Vaccination against- Rotavirus- the use of Rotarix. An update for Registered healthcare practitioners February 2018

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1 Vaccination against- Rotavirus- the use of Rotarix An update for Registered healthcare practitioners February 2018 A rotavirus immunisation programme was introduced into the routine childhood immunisation programme from 1 July 2013 for infants aged 2 and 3 months. Rotavirus is a very common and potentially serious infection of the gut in young babies. 1 Rationale of resource This resource is designed to support registered healthcare practitioners involved in discussing vaccination with parents/guardians and providing them with evidence based about vaccination against rotavirus and guidance on the administration of this new vaccine. 0

2 Rotavirus the use of Rotarix July Update to exclusion criteria Rotarix should not be given to: Infants whose mothers have received immunomodulating biologics (such as monoclonal antibodies or receptor antagonists which interfere with the immune system e.g. anti-tnf agents) in pregnancy Page 1 1

3 Rotavirus the use of Rotarix July Immunosuppression For infants with other immuno-suppressive disorders (other than SCID) there are limited data on the safety and efficacy of Rotarix. In such cases the infants GP in collaboration with the clinician dealing with the child s underlying condition should assess the infant and consider vaccination Page 2

4 Key Message Rotavirus is the most common cause of gastroenteritis in young children. Most children will experience at least one infection with rotavirus by the time they are five years old, with some requiring hospitalisation for dehydration. An oral vaccine against rotavirus has been introduced into the infant immunisation programme at the 2 and 3 months appointment. Rotavirus vaccination should significantly reduce rotavirus gastroenteritis in young children Page 1 3

5 Aims of the resource To support staff involved in discussing vaccination against rotavirus with parents/carers by providing evidence based To raise awareness of rotavirus epidemiology and the benefits of rotavirus vaccination for young infants To provide guidance on the administration of this oral vaccine, including how to administer the vaccine, contraindications, precautions and potential adverse reactions Page 2 The key roles of registered healthcare professionals in relation to vaccination against rotavirus: To advise parents/carers that it is strongly recommended that their infant is vaccinated against rotavirus Explain what rotavirus infection is, its potential complications and that vaccination will provide protection to young infants against the main strains of rotavirus Explain which vaccine will be used, the contraindications and possible side effects to vaccination and the evidence for this vaccination programme To safely administer this new oral vaccine to young infants To ensure vaccination is administered according to the schedule To ensure any adverse events are managed and reported appropriately To ensure vaccination is recorded appropriately, along with other infant immunisation. 4

6 Learning outcomes After completing this resource registered healthcare practitioners will be able to: Describe the aetiology and epidemiology of rotavirus Have an understanding of how rotavirus is transmitted and the potential complications of infection in infants Discuss the importance of vaccination against rotavirus Have a knowledge of the contraindications for rotavirus vaccination Safely administer the vaccine Have an understanding of potential adverse reactions and how to report these Be aware of sources of additional Page 3 5

7 Contents What is rotavirus? Why vaccinate against rotavirus? Vaccination against rotavirus- the use of Rotarix The role of registered healthcare practitioners Resources Page 4 6

8 What is rotavirus? Page 5 7

9 What is rotavirus? Rotavirus is a virus that causes gastroenteritis in particular in infants and young children Estimated that all children will become infected with rotavirus at least once by the time they are five years old Estimated that rotavirus causes around half of all gastroenteritis in children aged under five years Page 6 Rotavirus is a leading cause of gastroenteritis in infants and young children throughout the world Gastroenteritis can have a number of possible causes, including norovirus infection or food poisoning. However, rotavirus is the leading case in children. It is an ubiquitous virus, virtually all children, rich and poor, living in the industrialised or developing world will become infected with rotavirus at least once by the time they are five years old. Individuals can have repeat infections, but the repeat infections tend to be less severe than the original infection. 2 Rotavirus is so named because of its wheel like appearance under the electron microscope the name rotavirus being derived from the Latin rota, meaning wheel. There are a number of different strains of rotavirus. The vaccine protects against the most common circulating strains. 8

