ROTAVIRUS VACCINE

06-15-2007 - The US FDA has approved a revised package insert for Merck and Co's rotavirus vaccine, RotaTeq. The label now includes this information regarding Kawasaki disease:

In the phase 3 clinical trials, infants were followed for up to 42 days of vaccine dose. Kawasaki disease was reported in 5 of 36,150 vaccine recipients and in 1 of 35,536 placebo recipients with unadjusted relative risk 4.9 (95% CI 0.6, 239.1).

The reported cases of Kawasaki disease following RotaTeq are not more than would be expected in the general population.

Rotavirus infection is a common cause of severe diarrhea and hospitalization. The cause of Kawasaki disease, characterized by high fever, is unknown and has not been linked to any vaccine including rotavirus vaccine.

CDC and FDA continue to monitor the safety of RotaTeq (and all vaccines) and encourage reporting of any cases of Kawasaki disease (and any severe adverse event) following vaccination to VAERS. For a copy of the vaccine reporting form, call 1-800-822-7967 or report online to www.vaers.hhs.gov.

More information is available from the CDC at http://www.cdc.gov/od/science/iso/concerns/kawasaki_disease_rotavirus.htm

02-14-2007 - FDA issues information update on roatvirus vaccine

The US Food and Drug Administration (FDA) posted a notification on February 13, 2007, to encourage health care workers to recognize and report possible vaccine adverse events following the introduction of Merck & Co., Inc.’s RotaTeq® vaccine. The notification is intended to provide health care workers with an update on information collected as part of the US Vaccine Adverse Event Reporting System (VAERS), which is routinely used for tracking vaccine safety.

In February 2006, the Advisory Committee on Immunization Practices (ACIP) to the CDC unanimously recommended routine use of RotaTeq® in US infants to prevent rotavirus, the leading cause of severe diarrhea, vomiting, fever, and dehydration in infants and young children.

Because of a suspected association between intussusception (a rare, life-threatening blockage of the intestine) and an earlier rotavirus vaccine (RotaShield®), the US CDC and FDA are monitoring the new RotaTeq® vaccine with particular care. Prior to last year’s FDA approval of Merck’s vaccine, investigators conducted a rigorous clinical trial with more than 70,000 subjects and found that RotaTeq® was not associated with an increased risk of intussusception, or other serious adverse events, when compared to placebo.

In the US, intussusception is estimated to spontaneously occur in approximately one in 2,000 healthy young infants and children per year. While 28 reported cases of intussusception were identified through post-marketing surveillance following administration of RotaTeq®, it is important to note, as the FDA states, the number of intussusception cases reported to date after RotaTeq administration does not exceed expected background rates among unvaccinated children of the same age. In fact, the number of reported cases is lower than expected based on estimates of naturally-occurring episodes of intussusception in children in this age range (CDC, unpublished data).

Media reports of the FDA notice implied a link between the vaccine and intussusception that is not supported by the data. The ACIP will conduct their regularly-scheduled review of the safety tracking data during their upcoming meeting on February 21, 2007.

Click here to read the FDA notice.
Click here to read the vaccine manufacturer’s official response.
DC recommends no changes in ACIP recommendations. Statement and Q&A on RotaTeq & Intussusception [15 Feb 07]
WHO Statement [15 Feb 07]

The US FDA approved a new rotavirus vaccine, RotaTeq, for use at 2, 4 and 6 months of age (to be completed by 32 weeks of age). RotaTeq, approved on February 3, 2006, is a 3-dose, oral vaccine marketed by Merck and Company. This vaccine contains no thimerosal (or any other preservative).

The CDC's advisory committee (ACIP) recommended rotavirus vaccine be given to infants at well-baby visits at 2, 4 and 6 months of age.

RotaTeq is a different vaccine from the rotavirus vaccine withdrawn from the market in 1999 because of an association with an increased risk of intussusception (a rare blockage or twisting of the intestine). RotaTeq was specifically evaluated in a large-scale study of 70,000 children for signs of a similar association and no association was found. Because of the experience with the previous vaccine, RotaTeq will continue to be monitored closely: a post-licensure study will be conducted in 44,000 children and the manufacturer will follow stringent reporting criteria for 3 years.

CDC Press Release on ACIP's Recommendation for Rotavirus Vaccine (Feb 21 06)
CDC's Q&A on Rotavirus (disease and vaccine)
FDA Press Release on Approval of RotaTeq (Feb 03 06)
FDA's Q&A on RotaTeq
Merck's RotaTeq package insert (issued February 2006)

This page was last updated on January 23, 2008