National Immunisation Programme

The rotavirus vaccination is included in the National Immunisation Programme as of  2024. All parents of babies born on or after 1 January 2024 will receive an invitation for the rotavirus vaccination.

Questions about the rotavirus vaccination

1. How effective is vaccination against rotavirus?
2. If my child is vaccinated against rotavirus, does that mean my child can no longer get a rotavirus infection?
3. Is the rotavirus vaccination safe?
4. Which side effects are possible?
5. Is there any experience with rotavirus vaccination in other countries?
6. Who can be vaccinated against rotavirus, and when?
7. Are there any children for whom the rotavirus vaccine is not suitable?
8. How long does a rotavirus vaccination work?
9. Does the rotavirus vaccination need to be repeated?
10. If I want to have my children vaccinated against rotavirus, do I have to pay for it myself?
11. Can the rotavirus vaccination be given at the same time as other vaccinations from the National Immunisation Programme?
12. Are there other effective ways to protect against rotavirus?

Questions about the vaccine

1. Which rotavirus vaccines are registered in the Netherlands?
2. The rotavirus vaccine is a live attenuated vaccine. What does that mean?
3. How is the rotavirus vaccine administered?
4. What is in a rotavirus vaccine?

How effective is vaccination against rotavirus?

Various studies have been conducted on the effectiveness of rotavirus vaccines [4,5,6].These studies looked at the number of babies who were admitted to hospital with rotavirus. In this context, researchers compared a group of babies who had been vaccinated to a group of babies who had not been vaccinated. All studies showed that of the group that had been vaccinated, 80-98% fewer babies with rotavirus ended up in hospital, compared to the group of babies who had not been vaccinated.

If my child is vaccinated against rotavirus, does that mean my child can no longer get a rotavirus infection?

Vaccination against rotavirus does not guarantee that your child will not get a rotavirus infection at all, but it does make it less likely that your child will become very ill from rotavirus.

Is the rotavirus vaccination safe?

Yes, vaccinating against rotavirus is safe. The rotavirus vaccine was researched extensively before it received marketing authorisation. Other countries, such as Belgium and the UK, have also have a lot of experience with rotavirus vaccination by now. The vaccine is given orally by putting liquid drops in the child’s mouth.

Intussusception
A previous rotavirus vaccine (Rotashield®) is no longer used. This first vaccine was found to be associated with an increased risk of intussusception after administration to babies over 3 months old. Intussusception is a rare and serious condition in which part of the bowel ‘telescopes’, folding in on itself [7,8]. This vaccine was taken off the market in 1999. The current vaccines may also be associated with a slightly increased risk of intussusception in the first week after vaccination [9-14]. There are also studies showing that the risk of intussusception is not higher after vaccination, and may even be lower [9, 15].To minimise the risk, it is important to administer the first dose of the vaccine to babies while they are younger than 3 months old.

Which side effects are possible?

Mild side effects can be expected, as with all vaccinations. Very rare side effects, such as a severe allergic reaction, cannot be excluded. For more information and a summary of reported possible side effects after vaccination, visit the website of the Pharmacovigilance Centre Lareb. These possible health problems (‘adverse events’) are considered possible side effects by the person submitting the report. This means that there is not a confirmed connection to the vaccine. The reported response may also be a physical reaction that occurs for some other reason and coincidentally happens at the same time as the vaccination.

A few very rare side effects of rotavirus vaccination:

• Intussusception (a serious condition in which part of the bowel ‘telescopes’, folding in on itself). See also ‘Is the rotavirus vaccination safe?’.
• Babies that were born very prematurely (<28 weeks gestation) may have apnoea (temporary stopping of breathing) in the first 24 hours after vaccination. These pre-term babies are generally still hospitalised when they are eligible for the rotavirus vaccination.

A detailed description of possible side effects can be found in the package leaflet for the vaccine.

Is there any experience with rotavirus vaccination in other countries?