10 What is rotavirus? Incubation Period The incubation period is approximately 2 days Infectious period Shedding of the virus in faeces may begin before the onset of major symptoms and may continue for several days after symptoms have resolved Page 7 The incubation period for rotavirus is approximately 2 days. Rotavirus is very infectious as the shedding of the virus in faeces may begin before the onset of major symptoms and may continue for several days after symptoms have resolved

11 Clinical Presentation of rotavirus Rotavirus gastroenteritis usually begins with the symptoms of: Diarrhoea Vomiting The child may also have: A fever (high temperature) of 38 o C or above Abdominal pain The symptoms of vomiting usually pass within one or two days. In most children, vomiting will not last longer than three days The symptoms of diarrhoea usually pass within five to seven days. Most children s diarrhoea symptoms will not last longer than two weeks Page 8 Rotaviruses affect one of the main functions of the intestines the absorption of water from digested food into the body. This is why one of the common symptoms is diarrhoea. More on the clinical presentation is available at NHS Inform. 5 10

12 Complications of rotavirus Gastroenteritis can cause dehydration: This can be more serious than the rotavirus infection itself- and can require hospitalisation for intravenous rehydration 1200 children are estimated to be admitted to hospital each year with rotavirus in Scotland Page 9 The combination of the symptoms of vomiting, diarrhoea and fever can lead to dehydration, requiring admission to hospital for intravenous rehydration. Almost all babies will get rotavirus within the first five years of life and about one in every five will need medical attention and about one in ten of these will be admitted to hospital with illness caused by the infection. Estimated that about 1200 children under 5 in Scotland are admitted to hospital each year with rotavirus. Although deaths from rotavirus are rare and are difficult to quantify accurately, there are likely to be approximately three to four a year in the UK. 6 11

13 Transmission of rotavirus Rotavirus is highly infectious: As few as virus particles may cause disease Transmission mainly via the faecal-oral route If a child leaves tiny samples of infected faeces on surfaces or utensils for example after not washing their hands properly after going to the toilet, they can be picked up by another child Small droplets of infected faeces can also be carried in the air, which children can breathe in Page 10 Infants with rotavirus gastroenteritis can shed 100 billion infectious particles per gram of faeces 7 but the infectious dose for humans may be as low as 10 infectious particles. 3 Thus, rotavirus is a very infectious pathogen. Studies have also shown that in addition to being stable in most environmental conditions, rotavirus is also relatively resistant to most commonly used soaps and disinfectants. This allows the virus to persist in the environment and retain the potential to cause infection for significant periods of time. 8 12

14 Why vaccinate infants against rotavirus? Page 11 13

15 Why vaccinate against rotavirus? Only a very small proportion of cases are confirmed by laboratory testing These cases are just the tip of the iceberg Page 12 This graph shows that each year in Scotland between about 1280 and 1800 people are laboratory confirmed with rotavirus. Most cases of rotavirus do not require a stool sample to be submitted for testing, so these laboratory confirmed cases are just the tip of the iceberg. In 2012, 1283 laboratory confirmed cases of rotavirus were reported in Scotland. A study of infectious intestinal disease 9 has estimated that for every case of rotavirus that is laboratory confirmed another 43 (confidence interval range 30-62) occur in the community. 14

16 Why vaccinate against rotavirus? Epidemiology of rotavirus in Scotland - who is most at risk? Page 13 The graph shows the age of the laboratory confirmed cases of rotavirus in 2012, most (95%) of these occurred in children under five years of age, and about two thirds of these were children less then two years old. The highest incidence was in children aged one year, with an incidence of 835 laboratory cases for every 100,000 children aged one year, but these are just the tip of the iceberg, as most cases won t be laboratory confirmed. As discussed previously people of any age can be affected with rotavirus but most infections occur in children between one month and four years of age. Children under one year and in particular if they are younger than six months, are at increased risk of dehydration. Infection in new-borns is common but tends to be either mild or asymptomatic because of protection from circulating maternal antibodies

