Vaccine Information: RotaTeq (Page 2 of 4)

6.2 Post-Marketing Experience

The following adverse events have been identified during post-approval use of RotaTeq from reports to the Vaccine Adverse Event Reporting System (VAERS).

Reporting of adverse events following immunization to VAERS is voluntary, and the number of doses of vaccine administered is not known; therefore, it is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to vaccine exposure using VAERS data.

In post-marketing experience, the following adverse events have been reported following the use of RotaTeq:

Immune system disorders:

Anaphylactic reaction

Gastrointestinal disorders:

Intussusception (including death)

Hematochezia

Gastroenteritis with vaccine viral shedding in infants with Severe Combined Immunodeficiency Disease (SCID)

Skin and subcutaneous tissue disorders:

Urticaria

Angioedema

Infections and infestations:

Kawasaki disease

Transmission of vaccine virus strains from vaccine recipient to non-vaccinated contacts.

Post-Marketing Observational Safety Surveillance Studies

The temporal association between vaccination with RotaTeq and intussusception was evaluated in the Post-licensure Rapid Immunization Safety Monitoring (PRISM) program {2}, an electronic active surveillance program comprised of 3 US health insurance plans.

More than 1.2 million RotaTeq vaccinations (507,000 of which were first doses) administered to infants 5 through 36 weeks of age were evaluated. From 2004 through 2011, potential cases of intussusception in either the inpatient or emergency department setting and vaccine exposures were identified through electronic procedure and diagnosis codes. Medical records were reviewed to confirm intussusception and rotavirus vaccination status.

The risk of intussusception was assessed using self-controlled risk interval and cohort designs, with adjustment for age. Risk windows of 1-7 and 1-21 days were evaluated. 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. Based on the results, approximately 1 to 1.5 excess cases of intussusception occur per 100,000 vaccinated US infants within 21 days following the first dose of RotaTeq. In the first year of life, the background rate of intussusception hospitalizations in the US has been estimated to be approximately 34 per 100,000 infants.{3}

In an earlier prospective post-marketing observational cohort study conducted using a large US medical claims database, the risks of intussusception or Kawasaki disease resulting in emergency department visits or hospitalizations during the 30 days following any dose of vaccine were analyzed among 85,150 infants receiving one or more doses of RotaTeq from February 2006 through March 2009. Medical charts were reviewed to confirm these diagnoses. Evaluation included concurrent (n = 62,617) and historical (n=100,000 from 2001-2005) control groups of infants who received diphtheria, tetanus and acellular pertussis vaccine (DTaP) but not RotaTeq.

Confirmed intussusception cases in the RotaTeq group were compared with those in the concurrent DTaP control group and in the historical control group. The data were analyzed post-dose 1 and post any dose, in both 7 day and 30 day risk windows. A statistically significant increased risk of intussusception after RotaTeq vaccination was not observed.

One confirmed case of Kawasaki disease (23 days post-dose 3) was identified among infants vaccinated with RotaTeq and one confirmed case of Kawasaki disease (22 days post-dose 2) was identified among concurrent DTaP controls (relative risk = 0.7; 95% CI: 0.01-55.56).

In addition, general safety was monitored by electronic search of the automated records database for all emergency department visits and hospitalizations in the 30-day period after each dose of RotaTeq compared with: 1) days 31-60 after each dose of RotaTeq (self-matched controls) and 2) the 30-day period after each dose of DTaP vaccine (historical control subset from 2004-2005, n=40,000). In safety analyses which evaluated multiple follow-up windows after vaccination (days: 0-7, 1-7, 8-14 and 0-30), no safety concerns were identified for infants vaccinated with RotaTeq when compared with self-matched controls and the historical control subset.

Reporting Adverse Events

Parents or guardians should be instructed to report any adverse reactions to their health care provider.

Health care providers should report all adverse events to the U.S. Department of Health and Human Services’ Vaccine Adverse Events Reporting System (VAERS).

