rotavirus oral vaccine, live (Rx)

Suspected adverse events after administration of any vaccine may be reported to Vaccine Adverse Events Reporting System (VAERS), 1-800-822-7967

Within 42 days of any dose

>10%

Diarrhea (24.1%)

Vomiting (15.2%)

Otitis media (14.5%)

Fever (17-43%)

Fussiness/irritability (3-52%)

1-10%

Nasopharyngitis (6.9%)

Bronchospasm (1.1%)

Faltulence (2%)

Postmarketing Reports

Gastroenteritis with vaccine viral shedding in infants with severe combined immunodeficiency disease (SCID)

Hematochezia

Thrombocytopenia (immune)

Urticaria

Intussusception within first 31 days following first dose (particularly within first 7 days)

Kawasaki disease

Contraindications

Hypersensitivity

Immunosuppression

Infants with severe combined immunodeficiency disease (SCID)

Infants aged <6 weeks and >32 weeks

History of uncorrected congenital malformation of the GI tract that would predispose infant to intussusception

Infants with a history of intussusception

Cautions

Do not reconstitute or dilute

Pospone administration in moderate or severe acute illness (with or without fever)

Caution with history of GI disorders

Not for use in adults

Use caution when administered in presence of immunocompromised family members (viral shedding occurs within the first weeks of administration)

Safety and efficacy not established for use in immunocompromised infants

Postmarketing reports of Kawasaki disease in some recipient infants

Effectiveness unknown for postexposure prophylaxis

Vaccination may not result in effective immunity in all patients

Intussusception

• Postmarketing reports of intussusception and hematochezia; interim postmarketing safety data from study suggest increased risk of intussusception in the 31 days following first dose (most often within the first 7 days)
• Intussusception incidence in U.S. is estimated to be 1 to 5 cases per 100,000 vaccinees In a study of 1.5 million infants, the monovalent vaccine showed a relative risk of 8.4 and the pentavalent vaccine did not show increased risk compared with historical background rates of intussesception; N Engl J Med Jan 2014
• Another study observed an increased risk with the pentavalent vaccine, but was underpowered to evaluate the monovalent form and involved ~600,000 infant-years; N Engl J Med Jan 2014

Pregnancy Category: Not for use in adults

Lactation: Not for use in adults

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Live, attenuated vaccine; following immunization, immunogenicity occurs by antibody response; seroconversion is defined as antirotavirus IgA antibodies >20 U/mL post-vaccination; conveys active immunity via stimulation of production of endogenously produced antibodies

Replicates in small intestine and incudes immunity

Rotarix is indicated for prevention of rotavirus gastroenteritis caused by serotypes G1, G3, G4, and G9; RotaTeq is indicated for gastroenteritis caused by serotypes G1, G2, G3, and G4; both vaccines may provide immunity to other serotypes

Pharmacokinetics

Onset: Antirotavirus IgA antibodies noted 1-2 months in 77-87% of infants after 2 doses administered for Rotarix; antirotavirus antibodies noted after 3 doses in 93-100% of infants for RotaTeq

Duration: Efficacy was at 70-79% against any grade of rotavirus through two seasons