17 Why vaccinate against rotavirus? Seasonality of rotavirus infection Page 14 Rotavirus infection in the UK is seasonal, occurring mostly in winter and early spring (January to March), although there are also a small number of cases during the summer months. 16

18 Why vaccine against rotavirus? Recommendation from JCVI for rotavirus vaccine The Joint Committee on Vaccination and Immunisation (JCVI) is the UK s independent panel of immunisation experts: JCVI recommends that rotavirus vaccination should be given to infants at two and three months of age i.e. two doses Rotavirus vaccination should significantly reduce rotavirus gastroenteritis in young children Page 15 The JCVI (Joint Committee on Vaccination and Immunisation) is the advisory body for all immunisation policy. In 2009 JCVI considered the evidence on the burden of rotavirus infection and work on the cost effectiveness of rotavirus vaccination. The JCVI based on the available evidence advised that the licensed rotavirus vaccines would have a significant impact on reducing gastroenteritis in young children, and that the UK health departments should introduce the vaccines if they could be procured at a cost effective price. 12 This advice was reiterated in 2011 following consideration of a further cost effectiveness study. In November 2012, Scottish Government announced 13 that the vaccine had been procured at a price which meant the programme would be cost effective and the programme would start in This programme started in July

19 Why vaccinate against rotavirus? Effectiveness of the vaccine Very effective at protecting against the most common strains of rotavirus Very effective in protecting against severe rotavirus infection requiring hospitalisation 1 st year of life Rotarix N= 2572 Placebo N= nd Year of Life Rotarix N= 2554 Placebo N=1294 Vaccine Efficacy (%) against rotavirus gastro-enteritis required medical attention (95% CI) Circulating rotavirus strains 91.8 (63:96,3) 76.2 (63,0:85.0) Vaccine efficiency (%) against hospitalisation due to rotavirus gastro-enteristis required medical attention (95%CI) Circulating rotavirus strains 100 (81,8:100) 92.2 (65,6:99,1) Page The Rotarix rotavirus vaccine has been shown to be very effective in protecting against the most common strains of rotavirus and severe rotavirus infection (infection resulting in hospitalisation). Rotavirus vaccine will not prevent diarrhoea or vomiting cased by other pathogens. The vaccine is over 85% effective at protecting against severe rotavirus gastroenteritis in the first two years of life (More details of the vaccine efficacy from the clinical trials are available in the Rotarix SPC 14 ) Rotavirus vaccines, including the Rotarix vaccine which will be used in Scotland and the rest of the UK, are already used to routinely vaccinate children in the USA and many other countries. In the USA, studies have shown that rotavirus-related hospital admissions for young children have been cut by more than two thirds since rotavirus vaccination was introduced. 15 A study has estimated that vaccinating a birth cohort of infants in England and Wales may report around 90,000 infections and 10,000 hospitalisations and around two deaths due to rotavirus in that cohort over the first five years of life. 16 It may also provide some additional protection to the wider population through herd community

20 Vaccination against rotavirus The use of Rotarix Image courtesy of GSK Page 17 19

21 Vaccination against rotavirus- use of Rotarix Rotarix Since 1 July 2013 Rotarix has been used for rotavirus immunisation programme Generic name: Rotavirus vaccine, Live Marketed by GlasxoSmithKline Licensed from 6 weeks to 24 weeks Oral suspension in a prefilled tube Container dimensions 53x87x25mm This is an oral vaccine and must not be injected. Page 18 Rotarix is a live attenuated vaccine (a weakened form of virus which cannot cause disease but which protects against rotavirus). This is an oral vaccine and must not be injected. The packaging is similar in size to many currently used childhood vaccines. The vaccine was procured following a tendering exercise undertaken by the Department of Health of behalf of UK nations and ensured the vaccine was available at a cost-effective price. 20

22 Laboratory reports What has been the impact of the programme? Weekly laboratory reports of rotavirus to HPS for infants age<1 year in 2014 and first 15 weeks of 2015 compared to an average of Week Age<1 ( average) Age<1 (2014) Age<1 (2015) Page 19 This graph shows there has been a very significant reduction in the number of laboratory confirmed cases of rotavirus in infants less than one year of age since the rotavirus immunisation programme was introduced. A reduction has also been observed in the number of young infants presenting at General Practice and admitted to hospital with rotavirus. 21

