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ROTAVIRUS VACCINE

Rotavirus Vaccines and Intussusception - a Mini-Sentinel Postlicensure Observational Study.  The association between intussusception and RotaTeq and Rotarix vaccination was evaluated in Mini-Sentinel’s PRISM program and identified an increased risk of intussusception 21 days following the first dose of RotaTeq, with the majority of cases occurring in the first 7 days. No increased risk was identified after the second or third doses. Based on these results, approximately 1 to 1.5 additional cases of intussusception would occur per 100,000 vaccinated U.S. infants within 21 days following the first dose of RotaTeq.

FDA believes that the benefits of RotaTeq and Rotarix vaccination continue to outweigh the risks associated with vaccination, including the risk of intussusception. FDA recommends that parents closely watch their infants for signs of intussusception, especially within the first 7 days after vaccination with RotaTeq or Rotarix. These symptoms include stomach pain, vomiting, diarrhea, blood in the stool or change in bowel movements. It is important to contact the child's healthcare provider if the child has any of these signs at any time after vaccination, even if it has been several weeks since the last dose of vaccine. FDA Safety Communication 6-13-13

 

RotaTeq package insert updated to include updated information on intussusception. A Mini-Sentinel PRISM study, the largest study of intussusception after rotavirus vaccines to date, identified an increased risk of intussusception in the 21 day time period after the first dose of RotaTeq, with most cases occurring in the first 7 days after vaccination. No increased risk was found after the second or third doses. These findings translate into 1 to 1.5 additional cases of intussusception per 100,000 first doses of RotaTeq.  RotaTeq Package Insert | FDA Safety Communication 6-13-13

 

Rotarix package insert updated to include 2 items under Warnings and Precautions:  (1) Rotavirus shedding in stool occurs after vaccination with peak excretion around day 7 after Dose 1. (2)  In a postmarketing, observational study conducted in Mexico, cases of intussusception were observed in temporal association within 31 days following the first dose of ROTARIX, with a clustering of cases in the first 7 days.  Rotarix Package Insert | FDA update 9-7-12

 

Rare potential risk of vaccine-associated gastroenteritis; the benefits of vaccination outweigh any small risk
Several investigators have identified rare cases of gasteroenteritis that may have been caused by rotavirus vaccine in the US, Australia and elsewhere.  Rarely, cases have occurred in vaccine recipient’s close household contacts.  Virus strains in the vaccine may reassort to make a virus that can cause diarrhea.  Donato CM et al.  JID 2012;206(3):377-83 | Payne DC et al. Pediatrics 2010;125(2):e438-41

Study finds Rotavirus Vaccine not linked to intussusception in infants
Among US infants 4-34 weeks old who received RV5, there was no increase in the risk of intussusception compared with infants who did not receive the rotavirus vaccine.
  Shui IM et al. JAMA 2012;307(6):598-604.

Rotarix Rotavirus Vaccine: Rare Side Effect Possible
Questions and answers for parents and caregivers on CDC website. [Sep 22 2010]
Package insert updated [Sep 2010]

FDA Revises Recommendations for Rotavirus Vaccines
The US FDA has further evaluated the scientific information and determined that vaccination should continue using both approved products - RotaTeq and Rotarix.  Both vaccines have proven safety records and the earlier recommendation to suspend use of Rotarix was made so the FDA could more closely examine the evidence.  Currently available information indicates that neither PCV-1 nor PCV-2 poses a health risk to humans. [May 14, 2010]  FDA Updates on Rotavirus Vaccine

FDA Advisory Committee holds meeting on PCV-1 and Rotavirus
Following a recent finding that porcine circovirus type 1 has been detected in Rotarix vaccine, a GSK rotavirus vaccine, the Vaccines and Related Biological Products Advisory Committee convened a public meeting on May 7 to discuss current knowledge and emerging data.  No decisions regarding rotavirus vaccine use or recommendations were expected or occurred at this meeting; the FDA will take the discussion into account when making future recommendations regarding rotavirus vaccine use.  The majority of committee members believe that the benefits of rotavirus vaccines far outweigh the risks; most members called for further studies and believe that physicians will need to explain the risks and benefits to their patient’s parents. [May 7, 2010]

Advisory Committee website (transcript and meeting slides should be posted shortly) | unofficial transcript

Journal of Virology paper on PCV 1 in Rotarix
Victoria, et al have published results of analysis of 8 vaccines: one vaccine, a GSK rotavirus vaccine called Rotarix, contained a porcine circovirus-1 (PCV-1).  The authors conclude the paper with this statement, "In view of the demonstrated benefit and safety of Rotarix the implications (if any) on current immunization policies of the detection of PCV1 DNA of unknown infectivity for humans needs to be carefully considered."  link [April 13 2010]

More information on the study on FDA website.  link

FDA Advisory Panel Meeting
A plan from GlaxoSmithKline and further recommendations will be announced at the FDA Advisory Panel meeting on May 7, 2010.

FDA recommends temporary suspension of use of Rotarix; no restrictions on more widely used rotavirus vaccine, RotaTeq
PCV1 (porcine circorvirus 1) DNA has been detected in Rotarix; PCV1 is not known to cause harm in humans or other animals. (Mar 22 2010)  Link to FDA Press Release | link to other FDA documents | GSK statement

Two Rotavirus Vaccines now available in the U.S.
The FDA has approved Rotarix, making is the second Rotavirus vaccine available on the US market (in addition to Merck's RotaTeq).  GlaxoSmithKline's vaccine is a two dose series to be given between 6 and 24 weeks of age.  Rotarix protects against G1, G3, G4 and G9 strains of rotavirus.
Neither vaccine has been associated with any increased risk of intussusception. [April 2008]

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 [06-15-2007]:

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
 

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

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.

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.

 

 

This page was last updated on February 12, 2014

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