Yes, rotavirus vaccination is part of the national childhood immunisation programme in various countries, including Austria, Belgium, Luxembourg, Finland, Germany, Norway and the UK.

Who can be vaccinated against rotavirus, and when?

Rotavirus vaccination is authorised for babies between 6 and 24 weeks or between 6 and 32 weeks (depending on the vaccine). It is important that the first vaccine dose – out of two or three in total – is given before the infant reaches the age of 12 weeks. The rotavirus vaccine can also be given to premature babies.

Are there any children for whom the rotavirus vaccine is not suitable?

Yes, the rotavirus vaccine should not be given to:

• babies younger than 6 weeks or older than 24 weeks.
• babies with a history of intussusception (a serious condition in which part of the bowel ‘telescopes’, folding in on itself)
• babies with an uncorrected congenital anomaly that increases their risk of this possible side-effect (such as Meckel’s diverticulum).
• infants with confirmed or suspected severe combined immunodeficiency (SCID) or a family history of SCID.

You can consult with your doctor to discuss whether the vaccine is suitable for your child.

How long does a rotavirus vaccination work?

Rotavirus vaccination provides at least 2 years of protection against severe illness from rotavirus infections [16-19]

Does the rotavirus vaccination need to be repeated?

Depending on which vaccine is used, two or three doses of vaccine are needed, with an interval of at least 4 weeks.

If I want to have my children vaccinated against rotavirus, do I have to pay for it myself?

No, the rotavirus vaccination is included in the National Immunisation Programme. All babies can get the vaccine for free.

Can the rotavirus vaccination be given at the same time as other vaccinations from the National Immunisation Programme?

Yes, rotavirus vaccination can be administered simultaneously with the vaccinations from the National Immunisation Programme that are given to children at this age. No specific interval is required if the rotavirus vaccination is not administered simultaneously with the other vaccinations.

Are there other effective ways to protect against rotavirus?

Rotavirus is highly contagious. Good hygiene helps prevent the disease from spreading. 

Which rotavirus vaccines are registered in the Netherlands?

Two rotavirus vaccines have been registered for use in the Netherlands. Both are oral vaccines that are administered by putting drops in the child’s mouth. A child needs two or three doses of the vaccine. It is important that the first vaccine dose is given before the age of 12 weeks. (Click on the brand name for the vaccine leaflet.) 

* Vaccine in drop form, for oral administration.

Please note that a vaccine that is registered may not automatically also be available in the Netherlands.

The rotavirus vaccine is a live attenuated vaccine. What does that mean?

The rotavirus vaccine is what is known as a live attenuated vaccine. This means that the natural pathogen (the virus) is weakened until it no longer causes disease, but still produces an immune response. Live attenuated vaccines trigger a response in the body that resembles a much weaker form of the disease. As a result, they provide effective and long-lasting protection.

How is the rotavirus vaccine administered?

The rotavirus vaccine is not an injection, but an oral vaccine. The liquid drops have a slightly sweet flavour.

What is in a rotavirus vaccine?

A rotavirus vaccine contains three types of ingredients:

1. Antigens: these are weakened (attenuated) parts of the rotavirus that prompt your body to give you protection (immunity).
2. Excipients (such as adjuvants): these are substances added to the vaccine to improve effectiveness, extend shelf life, keep the vaccine stable, make it easier to administer the vaccine, etc. They are substances that have been well researched and used in actual practice for many years.
3. Residues: these are trace amounts of substances left over from the vaccine production process. For example, there could be residues of substances that were used to prevent unwanted bacteria from growing during the production process. These residues are removed as much as possible before the vaccine is put into use, but very small quantities could still be present. These trace amounts are so minimal that they cannot cause any harm.

The package leaflet states exactly what ingredients are present in the rotavirus vaccine.

More information about the different ingredients and their purposes is available on the website of the National Immunisation Programme.