23 Vaccination against rotavirus-the use of Rotarix Rotarix Composition Active ingredient Human rotavirus R1X4414 strain Live attenuated Not less that CCID 50 Excipients Sucrose Di-sodium Adipate Dulbecco s Modified Eagle Medium Sterile water Page 20 The live attenuated virus in Rotarix is Human rotavirus RIX4414 strain which is produced on vero cells (monkey cell line). The virus was initially isolated from the stool of a 15 month old child and then attenuated by serial cell culture passage. 18 Each dose contains not less than 10 6 Cell Culture Infectious Dose 50 (the amount of virus required to produce an effect in 50% of inoculated tissue culture cells) There are relatively few excipients. Disodium Adipate is an acidity regulator and Dulbecco s Modified Eagle Medium is a cell culture medium. Rotarix does not contain any antibiotic traces, formaldehyde or preservatives such as thiomersal. The squeezable tube (polyethylene) fitted with a membrane and a tube cap (polypropylene), which should not affect latex sensitivities. 22

24 Vaccination against rotavirus-the use of Rotarix Rotarix presentation A prefilled squeezable tube containing 1.5ml of oral suspension Image courtesy of GSK Page 21 Rotarix is presented as a prefilled squeezable tube containing 1.5ml of oral suspension. The tube is ready to use. No reconstitution or dilution is required. The oral suspension should be a clear colourless liquid, free of visible participles. Before administration the vaccine should be visually inspected for particulate matter and/or abnormal physical appearance. In the event of either being observed the vaccine should be discarded. 23

25 Vaccination against rotavirus-the use of Rotarix Storage of Rotarix Rotarix must be stored in accordance with manufacturers instructions Cold chain must be maintained Store between +2 C and +8 C Store in original packaging Protect from light Page 22 Rotarix must be stored in accordance with the manufacturer s instructions. As with most vaccines Rotarix should be stored between +2 o C and +8 o C. The vaccine should be stored in the original packaging. This makes it easy to identify in the vaccine fridge, provides some protection against fluctuation of temperature and will protect from light. Vaccines are expensive and it is important to minimise wastage through inappropriate storage. 24

26 Vaccination against rotavirus-the use of Rotarix Rotarix dosage and schedule 2 dose schedule: First dose of 1.5ml at 8 weeks (two months) of age Second dose of 1.5ml at least four weeks after the first (i.e. 12 week appointment) It is preferable that the full course of 2 doses is completed before 16 weeks of age, Rotarix must be given no later than 24 weeks (i.e. 23 weeks 6 days) The first dose must be given before 15 weeks of age. If infant does not have first dose before 15 weeks then do NOT give Rotarix If the course is interrupted it should be resumed but not repeated, provided that the second dose can be given before 24 weeks If infant spits out/regurgitates most of dose, a replacement dose may be given at same visit Page 23 Objective is to provide 2 doses of rotavirus vaccine to infants before 24 weeks (i.e. 23 weeks and 6 days) of age to protect against rotavirus infection. The course is two doses with an interval of at least 4 weeks between doses. 19 The routine programme will offer a first dose at the 8 week (2 month) visit when an infant receives their first primary immunisations. The second dose should be given at least four weeks after the first dose, ideally at the second visit for their primary immunisations due when they are 12 weeks (3 months) old. Both doses of Rotarix must be given by 24 weeks of age (i.e. 23 weeks and 6 days) but ideally before 16 weeks of age. Vaccination should not be initiated after 15 weeks of age (i.e. 14 weeks and 6 days) (this is in line with recommendation from WHO) As they get older, some infants (about 120 per 100,000) develop intussusception. The background risk of intussusception increases to peak at around 5 months of age. Research from some countries suggests that Rotarix may be associated with a very small increased risk of intussusception within seven days of vaccination, possibly two cases per 100,000 first doses given. The benefits of vaccination in preventing the consequences of rotavirus infection outweigh this small potential risk in young children. Because of the potential risk, and to reduce the likelihood of a temporal association with rotavirus vaccine, the first dose of vaccine should not be given after 15 weeks of age (i.e. 14 weeks and 6 days). Infants who receive the first dose before week 15 should have their second does four weeks later and before 24 weeks (i.e. 23 weeks and 6 days) 25

