Rotateq® vaccine example

Since the US introduction of RotaTeq® in 2006, the USA's Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) has routinely reviewed post-licensure safety surveillance data recorded through the Vaccine Adverse Event Reporting System (VAERS).

One year following introduction, ACIP reviewed available data to evaluate the rate of reports of intussusception following RotaTeq® vaccination and found that it did not exceed expected background rates in the absence of vaccination. Additionally, active surveillance among a population of insured children did not identify any reports of intussusception within 30 days of more than 28,000 administered doses.22 As a result, the committee has expressed no safety concerns regarding use of this vaccine and reaffirmed its 2006 recommendation for routine administration to all infants in the USA at ages two, four, and six months.23 Since introduction, the use of second generation rotavirus vaccines in routine immunization has reduced hospitalizations for severe diarrhoea by 70 to 80% and may have prevented illness in unvaccinated children by limiting the infections that spread the virus to others.