Rotarix vaccine launched in Australia - GlaxoSmithKline Australia

A new oral vaccine for the prevention of 'rotavirus' gastroenteritis – a disease that hospitalises thousands of Australian children each year – is now available in Australia.¹

Professor Tony Catto-Smith, Director, Department of Gastroenterology and Clinical Nutrition Royal Children's Hospital, Melbourne said today that rotavirus is the most common cause of gastroenteritis in children2 and can have a significant emotional and financial impact on thousands of families each year.^8-9

"By the age of five, almost all children from any sector of society will have had at least one episode of rotavirus gastroenteritis," Professor Catto-Smith said.³

Rotarix, an oral vaccine given in two doses, will help provide protection for young babies before the peak incidence of rotavirus gastroenteritis between the age of six months and two years.^1,10-13

Rotarix can be given at the same time as other vaccines on the National Immunisation Program Schedule at two and four months of age.^1,15 As Rotarix is an oral vaccine, it avoids the need for babies to have another injection.

Rotavirus is highly contagious, difficult to prevent^3,12 and its impact is far-reaching.

An estimated 10,000 children are hospitalised each year due to dehydration caused by severe rotavirus gastroenteritis, with many thousands more having to seek treatment from their general practitioner.^4-6,7

"This is not only because of the thousands of sick and dehydrated children that can fill hospital beds at certain times each year, but also the anxiety for families with a sick child, disruption to family life including time off work for parents and the additional costs of healthcare, extra nappies, foods and formulas," said Professor Catto-Smith.^7-9,14

A Newspoll survey conducted this month found that almost half of mothers (45%) with children aged 5 years or under reported at least one child in this age group that had experienced symptoms like those caused by rotavirus infection - such as diarrhoea, fever and vomiting lasting a few days or longer.*

Of these, three-quarters of the mothers (78%) said they had to take their child to the doctor, about 2 in 10 (18%) had to take the child to hospital, and 7 in 10 (69%) had to take their child out of childcare or school.*

Nearly 8 out of 10 of the mothers reported their child's illness had a significant or severe impact on their family.* Furthermore, more than half the mothers with sick children (54%) said they or their partner had to take one day or more off work to look after the child and 1 in 10 (12%) needed to take four or more days.*

Professor Catto-Smith said vaccination was the only control measure likely to reduce the incidence of severe rotavirus disease.

In addition to the impact on families and health services, rotavirus gastroenteritis can also be a real problem in childcare centres.

Anne Clark, President, Childcare Associations Australia says, "Rotavirus outbreaks can cause significant disruption in our childcare centres with upheaval to families' childcare arrangements¹⁶. Even with our high standards in sanitation and hygiene, rotavirus is highly contagious and cannot always be easily avoided".^3,12

"If a child has rotavirus infection, it can very easily be passed on to other children¹⁷. This can result in children having to be excluded from childcare^16,18 and in more severe cases it may cause temporary closure of a centre. Rotavirus can also easily spread to childcare centre staff, family members of the infected child and other children who may also experience symptoms," she said.^2,16-17

Rotarix will be available from the GP on a private prescription at a cost of about $110 per dose to parents/users. The vaccine is also currently being considered by the Pharmaceutical Benefits Advisory Committee (PBAC) for future funding on the National Immunisation Program schedule.

Dr Irving Boudville,Director, Clinical R&D and Medical Affairs, GSK Biologicals, said, "We are delighted to be able to introduce an oral vaccine with the potential to protect Australian children from the worst episodes of rotavirus infection. It is exciting when our efforts in the research and development of new and innovative medicines, yields a vaccine like Rotarix, which can do so much for the health of Australian children."

PBS Information: Rotarix is not listed on the PBS

About Rotavirus

Gastroenteritis caused by rotavirus can be potentially serious for young babies and has fast appearing symptoms of diarrhoea, fever and vomiting.¹² The diarrhoea usually lasts for five to eight days which, in combination with the fever and vomiting, can result in babies becoming dehydrated and if severe may require admission to hospital."^7,12 Unrecognised prior to its discovery in 1973¹⁹, it is possible that rotavirus is still under-diagnosed in Australia. It is, however, known to be a common virus that accounts for up to 50% of all severe acute cases of childhood gastroenteritis where a child is hospitalised.⁷

As rotavirus is a seasonal disease, with generally more cases over the colder months.⁷ Professor Catto-Smith said that this may place additional demand on hospital and other healthcare services around this time of year.

About Rotarix

Rotarix is indicated for the prevention of rotavirus gastroenteritis.¹

Rotarix has been studied for effectiveness and safety. Like all medicines and vaccines it may have unwanted side effects in some children. Most side effects reported with Rotarix are mild.¹ The most common side effects are – irritability, fever more than 38°C, fatigue, loss of appetite, diarrhoea, vomiting, flatulence and abdominal pain.¹

Rotarix can be given at the same time as other infant vaccines - diphtheria-tetanus-acellular pertussis vaccine (DTPa), Haemophilus influenzae type b vaccine (Hib), inactivated polio vaccine (IPV), hepatitis B vaccine and pneumococcal vaccine.¹

For further information about Rotarix please click here to see the Consumer Medicines Information.

* Newspoll survey of 250 mothers of children aged between 0 and 5 years in Queensland, NSW and Victoria. May 2006

References:

1. GlaxoSmithKline 2006. Approved Australian Product Information – Rotarix.

2. Parashar UD et al. Emer Inf Dis 1998; 4(4): 561-570.

3. Parashar UD et al. Emer Inf Dis 2003; 9(5):565-572.

4. Djuretic et al. Acta Paediatrica Supplement. 1999;426:38-41.

5. Hellard et al. J Gastro & Hepatol. 2003;18:322-328.

6. Britt et al., Aust Fam Phys 2005 34(4) 218-219.

7. Carlin JB et al. MJA 1998;168:252-256.

8. Liddle et al. Med J Aust 1997;167:304-307.

9. Lee BP et al., Pediatr Infect Dis J 2005; 24(11) : 984-988.

10. Kirkwood C et al. Comm Dis Intell 2004;28:481-485.

11. Ruiz-Palacios GM et al. N Eng J Med 2006 354;1; 11-22.

12. Linhares AC, Bresee JS. Pan Am J Pub Health 2000; 8(5): 305-330.

13. De Vos B et al. Pediatr Infect Dis J 2004;23:S179-82.

14. Takala AK et al. Clin Infect Dis 1998;27:272-282.

15. National Health and Medical Research Council, The Australian Immunisation Handbook 8th edition, National Capital Printing - Canberra 2003.

16. Ferson MJ, et al. J Paeditr Child Health 1997; 33: 157-160

17. Dennehy PH. Pediatr Infect Dis J 2000;19 (10 Suppl):S103-5.

18. National Health and Medical Research Council (2001): http://www.nhmrc.gov.au/publications/_files/ch40.pdf Accessed on: 8 March, 2006

19. Bishop R et al. Lancet 1973;2:1281-1283.