27 Infants may receive their first dose of primary immunisations from 6 weeks of age in exceptional circumstances e.g. pre-travel but is not routinely recommended to offer infants vaccine before 2 months of age. Rotarix is licensed from 6 weeks of age. 25

28 Vaccination against rotavirus-the use of Rotarix Administration of Rotarix Rotarix is different from other infants vaccine as it s a LIVE ORAL vaccine and must not be injected Rotarix can be administered at the same time as other childhood vaccines Image courtesy of GSK Page 24 Rotavirus vaccine can be given at the same time as the other vaccines administered as part of the routine childhood immunisation programme, including BCG, and so should ideally be given at the scheduled two month and three month vaccination visits. However, rotavirus vaccine can be given at any time before or after the routine infant immunisations and at any time before or after BCG vaccine. The recommendation for administering live vaccines either at the same time or after an interval of four weeks only applies to injectable live viral vaccines and, therefore, not to BCG or to the oral rotavirus vaccines. It is suggested to give Rotarix to the infant at the beginning of their immunisation visit, before administration of intramuscular vaccines which may unsettle the infant. 26

29 Vaccination against rotavirus-the use of Rotarix Administration of Rotarix A What you need to do before giving Rotarix Check the expiry date. Check the tube has not been damaged nor is already open. Check the liquid is clear and colourless, without any particles in it. If you notice anything abnormal, do not use the vaccine. This vaccine is given orally - straight from the tube. It is ready to use - you do not need to mix it with anything SPC 6.6 Special precautions for disposal and other handling 14 The vaccine is presented as a clear, colourless liquid, free of visible particles, for oral administration. The vaccine is ready to use (no reconstitution or dilution is required). The vaccine is to be administered orally without mixing with any other vaccines or solutions. The vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance. In the event of either being observed, discard the vaccine. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Image courtesy of GSK 27

30 Vaccination against rotavirus-the use of Rotarix B Get the tube ready 1. Pull off the cap Keep the cap you need this to pierce the membrane. Hold the tube upright. 2. Repeatedly flick the top of the tube until it is clear of any liquid Clear any liquid from the thinnest section of the tube by flicking just below the membrane. 28

31 Vaccination against rotavirus-the use of Rotarix 3. Position the cap to open the tube Keep the tube held upright. Hold the side of tube There is a small spike inside the top of the cap - in the centre. Turn the cap upside down (180 ). 29

32 Vaccination against rotavirus-the use of Rotarix 4. To open the tube You do not need to twist. Press the cap down to pierce the membrane. Then lift off the cap. 30

33 Vaccination against rotavirus-the use of Rotarix C Check the tube has opened correctly 1. Check the membrane has been pierced There should be a hole at the top of the tube. 2. What to do if the membrane has not been pierced If the membrane has not been pierced return to section B and repeat steps 2, 3 and 4. 31

34 Vaccination against rotavirus-the use of Rotarix D Give the vaccine Once the tube is open check the liquid is clear, without any particles in it. If you notice anything abnormal, do not use the vaccine. Give the vaccine straight away. 1. Position the child to give the vaccine Seat the child leaning slightly backwards. 2. Administer the vaccine Squeeze the liquid gently into the side of the child's mouth - towards the inside of their cheek. You may need to squeeze the tube a few times to get all of the vaccine out - it is okay if a drop remains in the tip of the tube Discard the empty tube and cap in approved biological waste containers according to local regulations 32

