Key Messages on Rotavirus Vaccines for NIP Managers* - Path

<strong>Key</strong> <strong>Messages</strong> on Rotavirus Vaccines for NIP Managers*
April 2013
General
• Rotavirus is the leading cause of severe and fatal diarrhoea in children worldwide (~36% of diarrhoea
hospitalisations in children under five-years old are due to rotavirus). 1 More than 90% of rotavirus
deaths occur in developing countries where access to treatment is limited or unavailable. 2
• No specific therapy currently available such as antibiotics is effective against rotavirus. As with other
childhood diarrhoeas, the cornerstones of treatment for rotavirus are fluid replacement to prevent
dehydration and zinc treatment, which decreases the duration and severity of diarrhoea. 3
• Rotavirus vaccination is the best way to prevent this highly contagious disease. 3 Rotavirus remains
common even in industrialised countries with clean water and sanitation. 4 Without vaccination, nearly
all children will have rotavirus infection by three to five years of age. About 80% of children born in low
income countries have been infected by rotavirus by 12 months of age. 5
• Many countries that have introduced rotavirus vaccine have experienced substantial reductions in
hospitalisations and deaths due to rotavirus and all-cause diarrhoea. 3,6
• Two rotavirus vaccines are prequalified by the World Health Organization (WHO): Merck’s RotaTeq®
(RV5) and GlaxoSmithKline’s Rotarix® (RV1).
• Rotavirus vaccine is given with other infant vaccines (usually at 6, 10, and 14 weeks) with RV5 requiring
three doses and RV1 requiring two doses. WHO considers both vaccines similarly safe and effective.
• Price, availability, packed volume and vaccine vial monitor (VVM) information are in the GAVI Product
Menu; 7 and data on each vaccine is available on WHO’s website of prequalified vaccines. 8
• The use of rotavirus vaccine should be part of a comprehensive diarrhoea programme that includes
scaling up of prevention (early and exclusive breastfeeding, hand-washing with soap, improved water
supply and sanitation) and treatment with oral rehydration solution (ORS) and zinc. 3,9
Timing and Risks
• Introduction of rotavirus vaccine should be used to improve immunisation coverage and timeliness.
• Timely immunisation is vital, as a vaccine can only protect if given before infection; this is especially
critical for rotavirus vaccine, as infections can start from the first weeks of life, and children under 6
months are particularly vulnerable to rotavirus infection. 10
• Rotavirus vaccines are safe, with most children having no or mild reactions; the only known serious
adverse event following immunisation (AEFI) is intussusception, a very rare type of bowel blockage (1-2
cases per 100,000 vaccinated infants).
• Because the risk of intussusception is age-related, peaking at about 6 months of age, WHO initially
recommended upper age limits of 15 weeks and 32 weeks for first and last doses, respectively. 11
Following a review of new evidence in 2012, WHO recommended removing the strict age limits for
rotavirus vaccination. 3
• WHO continues to recommend that every infant receives his/her first dose of rotavirus vaccine as
soon as possible after 6 weeks of age along with vaccination against diphtheria-tetanus-pertussis (DTP)
and subsequent doses as closely to the national immunisation schedule as possible. 3
• WHO recommends that RV1 should be administered orally in a 2-dose schedule at the time of DTP1 and
DTP2 with an interval of at least 4 weeks between doses. RV5 should be administered orally in a 3-dose
schedule at the time of the DTP1, DTP2, and DTP3 with an interval of at least 4 weeks between doses.
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With both vaccines, prematurely born infants should follow the vaccination schedules recommended for
their chronological age. 3
• The benefits from preventing rotavirus deaths through vaccination are much greater than the possible
risk of intussusception. 12 Due to the typical age distribution of rotavirus infection, there is unlikely to be
much benefit from vaccinating children above two years of age with rotavirus vaccine. 3,13
Administration of Vaccine
• Rotavirus vaccine prevents severe rotavirus diarrhoea but does not prevent diarrhoea caused by other
pathogens. Thus, when a vaccinator gives rotavirus vaccine, it is a crucial opportunity to remind
caregivers about (1) other healthy actions to prevent diarrhoea—especially breast-feeding and handwashing
with soap; (2) home treatment of diarrhoea with ORS and zinc; (3) how to recognise danger
signs of intussusception or severe dehydration and when to seek health care. 14
• The vaccinator must remind the caregiver of the need for timely completion of the immunisation
schedule for all vaccines and the date of the child’s next visit.
• Rotavirus vaccine is given orally, with a volume of 1.5 or 2 ml — depending on the product—through a
nozzle that has to pass through the lips and be delivered on the inside of the cheek (as compared to only
two drops of oral polio vaccine (OPV) that fall into the open mouth).
• For Rotarix®, it is important to open the vaccine tube correctly—reverse and twist cap to open; do not
snap off—to prevent the small nozzle being dropped into the tube and possibly ingested by the child. 15
Reaching the Most Vulnerable
• The poorest, most vulnerable children with limited access to treatment have the most to gain from
rotavirus vaccine; special efforts to reach these children on schedule will maximise impact of rotavirus
vaccine. 16
• Communities with infants who are currently un- or under-vaccinated are the ones with most to benefit
from rotavirus vaccine. Special focus on reaching these populations should be part of rotavirus vaccine
introduction planning. 9
• For communities reached four times (or less) per year with immunisation services, timely vaccination is
not feasible. As under-served communities tend to be at greatest risk of death from deadly dehydrating
rotavirus diarrhoea, additional efforts to provide more frequent immunisation sessions would be
beneficial, if possible.