Reference

1. Bruijning-Verhagen, P., et al., Rotavirus-related hospitalizations are responsible for high seasonal peaks in all-cause pediatric hospitalizations. Pediatr Infect Dis J, 2012. 31(12): p. e244-9.
2. Friesema, I.H., et al., Etiology of acute gastroenteritis in children requiring hospitalization in the Netherlands. Eur J Clin Microbiol Infect Dis, 2012. 31(4): p. 405-15.
3. Bruijning-Verhagen, P., et al., Targeted rotavirus vaccination of high-risk infants; a low cost and highly cost-effective alternative to universal vaccination. BMC Med, 2013. 11: p. 112.
4. Lamberti LM, Ashraf S, Walker CL, Black RE. A Systematic Review of the Effect of Rotavirus Vaccination on Diarrhea Outcomes Among Children Younger Than 5 Years. Pediatr Infect Dis J 2016; 35(9): 992-8.
5. Karafillakis E, Hassounah S, Atchison C. Effectiveness and impact of rotavirus vaccines in Europe, 2006-2014. Vaccine 2015; 33(18): 2097-107.
6. Jonesteller CL, Burnett E, Yen C, Tate JE, Parashar UD. Effectiveness of Rotavirus Vaccination: A systematic review of the first decade of global post-licensure data, 2006-2016. Clin Infect Dis 2017.
7. Centers for Disease, C. and Prevention, Intussusception among recipients of rotavirus vaccine--United States, 1998-1999. MMWR (Morbidity and Mortality Weekly Report)Morb Mortal Wkly Rep, 1999. 48(27): p. 577-81.
8. Murphy, T.V., et al., Intussusception among infants given an oral rotavirus vaccine. N Engl J Med, 2001. 344(8): p. 564-72.
9. Buttery, J.P., et al., Intussusception following rotavirus vaccine administration: post-marketing surveillance in the National Immunization Program in Australia. Vaccine, 2011. 29(16): p. 3061-6.
10. Oberle, D., et al., Rotavirus vaccination: a risk factor for intussusception? Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz, 2014. 57(2): p. 234-41.
11. Patel, M.M., et al., Intussusception risk and health benefits of rotavirus vaccination in Mexico and Brazil. N Engl J Med, 2011. 364(24): p. 2283-92.
12. Velazquez, F.R., et al., Postmarketing surveillance of intussusception following mass introduction of the attenuated human rotavirus vaccine in Mexico. Pediatr Infect Dis J, 2012. 31(7): p. 736-44.
13. Weintraub, E.S., et al., Risk of intussusception after monovalent rotavirus vaccination. N Engl J Med, 2014. 370(6): p. 513-9.
14. Yih, W.K., et al., Intussusception risk after rotavirus vaccination in U.S. infants. N Engl J Med, 2014. 370(6): p. 503-12.
15. Zickafoose, J.S., et al., Hospitalizations for intussusception before and after the reintroduction of rotavirus vaccine in the United States. Arch Pediatr Adolesc Med, 2012. 166(4): p. 350-5.
16. Soares-Weiser K, Maclehose H, Bergman H, Ben-Aharon I, Nagpal S, Goldberg E, et al. Vaccines for preventing rotavirus diarrhoea: vaccines in use. Cochrane Database Syst Rev 2012; 11: CD008521.
17. Lamberti LM, Ashraf S, Walker CL, Black RE. A Systematic Review of the Effect of Rotavirus Vaccination on Diarrhea Outcomes Among Children Younger Than 5 Years. Pediatr Infect Dis J 2016; 35(9): 992-8.
18. Karafillakis E, Hassounah S, Atchison C. Effectiveness and impact of rotavirus vaccines in Europe, 2006-2014. Vaccine 2015; 33(18): 2097-107.
19. Jonesteller CL, Burnett E, Yen C, Tate JE, Parashar UD. Effectiveness of Rotavirus Vaccination: A systematic review of the first decade of global post-licensure data, 2006-2016. Clin Infect Dis 2017.