35 Vaccination against rotavirus-the use of Rotarix Contraindications Confirmed anaphylactic reaction to a previous dose of rotavirus vaccine Confirmed anaphylactic reaction to any component of rotavirus vaccine Previous history intussusception Infants aged 24 weeks and zero days of age or older Infants who have not received their first dose before 15 weeks of age i.e. older than 14 weeks and six days Severe combined immunodeficiency disorder (SCID) Malformation of GI tract that could predispose to intussusception. Rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency Infants whose mothers have received immunomodulating biologics (such as monoclonal antibodies or receptor antagonists which interfere with the immune system e.g. anti-tnf agents) in pregnancy. There are very few infants who cannot receive rotavirus vaccine Page 26 There are very few infants who cannot receive rotavirus vaccine. Breast-feeding and medications for gastro-oesophageal reflux are not contraindications for rotavirus vaccination. The rotavirus vaccine can also be administered before, at the same time as, or after administration of any blood product, including those containing antibody/immunoglobulin. Where there is doubt, appropriate advice should be sought from an immunisation co-ordinator or consultant in health protection rather than withholding vaccination. 33

36 Vaccination against rotavirus-the use of Rotarix Immunosuppression and HIV Should not be administered to infants known to have severe combined immunodeficiency disorder (SCID) For infants with other immuno-suppressive disorders (other than SCID) there are limited data on the safety and efficacy of Rotarix. In such cases the infant s GP in collaboration with the clinician dealing with the child s underlying condition should assess the infant and consider vaccination. Rotarix vaccination is advised in HIV infected infants. Additionally infants of unknown HIV status, but born to HIV positive mothers should be offered vaccination Page 27 Rotavirus vaccination should not be administered to infants known to have severe combined immunodeficiency disorder (SCID). There is a lack of safety and efficacy data on the administration of rotavirus vaccine to infants with other immuno-suppressive disorders. Given the high risk of exposure to natural rotavirus, however, the benefits of administration is likely to outweigh any theoretical risks and therefore should be actively considered, if necessary in collaboration with the clinician dealing with the child s underlying condition. However, in a clinical study, 100 infants with HIV were administered Rotarix lyophilised formulation or placebo. The safety profile was similar between Rotarix and placebo recipients. 20 Therefore vaccination is advised in HIV infected infants. Additionally, infants with unknown HIV status, but born to HIV positive mothers should be offered vaccination

37 Vaccination against rotavirus-the use of Rotarix Precautions Acute severe febrile illness Defer until recovered Acute diarrhoea or vomiting Defer until recovered Minor illnesses without fever or systemic upset are not valid reasons to postpone immunisation Page 28 Minor illnesses without fever or systemic upset are not valid reasons to postpone immunisation. If infant is acutely unwell the immunisation may be deferred until they have recovered this is to avoid confusing the differential diagnosis of acute illness by wrongly attributing signs or symptoms as adverse effects of the vaccine. Infants with acute diarrhoea or vomiting the vaccine should be postponed until they have recovered this is to make sure the vaccine is not regurgitated or passed through GI tract too quickly which could reduce the effectiveness of the vaccine. 35

38 Vaccination against rotavirus-the use of Rotarix Precautions Potential transmission of live attenuated virus from infant Vaccination of infant will offer protection to household contacts from wild-type rotavirus disease and outweigh any risk from transmission of vaccine virus to any immunocompromised close contacts Those in close contact with recently vaccinated infants should observe good personal hygiene Page 29 There is a potential for transmission of live attenuated virus in Rotarix from the infant to severely immunocomprised contacts through faecal material for at least 14 days However, vaccination of the infant will offer protection to household contacts from wild-type rotavirus disease and outweigh any risk from transmission of vaccine virus to any immunocompromised close contacts. Those in close contact with recently vaccinated infants should observe good personal hygiene e.g. washing their hands after changing a child s nappy. The JVCI considered the issue of rotavirus vaccination for infants who are still in neonatal units when they become eligible for rotavirus immunisation. Their opinion is Rotarix can and should be given to preterm infants who remain on the neonatal unit at the appropriate time for vaccination. The committee appreciate that this advice differs from that previously given in terms of OPV (oral polio vaccine) one of the concerns in terms of OPV was that of potential reversion to wild-type virus. This is not thought to be an issue with rotavirus vaccine. Further more, the potential clinical sequelae of polio infection differs considerably from rotavirus. It is recognised that infants on the neonatal unit may be exposed to natural rotavirus within the hospital environment, hence the benefits of vaccination are considered to far outweigh any risks. If a recently vaccinated infant is hospitalised for any reason, no precautions other than standard infection control precautions need to be taken to prevent the spread 36