Additional Rotavirus Communication, Training, and Information Resources
• GAVI – rotavirus new vaccine support http://www.gavialliance.org/support/nvs/rotavirus/
• PATH – rotavirus advocacy and communication toolkit (available in English and French)
http://sites.path.org/rotavirusvaccine/rotavirus-advocacy-and-communications-toolkit/
• PATH’s RotaFlash – e-news alert that provides breaking scientific news and updates on progress
made toward increasing access to vaccines against rotavirus
http://sites.path.org/rotavirusvaccine/current-issue-of-rotaflash-jpg/
• UNICEF – Communication Framework for New Vaccines and Child Survival
https://sites.google.com/site/commframe/
• US Centers for Disease Control and Prevention (CDC) - rotavirus information
http://www.cdc.gov/rotavirus/index.html
• WHO – rotavirus information and resources http://www.who.int/nuvi/rotavirus/en/
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*”<strong>Key</strong> <strong>Messages</strong> on Rotavirus Vaccines for NIP Managers” was prepared by the Rotavirus Communications
Working Group, a partnership of WHO, UNICEF, GAVI, PATH, JSI, MCHIP, and USAID.
References
1 WHO. Global Rotavirus Information and Surveillance Bulletin Volume 6: October 2012 Reporting period: January to
December 2011. http://www.who.int/nuvi/rotavirus/RV_bulletin_Jan_Dec_2011_FINAL.pdf
2 Tate JE, Burton AH, Boschi-Pinto C, et. al. 2008 estimate of worldwide rotavirus-associated mortality in children
younger than 5 years before the introduction of universal rotavirus vaccination programmes: a systematic review and
meta-analysis. The Lancet Infectious Diseases. 2012;12(2):136–141.
http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(11)70253-5/abstract
3 Rotavirus vaccines: WHO position paper. Weekly Epidemiological Record. No. 5, 2013, 88, 49–64. 2013.
http://www.who.int/entity/wer/2013/wer8805.pdf [N.B. 2013 WHO Rotavirus position paper replaces 2007 WHO
rotavirus position paper Rotavirus vaccines: WHO position paper. Weekly Epidemiological Record.2007; 82(32): 285-
296. http://www.who.int/wer/2007/wer8232.pdf and 2009 update Rotavirus vaccines: an update. Weekly
Epidemiological Record. 2009;84(50):533–540. http://www.who.int/wer/2009/wer8451_52.pdf)]
4 Yen C, Tate JE, Patel MM, et al. Rotavirus vaccines: update on global impact and future priorities. Human Vaccines.
2011;7(12): 1282–1290. www.landesbioscience.com/journals/13/article/18321/ [subscription].
5 Sanderson C et al (2011) Global review of rotavirus morbidity and mortality data by age and WHO region. Report to
WHO/IVB. http://www.who.int/immunization/sage/meetings/2012/april/Sanderson_et_al_SAGE_April_rotavirus.pdf
6 Patel M, Steele AD, Gentsch JR, Wecker J, Glass RI, Parashar UD. Real‐world impact of rotavirus vaccination. Pediatric Infectious
Disease Journal. 2011;30(1):S1–S34.
http://journals.lww.com/pidj/Fulltext/2011/01001/Real_world_Impact_of_Rotavirus_Vaccination.1.aspx.
7 Product Menu for Vaccines Supplied by UNICEF for GAVI. http://www.unicef.org/supply/index_gavi.html
8 WHO prequalified vaccines.
http://www.who.int/immunization_standards/vaccine_quality/PQ_vaccine_list_en/en/index.html
9 UNICEF and WHO. Integrated Global Action Plan for Prevention and Control of Pneumonia and Diarrhoea (GAPPD).
April 2013. (English and French versions)
http://www.who.int/maternal_child_adolescent/documents/global_action_plan_pneumonia_diarrhoea/en/index.html
10 Rotavirus. Epidemiology and Prevention of Vaccine-Preventable Diseases. The Pink Book: Course Textbook - 12th
Edition Second Printing (May 2012). http://www.cdc.gov/vaccines/pubs/pinkbook/rota.html
11 Rotavirus vaccines: an update. Weekly Epidemiological Record. 2009;84(50):533–540.
http://www.who.int/wer/2009/wer8451_52.pdf
12 Patel MM, Clark AD, Sanderson CFB, Tate J, Parashar UD. Removing the Age Restrictions for Rotavirus Vaccination: A
Benefit-Risk Modeling Analysis. PLOS Medicine. 2012;9(10):e1001330.
http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001330
13 Meeting of the Strategic Advisory Group of Experts on immunization, April 2012 – conclusions and recommendations.
Weekly Epidemiological Record. 2012;87(21):201-216. http://www.who.int/wer/2012/wer8721.pdf
14 WHO/UNICEF Integrated Management of Childhood Illness (IMCI) Handbook.
http://whqlibdoc.who.int/publications/2005/9241546441.pdf
15 See WHO’s training module 4 “Rotavirus Vaccine Administration.”
http://www.who.int/entity/nuvi/rotavirus/RotaTrainingPackage_Mod4_28Feb.ppt
16 Rheingans R, Atherly DE, Anderson J. Distributional impact of rotavirus vaccination in 25 GAVI countries: Estimating
disparities in benefits and cost-effectiveness. Vaccine. 2012;30(1):A15–A23).
http://www.sciencedirect.com/science/article/pii/S0264410X12000333
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