What is the relationship between Rotavirus vaccination and the risk of Intussusception (a medical condition where a part of the intestine folds into the section next to it)?

From the Guidelines

Rotavirus vaccination is recommended for infants despite a small increased risk of intussusception, as the benefits of vaccination far outweigh the risks of this rare condition. The first dose of rotavirus vaccine should be administered between 6-14 weeks of age, with subsequent doses completed by 8 months. Two vaccines are available: RotaTeq (three doses at 2,4, and 6 months) and Rotarix (two doses at 2 and 4 months).

Key Points

• There is a slightly increased risk of intussusception following rotavirus vaccination, estimated at 1-5 additional cases per 100,000 vaccinated infants, primarily in the first week after the first dose 1.
• Parents should be informed about warning signs of intussusception, including severe abdominal pain, persistent vomiting, bloody stools, and lethargy, and should seek immediate medical attention if these occur.
• The risk of intussusception is higher in infants with a history of intussusception, so the vaccine is contraindicated in these children.
• Rotavirus vaccines work by stimulating immunity against the most common rotavirus strains, preventing severe gastroenteritis that can lead to dehydration and hospitalization 1.

Considerations

• The World Health Organization Global Advisory Committee on Vaccine Safety (GACVS) has concluded that the risk for RRV-TV-associated intussusception was high in infants vaccinated after age 60 days 1.
• Postlicensure surveillance data are required to confirm that the current vaccine is not associated with intussusception at a lower rate than would have been detected in prelicensure trials 1.
• Infants with a history of intussusception might be at higher risk for a repeat episode than other infants, and the risks for and the benefits of vaccination should be considered when vaccinating these infants 1.

From the FDA Drug Label

5.3 Intussusception Following administration of a previously licensed live rhesus rotavirus reassortant vaccine, an increased risk of intussusception was observed. {1} In a post-marketing observational study in the US cases of intussusception were observed in temporal association within 21 days following the first dose of RotaTeq, with a clustering of cases in the first 7 days. [See Adverse Reactions (6.2).] In worldwide passive post-marketing surveillance, cases of intussusception have been reported in temporal association with RotaTeq. [See Adverse Reactions (6.2).]

The relationship between Rotavirus vaccination and the risk of Intussusception is that there is an increased risk of intussusception observed after administration of the vaccine, particularly within 21 days following the first dose, with a clustering of cases in the first 7 days 2. Key points to consider:

• Temporal association: Cases of intussusception have been observed in temporal association with RotaTeq.
• Post-marketing surveillance: Cases of intussusception have been reported in worldwide passive post-marketing surveillance.
• Increased risk: An increased risk of intussusception was observed after administration of a previously licensed live rhesus rotavirus reassortant vaccine.

From the Research

Relationship Between Rotavirus Vaccination and Intussusception Risk

• The risk of intussusception after rotavirus vaccination has been a concern, with studies indicating a small but increased risk, particularly in the first week after vaccination 3, 4, 5, 6.
• A study published in 2006 found that the risk of intussusception did not differ significantly between vaccination strategies, but the number of intussusception events was lower with a strict vaccination schedule due to lower vaccine coverage 3.
• Another study in 2016 found that the risk of intussusception was lowest when the first two doses of rotavirus vaccine were given at less than 3 months of age, with an estimated risk of 1 in 49,000 4.
• A 2024 study in Japan found no increased risk of intussusception after rotavirus vaccination, possibly due to the high background rate of intussusception in the country 7.
• A 2015 study using worldwide spontaneous reporting data found an increased risk of intussusception 3-7 days after vaccination, mainly after the first dose, with an incidence risk ratio of 3.45 (95% CI 1.84-6.55) 5.
• The estimated risk of intussusception with the first rotavirus vaccine, Rotashield, was between 1 in 10,000 to 1 in 32,000 vaccinees, with the highest risk in the 3 to 14 days following receipt of the first dose in infants older than 3 months of age 6.

Factors Influencing Intussusception Risk

• Age at first vaccination: Studies suggest that the risk of intussusception is lower when the first two doses of rotavirus vaccine are given at less than 3 months of age 4, 7.
• Vaccination schedule: A strict vaccination schedule may reduce the number of intussusception events due to lower vaccine coverage, but the risk of intussusception does not differ significantly between vaccination strategies 3.
• Background rate of intussusception: The risk of intussusception after rotavirus vaccination may be influenced by the background rate of intussusception in the population, with higher background rates potentially masking the increased risk associated with vaccination 7.