39 of vaccine virus in the hospital setting. 36

40 Vaccination against rotavirus-the use of Rotarix Adverse reactions The most common adverse reactions observed after Rotarix are: Diarrhoea Irritability Other reactions commonly reported are: Vomiting Abdominal pain Flatulence Skin inflammation Regurgitation of food Fever Loss of appetite Page 30 The full list of adverse reactions associated with Rotarix is available in the marketing authorisation holder s Summary of Product Characteristics. 14 Anaphylaxis is a very rare side effect of most vaccines and facilities for its recognition and management must be available. 37

41 Vaccination against rotavirus the use of Rotarix Intussusception Intussusception is naturally occurring condition of intestines Research from some countries suggests that Rotarix may be associated with a very small increased risk of intussusception Even with this small potential risk, the benefits of vaccination in preventing the consequences of rotavirus infection outweigh any possible side effects Page 31 Intussusception is a naturally-occurring condition, with a background annual incidence of around 120 cases per 100,000 children aged under one year. Intussusception occurs when a section of the bowel folds in on itself, like a telescope closing, typically at the junction of the ileum and the colon. It can lead to disruption of the blood supply to the bowel and can lead to perforation and gangrene. The main symptom of intussusception is severe abdominal pain that comes and goes. Each episode tends to last 2-3 minutes in between episodes the infant will look very pale, tired and floppy. After the 12 hours or so the pain becomes more constant and the infant will usually go off food and may vomit. Due to vomiting the infant may become dehydrated. The child may also have a high temperature and a swollen stomach. The child s faeces may contain blood and mucus. 23 Intussusception can be life threatening and requires prompt medical treatment. Research from some countries suggests that Rotarix may be associated with a very small increased risk of intussusception within seven days of vaccination, possibly 2 cases per 100,000 first doses given. The benefits of vaccination in preventing the consequences of rotavirus infection outweigh this small potential risk in young children. Because of the potential risk, and to reduce the likelihood of a temporal association with rotavirus vaccine, the first dose of vaccine should not be given after 15 weeks of age. 19 Parents should be advised that if the infant develops severe vomiting, abdominal 38

42 pain and pass what looks like red current jelly in their stools, they should contact their doctor immediately. 38

43 Vaccination against rotavirus the use of Rotarix Reporting suspected adverse reactions Yellow card scheme - Voluntary reporting system for suspected adverse reaction to medicines/vaccines Success depends on early, complete and accurate reporting Report even if uncertain about whether vaccine caused condition See chapter 9 of Green book for details Page As with all vaccines and other medicines, registered healthcare practitioners and patients are encouraged to report suspected adverse reactions to the Commission on Human Medicines (CHM) using the yellow card reporting scheme

44 Vaccination against rotavirus the use of Rotarix Data Management- Call and recall Infants will be called for their immunisation against rotavirus at the same time as for their other immunisations at two and three months, via SIRS (Scottish Immunisation & Recall System) Page Infants will be called for their rotavirus vaccine at the same time as their other infant immunisations at two and three months of age, using the SIRS system (Scottish Immunisation & Recall System) Vaccination will be recorded in the same way as the other infant immunisations. Note: If an infant attends late for the two or three months immunisations it is important to remember that both doses should be given by 24 weeks (i.e. 23 weeks and 6 days) of age but preferably before 16 weeks of age and infants who have not received a first dose by 15 weeks of age (i.e. 14 weeks and 6 days) should not be offered Rotarix This does not apply to the other routine infant vaccinations which can be given if the infant presents late. 40

45 The registered healthcare practitioners key role To provide clear and concise to parents/guardians regarding vaccination against rotavirus To safely administer this oral vaccine to young infants according to the schedule Page 41

