Approaches to monitoring intussusception following rotavirus vaccination

ABSTRACT

Introduction: In 1998, the first licensed rotavirus vaccine was associated with intussusception, an unexpected adverse event, following reports of this condition to an adverse event reporting system. This rotavirus vaccine was withdrawn from the market and newer rotavirus vaccines have been extensively evaluated for an association with intussusception.

Areas covered: We review the different study designs that have been used both pre- and post-licensure to evaluate the association of rotavirus vaccines with intussusception and discuss the pros and cons of each design. Each of these study designs has their own strengths and weaknesses and the choice of the design often depends on the objective and the timing of the study and the resources available. For post-licensure monitoring of rotavirus vaccines, the self-controlled case-series design has become the most commonly used design to monitor this association.

Expert opinion: Use of this common study design has enabled comparison of findings across diverse settings. As new rotavirus vaccines enter the market, use of the self-controlled case-series design will enable examination of this association in a timely manner.

KEYWORDS:

• Rotavirus vaccine
• intussusception
• rotavirus
• adverse event following immunization

Article highlights

• Rotavirus vaccines have been associated with a small increased risk of intussusception in some settings.

• Numerous study designs have been used to examine the association between rotavirus vaccination and intussusception.

• The choice of study design depends on the objective and timing of the study and the resources available.

• The self-controlled case-series design has become the most commonly used design to monitor the association between rotavirus vaccination and intussusception.

• As new rotavirus vaccines become available, the self-controlled case-series design should be used to monitor the association between rotavirus vaccination and intussusception.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer Disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.