotavirus vaccination with the oral pentavalent rotavirus vaccine: a systematic review of the experience in industrialized countries. Human Vaccines. 2011; 7: 734–748.

27. Richardson V. et al. Effect of rotavirus vaccination on death from childhood diarrhea in Mexico. New England Journal of Medicine. 2010; 362: 299–305.

28. do Carmo G.M. et al. Decline in diarrhoea mortality and admissions after routine childhood rotavirus immunization in Brazil: a time-series analysis. PLoS Medicine. 2011; 8: e1001024

29. Wang F.T. et al. Effectiveness of an Incomplete RotaTeq® (RV5) Vaccination Regimen in Preventing Rotavirus Gastroenteritis in the United States. The Pediatric Infectious Disease Journal. 2012. [Epub ahead of print].

30. Vesikari T. et al. Safety and efficacy of pentavalent humanbovine (WC3) reassortant rotavirus vaccine in preventing rotavirus gastroenteritis and reducing associated health care resource utilization. The New England Journal of Medicine. 2006; 354: 23–33.

31. Vesikari T. et al. Efficacy of the pentavalent rotavirus vaccine, RotaTeq®, in Finnish infants up to 3 years of age: the Finnish Extension Study. European Journal of Pediatrics. 2010; 169: 1379–1386.

32. Linhares A.C. et al. Efficacy and safety of an oral live attenuated human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in Latin American infants: a randomised, double-blind, placebo-controlled phase III study. Lancet. 2008; 371: 1181–1189.

33. Vesikari T. et al. Efficacy of human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in European infants: randomised, double-blind controlled study. Lancet. 2007; 24 (370): 1757–1763.

34. Phua K.B. et al. Rotavirus vaccine RIX4414 efficacy sustained during the third year of life: a randomized clinical trial in an Asian population. Vaccine. 2012; 30: 4552–4557.

35. Armah G.E. et al. Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in sub-Saharan Africa: a randomised, double-blind, placebo-controlled trial. Lancet. 2010; 376:606–614.

36. Madhi S.A. et al. Efficacy and immunogenicity of 2 or 3 dose rotavirus-vaccine regimen in South African children over two consecutive rotavirus-seasons: a randomized, double-blind, placebo-controlled trial. Vaccine. 2012; 30 (Suppl. 1): A44–51.

37. Madhi S.A. et al. Effect of human rotavirus vaccine on severe diarrhoea in African infants. New England Journal of Medicine. 2010; 362: 289–298.

38. Grading of scientific evidence — Tables 5–6: Is giving a third dose of RV1 superior to the currently recommended 2-dose schedule? (Table 5); Is partial vaccination also efficacious against severe rotavirus diarrhoea? (Table 6). Available from http://www.who.int/immunization/position_papers/rotavirus_grad_rv1_3rd_dose

39. Steele A.D. et al. Safety, reactogenicity, and immunogenicity of human rotavirus vaccine RIX4414 in human immunodeficiency virus-positive infants in South Africa. Pediatric Infectious Disease Journal. 2011; 30: 125–130.

40. Laserson K.F. et al. Safety of the pentavalent rotavirus vaccine (PRV), RotaTeq (®), in Kenya, including among HIV-infected and HIVexposed infants. Vaccine. 2012; 30 Suppl 1: A61–70.

41. See http://us.gsk.com/products/assets/us_rotarix.pdf

42. See http://www.merck.com/product/usa/pi_circulars/r/rotateq/rotateq_pi.pdf

43. Soares-Weiser K. et al. Rotavirus vaccine schedules: a systematic review of safety and efficacy from RCTs and observational studies of childhood schedules using RV1 and RV5 vaccines. Report to WHO/Initiative for Vaccine Research, 2012. Available from http://www.who.int/immunization/sage/meetings/2012/april/Soares_K_et_al._SAGE_April_rotavirus.pdf, accessed January 2013.

44. Goveia M.G. et al. Efficacy of pentavalent human-bovine (WC3) reassortant rotavirus vaccine based on breastfeeding frequency. The Pediatric Infectious Disease Journal. 2008; 27: 656–658.

45. McClenahan S.D. et al. Molecular and infectivity studies of porcine circovirus in vaccines. Vaccine. 2011; 29: 4745–4753.

46. Global illness and deaths caused by rotavirus disease in children. Emerging Infectious Diseases. 2010; 30: 285–292.

47. Acute intussusception in infants and young children (WHO/ V&B/.02.19). Geneva, World Health Organization. 2002. Available at http://www.who.int/vaccinesdocuments/DocsPDF06/www640.pdf, accessed January 2013.

48. Buttery J.P. et al. Intussusception following rotavirus vaccine administration: postmarketing surveillance in the National Immunization Program in Australia. Vaccine. 2011; 29: 3061–3066.

49. Ruiz-Palacios G.M. et al. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. New England Journal of Medicine. 2006; 354: 11–22.

50. Patel M.M. et al. Intussusception risk and health benefits of rotavirus vaccination in Mexico and Brazil. New England Journal of Medicine. 2011; 364: 2283–2292.

51. Velazquez F.R. et al. Postmarketing Surveillance of Intussusception Following Mass Introduction of the monovalent human Rotavirus Vaccine in Mexico_(UGG)_(EPI PLAN). The

52. Pediatric Infectious Disease Journal. 2012; 31: 736–744.

53. Shui I.M. et al. Risk of intussusception following administration of a pentavalent rotavirus vaccine in US infants. JAMA: the Journal of the American Medical Association. 2012; 307: 598–604.

54. Loughlin J. et al. Postmarketing evaluation of the short-term safety of the pentavalent rotavirus vaccine. The Pediatric Infectious Disease Journal. 2012; 31: 292–296.

55. Weekly Epidemiological Record. 2012; 6: 53–60. URL: http://www.who.int/wer

56. Grade table 7: Is it safe to administer the first dose of vaccine at different ages? Available from http://www.who.int/immunization/position_papers/rotavirus_grad_safe_first_dose_ages

57. Cherian T. et al. Rotavirus vaccines in developing countries: the potential impact, implementation challenges, and remaining questions. Vaccine. 2012; 30 (Suppl. 1): A3–6.

58. van Hoek A.J. et al. (2012) A cost effectiveness and capacity analysis for the introduction of universal rotavirus vaccination in Kenya: Comparison between Rotarix and RotaTeq Vaccines. PLoS ONE. 2012; 7: e47511.

59. Postma M.J. et al. Comparative review of 3 cost-effectiveness models for rotavirus vaccines in national immunization programs; a generic approach applied to various regions in the world. BMC Medicine. 2011; 9: 84.

60. Diarrhoea: why children are still dying and what can be done. Geneva, WHO/UNICEF. 2009. Available from http://www.who.int/maternal_child_adolescent/documents/9789241598415/en/index.html, accessed January 2013.

61. Pneumonia and diarrhoea: tackling the deadliest diseases for the world’s poorest children. New York, UNICEF. 2012. Available from http://www.unicef.org/media/files/UNICEF_P_D_complete_0604.pdf, accessed January 2013.

62. Weekly Epidemiological Record. 2011; 8: 61–72. URL: http://www.who.int/wer