46 Resources Green Book Health Scotland leaflet Patient Group Direction (National specimen) NHS Education for Scotland training resources CMO Letter Page 42

47 Key Messages Rotavirus is the most common cause of gastroenteritis in young children. Most children will experience at least one infection with rotavirus by the time they are five years old, some requiring hospitalisation for dehydration. An oral vaccine against rotavirus has been introduced into the infant immunisation programme at the 2 and 3 month appointments Rotavirus vaccination should significantly reduce rotavirus gastroenteritis in young children Page 43

48 References 1. Chief Medical Officer Rotavirus letter. Important changes to the Scottish Immunisation Programme in Rotavirus Immunisation Programme, April p 2. Bernstein DI, Ward RL, Rotavirus. In Feigin RD, Cherry JD, eds. Textbook of Paediatric Infectious Diseases. 5 th ed Vol 2. Philadelphia, Pa:Saunders: 2004:4: Bishop RF (1996) natural history of human rotavirus infection. Arch Virol 12 (Suppl) Raebel MA, Ou BS (1999) Rotavirus disease and its prevention in infants and children. Pharmacotherapy 19: NHS Inform Rotavirus. Page 44

49 References 6. Jit M, Pebody R, Chen M et al (2007) Estimating the number of deaths with rotavirus as a causes in England and Wales. Hum Vaccin 3 (1) Ansari SA, Springthorpe VS, Satter SA. (1991) Survival and vehicular spread of human rotaviruses: Possible relation to seasonality of outbreaks. Rev infect Dis 13: Offit PA, Clark HF Rotavirus. In Mandell GL, Bennett JE, Dolin R, eds. Mandelll, Douglas, and Bennett s: Principles and Practice of Infectious Diseases. 5 th ed. New York: Churchill Livingstone; 2000: The infectious intestinal disease 2 study Grillner L, Broberger U, Chrystie I et al (1985) Rotavirus infections in new-borns: an epidemiological and clinical study, Scand j Infect Dis 17 (4) Page 45

50 References 11. Bishop RF (1994) natural history of human rotavirus infection. In Kapikian AZ (ed) Viral infections of the gastroenteritis tract. New York: Marcel Dekker; p JCVI statement on Rotavirus s/@dh/@ab/documents/digitalasset/dh_095177/pdf 13. Scottish Government news release for announcement of start of programme. accine Rotarix SPC, available on ema website R_-_Product_Information/human/000639/WC pdf 15. Tate JE, Cortese MM, Payne DC, Curns AT, Yen C, Esposito DH, Cortes JE, Lopman AB, Gentsch JR, Parachar UD (2011) Uptake, impact and effectiveness of rotavirus vaccination in the United States: review of the first 3 years of postlicencsure data. Pediatr Infect Dis J 30 (I Suppl) S56-60 Page 46

51 References 16. Jit M, Edmunds WJ (2007) Evaluating rotavirus vaccination in England and Wales. Part II. The potential cost-effectiveness of vaccination. Vaccine 25: Anderson EJ, Shippee DB, Weinrobe MH et all (2013) Indirect protection of adults from rotavirus by pediatric rotavirus vaccination. Clin Infect Dis 56 (6) De Vos B, Vesikari T, Linhares AC et al (2004) A rotavirus vaccine for prophylaxis of infants against rotavirus gastroenteritis. Pediatr Infect Dis J 23 (10 Suppl) S170-82) 19. Rotavirus, Green Book Chapter. England/series/immunisation 20. Steele AD, Madhi SA, Louw CE, et al (2011) safety, Reactogenicity and Immunogenicity of human rotavirus vaccine RIX4414 in Human Immunodeficiency Virus positive infants in South Africa, Pediatr infect Dis J 30 (2) Page 47

52 References 21. Anderson EJ. (2008) Rotavirus vaccines: viral shedding and risk of transmission. Lancet Infect Dis 8 (10) Commission on Human Medicines (CHM) Great Ormond Street Hospital for Children. Information on intussusception. Page 48