VAERS accepts all reports of suspected adverse events after the administration of any vaccine, including but not limited to the reporting of events required by the National Childhood Vaccine Injury Act of 1986. For information or a copy of the vaccine reporting form, call the VAERS toll-free number at 1-800-822-7967 or report on line to www.vaers.hhs.gov.{4}

7 DRUG INTERACTIONS

Immunosuppressive therapies including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to vaccines.

7.1 Concomitant Vaccine Administration

In clinical trials, RotaTeq was administered concomitantly with diphtheria and tetanus toxoids and acellular pertussis (DTaP), inactivated poliovirus vaccine (IPV), H. influenzae type b conjugate (Hib), hepatitis B vaccine, and pneumococcal conjugate vaccine [see Clinical Studies (14)]. The safety data available are in the ADVERSE REACTIONS section [see Adverse Reactions (6.1)]. There was no evidence for reduced antibody responses to the vaccines that were concomitantly administered with RotaTeq.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

RotaTeq is not approved for individuals 32 weeks of age and older. No human or animal data are available to assess vaccine-associated risks in pregnancy.

8.2 Lactation

No human or animal data are available to assess the impact of RotaTeq on milk production, its presence in breast milk, or its effect on the breastfed infant.

8.4 Pediatric Use

Safety and effectiveness of RotaTeq have not been established in infants less than 6 weeks of age or greater than 32 weeks of age.

Data are available from clinical studies to support the use of RotaTeq in pre-term infants according to their age in weeks since birth [see Adverse Reactions (6.1)].

Data are available from clinical studies to support the use of RotaTeq in infants with controlled gastroesophageal reflux disease.

10 OVERDOSAGE

There have been post-marketing reports of infants who received more than one dose or a replacement dose of RotaTeq after regurgitation [see Dosage and Administration (2.2)]. In limited post-marketing experience of reported overdosage, the adverse events reported after incorrect administration of higher than recommended doses of RotaTeq were similar to adverse events observed with the approved dosage and schedule.

11 DESCRIPTION

RotaTeq is a live, oral pentavalent vaccine that contains 5 live reassortant rotaviruses. The rotavirus parent strains of the reassortants were isolated from human and bovine hosts. Four reassortant rotaviruses express one of the outer capsid proteins (G1, G2, G3, or G4) from the human rotavirus parent strain and the attachment protein (type P7) from the bovine rotavirus parent strain. The fifth reassortant virus expresses the attachment protein, P1A (genotype P[8]), herein referred to as type P1A[8], from the human rotavirus parent strain and the outer capsid protein of type G6 from the bovine rotavirus parent strain (see Table 7).

Table 7
Name of Reassortant Human Rotavirus Parent Strains and Outer Surface Protein Compositions Bovine Rotavirus Parent Strain and Outer Surface Protein Composition Reassortant Outer Surface Protein Composition (Human Rotavirus Component in Bold) Minimum Dose Levels (106 infectious units)
G1 WI79 – G1P1A[8] WC3 — G6, P7[5] G1 P7[5] 2.2
G2 SC2 – G2P2[6] G2 P7[5] 2.8
G3 WI78 – G3P1A[8] G3 P7[5] 2.2
G4 BrB – G4P2[6] G4 P7[5] 2.0
P1A[8] WI79 – G1P1A[8] G6P1A[8] 2.3

The reassortants are propagated in Vero cells using standard cell culture techniques in the absence of antifungal agents.

The reassortants are suspended in a buffered stabilizer solution. Each vaccine dose contains sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80, cell culture media, and trace amounts of fetal bovine serum. RotaTeq contains no preservatives.

RotaTeq is a pale yellow clear liquid that may have a pink tint.

The plastic dosing tube and cap do not contain latex.

12 CLINICAL PHARMACOLOGY

Rotavirus is a leading cause of severe acute gastroenteritis in infants and young children, with over 95% of these children infected by the time they are 5 years old.{5} The most severe cases occur among infants and young children between 6 months and 24 months of age.{6}

12.1 Mechanism of Action

The exact immunologic mechanism by which RotaTeq protects against rotavirus gastroenteritis is unknown [see Clinical Studies (14.6)]. RotaTeq is a live viral vaccine that replicates in the small intestine and induces immunity.

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